tinalexander.github.io / notes / 2022 / 09 /
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Imported from Revue
So we have been in contact with NY but they currently don’t meet the criteria for data inclusion, which is: A jurisdiction’s data may be included if it has met the following criteria: if age and sex assigned at birth or gender identity was available for ≥70% of all cases reported, AND 1) data on vaccination status was available for ≥50% of cases in males (defined by either sex assigned at birth or gender identity) aged 18– to 49 years OR 2) we have received confirmation that your jurisdictions have included all data in IIS.
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At the September 1, 2022 meeting, ACIP had the opportunity to review and discuss data about updated (bivalent) COVID-19 boosters for all age groups for which monovalent COVID-19 boosters had been previously recommended. These groups included people ages 12 years and older, as well as children ages 5 through 11 years. Before ACIP can vote to recommend any specific vaccine product, however, FDA needs to issue an emergency use authorization (EUA) for that product. The day of the ACIP meeting, EUAs were available for updated (bivalent) boosters for people ages 12 years and older, but not for children ages 5 through 11. This was due to ongoing work in manufacturing and production of products for the younger age group. Since ACIP has already reviewed the relevant data—and in order to avert delays in providing updated boosters for children ages 5 through 11 years—once manufacturing and production are complete and EUAs are available, we anticipate CDC will make a recommendation for use of these products, and help make them available to children ages 5 through 11 across the United States.
DEMETRE DASKALAKIS, WHITE HOUSE [00:01:20] Nationally, reports of new cases are decelerating week over week. Even so, we are monitoring trends closely in individual states and jurisdictions, since progress is not consistent across the country. Over the past several weeks, we have also seen the racial and ethnic makeup of this outbreak evolve. Although we are seeing equivalent declines in monkeypox across all racial and ethnic groups, the outbreak is concentrating in communities of color, specifically in black and brown communities.
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DEMETRE DASKALAKIS, WHITE HOUSE [00:15:46] Actually, you can look at the technical report from CDC that just came out late last night. It’s available online. It actually shows the five largest jurisdictions, which continue to see deceleration. So, though I don’t have a list of jurisdictions that are stable or increasing, you can definitely get a sense of what’s happening with at least the five largest jurisdictions, which most of them are continue to be in decline. There’s a little plateau that’s happening, I think, in Texas. So we’re going to have to monitor that carefully. But that’s available in the technical report if you have not seen it.
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DEMETRE DASKALAKIS, WHITE HOUSE [00:14:01] This is one of the reasons it’s so important that we get the word out to providers, as well as people who may be experiencing Tpoxx, that this is a really important option for how to get treated. I think that as the case– as cases decline, this becomes challenging, but we do have folks who know how to refer individuals to studies. And this is a really important one. Because though the numbers are declining now, we have to keep it that way. We really need to continue pushing on the gas pedal that Carl Dieffenbach talked about with vaccines, but also really know about the drugs to treat this condition, so that we can do a better job in the future in terms of making it accessible to people in more routine fashion.
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DEMETRE DASKALAKIS, WHITE HOUSE [00:16:15] In terms of the messaging at the gay, bisexual, and other men who have sex with men, I think we’ve been pretty clear about the notion that this is really temporary as we work to improve vaccine access. I will just echo what Dr. Dieffenbach said, that this is a two dose vaccine. And what’s really important is that we get people maximally protected and, though we have some good early evidence that that first dose works, it’s not until a couple of weeks out to that second dose that folks may return to more approximating their behaviors before the outbreak. With that said, remember, no vaccine is a hundred percent. And I think that people will make their own decisions based on the clear recommendations and clear guidance that are being given by CDC, so they could really use their own harm reduction strategy after they’ve been fully vaccinated.
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CARL DIEFFENBACH, NIAID [00:21:44] The ongoing Jynneos trial which is looking at standard dose and then reduced dose, for the purpose of seeing what the functional titer of the antibody against monkeypox we can induce with the two doses, is ongoing. It’s nearly fully enrolled.
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CARL DIEFFENBACH, NIAID [00:23:01] The next study that we would like to see done, that we think is really important, is to make sure that people of all ages have access to the Jynneos vaccine. So the next step that we will see, potentially going forward, is a dose-sparing– a dose reduction– age de-escalation study to make sure that first adolescents, and then ultimately children down to infants, do have access to this vaccine.
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TIMOTHY WILKIN, STOMP TRIAL [00:23:59] For the STOMP trial, we began enrolling about 2 to 3 weeks ago. The enrollment has been limited mainly because we have smaller numbers of sites that are on board. So we have a lot of sites to ramp up. And in addition, we will have, with the possibility of going to a remote based trial, it’ll open up our potential population enormously. We are seeing slower than expected enrollment. Good news because of the declining case counts, or the deceleration. So we will need to modify the trial to really adapt to that situation to get timely data.
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CARL DIEFFENBACH, NIAID [00:29:51] The idea that the APOBEC three mutations would cause such a big change in the in the virus that it would essentially avoid the immune response against all the proteins of the poxvirus is a really interesting one, one that’s worth continuing to think about. And I think that that can be monitored through the tools that the CDC has in place for sequencing the viruses that they are isolating. And I think that will be– that is a lesson that we learned in coronavirus that we are applying here as well. So I’m not really that worried about it, but I think it’s, as you’re as you’re suggesting, it’s definitely something to consider. Also, remember that for smallpox, we use the same vaccine globally. And I don’t think– if we went back and looked at smallpox, we would see also a similar level of APOBEC types of changes, but remember, we didn’t know what the heck APOBEC was when we were dealing with smallpox eradication.
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TIMOTHY WILKIN, STOMP TRIAL [00:31:07] For those people we are seeing in person, we’ll be able to get detailed characterization of the virus at baseline in multiple compartments, oral, rectal, vaginal, urine, as well as skin lesions, and then we’ll be able to follow them over time and to see if there’s changes in the virus, and then be able to relate them to the clinical outcomes. That’s the reason why we gave two out of three people tecovirimat, so we could really have a more robust assessment of resistance. And that’s an additional reason of why we have that open labeled portion with immune suppressed individuals, so that in a group that’s the highest risk for developing these changes to the virus, we’ll be able to detect it. Because they occur in an individual in treatment does not necessarily mean that that’s going to spread to other people. So it’ll be very important over time, especially if access to the drug increases, to really have sentinel surveys of the virus to see if there is resistant virus that’s being transmitted so we can know whether this is an important clinical phenomenon.
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CARL DIEFFENBACH, NIAID [00:34:58] One of the interesting things to think about is, when a lot of these correlates of protection were developed for poxviruses, all we really looked at was the antibody response. And so everything keyed of that. Over the past 30 years, we’ve learned a thing or two about CD8 T cells and the importance of T cells in clearing a viral infection and also innate immunity and trained innate immunity. So when you have newly vaccinated people, they’re they’re maximally responsive for CD8’s trained innate immunity, and also then the antibody titers growing. So I think it is completely feasible that the vaccine works as the CDC demonstrated in their publication. What we have seen in the past, though, is that when people don’t get the second vaccination, the force field drops to zero, the antibody titer drops. So one of the major reasons to get the second shot is – a booster, is because then you have sustained antibody response. So I want to make the point that it’s really an important piece of news. I don’t want people to get complacent and say, ‘well, I’m good now,’ but to stick with this Star Trek analogy, we do not want people to lose their force field by skipping the second shot.
Imported from Revue
11:50:21 AM ROCHELLE WALENSKY, CDC: There have been limited data on how well the Jynneos vaccine performs against monkeypox in real world conditions. These new data provide us with a level of cautious optimism that the vaccine is working as intended. These early findings, and similar results from studies in other countries, suggest that even one dose of the monkeypox vaccine offers at least some initial protection against infection. That said, we know from laboratory studies that immune protection is highest two weeks after the second dose of vaccine. And it is for that reason that we continue, even in light of these promising data, to strongly recommend people receive two doses of Jynneos vaccine spaced out 28 days apart to ensure durable, lasting immune protection against monkeypox. CDC will continue to evaluate how these vaccines are working in the current outbreak, through a portfolio of vaccine effectiveness projects, that will help us understand the level of protection provided and how long that protection lasts. And we will continue to deliver these data to you as soon as we have them.
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11:51:32 AM ROCHELLE WALENSKY, CDC: Since the early days of this outbreak, CDC has sought to encourage vaccination of those at highest risk for infection. As more supply became available, we expanded eligibility. Today, we are now prepared to again expand eligibility, moving to pre-exposure prophylaxis or PrEP. By expanding eligibility and shifting to a PrEP strategy across the country, we’re looking to ensure those at the highest risk for monkeypox receive a vaccine before exposure and that vaccines continue to be made available equally to those who need them.
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11:52:36 AM ROCHELLE WALENSKY, CDC: Remember protection from your vaccine is highest two weeks after your second dose of vaccine, and people who are vaccinated, should continue to further protect themselves from infection by avoiding close skin to skin contact, including intimate contact with someone who has monkeypox, and consider reducing the behaviors that could increase risk of exposure. These prevention measures are key to continuing to drive down monkeypox infections.
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11:55:08 AM DEMETRE DASKALAKIS, WHITE HOUSE: Secondly, as Dr. Walensky said, we’re moving to a PrEP strategy, pre-exposure prophylaxis, that increases who is eligible for vaccination and encourages vaccine providers to minimize the risk assessments of people seeking vaccine. Fear of disclosing sexuality and gender identity must not be a barrier to vaccination. This new PrEP strategy means that more people who might be at present, or future risk for monkeypox now qualify for the vaccine. That includes gay, bisexual, and other men who have sex with men, transgender or gender diverse people who have had more than one sex partner in the last six months, had sex in a place associated with higher monkeypox risk, or have had a sexually transmitted infection diagnosed over that same time period. PrEP also extends vaccines to sexual partners of people with the above risks. And that includes commercial sex workers.
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11:56:11 AM DEMETRE DASKALAKIS, WHITE HOUSE: Thirdly, people can choose where on their body they want vaccines. Many jurisdictions and advocates have told us that some people decline vaccine to monkeypox because of the stigma associated with the visible, but temporary mark, often left on their forearm. New guidance from CDC allows people who don’t want to risk a visible mark on their forearm to upper vaccine on the skin by their shoulder or their upper back. Those are areas more frequently covered by clothes.
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11:58:21 AM ROCHELLE WALENSKY, CDC: That’s a really important question. You know, what we have right now is data on how well and how our vaccine is working after a single dose. What we don’t yet have is what happens after a second dose and how durable that protection is. And what I can tell you is we will continue to give you data as soon as we have it. I think those durability of protection will be really important to address exactly your question.
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11:59:53 AM ROCHELLE WALENSKY, CDC: I am not aware of severe cases that have occurred in vaccinated people, but that– we should– we will have updated data on severe cases forthcoming as well. I’m not aware of any of those cases having happened. Of course, that depends on how one is going to define the word severe. I don’t mean to imply that people who have potentially been infected after vaccination haven’t experienced severe pain. But some of those relating to hospitalization and organ challenges, I don’t believe we have yet seen.
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12:00:32 PM DEMETRE DASKALAKIS, WHITE HOUSE: I think we’ve been working very closely with our jurisdictions and really, from the perspective of supply and demand, and what we’re seeing on the ground, this is the perfect timing to be able to move from from the PEP plus plus to PrEP given, again, the need to make sure that we are getting second doses in people’s arms as well as what we’re seeing in terms of demand for first doses. So I think that the combination of PrEP, plus the amazing early news of the effectiveness of the good performance of this vaccine, is going to be really critical in us making sure that we keep getting vaccines in arms first and second doses.
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12:01:51 PM ROCHELLE WALENSKY, CDC: This is a really important question. So first to say, this is just data that has been limited to those who have– who are two weeks after their first dose. We have not yet stratified the data by intradermal versus subcutaneous injection, and that is something that we were going to– we’re going to need a little bit more time and a bit more numbers in order to be able to do. We are going to have more of these data posted online today and more data forthcoming. This is really in an effort to give you all the data as soon as we have it. But we’ll have more data posted on online for you to be able to see some of the details of how we’ve conducted this analysis.
NEAL CARNES, CDC [00:27:39] This title points to social media and how some are suggesting that the few pediatric cases that have been reported and confirmed are a result of pedophilia and the notion that gay, bisexual, and other men who have sex with men wish to groom young children to become gay, bisexual, or other men who have sex with men. This, too, stigmatizes those disproportionately affected. Each pediatric case– and let me be clear, each pediatric case of monkeypox is followed up to understand likely transmission and no case has indicated transmission occurred as a result of sexual contact between an adult and a child. Further, these Twitter posts play on an existing stereotype, that has been disproved, that gay and bisexual men are more likely to be pedophiles. That is false.
Imported from Revue
ASHISH JHA, WHITE HOUSE [00:23:25] It’s interesting because I hear lots of chatter about the future of the COVID team and what are you going to do? And I will tell you, those are not conversations that I’m actually having with our chief– the president’s chief of staff or with the president. The conversations we are having are like, what do we need to drive deaths down? How do we make sure we’re better prepared for the winter? What you know– what do we need to do to– think about as we transition out of the U.S. government buying all of these products, that it’s not disruptive. That it doesn’t create new financial burden on Americans. And you know, when that time comes, there will come a day in the future, because of course every job ends, when there will not be a need for a COVID response team. But that is not a– I would say it’s just not an active conversation, because I feel like a lot of work to do. And when you’ve got a lot of work to do, the conversation of when does it work end, I don’t know. Just doesn’t quite feel like on point. So right now, it’s just, let’s get– let’s get going on the work we have to do. And then at some point we can have that conversation.
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ASHISH JHA, WHITE HOUSE [00:07:07] We don’t have– we don’t have a target. I don’t have a target. We haven’t discussed the target internally. I really think that we want to get as many Americans vaccinated and boosted, get this new COVID shot. I think it is available to everybody over the age of 12. It’s going to actually be available to 5 to 11 year olds soon, if FDA looks at some new data and makes its decision. But– but if we get to an annual COVID vaccine, we really do want broad uptake. If we get that, we are going to make a really big difference in terms of how– what kind of fall and winter we end up having.
Our focus for wastewater surveillance in Colorado remains on COVID-19. However, we are working closely with our academic partners and CDC colleagues to build upon everything we have learned and evaluate wastewater tests for other pathogens of public health significance, including possibly polio. Paul Galloway Colorado Department of Public Health and Environment
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Because of NYSDOH’s efforts and the hard work of our local county health departments working with us to drive immunizations on the ground, from July 21 to September 22, 2022, a total of 6,141 doses of polio vaccine were administered to people less than 19 years of age in Rockland County and 5,187 doses were administered to people less than 19 years of age in Orange County, based on data submitted to the New York State Immunization Information System (NYSIIS). The work to vaccinate unvaccinated and under-vaccinated New Yorkers, particularly in the affected communities, is ongoing and will continue. Samantha Fuld New York State Department of Health
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CDPH is not currently monitoring wastewater samples for polio. We can’t speak for every community in the state, but at this time CDPH is working with academic partners and the CDC, including the National Wastewater Surveillance System (NWSS) team and Poliovirus laboratory, to see if wastewater testing for poliovirus can be integrated for public health monitoring in California. CDPH already has ongoing systems to monitor for cases of polio through health care provider and laboratory reports. California Department of Public Health
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CDPH has a robust wastewater monitoring system that is being used for SARS-CoV-2: https://www.chicago.gov/city/en/sites/covid-19/home/covid-19-wastewater-surveillance.html . This surveillance system is adaptable to other emerging pathogens, and we are developing, refining and considering methods to test for influenza, monkeypox and poliovirus locally, and have been in touch with the CDC since July 2022 for technical guidance. Expanding wastewater surveillance beyond SARS-CoV-2 is still in the planning/development phase, but we hope to start generating results in the coming weeks and months. We are monitoring the epidemiologic situation of poliovirus in New York, London and elsewhere closely, and stand ready to respond as local public health needs arise. Chicago Department of Public Health
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We have not begun wastewater surveillance for polio but are in talks about possibly starting. It is somewhat complicated for polio as the oral polio vaccine which is given abroad will lead to excretion in wastewater of the vaccine-derived virus. Vaccine-derived poliovirus is a strain of the weakened poliovirus that was included in oral polio vaccine and that has continued to replicate and change over time so it behaves more like the wild or naturally occurring virus. Vaccine-derived poliovirus emerges in populations with low vaccination coverage and affects people who are unvaccinated. This form of the vaccine is no longer given in the US, however we have many visitors from abroad where it is still used. This is the virus that is circulating in NYS. Many visitors to LA may have recently received OPV vaccine in other countries this would be detected in wastewater. We would need adequate coverage and a baseline to better understand what is happening. For the foreseeable future our best form of surveillance will be reportable diseases. Los Angeles County Department of Public Health
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Polio is a tragic disease preventable by vaccination, and we encourage all Michigan residents who may not be vaccinated to do so. It can be identified through presenting of suspected cases to health care professionals. Wastewater monitoring for polio is currently not taking place in Michigan. The technology and standards for this testing are under development and we are actively engaging the CDC to consider supporting an expansion of our wastewater surveillance program to include polio testing at some scale. Lynn Sutfin, Michigan Department of Health & Human Services
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Over the past two and a half years, the state of Minnesota has had a collaborative effort to both study and monitor wastewater as a surveillance tool. Working with the University of Minnesota, the Metropolitan Council and more than 40 wastewater treatment plants statewide, we’ve been able to predict the clinical impact of COVID-19 in regions of the state. We are now in conversations about the potential for polio surveillance with the University, the best method to detect the virus, and how to understand and manage any positive polio samples. We are aware that the University of Minnesota Medical School is working with the CDC to develop assays that will be effective in detecting the polio virus and to determine the value of such a tool for public health. Doug Schultz, Minnesota Department of Public Health
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The Ohio Department of Health has been working with the Centers for Disease Control and Prevention (CDC) on the topic of polio monitoring in wastewater. The CDC is in the process of developing a standardized method for polio testing in wastewater and is also determining in which states and communities to implement testing. ODH is awaiting guidance from the CDC and is not currently monitoring for the virus. From Ken Gordon, Ohio Department of Health
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The New Jersey Department of Health is collaborating with the Centers for Disease Control and Prevention on wastewater testing via the National Wastewater Surveillance System. which was initially set up to track the presence of SARS-CoV-2 in wastewater samples. Specimens that were previously collected for COVID-19 testing from May to August were tested for poliovirus, including 32 samples tested that came from 5 sites (Essex, Hudson, Middlesex, Passaic, Union). These samples recently tested by the CDC from New Jersey sites are negative for poliovirus. The Department is working with CDC to enroll additional sites in the National Wastewater Surveillance System to support the response to the current outbreak and test for poliovirus. Nancy Kearney, New Jersey Department of Health
Imported from Revue
DEMETRE DASKALAKIS, WHITE HOUSE [01:07:08] I’ll remind you, though, that it’s not because of consistency throughout the country. So these data are getting a bit long in the tooth. They are from our technical report that CDC put out on September 1st. There will be an update to this technical report in October.
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DEMETRE DASKALAKIS, WHITE HOUSE [01:21:46] I think that vaccine is going to be a player here. We’re also going to have– we’re going to have some good studies that we’re going to be sharing more information about soon. In fact, I should footnote, there will soon be a single landing page on the web to sort of go over all of the government funded research studies, including our view into what the VE studies look like. So that’s coming really soon.
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DEMETRE DASKALAKIS, WHITE HOUSE [01:25:01] So it’s actually CDC that gauges sort of like who is eligible for vaccine. So I think we’re having really great conversations now about what our stance is going to be like. Do we stay where we are, in this PEP plus plus? Or do we move on to more of a PrEP stance? And so those discussions are happening now. And I think that they are really focusing not only on the population that we know is overrepresented, but also some populations that other– that some jurisdictions are seeing activity in. And so I think that all of that is on the table. And I would say watch this space carefully and not too long from now.
KRISTEN LYKE, UNIVERSITY OF MARYLAND [00:22:28] And if you have been following some of the newer sublineages, I can tell you that the BA.2.75 is roughly equivalent to somewhere between BA.3 and BA.4, so approximately the BA.2.12. And then there’s a newest sublineage, which is the BA.2.75.2 coming out of India, which essentially has very little neutralizing antibody result.
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KRISTEN LYKE, UNIVERSITY OF MARYLAND [00:22:57] And so our conclusions are that the vaccine boost as the first primary boost substantially increases Omicron neutralizing antibody titers, the boosted neutralizing titers to Omicron, but not prototypical D614G, declined rapidly. The Janssen is better as a prime or a boost with mRNA vaccines than as a homologous boost. And the Omicron some lineages exhibit 5 to 12 times reduced considerably neutralization by the Moderna boost sera. So our next steps are to introduce the bivalent D614G and the BA.4/5 Omicron boost, as well as we’re moving into assessing mucosal immunity.
AGAM RAO, CDC [00:42:49] Now, despite the decrease in case counts, we are hearing about severe infections and that’s the reason for today’s call. We want to bring attention to the fact that in recent weeks we’ve been hearing about some severe infections. Now the demographics of the affected patients are shown here. 100% of them have been male. They’ve been in ages have been 21 to 58 years of age, with a median of 32 years. The majority have been Hispanic or non-Hispanic Black men. And so this goes back to the equity concerns that I raised earlier. Most are immunocompromised due to advanced HIV, so extremely low CD4 count. Often, very often, less than 50 CD4 count. Two patients were receiving chemotherapy for cancer. Now, these patients have had progressive illness. They’ve had over a hundred lesions in many cases, new lesions, despite being on tecovirimat. And they have coalesced lesions, necrotic lesions. They have significant lymphadenopathy. Sometimes hemodynamic instability and sometimes sepsis and secondary infections. And so even though we’re finding it, I guess, comforting or reassuring that the number of case counts are decreasing, we just want to highlight that there are some severe infections occurring.
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AGAM RAO, CDC [00:46:00] You may have heard that we do have concern that perhaps there could be the potential for resistance to develop to tecovirimat. However, despite over 600 specimens, I believe, being evaluated for this around the country, we have not seen any evidence of resistance. But if you are seeing a patient who, for example, is seeing lesions crop up despite treatment, we can certainly facilitate that– that testing to understand whether or not tecovirimat resistance has occurred.
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MEGHAN PENNINI, ASPR [00:25:11] We just want to make sure that everyone has access as best we can. And so this is one other initiative we have that’s now available for patients and providers who are really trying to get product again to patients that may not be insured or may be underinsured. So how this program works is, essentially if a provider has has purchased a commercial supply, but then gives that dose, treats an underinsured patient or an uninsured patient, so there’s no expectation that they would get cost recovery from that particular dose, they can actually request a free dose as a replacement from HHS. And they do that through through HPOP, which is the Health Partner Ordering Portal. So if there are providers out there who are already part of that universe, they can access this initiative right away. They can make that request. They just need to attest that they did some level of verification that that patient really falls into those categories. If a provider is not currently part of HPOP, they can certainly register to have access to those to that, to make those requests, they just need to reach out to their state or territorial health officials.
The Centers for Disease Control and Prevention (CDC) has updated its Infection Prevention and Control (IPC) guidance for healthcare settings to streamline and consolidate existing guidance. Updates reflect the high levels of vaccine- and infection-induced immunity and the availability of effective treatments and prevention tools in the United States. These updates provide additional protection measures for patients and healthcare workers, especially in hospitals and nursing homes, where COVID-19 is more likely to spread quickly or cause severe disease. These facilities should continue to monitor Community Transmission levels in their area for indicators of surges in the community.
Q [00:23:02] I have also heard that CDC is considering other intradermal sites of injection, besides the forearm, because people are declining that due to the very large reactogenic lesions that they’re getting. Is that something that you can comment on yet? DEMETRE DASKALAKIS, WHITE HOUSE [00:23:15] So I’ll start by saying that the FDA EUA comments that if a forearm is unavailable, then an alternate site can be used. And I would watch this space very carefully in the next week to see sort of what happens in terms of clinical guidance. So I think it’s it’s not– it’s out there. It exists. And I think that we’ve heard really clear feedback from multiple states and jurisdictions and other providers about the need to be flexible. So watch that space, too.
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DEMETRE DASKALAKIS, WHITE HOUSE [00:24:46] So definitely there is some expired vaccine and at one point was that was being looked at more actively. But because of the various things that we’ve done, including the switch to intradermal, as well as two really important supply side things, which includes Bavarian Nordic actually producing more vaccine and also our new fill and finish plant that is in Michigan, we’re not looking at that correctly as a needed option based on our projections of need for the vaccine.
Imported from Revue
FARIDA AHMAD, CDC [00:39:42] I can add a little bit regarding data on occupation data in relation to death certificate data. We do, the Division of Vital Statistics, we’re working with some colleagues at NIOSH to standardize the coding of occupation data that we have existing from death certificates. I’m not sure when that will become– when the data will be published, but I do know that that work is underway, and it is a priority to get that information out, not just for prior years, but also going forward. So I think it’s really important and it is something that we’re actively working on.
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FARIDA AHMAD, CDC [00:41:25] In terms of Long COVID, that is something that we’re looking at and hope to have– we’re– that’s something that we’re trying to analyze and see if we can glean that data from death certificates on long COVID. But we don’t have a standardized way to do that yet.
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ALLISON NALEWAY, KAISER PERMANENTE [00:51:16] So we have been using the enhanced pregnancy episode algorithm to support some recent VSD studies of maternal COVID vaccination, including looking at outcomes of spontaneous abortion and stillbirths. We’ve also used our dynamic pregnancy algorithm to select samples of pregnant individuals, so we can conduct phone surveys with them about influenza and COVID vaccination uptake in the VSD. And we’ve also been using these algorithms to describe COVID and influenza vaccination coverage and pregnant women in the VSG. And we are hoping to launch a report describing monkeypox vaccination uptake in pregnant individuals very soon, hopefully in the next couple of weeks.
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JONATHAN DUFFY, CDC [00:00:34] And so this is a system that has not previously been used for any other vaccines other than the COVID-19 vaccines. And so it’s been determined that, due to the success and the positive feedback received in the context of the COVID-19 vaccination program, that we want to use V-safe to collect similar data in the context of the monkeypox vaccination program and outbreak response. But, due to the fact that the system has not previously been used for other vaccines, this entailed additional administrative and technical work to create a new module. And so as of today, a monkeypox vaccine module in V-safe is not yet ready for people to enroll, but CDC has been working to make that available as soon as possible. And we do anticipate that these V-safe will be able to begin enrolling people and people will be able to enroll and submit data in the near future. And again, this will be something that will be communicated and sort of advertised to vaccine recipients as as a thing that they can participate in at the time that they’re actually able to enroll.
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JONATHAN DUFFY, CDC [00:01:48] So in conclusion, in summary, just say that our vaccine safety monitoring to date in the context of the multinational monkeypox outbreak has not identified any new vaccine safety concerns and that CDC is committed to continue vaccine safety monitoring throughout this monkeypox vaccination program.
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JONATHAN DUFFY, CDC [00:21:51] Even prior to the monkeypox outbreak, to the expansion of V-safe to be used for other vaccines had been under consideration. And, I think it was just unfortunate timing that there hadn’t been a chance to put those– that that new sort of infrastructure in place to expand and beyond COVID vaccines. It was sort of bad timing that this outbreak started before that was able to be done. But I think that’s certainly still under consideration of expanding V-safe for use for other vaccines in the future. And, hopefully once that’s in place, it will be a lot easier to have a more adaptable system for when these sort of emergency response situations arise.
Since BF.7 was predicted to be circulating above 1% in the week ending 9/17/2022, it was separated from its parent lineage in the NOWCAST estimates and weighted data on the COVID Data Tracker. Nationally, CDC estimates 1.7% (1.2-2.4%) of cases are BF.7 in the week ending 9/17/2022, and the proportion of cases caused by BF.7 has been increasing in the United States in recent weeks. BF.7 has one additional genetic change in the gene coding for the Spike protein in comparison to parental BA.5 lineage viruses. Data indicates that this specific genetic change could reduce the efficacy of Evusheld, a prophylactic monoclonal antibody treatment. At this point, there is no indication that vaccines or diagnostic tests are affected by this genetic change. CDC continues to share viral genomic proportion data with the SARS-CoV-2 Interagency Group (SIG), which will evaluate the impact of these genetic changes on the effectiveness of Evusheld and update clinical recommendations, if necessary.
Q [00:11:48] The first one is a quick one. Are there any updates to the death of the patient who had severe illnesses and monkeypox? ERICKA BROWN, HARRIS COUNTY PUBLIC HEALTH [00:11:56] And so the investigation, the autopsy, is in partnership with the CDC around that case is still ongoing. And as we receive additional information that we are able to share, we certainly will do so.
The following is attributable to our Senior Vice President of Quality, Regulatory and Clinical Services Holly Harmon: “The revised guidance is welcome news for millions of nursing home residents, their families, and staff. While our commitment to infection prevention and control continues, adapting COVID protocols means recognizing the current stage of this pandemic as well as the importance of quality of life for our nation’s seniors. After more than two years, residents will get to see more of their caregivers’ smiling faces, and our dedicated staff will get a moment to breathe. “We look forward to ongoing collaboration with the CDC and other public health officials to help ensure long term care facilities receive the necessary support to best serve our nation’s seniors.”
Both BA.2.75.2 and BF.7 have been detected via CDC’s Traveler-based SARS-CoV-2 Genomic Surveillance program. As of August, we have detected BA 2.75.2 from flights from India and as of July we have detected BF.7 in flights from France
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CDC monitors emerging sublineages in the United States, but does not add them to the COVID Data Tracker until they reach at least 1%. Sublineages circulating less than 1% are not separated and may be grouped with their parent lineages. BA.2.75.2 is currently aggregated with its parent lineage BA.2.75. The proportion of BA.2.75.2 has been gradually increasing over the last few weeks. CDC will continue to monitor the variants for any changes in rates. Please see the COVID Data Tracker to track the lineages of Omicron and new variants as they emerge in the United States. CDC updates these data each week.
Imported from Revue
During its routine inspection of our Bloomington facility, the FDA found no issues related to the safety or efficacy of the Moderna product. Production at the facility, including of COVID-19 vaccines, has continued without interruption. Nevertheless, Catalent takes all observations very seriously, and we have already begun employing all necessary steps to address each observation as quickly as possible. Chris Halling
[00:59:17] JUDITH HEWITT, NIAID: The animal models have been– they’re highly controlled. We like to control the the amount of virus that individual animals get. So we have not really studied that. I would say, though, that now, in hindsight, looking back at some of the data from the animal studies, for example, the pathology results, we do see evidence of virus in tissues like testes. And so, while that we didn’t study that, there is a hint there that that’s something to look at.
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[00:55:06] LAURA BACHMANN, CDC: A separate team was created within the CDC monkeypox response called the COPE team, or the Community Outreach and Partnership Engagement team. This team applies lessons learned from STI and HIV communications and recognizes the importance of gay and bisexual men leading much of the response efforts. A harm reduction approach which employs non stigmatize and gender neutral and sex positive language is being used. COPE has also worked closely with Building Healthy Online Communities to develop messages for dating apps that have used existing relationships with influencers to reach priority populations.
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[00:26:15] AGAM RAO, CDC: There are a small number of very severe infections that involve larger and more extensive lesions that have occurred among people, for example, with poorly controlled HIV. And we we highly recommend, and we are here to provide consultation, if you reach out to us, we highly recommend consultation with us. We can be consulted 24/7 at CDC and we can help with things like providing guidance about whether IV tecovirimat should be considered, whether resistance testing can be done at CDC, whether additional testing can be done, serology to evaluate a patient’s immune response if they’ve had poorly controlled HIV and are now been started on antiretrovirals, for example. And we’re acquiring more information as we’re performing these consultations, and we hope to provide some more guidance in a publication format soon, interim guidance, that might further help clinicians navigate this as as we continue to learn more.
[00:11:44] STEVEN WASSILAK, CDC: So here’s the issue. We have a problem with focus by countries, on making polio a priority for some of these outbreaks. What we are doing is trying to improve local areas with the most difficult problems, with all the partners. And we have to address insecurity and it’s been a chronic problem. Surprisingly, Afghanistan has been doing better, except in the north, with the default government in charge than it was because they were previously preventing campaigns in many areas. But there’s also a funding problem. So the overall message I want to give is: we can reach polio eradication, but we have a lot of challenges. And in terms of the IPV use in Western countries, it can stop poliovirus circulation, even if it’s not effective as much as Sabin in reducing mucosal and fecal spread.
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[00:17:58] PATRICIA SCHNABEL RUPPERT, ROCKLAND COUNTY: We had our outreach and supplying of IPV to Rockland County providers. We’ve launched vaccination clinics in Rockland County on day four. We were notified on the 18th, and by the 22nd, had those pods up and running. And we are at present beginning to do– perform school and daycare audits as well.
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[00:18:16] PATRICIA SCHNABEL RUPPERT, ROCKLAND COUNTY: So this is a long term collaborative effort by all three levels of public health. CDC has already promised, and we’re very grateful that they have, that they will stay on board with us for 6 to 9 months. And New York State is totally supportive of that as well.
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[00:18:32] PATRICIA SCHNABEL RUPPERT, ROCKLAND COUNTY: 5,000 letters were sent to families in Rockland whose children were under-vaccinated or unvaccinated. There has been an urgent plea for vaccinations signed– it was a letter signed by CDC DIrector Dr. Walensky, by Rockland County Department of Health, myself, and New York State Department of Health Commissioner. Dr. Mary Bassett.
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[00:19:28] PATRICIA SCHNABEL RUPPERT, ROCKLAND COUNTY: And as of the end of August, sequencing analysis by CDC confirmed existence of polio virus in 43 positive samples. As of the September 14th, we’ve had positives in 89 samples. Well, 89 samples were tested. We continue to test now upstream samples as well. And wastewater samples from Rockland have genetically been linked to the United Kingdom and to Israel, though they have not had any paralytic cases. There has been in New York City positive, in Coney Island, which was not linked to us, and there were other positive sequencing that was inadequate. So it’s very hard to say. But others were linked to Rockland County, as is mentioned, Orange County, Sullivan County, etc.
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[00:41:46] PATRICIA SCHNABEL RUPPERT, ROCKLAND COUNTY: As far as the hesitancy, yes, we are seeing we have a lot of infiltration of especially our insular community in Rockland by the anti-vaxxers, and we are now working to supersede them, if you want to say, as best we can. It’s going to be very, very difficult. They have robocalls nightly on the phone. We had been part of– listening on part of them, not to speak, back to measles. This is not new.
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[00:42:55] PATRICIA SCHNABEL RUPPERT, ROCKLAND COUNTY: As far as our vaccination rates, we had an increase. I have actually have a graph here, I don’t know if you’d be able to see it from this far, but we had an increase in our rates of vaccination after the July 21st information was presented about our one polio case. Like we said, the tip of the iceberg. And we also try to educate in that regard as well that this is what it is. There’s not just one case out there. But anyway, but as you can possibly see, we’ve gone sort of back to the baseline already. So to give you the exact percentage, I don’t have that number with me today, but I can tell you that it’s unfortunate that we haven’t sustained that level of increased immunization in the areas that we need. We have a lot more work to do.
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[00:45:12] PATRICIA SCHNABEL RUPPERT, ROCKLAND COUNTY: So it’s unfortunate that we lost some of our community liaisons from measles to date. And the reason for that, from what we were told, is that they, like me, had received some death threats. And so they’ve pulled back. And that’s been a major problem for us, because those people that we counted on, you know, three or four years ago are no longer available to us. So we are now working with newer community groups and hopefully we will have additional liaisons coming forth.
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ROSALIND CARTER, CDC [00:24:49] We certainly have heard and and greatly appreciate the feedback from the jurisdictions on how difficult that process has made inventory reporting, wastage, and taking a system that much time, money, and expertise had gone into developing, and we were not able to use it for monkeypox distribution. I think as Steve was describing, because this MCM was part of the Strategic National Stockpile, we were just dependent on using their system and lots of time sensitivities to get something up and running and get vaccine out into the states. At this point, though, there has been a lot of time and discussion looking at the– the infrastructure and the details, hardware, software issues with HPOP and VTrckS. So we are planning that those issues that plagued us during the monkeypox rollout will not be the same issues that face us, should we need to engage with other medical countermeasures in the future. So a lot of active work happening to actually fix that problem for the future.
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STEVEN ADAMS, ASPR [00:22:32] There were also a number of, frankly, bureaucratic limitations. Some of them there for good reasons. But the funding that supported the the COVID response and the specific contracts in place for distribution of vaccine for COVID actually could not be used to support a monkeypox response. A number of appropriations issues and also contracts that had been put in place in 2020, under an emergency flag, to support the rapid creation of a distribution capability for COVID, that simply couldn’t be extended further legally. So these are bureaucratic answers that satisfy no one, but they’re the truth.
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STEVEN ADAMS, ASPR [00:24:11] I think it’s an open question as to how we look at vaccine availability if monkeypox becomes endemic. And I know there’s been a lot of discussion around a potential future commercialization of vaccine access, but I believe those are really open questions at this point.
[00:22:02] Q: Since supply constraints have been largely resolved, why isn’t the administration’s vaccine strategy at full PrEP eligibility right now? Why leave it up to jurisdictions? [00:22:11] DEMETRE DASKALAKIS, WHITE HOUSE: Yeah, all those discussions are happening now, so watch this space.
Imported from Revue
The safety of the American public is our top priority. The FDA continues to work to ensure that authorized batches of the updated Moderna COVID-19 Vaccine, Bivalent booster meet our expectations for safety, effectiveness and manufacturing quality. As part of our regulatory oversight work, the agency recently conducted an inspection at a Catalent manufacturing facility that was contracted by Moderna to produce batches of its updated COVID-19 vaccine booster. Because this inspection was still ongoing when FDA authorized the updated Moderna booster, FDA did not include this facility as an authorized manufacturing facility for the updated COVID-19 vaccine booster at that time. On Tuesday, FDA authorized distribution of numerous batches of the updated Moderna COVID-19 Vaccine, Bivalent booster manufactured at Catalent’s facility. This authorization was based on FDA’s determination that the batches met all applicable specifications, following a careful review of information provided by Moderna about the manufacture of these batches. The agency has no concerns with the safety, effectiveness, or quality of these batches. Batches from this facility were not released prior to this review and batches initially available were produced at another facility. Michael Felberbaum
[00:33:22] PETER MARKS, FDA: I think we just don’t know for sure whether this is going to be an annual vaccine yet. We have a sense that it probably will be, because COVID-19, which is caused by SARS-CoV-2, is not going away. SARS-CoV-2 continues to evolve. It’s become much like influenza in that regard, only it’s evolving even faster than influenza often is thought to. But I think we will only know that answer after this kind of transitional year we’re in, because we we don’t know if the vaccine– If the vaccine can be given once a year and protect us for the year, probably we will probably have an annual vaccine. And that composition of that vaccine may be updated annually, much like we do for the flu vaccine. On the other hand, if we find that during this year things change, we have to have an extra booster for some reason, which we’re really hoping we don’t, we may have to reevaluate things. The hope, though, the hope, and you’ve probably heard this from other sources, is that we’ll just have to give this one booster this year and it will hopefully hold us.
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[00:49:16] SARAH MEYER, CDC: So actually, this Thursday will be the first kind of reports of our vaccine booster coverage. So you’ll be able to see those online at our website on COVID Data Tracker. So currently, we don’t have those uptake numbers available, but those will be available this Thursday. It does take a little bit of time, you know, to get everything reported and all the numbers analyzed and things like that.
[00:49:47] MARK RAZA, FDA: Again, this morning, somebody sent me a tweet from the commissioner, I think it was legit, and said, ‘hey, they didn’t run this by us,’ but it was– he retweeted a picture of the secretary receiving his booster and the commissioner, I guess trying to be pithy or whatever, he said if I had, you know, if I had guns like that or if I had biceps like that, I’d give up all my bowties or something (laughs).
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[00:33:09] MARK RAZA, FDA: So I’ve been told I’m a, you know, I’m a dinosaur. So I’m admittedly old school. But, you know, we’re currently in litigation in the Southern District of Texas where that– where the allegation is that FDA impermissibly interfered with the practice of medicine. And that’s one of the one of the exhibits that’s cited. And that, FDA doesn’t have the ability to to speak, which we are vehemently opposing any kind of limitation in that in that way. But it is– it is a real issue going forward. And what’s– the commissioner was here in 2016, my office and I, we opposed him tweeting. And he’s still kind of bitter about that. He then left, Scott Gottlieb came in, and just tweeted all of– he didn’t even ask us. And I think it was very effective in how he kind of managed that.
To date, Pfizer has shipped more than 21 million doses of the BA4/5 adapted vaccine to the US to over 30,000 unique locations across all states and jurisdictions and plans to provide up to 100 million by the end of November. Pfizer initiated manufacturing of the bivalent vaccine earlier this year and had hundreds of millions of doses manufactured at risk across the network, prior to the EUA, in-part thanks to the upscaling of our manufacturing capabilities since the start of the pandemic. Pfizer’s Kalamazoo, MI site alone is currently manufacturing 10-15 million doses per week with capacity to increase this considerably. Pfizer will continue to use the Pleasant Prairie Wisconsin site for ultra-low temperature storage and as a distribution center for the Pfizer/BioNTech COVID-19 vaccine.
To date, we have shipped more than 26 million doses of the updated COVID-19 vaccine to tens of thousands of locations nationwide. In fact, over 90% of Americans have at least one site with these new vaccines within 5 miles of where they live. Following FDA’s authorization of the distribution of numerous batches manufactured at Catalent’s facility, we are making millions of additional doses of Moderna’s updated COVID-19 vaccine available for ordering to states, jurisdictions, and pharmacies. We anticipate that Moderna supply will continue to increase in the coming days and weeks. Pfizer’s updated COVID-19 vaccine is already widely available across the country. Those who have received their primary series vaccination and are eligible to receive an updated vaccine may receive Moderna or Pfizer, regardless of which primary vaccine they received.
We are working closely with U.S. Government to deliver significant amounts of updated, bivalent booster doses as we continue to see high demand in certain areas of the country. We anticipate that these availability constraints will be resolved in the coming days. We continue to be on track to meet our committed delivery of 70 million doses of our updated, bivalent vaccine by the end of this year.
[00:39:26] ANTHONY FAUCI, NIAID: Now, with regard to flu, we are expecting a pretty severe flu season because our counterparts in Australia, which is we usually get what they get when we get to our winter, they’ve had a pretty bad flu season. So I would not delay your flu shot. When the flu shot becomes available to you in your community, I would get the high dose flu shot for elderly people. Don’t get offended by the word elderly. I’m going to get the high dose flu shot when it becomes available. So get your flu shot first and wait three months from the time you’ve gotten infected with COVID to get your COVID updated vaccine.
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[00:22:28] ANTHONY FAUCI, NIAID: You know, Christina really not very sure. I– according to the rules of government, you can’t be preparing or negotiating for your next job, for the possibility of there being a conflict of interest. So I have completely put it aside. What my intend to do is I intend to find a venue where I can utilize the years– and by, say, years, I’ve been at the NIH for 54 years. I came here as a 27 year old physician who had just finished his medical residency in New York City. And I came down here for a fellowship in infectious diseases and immunology. And I’ve been, as you mentioned, the director of my institute for 38 years. So what I want to do is utilize the benefit of my decades of experience to inspire younger people, young scientists, and would-be scientists to consider a career in public service one, and hopefully in public health in the arena of medicine and science. That’s conceptually what I want to do. What I want to do in that first day is probably sleep late for the first time that I have in the last many years.
Imported from Revue
[00:32:23] CARLY ADAMS, CDC: And this here to show you a screenshot of the new DCIPHER data dashboard. And each dot here represents a site that has reported data in the past 15 days. This is where NWSS partners can go to view the data. This dashboard is not public facing, but there’s also a public facing dashboard called the COVID Data Tracker, which includes all of the same metrics except for the variants, the variant specific metrics. Partners can look at several different metrics on the dashboard, including percentiles, which are site specific and show their relative levels of virus presence in a community. Percent change, which is shown on the map here, and this is a magnitude and direction of virus levels in a community. Detection proportion, which shows how frequently the virus is detected in a community. For now, this metric isn’t super helpful because almost all the samples are positive. But hopefully this metric will have some more utility in the future. Most recently, there are variant specific metrics, which show if a known variant is present and at what proportion. Next slide, please. And this is showing the various metrics that I just mentioned. On the left, the dominant variant of concern is shown. And on the right, you can see trends of the dominant variant of concern for one site, which is shown by the colored bar on the bottom. And then this trend line is showing the SARS-CoV-2 levels in the wastewater. And the stars represent samples that were sequenced, which is about 50% of the samples shown here.
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[00:26:45] CRYSTAL GIGANTE, CDC: It’s a very small number. I would have to see how many have been identified, but it’s a handful. Fewer than ten cases total have been identified, that I’m aware of. One of those cases was identified at CDC. So that’s why I don’t have the exact– exact numbers. But yes, it is a very small number of the total cases.
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[00:49:42] TIMOTHY STENZEL, FDA: The FDA is tracking mutations and monkeypox. And for those tests where we know the design features, to date, we know that for the Quest EUA that’s been authorized, we know that for the CDC assay, we are tracking the impact of monkeypox mutations on those tests. So far, there’s no indication that the CDC NVO test is impacted by any mutations. But because we, as well, have observed these deletions in the monkeypox that has knocked out some of the monkeypox specific LDTs, we are encouraging developers to use multiple targets. We have been doing that encouragement for COVID for a long time. We think it makes sense. But there’s not a recommendation for– that two targets be be used in assay development. It’s just an encouragement, at this point.
[00:14:36] PETER MARKS, FDA: One question that I’ll answer right now, that may come up is, when are we going to have these vaccines for younger children? And I think we can say that, for the age range of five and up, that’s a couple of weeks away. And for the youngest children, it’s probably later this fall to early winter as the data come in and we can review it.
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[00:47:41] PETER MARKS, FDA: Very much so. So I think there is the idea– they were not ready for this year, but I would not be shocked if, by next year, we see vaccines– can’t promise, obviously– but I would not be shocked if we see vaccines that are able to cover both influenza and SARS-CoV-2.
01:08:25 PM ANTHONY FAUCI, NIAID: Having said that, in one breath, we still must be aware of how unusual this virus is, and continues to be, in its ability to evolve into new variants which defy the standard public health mechanisms of addressing an outbreak, where you would expect if that once a certain number of people get infected, and or get vaccinated, then you could essentially bring an end to the pandemic component of the outbreak. And we’ve experienced at least five, and Steve there will be more, variants. How we respond and how we’re prepared for the evolution of these variants is going to depend on us. And that gets to the other conflicting aspect of this, is the lack of a uniform acceptance of the interventions that are available to us in this country, where even now, more than two years, close to three years into the outbreak, we have only 67% of our population vaccinated and only one half of those have received a single boost. Now, for sure, the intensity of the outbreak now, even though it is, I believe, unacceptably high, where we’re having 400 deaths per day, when you compare it to the fulminant stages we’ve experienced over the past year or so, where we used to have 800 to 900,000 cases per day, and over 3,000 deaths per day, we are much better off now for a number of reasons that you mentioned. But we are not where we need to be, if we’re going to be able to, quote, live with the virus, because we know we’re not going to eradicate it.
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01:12:24 PM ANTHONY FAUCI, NIAID: We’re heading in that direction, but we must be aware that it is likely, Steve, that with the combination of the evolution of variants, as well as the seasonal aspects, that as we get into this coming late fall and winter, it is likely that we will see another variant emerge, and there’s already on the horizon one that looks suspicious that it might start to evolve as another variant, and that’s the BA.2.75.2.
[00:51:40] Q: So the next question here is what do you foresee as the biggest challenge in the next year of COVID? [00:51:49] ANTHONY FAUCI, NIAID: I think the biggest challenge is how– and it’s a combination of a societal challenge and a– and a scientific challenge. The question is going to be– and that has a lot to do with I think one of your first questions– is how do we get the protection of the community such that the level of virus in the community is low enough that it does not disrupt the social order? Because we really can’t go on for a long time, the way we’ve gone on, we’re almost three full years into an entirely disruptive pandemic. If we had a vaccine that was a highly effective, which we do, good news, bad news. It doesn’t protect for a durable period of time. The other challenge is the fact that unlike the viruses that we’ve conquered – polio, smallpox, measles – the ability of this virus to form variants that elude protection of vaccines more so against infection than against severe disease is in many respects unprecedented.
[00:28:47] Q: Now let’s look way ahead. I’m wondering if you see an end in sight to this pandemic, and what an end might look like? [00:28:57] ASHISH JHA, WHITE HOUSE: Yeah, every pandemic comes to an end. This pandemic will come to an end. There is rarely one moment or one date where you mark– you can mark beginnings of pandemics, when WHO declares it. And there’ll be a day when WHO declares the end of the pandemic, but in many ways the pandemic will have faded further into the background before then. The way I look at it is over time, the goal, if we continue to do our work right, all of us pulling together, is to make this virus less and less destructive, less and less disruptive. COVID’s going to be around. No one is talking about eradicating SARS-CoV-2. It will be around as a virus. But the question is, can we make it something that isn’t causing 3-400 deaths a day? Isn’t causing the level of disruption? The answer, of course, is we can. If we keep doing the things we’ve been talking about, building up population immunity, building more durable immunity, building more therapeutics and testing. One of the things we have not talked about as a long term strategy, which I think is extraordinarily important, is something we’re leaning very heavily into in the administration, is how we make indoor air space– indoor spaces safer. Right? We know outdoor spaces are relatively safe. Indoor spaces can become much safer. And so I think as a nation, we need to make significant investments in improving indoor air quality, ventilation, filtration. It will have a great benefit for COVID, for flu, RSV, and better indoor air quality improves cognition. We’ve just got to make sure that, given that most people spend most of their time indoors, (inaudible) technology, that’s another part of that long term strategy for getting out of this pandemic.
[00:02:33] ASHISH JHA, WHITE HOUSE: So the comment that I made about, you know, ‘that’s why God gave us two arms’ was an off the cuff, somewhat lighthearted. The truth is, actually, it doesn’t really matter where you get it. Your immune system can handle it. So I got two shots last week, I got it on Friday, and I got them both in my right arm. And my right arm was a little sore. Played basketball with my son on Saturday. He beat me. I blame it on my sore arm. He’s actually beat me before when I haven’t had the sore arm, so I don’t know that I can use that as an excuse, but– but the point is, your immune system is remarkable in its ability to manage one, two, three shots at the same time in the same arm, different arms. It’s all– it can do it just fine. So it’s not a problem.
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[00:10:21] ASHISH JHA, WHITE HOUSE: Yeah. And– and I would remind you, Zerlina, that the second sentence the president said after that comment was he said, ‘but clearly it is not over. And we still have a lot of work to do on COVID.’ And that is absolutely right. So you asked, what do I think about when I wake up in the morning and come to work every day? I think about a couple of things. That top of mind is the fact that about 400 Americans are still dying every day of this disease. That is an unacceptably high number by any metric, right? Because if you just annualize that, that’s like 130-140,000 deaths a year. To me, that’s intolerable. So we have got to drive that down. That’s sort of, arguably, priority number one. Priority number two is we’ve got to figure out how to get infections lower. And Long COVID is one of the issues. We’ve got to figure out how to reduce the burden of long COVID.
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[00:15:09] ASHISH JHA, WHITE HOUSE: What about preventing infection? We have had a very big program around getting tests out to people, because one of the ways I try to prevent giving other people infections – I have not been, thankfully, have not gotten infected yet – but every time I see my elderly parents, I take a test first. Why? Because I don’t want to bring COVID to them, right? So testing is a really important part.
[00:02:16] Q: So my first question is very simple. Is the COVID-19 pandemic over? [00:02:23] ANTHONY FAUCI, NIAID: You know, David, there’s a lot of misinterpretation about what the meaning of the word ‘over’ is. It means different things to different people. I’m sure you’re referring to the comment made by the president a day or two ago. If you’re talking about the fulminant phase of the outbreak, when we were having anywhere from eight hundred thousand to nine hundred thousand infections a day and three to four thousand deaths per day, that was several months ago. We are much, much better off now than we were then. So in that case, that fulminant phase of the outbreak is behind us. But as the president made very clear on the second half of his sentence, is that– which they don’t seem to show, is that he actually said, we still have a lot of work to do. There’s still a challenge ahead. We’ve got to get people vaccinated. We still have a number of cases. We have 400 deaths per day. That’s an unacceptably high level. So again, it depends on the semantics of what your definition is. We don’t want anyone to get the impression that we don’t have a lot of work to do. We’ve got to get the level of infection considerably lower than it is. And we’ve certainly got got to get the level of deaths lower than it is. So again, it depends on the semantics of what you mean by ‘end.’
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[00:03:51] Q: And so let’s get into that. Well, let’s get into those semantics then. What conditions would need to exist for the pandemic to be over? [00:04:00] ANTHONY FAUCI, NIAID: You know, that’s a call that officially is made by the World Health Organization. You know, my colleagues and I, oh, I must have been more than ten years ago, because of the lack of clarity on what a pandemic means to one person versus another, we wrote a paper in the Journal of Infectious Diseases in which we talked about all the different variations of interpretations. Is that a widespread phenomenon? That is it the widespread nature throughout the world that makes it officially a pandemic, or is it widespread and accelerating, or is it widespread causing serious disease? It means different things to different people. So rather than try and give a definition, that’s my definition versus another, we should stick with what the WHO is saying. And as Dr. Tedros said, that we’re seeing the light at the end of the tunnel on that. So, again, you might interpret that– well, if that’s the case, is it over? Well, again, what does ‘over’ mean? There’s a lot of semantics there, David. The easiest way not to confuse people is to say we still have a lot of cases. We still have 400 deaths. We only have 67% of the population vaccinated. We’ve got to do better than that. Of those, only one half have gotten a single boost. And as a nation, we lag behind other developed countries and even some low and middle income countries in the level of vaccinations that we’ve been able to implement.
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[00:07:02] ANTHONY FAUCI, NIAID: So if I got my last shot, let’s say in July, August, September, two months later, you should get the bivalent. If you were infected three months or more ago, you should then get the updated vaccine. Let me give you an example for clarity for the audience. I was infected in the end of June of this year, even though I had been vaccinated. Fortunately, because I was vaccinated, I had a relatively mild illness at my age. Had I not been vaccinated, the chances are I could have had a real severe outcome, because elderly are more prone to get severity of disease. So if you take the end of June, take the end of July, the end of August, the end of September, I plan to get my updated BA.4/5 bivalent at the end of September, the first week in October.
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[03;12] DR. DENNIS HRUBY, SIGA: So I I think that the statement that there’s a low barrier to resistance might be overstated. Poxviruses are DNA viruses. They have the ability to edit their DNA, as they’re replicating, and correct mistakes. As a result, the mutation rate in a poxvirus is a hundred to a thousand times lower than you would see in an RNA virus like COVID or influenza. So that’s the first thing. The other is how antivirals work. I mean, antivirals, basically, if they’re good drugs, they arrest the further replication of the virus and simply hold it and check until your immune system kicks in. And in the case of a monkeypox patient who has symptomatic disease, he’s already– he or she is already generating a protective immune response. So, giving your immunity a few days to catch up and eradicate the virus is really all an antiviral has to do. There’s also the data. We know you can in fact generate resistance to TPOXX. But it’s at a rate of about one in ten to the seventh. And we frankly have never seen in any of our animal trials failure of that therapy due to outgrowth of a resistant variant. And likewise, in all of our human experience, we’ve only seen one resistant virus and, again, it was a minority population. That patient was treated with drug for 82 days and ultimately cleared the virus. So we think at the– if the drug is used properly and taken for the prescribed length of time, the odds of resistance is relatively low.
[00:10:20] ASHISH JHA, WHITE HOUSE: Yeah. So my kids are obviously back in school. They do not mask in school. None of the schools require it, I don’t think. And the kids are not largely masking. On for myself, I will say that when I am in a crowded indoor space, I will still often mask because in crowded indoor spaces, you know, it’s just your risk of getting COVID is relatively high and I’m not– and masking is not a big deal. So it’s very relatively easy to do and I do it. In terms of dining, we dine out, I dine out. Whenever possible I will choose to be outside compared to indoors. I have dined indoors, but in general my preference is to dine outdoors. You know, I think three years ago I probably wouldn’t have thought about it. So it’s one of those things where it isn’t that there are major restrictions in my life. It’s that I do certain things a bit differently. Right? More willing to spend time– I’d rather spend time doing stuff outdoors more than indoors. Rather avoid crowds if we can. It’s always also in my mind and a question of what’s the tradeoff? What would I be missing? Would I be missing a wedding? Would I be missing something really important? That makes a big difference versus, you know, if the restaurant has both indoor and outdoor spaces, it’s easy enough.
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[00:14:11] ASHISH JHA, WHITE HOUSE: In my mind, for a vast majority of people, we are now at a point where this is an annual vaccine. Now, for a lot of people, that seems kind of jarring. They’re like, whoa, annual vaccine, how did we get there so fast? I remind them again, the average person in America is a 38 year old. That’s the median age. So if you take a typical 40 year old who’s not immunocompromised, does not have significant health issues, that 40 year old, if they had gotten a booster, sort of last fall as they became eligible, they wouldn’t have even been eligible for another shot until now. So essentially we got to a once a year vaccine regimen for non-high risk people. The average risk person, we were already there. And what we’re doing now is just calling it what is actually already happening. Which is, for the average person, once a year COVID shot should provide them a high degree of protection against serious illness all year. For high risk people, people who are older, people who are immunocompromised, they may need additional protection. So I think about my elderly parents. For instance, they’re in their eighties. My dad just got his COVID vaccine a week and a half ago. You know, is it possible that he may need another shot in the spring? Yeah, absolutely. So high risk people, maybe more than once a year. We’ll see what the data shows. But I think for a vast majority of people, this is now an annual shot. And that’s how people should be thinking about it.
[02:28:05] RITA SINGHAL, LOS ANGELES COUNTY: First, we have identified a healthcare worker with monkeypox who appears to have been exposed to the virus at their work site. This is the first case of monkeypox in a health care worker in the United States that has been linked to a worksite exposure. We have consulted with the CDC and, given that the risk of monkeypox for health care workers remains very low, we will continue to message on current infection prevention and control recommendations, and in particular, the use of appropriate PPE, pending additional guidance from CDC.
Lagevrio is authorized for treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. Therefore, if a patient is taking Paxlovid, an alternative COVID-19 treatment option authorized by the FDA, they would not be eligible for Lagevrio. Chanapa Tantibanchachai
The reason for the short duration is viral kinetics. We see best results for pathology (histopathology) on day 5 or 6 post SARS-CoV-2 infection in rhesus macaques. By that time, however, viral replication is already clearing. We went for peak virus replication (day 3 or 4) to better show the efficacy of the treatment with the downside of not being in the optimal time frame for histopathology. I hope this helps.
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10:39:48 AM BOB FENTON, WHITE HOUSE: Stepping back, we’re seeing the impact of this– of the administration’s comprehensive strategy to fight monkeypox in the latest case trends and other promising data points. Overall, new case numbers are down nearly 50% since early August. And in places like Atlanta, where we’ve worked closely with the public health community to surge vaccines, and information around events, like Black Pride, the rate of new cases has steadily declined. And in D.C., the new cases have declined 20% on average per week since a peak of July. And knowledge of our tools and interests and using them has increased. According to research released today from the University of Pennsylvania, knowledge of a monkeypox vaccine has jumped from approximately a third of Americans to over 60%. More than two thirds of Americans understand the risk profile and behaviors from monkeypox and nearly three quarters of Americans said they would get vaccinated if exposed to monkeypox.
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10:53:52 AM DEMETRE DASKALAKIS, WHITE HOUSE: And as Dr. Walensky and Mr. Fenton mentioned, we’re seeing encouraging signs in our fight against this monkeypox outbreak with cases regularly trending down. In fact, down by nearly 50% since its peak in early August. While there is more work we’re doing to reach all of the community at highest risk, I want to be clear. This is the result of our hard work together to increase the availability and use the testing, make vaccines readily available to the people who could benefit most, providing guidance on how to avoid monkeypox through changing behaviors, and the community has done it. But as you’re hearing, our work as far from over. As we’ve said, equity must remain the cornerstone of our response and currently, some jurisdictions are still seeing increasing rates of monkeypox infections while others are seeing a decline. We’re also seeing that monkeypox cases are concentrating in gay, bisexual, and other men who have sex with men of color, while, as you heard, most vaccines have been administered to white men Early adopters, as we see in the data, have begun or completed their vaccination series. We’re now entering the harder phase of the vaccination campaign, where we need to work to make sure that we continue to get first doses into arms and ease access for second doses. That means we need to use hyperlocal strategies that let us reach deeper into the community
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10:55:50 AM DEMETRE DASKALAKIS, WHITE HOUSE: Today, as you heard, we’re opening applications for our second equity intervention pilot that focuses on smaller projects, that help us reach the communities we need to link to monkeypox vaccines, education, testing, and treatment. Health departments will use their local experience and connection to the community to identify hyperlocal strategies to improve vaccine access to communities of color, specifically those that are overrepresented in this outbreak. CDC will provide them with vaccine, materials, and the technical assistance needed to realize these local interventions. And it will help us learn what works to get needed monkeypox vaccines and services to populations. We have allocated 10,000 vials, that’s up to 50,000 doses of vaccine, for these smaller equity interventions. And as Dr. Walensky said, the application is going to be available on CDC’s website and the administration will be promoting this new pilot program through direct communication with public health community partners as well as through social media.
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10:57:03 AM DEMETRE DASKALAKIS, WHITE HOUSE: Our data tells us that monkeypox is not an infection that exists in isolation. It travels with HIV and other sexually transmitted infections. An MMWR published last week tells us that 61% of people diagnosed with monkeypox either had HIV or an STI. We quickly used this data to change how monkeypox services can be supported by public health departments, clinics, and community-based organizations. Last week, CDC communicated to these funded health departments and directly funded HIV community-based organizations that their HIV and STD staff and dollars could be used to help us end the monkeypox outbreak. The same people we need to test for HIV and sexually transmitted infections, and lead to prevention and care, are the same people who need monkeypox related services, like testing, education, and vaccines. This important change in guidance to recipients of these funds allows our frontline health departments and community-based organizations to use their HIV and STD resources to accelerate us all to the end of the monkeypox outbreak, and will also help us do better HIV and STD prevention for the exact same population. This is just the latest example of us being responsive to what’s happening on the ground and pivoting our focus and our resources where they’re most needed.
In response to the COVID-19 pandemic, CDC launched the National Wastewater Surveillance System (NWSS) in September 2020. CDC’s NWSS is currently monitoring for SARS-CoV-2 in 46 states, five cities, and two territories. NWSS is expanding to begin monitoring for monkeypox in wastewater at multiple sites throughout the United States in the next 4-6 weeks. NWSS is working to support the polio investigation in New York. Several wastewater specimens from jurisdictions located in Connecticut and New Jersey adjacent to New York tested negative for poliovirus. However, it’s important to note that poliovirus testing is not a formal part of the NWSS program at this time. Expansion to new diseases, such as poliovirus, can take time and resources to ensure reliable, actionable data. CDC has begun working with jurisdictions to strategically select additional sites in areas at greatest risk for polio to test wastewater for polio. The considerations for selection of areas include local vaccination coverage, the extent of travel to and from countries where poliovirus is still circulating, and NWSS presence. Once the program is established, CDC will continue to evaluate the results and determine any potential need for expanding to additional jurisdictions or other actions. Wastewater data can be an important early warning signal, and should be used alongside other data, such as geographical context and clinical cases.
[00:40:58] Q: So what are the major challenges anticipated for next generation COVID 19 mucosal vaccines? [00:41:05] ANTHONY FAUCI, NIAID: Well, there there are a couple of challenges. The first is, you know, we don’t have very good mucosal vaccines for respiratory viruses. I mean, we do have the FluMist for flu, which seems to be quite good. But what we have not worked out is the– the combination of getting good protection at the source of entry in the upper respiratory mucosa, at the same time as getting good systemic protection at the systemic level. The other thing is that, something that people don’t really appreciate, is the safety issues. Because, if you’re talking about spike protein, it’s a very somewhat of a mysterious molecule. It’s that what we’re seeing about some of the important adverse effects from the disease itself, related to aberrant responses to the spike protein, and the spike protein– and its ability to inflame areas, for example, that have to do with taste and smell. There is a substantial safety issue– not– I take that back. We don’t know what the safety issue is, rather than to say a substantial safety issue. There’s a substantial safety question. And the other thing is, you know, as an immunologist, after all these years, I’m– I’m not a mucosal immunologist, but I’m sort of stunned by how little we know about mucosal immunity after so many, many years of great advances in immunology in general. And that very well may be to the difficulty in sampling. It’s so easy to sample blood and things like that. But to sample areas of the mucosa, I think, it’s important. So it’s lack of a track record of good new mucosally administered vaccines. That I think is going to be the biggest problem, as well as the theoretical and perhaps real, safety issue when it comes to COVID. Not when it comes to other vaccines like influenza, which you’ve already done the proof of concept with FluMist.
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[00:36:29] ANTHONY FAUCI, NIAID: That’s what we refer to when we say a return to normalcy or endemicity, which is a difficult to describe situation. But it would be somewhat similar to other respiratory viruses that don’t disturb the social order. It doesn’t interfere with the economy or our social interactions. And that’s respiratory syncytial virus, the common cold, coronaviruses, influenza. What we’re looking for is control at a low enough level, again, that doesn’t disturb our social interactions. And to get there, we believe we have to have the availability of intermittent vaccination, like we referred to just recently, about getting coronavirus vaccine at least on a yearly basis, as well as other things such as respiratory hygiene, attention to ventilation, and indoors masking, where appropriate, and the availability of effective virus antivirals and monoclonal antibodies.
[42;43] CRYSTAL GIGANTE: We also saw increased mutations in the 2022 monkeypox viruses, which were– many of which were GA to AA mutations, which is indicative of APOBEC3 activity, which is shown here in this graphic for the different lineages of monkeypox virus with clade I and clade IIa, which do not include the current outbreak. Most of the mutations shown here, with a horizontal line representing monkeypox genome, and each bar representing a mutation, either APOBEC-like mutations in blue and cyan or non APOBEC in red or gray. And you can see clade I which was formerly the Congo Basin clade, most mutations are– or many are red and gray. But in the current outbreak, and lineage a of West African clade IIb monkeypox, the majority of these mutations are APOBEC or blue shown here. So yes, that was one of the major differences in the mutations that we’ve seen in this outbreak so far. Another thing I wanted to bring up in this talk is we’ve been noticing several cases of large deletions and genomic rearrangements in about three percent of monkeypox virus genomes that we’re sequencing. And these deletions are concerning about 500 base pairs to up to 20 to 30 kb. Really large genomic rearrangements that have the potential to impact diagnosis or efficacy of therapies. These deletions are– have been reported similar deletions in vaccinia. And there’s a similar rearrangement to what we’ve been seeing reported for a clade one monkeypox virus in 2005. And that’s that’s been published. And these sorts of deletions have been seen before. There’s a Bayelsa monkeypox virus genome that contains a deletion in the terminal region as well. But we are seeing this in about three percent of monkeypox virus genomes in the U.S. And one thing we wanted to point out is the sensitivity of different diagnostic assays to these deletions. So any diagnostic assay targeting a terminal– a gene within the terminal region might be sensitive to this type of deletion. And that includes the monkeypox virus clade two, or West African specific, or monkeypox virus generic assays, that were published, which target the TNF receptor within the ITR. So in summary, genomic surveillance thus far and this outbreak has revealed multiple lineages of monkeypox virus in the U.S., and monkeypox virus sequences since 2017, have exhibited evidence of host antiviral editing by APOBEC3. And we’re seeing about three percent of monkeypox virus genomes contain large deletions or rearrangements. And we’re hoping to have a preprint available describing those results in more detail this week, hopefully. But it’s not out yet. Analysis are expected to continue as more sequences are reported.
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[00:02:11] MICHAEL WEIGAND, CDC: So although the CDC response to the current outbreak started sometime in May, it wasn’t until recently in July that we really stood up a unit focused on bioinformatic development specifically. And our our goal can be summarized here, that we’re trying to develop an automated and high throughput pipeline for sequence analysis and, importantly, public database submission. I think you can trace this really to just the shift in scale of our genomic surveillance. So our poxvirus and rabies branch previously was probably sequencing on the order of 10 to 20 genomes a year. And now, we’re at a scale of something like 100 genomes a week.
[00:06:24] STÉPHANE BANCEL, MODERNA: What happened with Omicron, as you know well, is the protection against transmission went down a lot. Around two months of protection after booster, because we had such a massive genetic drift from Omicron, from one to Omicron. And so we think that as we are teaching your immune system all those new tricks, that part of the Omicron mutation, that we should regain the duration of protection for transmission. But we believe level of protection, hospitalization and death, is going to remain extremely high. [00:04:17] Q: Now, just the other day, White House officials said they were hoping that we could move to an annual COVID shot scenario. Up till now, it’s been people yourself, myself, friends and family getting boosters every few months. Do we think that this could actually confer protection that lasts for a year? [00:06:24] STÉPHANE BANCEL, MODERNA: Yes, we think so. But we think that if you can adapt every year like flu, the COVID booster, to whatever is circulating right now, you’ll be able to get long protection.
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[00:06:24] STÉPHANE BANCEL, MODERNA: So for next fall is going to be too tight time wise to do combinations. There’s going be two shots. Potentially, would be better if you could see on the flu side, because you will be adapted to what’s circulating in the U.S., which might be a different vaccine than the U.K. or Japan, which you cannot really do with recombinant. And what we are already working in the clinic is a combination in the single dose of COVID and flu, but I think it’s more for the fall of 24, just because of the regulatory time and doing all the clinical studies.
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[00:22:32] STÉPHANE BANCEL, MODERNA: So if you think about it, we love to learn from nature. Those mRNA virus, they go in our body from the mouth and the nose mostly. So, if you can get an mRNA through the nose into the human body, which you’ve got a virus, there’s a way to get our mRNA into a nose. So we are working on it. It’s too early to talk about any kind of result that is worth getting into a clinic. But this has not escaped us, and the teams are working hard on it. [00:22:43] Q: So it’s a long term prospect, not nothing near term? [00:22:46] STÉPHANE BANCEL, MODERNA: I mean, we’re talking about this for, but not for these for, but you know with Moderna, things– go pretty fast. If you see what we’ve done with COVID, what we’ve done with flu and RSV, we went in the year from phase one start to phase three start, not only for COVID, that the world knows about, but flu and RSV we did the same. We did one year.
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10:49 AM DAWN O’CONNELL, ASPR: I’ve been pleased to make both of these medical countermeasures available for the current monkeypox outbreak. It is the right thing to do. But I have not lost sight of the fact that both Jynneos and Tpoxx were developed and stockpiled for use in a smallpox outbreak. I have consulted with the PHEMCE, the interagency body responsible for advising HHS on medical countermeasures, development, and procurement, and they have agreed with the approach we have taken. It is important, however, that as we move forward with our response, we consider ways to preserve our smallpox capability.
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10:59 AM DAWN O’CONNELL, ASPR: Thank you ranking member for that question. So we continue to maintain our smallpox preparedness, that’s critical. Our frontline vaccines continue to be available and have not been impacted by our monkeypox response. But we have added the capability to be able to provide the Jynneos vaccine to those that are immunocompromised in the case of a smallpox outbreak. And we are evaluating, with each dose that we make available to the monkeypox outbreak, what it means for that preparedness in smallpox. I’ve met with the PHEMCE. I’ve consulted with them to understand whether we need a separate monkeypox stockpile. So we can pull those vaccines off the shelf, and not worry about the preparedness for the immunocompromised in a smallpox outbreak.
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11:01 AM ROCHELLE WALENSKY, CDC: I will say from a health worker safety standpoint, at least as far as monkeypox is concerned. We have seen very little outbreak in healthcare workers. We have had one diagnosed health care worker after a needle stick injury. But we have seen very little health care worker outbreaks, due to our personal protective equipment, and the outreach that we’ve done in telling healthcare workers how to protect themselves.
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11:20 AM DAWN O’CONNELL, ASPR: So we have a similar challenge that Dr. Walensky mentioned, and with the states. The states aren’t able to use their COVID funding for the monkeypox response. We haven’t been able to use our COVID funding for the monkeypox response either. So when it came to digitizing the SNS process, we were going to have to put new money into either the Vtrcks system or the HPOP system. The HPOP system is currently being used in COVID-19 to order therapeutics. So states do have familiarity with HPOP. Vtrcks was being used for– for the vaccines. Only HPOP could do both. And we were faced with putting annual budget funding into one of these systems in order to digitize the SNS ordering. And we chose to put it into the system that could actually do both. We believe that was an important step in moving forward. But we do acknowledge, Senator Smith, that our public health department colleagues are worn out and tired. We have had countless office hours with them to make sure they understand the system. If they’re running into any problems, we’re available to answer them. And as hard as this change management is in the middle of two responses, it was the right thing to do to move forward to an interoperable system. We also have added additional distribution sites. That’s one of the things we did with the SNS. We could not just piggyback on the COVID-19 distribution network. That was funded with COVID dollars. We had to go with the SNS, do an entirely new contract with a different distributor with annual funds and set that up. So that was one of the reasons why there was a delay. We’ve needed to overcome this. And we’ll look forward to working with Congress on making response dollars more fungible in the future.
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11:45 AM ROBERT CALIFF, FDA: You know, the issue that occurred in this case was, it was a new plant that BN had switched to. It had not been inspected by the FDA. And I probably don’t need to remind you that we had more than one incident in COVID times of a manufacturing facility not being up to par, which created a lot of difficulty and trouble. So we felt it was essential to get there. And in fact, we got there very quickly after the application came in from the company to do it, and the outbreak occurred. But I think the balance here is the risk of a vaccine, which is not up to par, with the time it takes to make sure that the vaccine coming out actually will do the job that’s intended. And also just add, Europe doesn’t have a central inspections team for our vaccine facilities. Each country does its own, and we have had some discordance, historically, between findings in some of those facilities and what we found in our inspections. So we really felt we had to get this right, even if it took a bit more time.
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[23;01] STEPHEN HOGE, MODERNA: So clearly, that’s a demonstration of benefit, and it was able to be launched and rolled out and the approval, as we all know, happened just a couple weeks ago. The authorizations in the U.S., and now it’s rolling out globally. So that becomes the model, then the question really becomes, why are you picking your flu strains in January and February? It’s the same fundamental challenge, which is mismatch years, or drift, and you make a different decision, everybody admits at least one year in five. In the June timeline, there’s no reason why you have to be picking in February anymore. It’s not any more difficult to update the flu vaccine than it was the COVID vaccine, I would argue it’s gonna be a little bit easier, actually. And so, you know, from our perspective, there’s the very near term of how do we do the– how do we do the updates seasonally? But actually, the flu one is the one that we think should be accelerated. it, you really should happen later in the season for better match. And the COVID one, there’s really no reason to go back to a world where we’re– we’re doing this so early in the season that it is not well matched.
[16;15] ADAM SHERWAT, FDA: Data from randomized controlled trials are critically needed to address knowledge gaps related to efficacy, safety pharmacokinetics in humans with monkeypox, and to monitor for development of resistance to tecovirimat. All are essential in guiding clinical and regulatory decision making. Therefore, healthcare providers should encourage their patients with monkeypox infection to be evaluated for enrollment in NIAID’s randomized controlled trial. For patients for whom enrollment in this trial is not feasible, for example, a clinical trials site is not geographically accessible, the use of tecovirimat under CDC’s expanded access protocol should be consistent with applicable guidelines for tecovirimat use.
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[33;42] BRETT PETERSEN, CDC: One other treatment option is brincidofovir, which is an antiviral medication approved by FDA for treatment of smallpox. It is not currently available from the SNS. The BAR– BARDA has awarded a contract to procure brincidofovir for the SNS, and we do expect it to be available soon. And CDC is currently developing an expanded access IND protocol to help facilitate the use of this product as a treatment for monkeypox as well.
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[40;40] ADAM SHERWAT, FDA: Importantly, even if the requisite declaration for therapeutics were to be made, FDA would need to consider the circumstances and appropriateness of an EUA for a particular medical countermeasure and determine whether the criteria for issuance of an EUA has been met. Putting aside the explanation of the regulatory framework, we have been working very closely with our colleagues at CDC to fine tune access via the expanded access protocol, and with our colleagues at NIH and academia to facilitate the development of a randomized clinical trial that is now open for enrollment. As previously noted, at present, we have no data from randomized controlled trials demonstrating the safety or efficacy of tecovirimat for the treatment of monkeypox in humans. Data from randomized control trials are critically needed to address knowledge gaps related to efficacy, safety, pharmacokinetics, and to systematically monitor for the development of resistance to tecovirimat. All of which are essential in guiding clinical and regulatory decision making. Therefore, health care providers should encourage their patients with monkeypox infection to be evaluated for enrollment in the randomized controlled trial.
CDC is aware of a reported death of an individual who had severe illnesses and presumed positive for monkeypox in Los Angeles County, California. Our thoughts are with the family during this heartbreaking time.
It is important to remember that infections with the type of monkeypox virus identified in this outbreak—the Clade IIb —are rarely fatal. Most people who get this form of the disease are likely to survive. However, people with weakened immune systems may be more likely to get seriously ill or die. CDC continues to closely monitor the monkeypox outbreak and we are actively working with California officials to investigate this situation.
To date, more than 21,000 people in the United States have contracted monkeypox. Data suggest that gay, bisexual, and other men who have sex with men make up the majority of cases in the current monkeypox outbreak. However, anyone, regardless of sexual orientation or gender identity, who has been in close, personal contact with someone who has monkeypox is at risk.
Following the recommended prevention steps or getting vaccinated if you were exposed to monkeypox or are at higher risk of being exposed to monkeypox can help protect you and your community. Additionally, it is important to promptly seek medical care.
Thank you for your request. To date, we have not received any updates on this case since the results are still pending.
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Our report on the EV-D68 upsurge in Europe in 2021 was to alert clinicians and neurologists to be vigilant. We have currently gathered additional information on the 2021 EV-D68 outbreak seen in Europe and we have indeed received several reports of EV-D68 associated AFM. However, as seen in previous EV-D68 peak years, where several EV-D68 associated AFM cases have been reported as well, we have not seen a major upsurge of these AFM cases in 2021. Following the report of the upsurge of EV-D68 infections and the following upsurge of AFM cases in the USA this year, we have again alerted our clinicians and neurologists to be vigilant.
SAPNA BAMRAH MORRIS, CDC [00:11:52] So most patients with intact immune systems really need supportive care and pain control, but often do not need to be stepped up to antiviral treatment. We do need to kind of think about antimicrobial stewardship, and we do know that there’s a point mutation that could lead to resistance to tecovirimat or TPOXX, which is our primary antiviral being used. So we really do want to consider the need for antiviral therapy. We do anticipate some guidance from FDA and CDC later this week that really elucidates some of these concerns and tries to highlight the cases in which we think we should be using TPOXX.
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PETER MARKS, FDA [01:01:43] Remember, we– this was a bit of a leaning in forward that we did here, without having the breadth of data that we normally would when we do an authorization. And I think we’ll feel better about moving these towards a primary series after we have the data with the immunogenicity of the BA.4/5, and we’ll also, by later this fall, early winter, have data on primary series of different variants as well. So I think that’s going to help us feel more confident then. And you may– you may hear coming to a VRBPAC meeting near you, this discussion, over the fall to winter season.
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PETER MARKS, FDA [01:05:11] So I think I think we’re several weeks off from that, because we have to we have to get full data submissions from the manufacturers, and then we’ll act relatively quickly. So I would say several weeks off, but obviously we will move as quickly as we can. I do want to at least set expectations that for the youngest children, the six month to four or five year olds, that may be late fall, early winter before we have those data, because remember, that– that all was somewhat later on. And in some cases, we’re dealing with a three dose primary series that is then being followed up with booster. So it’s a little bit more complicated there, but we will move as quickly as we can.
ASHISH JHA, WHITE HOUSE [00:08:23] So if you’re a super high risk person, you may want to wait a little less time because, you know, during that time period, once you get beyond 60 days from your prior infection, for instance, your risk of reinfection starts climbing. And so the risk benefit changes. So I think if you’re a higher risk person, I’d go a little earlier. And then, in general, I think it’s really important for people to get it by Halloween. Why Halloween? Because three weeks after Halloween is Thanksgiving, and there’s a lot of travel, and you’re seeing family, and you’re seeing friends, and a few weeks later, it’s you know, it’s the holidays and you’re– and the idea here is– and one of the reasons we’ve been really thinking about this as a once a year shot for a vast majority of people, is that here we are, brand new vaccine. As you think about the fall and winter, we know respiratory viruses circulate at much higher levels in the fall and winter. It’s a really good time to get yourself protected. And even if you yourself are on the low risk side, you’re going to have family and friends you’re going to see. You don’t want to be the person who gives it to your grandma. You want to be the person who gives it to your vulnerable friend who is immunocompromised. Lots of good reasons for people to go get it this fall.
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ASHISH JHA, WHITE HOUSE [00:45:04] Yeah, look, we don’t have a ton of data, but the Chinese government just authorized a nasal vaccine. And we’ll see what kind of– how the data on that pan out. The Indian company Bharat Biotech, that makes Covaxin, has their own intranasal vaccine that is also, I think, got an authorization or about to from the Indian government. And there’s nothing close on the horizon for the U.S. ANDY SLAVITT, Q [00:45:32] We’re still in phase three, right? We’re still in phase three on a few things, on a few products? ASHISH JHA, WHITE HOUSE [00:45:35] Yeah, but– but then there’s issues of production, there’s just a lot of challenges ahead, that means no one I know thinks we’re going to have a mucosal vaccine available in the United States in the next year, unless we do something different. [00:45:48] Now, one is we need it for COVID. I just think for long term management of this virus, we need it. The virus will continue to take a large toll on the American people, in terms of infections, hospitalizations, disruption, unless, again, and we can keep the things we are doing today are going to continue driving that down. But that’s the long term game, those– that kind of next generation vaccines. The other part is we need to build the capability to do those things, to build, I believe, mucosal vaccines, and pan-sarbecovirus vaccines, because there will be future pandemics with respiratory pathogens, and the ability to build, manufacture, let’s say, an intranasal vaccine is going to hold us in very good stead for whatever comes next. And our failure to invest in those things, Andy, I think, leaves us vulnerable, not just for COVID, but it leaves us vulnerable for future pandemics. So this is a really, really important thing for Congress to do.
DR. ANTHONY FAUCI, NIAID [20;14] On the ninth of September, there was a clinical trial of TPOXX in the United States as outpatient treatment for people with monkeypox. And what’s pending now, and will soon start this month, is a TPOXX or tecovirimat study in patients with monkeypox in the Democratic Republic of the Congo, a study led by Dr. Cliff Lane.
Thanks for reaching out. As of Sept. 2, 2022, there have been 13 confirmed cases in 2022 out of 33 reports of patients under investigation (PUIs). CDC has a webpage with information on AFM cases counts: AFM Cases and Outbreaks | CDC, which is typically updated at the beginning of the month. As the number of reports of patients under investigation for AFM (or suspected cases) from health departments increases, we will update the webpage more often, as needed. Starting this Friday, it will be updated on a weekly basis - so we expect to have updated AFM case counts to share on Sept. 16. CDC’s process for classifying suspect cases of AFM, according to the Council of State and Territorial Epidemiologist (CSTE) case definition, requires a thorough review of medical and radiologic information by AFM medical experts. Case classifications can take up to a month to complete because of the time it takes to collect and review all information. This is why it might take longer for the number of confirmed cases to change. However, clinical diagnosis, management, and treatment of the patient should not rely on the case classification process, which is done for disease tracking purposes.
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[2;26;29] ARPA GARAY, MODERNA: So I can take the first one. In terms of the 70 million doses, in conversations with the U.S. government, they expect to consume them with within about five months. So probably bleeding a little bit into early next year. But they will be primarily just focused at this winter season, at which point they will stop engaging in procurement, and move to the commercial market. Globally, as we look at what the demand might look like, we will start– we’ve already started seeing some uptake in September. But the vast majority of demand and the uptake will be in the fourth quarter.
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[2;07;48] ARPA GARAY, MODERNA: As we head into more of the commercial markets, we will be looking at more value based pricing. That’s– that’s more appropriate for the commercial market. And as just as a point of reference, in 2021, CMS actually did their cost effective analysis and said the original, the 1273 vaccines, were valued at about $64. So I think, you know, as we see different governments around the world doing their own cost effectiveness analyses, we’re seeing they are recognizing the value of these vaccines.
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[2;03;51] ARPA GARAY, MODERNA: What we’re also expecting from a market dynamic is that the COVID market is going to start reflecting more like the flu market. So what I mean by that is: typically, and this is what we’re hearing from many national institutions around the world, there is a very good likelihood that the COVID boosters will become annual, and likely at the same time as the flu– as the flu vaccine. So this is going to turn into more of a seasonal type of pattern, where we’re going to see most of the purchases, the contracts signed early in the year. And all of the actual vaccinations and deliveries and doses shipped later in the year. Again, it’s very similar to the flu dynamics.
[50;01] LISA GROHSKOPF, CDC: In general, it’s recommended that giving– when you’re giving to injectable vaccines at the same time, they be given in different sites. That doesn’t necessarily mean they have to be in different arms. They could be basically an inch or more apart, which is often possible to do in one arm. They could be in different arms, if that’s preferred. There is also a recommendation to consider, it’s not a necessity– if you’re giving an influenza vaccine, that might be more likely to be associated with a local reaction, for example, arm soreness, you know, whatever might happen at the injection site, with a COVID-19 vaccine, you can consider giving them in separate arms if possible. For the purposes of flu vaccine, the things that might be more likely to cause a local reaction are the higher dose of– the high dose or the adjuvanted vaccine: Fluzone High-Dose Quadrivalent or Fluad Quadrivalent. It wasn’t consistent in all studies, but in some studies, those were more likely to basically cause things like tenderness at the injection site and– and pain. So that’s something that you could consider.
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[51;09] EVELYN TWENTYMAN, CDC: Absolutely, and (crosstalk) absolutely. And I’ll add only that our COVID-19 vaccine coadministration recommendations note specifically, only, the adjuvanted or high-dose influenza vaccine should be administered in separate limbs, for the reasons that Dr. Grohskopf just so well articulated. But of course, as she said, patient preference is always important to consider. And there’s there’s no reason that you could not administer two different vaccines in two different arms just because influenza vaccine was not adjuvanted or high dose. We completely support physician and patient autonomy.
[05;49] Q: For our next question. Do you see a similar vaccination schedule to the current OPV and IPV schedule? Or will it require a different one? KONSTANTIN CHUMAKOV, FDA: OPV? I mean, in this country, as well as in most developed countries, right now, we have only IPV schedule. And I think it probably will remain, until a novel OPV will become available. And at that time, there will be a determination made whether it will be worth adding it to the immunization schedule. It will probably depend on how this whole thing unfolds. Because at some point– it’s clear that developed countries are using combination vaccines that include IPV, and it will be an uphill battle to change anything. I mean, it’s so well established, and it works so well, there is no reason to do it. But in countries that are still using OPV, and that cannot afford more expensive vaccines, this novel OPV could probably be a solution, at least until their you know, economic circumstances improve.
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[07;01] Q: So for our next question, what is your prediction regarding a timeline for when this might be available for a pediatrician say? KONSTANTIN CHUMAKOV, FDA: Well, novel OPV trivalent vaccine? It’s probably we’re looking at three to five years from now, if everything goes well. And then of course, there will be some effort needed to create a trivalent combination, which may not be a trivial thing, either. So I would think that five years would be a good estimate.
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[09;14] Q: Do you think continued use of IPV only regimen will be able to stop transmission of the VDPV in the U.S.? KONSTANTIN CHUMAKOV, FDA: No, I don’t think so. And the reason is that– I mean, in the ideal world, if everybody would comply with recommended immunization schedule, that probably could be the case. And then in that case, maybe even some circulation of viruses in the environment would not be a big deal, because everybody would be protected. But sadly, in some places, the compliance with the vaccination is pretty low. Some people object to vaccination by what for religious reasons, or just think that is not necessarily. So some people think, “Oh, look, I mean, there’s no polio! Why would I immunize my kid?” I mean, it just– people became complacent. And just– but also, of course, there is also a certain number of people who are immunodeficient and who are at risk because of the medical treatment that they are receiving, and so on. So, of course, it would be nice to not to have virus in circulation. So, for this, there is a clear solution. I mean, you immunize everybody with IPV and then follow it by OPV. That actually gives you protection all, both on the individual level and on the kind of community level. But that, of course, requires additional efforts. And I’m not sure that this will be accepted as a common practice, but potentially this could be a solution.
[03;14] DEMETRE DASKALAKIS, WHITE HOUSE: We continue to evaluate the investigational drug TPOXX or tecovirimat. The exciting news, that is in a few days, the NIH sponsored studies will launch of tecovirimat while we continue to work on the expanded access. One of the sort of big news flashes is it used to take several hours to complete the IND paperwork for TPOXX, from the perspective of access. Now it’s down to about 15 to 30 minutes per patient. So really exciting.
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[04;41] DEMETRE DASKALAKIS, WHITE HOUSE: So I’ll say that– that we’re not really making up for anything. What we’re doing is finally able to do extended work, because we’re not in a scarcity model for vaccine anymore. And so I think that the very first step in the equity interventions is not one that is one of the pilots, but it’s actually making sure we have enough vaccine to be able to really work hard to get it everywhere, in the arms that needs to get. So bringing it closer to people, as opposed to having people try to find a vaccine. So that’s all very exciting.
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The way we bill for COVID-19 vaccinations has not changed with the availability of the bivalent COVID-19 boosters. We connected with the pharmacy team to discuss the patient’s experience and have reminded them about our billing practices.
[3:23 PM] SARA OLIVER, CDC: It is important, however, to acknowledge what we don’t know. Right now we don’t know the rates of myocarditis after bivalent COVID-19. vaccines. It’s unlikely that the inclusion of Omicron would increase myocarditis rates. What we know that does impact myocarditis is age and sex of the individual, interval since previous dose, and potentially total dose may be related, but it’s unlikely that the inclusion of Omicron would have an impact. We don’t know the incremental increase in vaccine effectiveness. Antibody titers to currently circulating variants were higher after a bivalent booster dose than with the current monovalent booster. However, most of the data to inform recommendations were from that BA.1 bivalent vaccine. The incremental benefit from going from bi BA.1 to BA.4/5 are unknown. We also don’t know the duration of protection for these vaccines. However, antibody titers (inaudible) vaccine and prior infection were robust. This combination of prior infection and the bivalent vaccine may prolong the duration of protection, which can actually decrease a need for frequent boosters. However, as with all vaccines, the duration of protection may vary by age and immune status.
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[4;54 PM] SARA OLIVER, CDC: We also fully acknowledge that there will be a time of transition as the recommendations move from counting dose number to optimal timing of the vaccination campaigns. And we very clearly know, and have learned for the last two years, that vaccine recommendations that are simple and easy to communicate are important. The work group also discussed that, if SARS-CoV-2 becomes a seasonal virus, an annual vaccine program could be an effective strategy for the future. So all of this highlights that there’s a distinct effort to simplify vaccine recommendations through a transition to what could be a more sustainable and long term COVID vaccination program.
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[5:58 PM] BETH BELL, ACIP: Having said all of that, I think there are good arguments for going forward with that. The other comment that I wanted to make is that, while I wholeheartedly embrace this idea of being more routine, and this will– now we’re gonna have just maybe one booster, and that sort of path forward, as Dr. Wharton outlined at the very beginning of this meeting. I think it is important for people to understand that, while we will– we hope that we can go in that direction, and we’re all ready to change the way we’re dealing with this pandemic, I just think it’s important to recognize and to say that things might change, we don’t know what the future is going to hold, and while we would like to be more routine, it may be that we have to continue in this vein, depending on what happens with the virus and with the pandemic. I just don’t want people to totally get their hopes up, when I think we all recognize that we might not get there as quickly as we would like.
[19;06] PETER MARKS, FDA: That’s a great question because I get asked a fair amount about how does SARS-CoV-2 and influenza– how do they compare to one another? You know, influenza is something we’ve had a long history of. We have tracking systems around the globe. We have a vaccine that, in any given year is not really that perfect anyway, and we tend to get it more or less right by tracking the shift. We have two shots each year, because we have northern hemisphere and southern hemisphere strain selections. It’s a seasonal illness, perhaps not perfectly, but it’s been something that we’ve been able to follow, and generally the process is now kind of settled down upon. And we have a yearly annual vaccine. Here, for SARS-CoV-2, we’re in a situation that things are just evolving so fast that some of the cross protection that we sometimes see with influenza vaccines is hard to know how much of that we’re going to get, because of the nature of the evolution of these variants. We’ve had enough change that we’re talking about potentially having to vaccinate people more than once a year right now. So although there might be some similarities, there are also a fair number of differences. And I think it remains to be seen how similar they will be or will not be. And some of that, I think, will depend on where our vaccine technologies come over the coming year or two or three, in terms of being able to have better depth and breadth of protection that might last for a whole season or longer.
[11:28 AM] MIKAEL DOLSTEN, PFIZER: We are on one hand thrilled for the BA.4/5 EUA approval in the United States. And I think, as we speak, you can start to get slots for vaccination at many vaccination centers in United States. And we are making great progress also in Europe, and other places, to get these new updated variant vaccine. From the science that’s available today, I think it will provide a much desirable upgrade of the protection, as the virus has evaded the first generation of vaccines.
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[11:29 AM] MIKAEL DOLSTEN, PFIZER: We are working on additional improvement to make vaccination more durable, with propriety engineering of the vaccine. We think that can improve the overall protection of the vaccine, including symptoms. And then we are planning later this year for a study that includes more of a pan-SARS-CoV-2 variant vaccines that should allow you to be less vulnerable, as new strains evade.
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[11:30 AM] MIKAEL DOLSTEN, PFIZER: I don’t think that inhaled or intranasal is going to be an alternative for an intramuscular vaccine. I think the learning we have done in immunology of vaccines tells us those are the most reliable, most potent ways to get the systemic protection. I am intrigued that, for example, intranasal, which is a much more, I would say, local delivery, than going deep into the line, intranasal may be an adjunct approach. What do I mean by adjunct? It may be an opportunity to augment, particularly if there is a rapid, surprising, strain shift, augment your protected– protection from the mild symptoms. So this is something we’re intrigued and monitor to see if it could be an adjunct, but not a replacement substitution for the intramuscular. I think it would be just a top-off, in order to maybe remove or attenuate some of the upper airway symptoms, which could benefit from delivery of possibly mRNA based technologies into the nose. So something we are looking at, but right now, I think you should see them more as an add on, and I have no reason to believe that they would ever replace an intramuscular.
[23;58] RITA SINGHAL, LOS ANGELES COUNTY: It is variable, we will be doing an autopsy. So it does take time for those results to come back. So it may be as soon as a few days, or it may take a few weeks.
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[23;26] RITA SINGHAL, LOS ANGELES COUNTY: So I do want to confirm first that it’s not a confirmed death due to monkeypox. So we do have a death of a person who was– who did have a diagnosis of monkeypox. And so this is something that we will investigate further. Part of the investigation, we’ll be working with CDC and with the state to determine if there is any changes that are needed in the guidelines that they have put out regarding how we treat persons with monkeypox, especially if they’re getting severely ill.
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[15;14] RITA SINGHAL, LOS ANGELES COUNTY: We are currently investigating a death of a person with monkeypox in Los Angeles County. We are early in the investigation, and do not have additional details available at this time. As soon as details become available, we will share them, while maintaining confidentiality and privacy. This is one of two deaths in the United States that are currently under investigation to determine whether monkeypox was a contributing cause of death. Across the world, there have been seven confirmed deaths among monkeypox cases in non endemic countries.
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Public Health is currently investigating a death of a person with monkeypox in Los Angeles County. We are early in the investigation and do not have additional details available at this time. An autopsy is scheduled tomorrow and preliminary and final findings will inform the investigation. Public Health will share updates as appropriate while maintaining the confidentiality and privacy of individuals.
The California Department of Public Health is communicating with Los Angeles County Public Health about a potentially MPX-related death in Los Angeles. Additional questions about this case investigation should be directed to the Los Angeles County Public Health Department. While fatalities from MPX remain rare across the globe, this case investigation is a somber reminder that more progress is needed to curtail the outbreak of MPX. The risk of MPX to the public is currently low. While MPX can infect anyone, certain communities have been particularly impacted and face higher risks, especially persons self-identifying as men who have sex with men (MSM). Among all populations, people who may be at risk for more severe illness include those with a weakened immune system, children (particularly those younger than 8 years of age), those who are pregnant or breastfeeding, and those with a history of certain skin diseases like eczema. It is important to talk to your health care provider if you have symptoms of MPX and are experiencing pain or irritation due to the rash or sores. Information on appointments and eligibility criteria for MPX vaccination are available through My Turn - California COVID-19 Vaccine Scheduling & Notifications.
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As recently shared by CDC Director Dr. Rochelle Walensky, there is a strategic imperative to modernize CDC so that it consistently delivers public health information and guidance to Americans in real time – a mission recognized by the talented people who work there and by public health experts around the globe. Throughout her tenure as director, and over the last few months in particular, Dr. Walensky has evaluated CDC operations; she listened – to voices from within CDC, to its partners and other interested parties, and to external reviewers. In response, the director recently announced a series of changes that will prioritize public health action to help equitably protect and promote the health of the American people. To move the agency forward, Dr. Walensky is convening an implementation team that will lead these efforts, headed by former HHS Deputy Secretary Dr. Mary Wakefield. Dr. Walensky and Dr. Wakefield have asked BPHC Associate Administrator Jim Macrae to join this team for the next few months beginning Thursday, September 1. During Jim’s detail, BPHC Deputy Associate Administrator Tonya Bowers will serve as Acting Associate Administrator. We congratulate Jim on this opportunity to share his experience and expertise, and we look forward to welcoming him back upon his return.
11:12:27 AM ASHISH JHA, WHITE HOUSE: In addition to providing our perspective on the state of the pandemic, we are going to focus today on a major milestone– a major milestone we marked heading into the Labor Day weekend. The FDA authorized, and the CDC recommended, new updated COVID-19, vaccines for all Americans 12 and above. This makes us, the United States, the first nation with new vaccines that match the version of the Omicron variant that is currently dominant, dominant both here at the U.S> and around the world. For the first time, since December of 2020, these vaccines– our vaccines have caught up with the virus. And as Secretary Becerra and I will discuss, the Biden administration has been preparing for this moment, in close partnership with state and local health departments, with pharmacies and community health centers, rural health clinics, physicians, and other health care providers. This is a moment when people can keep themselves healthy and safe as they think about the road ahead. So we have worked extremely hard to make sure we have ample supply of these new updated vaccines available for the American people, and these vaccines will continue to remain free. Now, we have been working over the weekend to get these vaccines out to tens of thousands of convenient, trusted locations around the country.
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11:14:15 AM ANTHONY FAUCI, NIH: It is becoming increasingly clear that, looking forward, with the COVID-19 pandemic, in the absence of a dramatically different variant, we likely are moving towards a path with a vaccination cadence similar to that of the annual influenza vaccine, with annual updated COVID-19 shots matched to the currently circulating strains for most of the population. However some, particularly vulnerable groups, may continue to need more frequent vaccination against COVID-19.
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11:19:09 AM ASHISH JHA, WHITE HOUSE: So barring any new variant curveballs – we’ve seen curveballs – but barring those variant curveballs, for a large majority of Americans, we are moving to a point where a single annual COVID shot should provide a high degree of protection against serious illness all year. That’s an important milestone. Now, let me be clear. For our highest risk individuals, and here I’m thinking about my elderly parents for instance, who are in their 80s, or one of my close friends who recently had a liver transplantation, individuals like that may need more than annual protection. And we will ensure, in this administration, that they get whatever protection they need
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11:23:00 AM XAVIER BECERRA, HHS: Doses should start arriving, in fact actually, I think, as of this past Friday, they started arriving, and by the end of this week, over 90% of Americans will live within five miles of these new, updated vaccines. Americans can start to visit vaccines.gov to find a location near them with new updated vaccines. CVS, Walgreens, and other pharmacy partners began making appointments over the weekend, and we expect the appointments to be widely available within the next week or so.
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11:23:50 AM XAVIER BECERRA, HHS: As we work to deliver vaccines equitably, our focus is on reaching the highest risk of Americans, particularly people ages 50 and up. We will be ramping up our education and outreach efforts this month, as we head into October, when we expect more people to get their updated shots potentially together with their flu shots, as Dr. Jha mentioned, and heading into Thanksgiving, we’ll emphasize the importance of getting an updated shot. So for example, in the coming weeks, the Centers for Medicare and Medicaid Services will reach out to the more than 60 million people who receive Medicare emails to share information on these updated vaccines, including when and how to get them. And we’re engaging trusted partners and messengers to help spread the word To date, we’ve closed vaccine rates of disparity throughout the country. We have closed a ten point disparity gap in our nation’s vaccine rate, between white Americans and Black and Latino communities. We’ve engaged well over a thousand organizations that have reached over 26 million people and held hundreds of community events. And we launched the COVID-19 Community Corps, a national network of nearly 20,000 community leaders and volunteers who serve as trusted voices. Finally, we’re launching a national coordinated effort in collaboration with national, regional, and local community-based organizations to help meet people where they are. So, in September, the local chapters of the national PTA, the parent teacher association, will host “shots to go” vaccination clinics throughout the month. Organizations with strong reach among racial and ethnic minority communities, including the national coalition of 100 Black Women, Montague Cobb, and the National Hispanic Pastors Alliance, will host community health expos and vaccine drives throughout America and various cities. Faith-based groups, such as the Women’s Missionary Society Foundation, will host a series of vaccine events at AME Churches in several states. And groups of strong reach across rural communities, such as Healthy Trucking of America will host pop-up clinics. We have another opportunity to get ahead of this pandemic, and the Biden Harris administration will continue working with– with you, with all Americans every– every day to get everyone protected from COVID.
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11:28:46 AM ASHISH JHA, WHITE HOUSE: But as the president has said from day one, everyone has a part to play. So today, we’re calling on all Americans: roll up your sleeve and get your COVID-19 vaccine shot. If you don’t think you need it, because you are healthy, do it for your grandmother, do it for your vulnerable uncle, or for your friend And to state and local leaders and employers and school leaders, please help your communities get vaccinated this fall. Vaccines are not partisan, They are not political. We want everyone in your community, in your business, in your school, to stay healthy and safe without disruption.
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11:30:25 AM ROCHELLE WALENSKY, CDC: The seven-day average of hospital admissions is about 45 hundred per day, a decrease of about 14% over the prior week. Since April, we have seen a greater increase in hospitalization rates in older adults, relative to other age groups. For the week of September 3rd, over 63% of hospitalizations are in those 60 older, and about 46% of hospitalizations are in those 70 and older. The seven day average daily deaths are still too high. About 375 per day, well above the around 200 deaths a day we saw earlier this spring, and in my mind far too high for a vaccine preventable disease.
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11:36:26 AM ASHISH JHA, WHITE HOUSE: Let me just start off very quickly saying, we know FDA’s is working on both updating the primary series and making booster shots for kids under 12, the bivalent, but that work is ongoing. Obviously, in every one of these decisions, FDA looks at the totality of the evidence, and the FDA scientists make an independent decision. What I’m aware of is that they’re looking at the evidence, they are making assessments, I expect that there may be updates on the booster for kids under 12 at some point down the– later in the fall. But I don’t have any specific timeline or specific thing to offer.
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11:37:11 AM ANTHONY FAUCI, NIH: What I think what people need to appreciate, although it’s very important that we are now matching the new updated vaccine with the circulating, that the original ancestral strain vaccine created a very broad degree of coverage that did very well against many of the variants, as you know, from the D614G, to the Alpha, Beta, Gamma, Delta, and even Omicron. So we don’t want to deprive the population of getting that broad coverage, at the same time as we’ve given the added benefit of a variant specific that circulating. So I think it’s a very positive thing that, when you get people to get their primary vaccination, you give them the benefit of that initial broad coverage. So there’s a good reason to do that.
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11:44:36 AM ROCHELLE WALENSKY, CDC: This was not a CDC based modeling story, it was a modeling study done by others, but it was critically important and it does demonstrate, if we can get uptake, similar to a flu vaccine uptake, similar to what we get every single year from a flu vaccine, we could avert over a hundred thousand hospitalizations. In terms of projections, and we of course know where we are with around, you know, 45 hundred hospitalizations right now, and many of these projections anticipate, what we might see, as Dr. Jha indicated, with respiratory viruses and leading to more cases and potentially more hospitalizations. But those those projections, very much depend on everyone going out and doing exactly what we’re recommending, which is getting your updated COVID-19 vaccine now, which can avert all of the the challenges that we otherwise might anticipate.
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11:51:35 AM ASHISH JHA, WHITE HOUSE: So let me start off, and I suspect Mr. Secretary, you may have some thoughts on this as well. I had warned that we did not have funding for enough vaccines. We found ourselves in a, what I would say, is an impossible situation, of looking at the fall and winter and asking, even though Congress has failed to act, can we really go into the fall and winter without having vaccines for Americans. Watching Europeans, watching others have access to these bivalent vaccines. And we thought that was unacceptable. And so we have gone and pulled resources out of critical public health efforts. We had planned on having an adequate stock pile of PPE a person protective equipment, should there be another surge. We will not have that stockpile, We had to shut down covidtests.gov, a wildly popular program where two-thirds of American households had ordered tests, shut it down because we do not have enough tests in our stockpile, we do have the ability to continue. We will not have enough tests in our Strategic National Stockpile should we see another Omicron-like event. We had promised the American people, we would make sure that we did not get into that, but with– but we needed Congress to step up. Congress has not stepped up. So we are constantly making what I think are impossibly difficult decisions. But our commitment is to absolutely make sure that vaccines and treatments are widely available, easily accessible, and free. And that’s where we are and that is a set of decisions we’ve made. We think it is the the right set of decisions, but it certainly has not been easy ones.
I’m looking into the specifics of this individual situation, but I can tell you that the updated booster is available at no cost to any eligible patient either through insurance or if uninsured.
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The way we bill for COVID-19 vaccinations has not changed with the availability of the bivalent COVID-19 boosters. We connected with the pharmacy team to discuss the patient’s experience and have reminded them about our billing practices.
Imported from Revue
10:23 AM MELINDA WHARTON, CDC: So with FDA’s regulatory action approving the updated bivalent booster yesterday, we have an opportunity to update and simplify our recommendations for vaccine use. We hope this is the start of moving toward a more usual type of vaccine recommendations and process as well as a more normal cadence of ACIP meetings. This will be a transition now, and I’m sure there’ll be some bumps in the road, but it’s an important move towards simpler recommendations as well as an updated vaccine that we expect to provide broader immune protection. We thank the committee for their ongoing support.
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11:21 AM RUTH LINK-GELLES, CDC: Here we see relative VE for three versus two doses against symptomatic infection by age group, with VE estimates in the solid lines and 95% CIs by age group in the dotted lines. Estimates for individual age groups are less important here than the overall trend, which is the same across age groups. We have less follow up time for the 5 to 11 year olds due to the booster recommendation being more recent. However, so far, the trend is the same as for older age groups. As a reminder, we’ve seen previously that the primary series of VE against infection wanes to zero within a few months. So these results should be taken in that context. Next slide. Here we have VE of three versus zero doses against symptomatic infection on the left, and relative VE for four versus three doses on the right, with 50 to 64 year olds in blue, and 65 and older in orange. As with younger age groups, we see waning at or close to zero VE within a few months of three doses, with potentially less waning of the fourth dose, although we have limited follow up time given when the recommendation was made.
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11:23 AM RUTH LINK-GELLES, CDC: This slide shows VE during Omicron for 5 to 11 year olds on the top and 12 to 15 year olds on the bottom by time since last dose. Two dose estimates are in green and three dose in blue. You see similar patterns here across age groups, with VE of two doses against ED and UC visits waning substantially. In 12 to 15 year olds we see a nice bump in VE with a third dose, but did not have enough 5 to 11 year olds with booster doses to provide an estimate in that age group. Next slide. Now moving on to adult VE during BA.2 on the top and BA.4 and 5 on the bottom, with the same colors as before: two doses in green, three doses in blue, and now four doses in black – which is estimated only at 50 years and up. We see similar patterns in the two time periods with waning by time since the most recent dose. During BA.4 and 5, when we have more data on the fourth dose available, it appears that the fourth dose waned somewhat more slowly compared to two and three doses. Next slide.
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11:25 AM RUTH LINK-GELLES, CDC: These are results again from VISION, this time against hospitalization among immunocompetent adults. As we’ve seen from earlier variants, VE against hospitalization continues to be higher and more sustained over time versus less severe outcomes. Note that we’ve not included estimates for the 14 to 149 days after the second dose, due to small numbers of people recently finishing their primary series during the summer. VE during BA.4 and 5 was generally similar to VE during BA.2 predominance and so far the fourth dose, shown in black at the bottom of the slide, appears to be waning somewhat more slowly compared with a third dose, although again, confidence intervals are too wide to be conclusive. Next slide.
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11:27 AM RUTH LINK-GELLES, CDC: So to summarize, VE against severe disease continues to be higher and more sustained over time then VE against infection. VE during BA.4 and 5 dominance was generally comparable to VE during the BA.2 predominance. A third dose provided significant additional protection against infection and severe disease in all ages. And while the third dose did wane, especially against infection, it appears to wane slightly more slowly compared to the second dose, with similar patterns seen across age groups. Finally, fourth dose coverage was too low to draw conclusions, but additional benefits were demonstrated against all outcomes, with slower waning apparent, especially against hospitalization. Next slide.
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1:10 PM JACQUELINE MILLER, MODERNA: And finally, I will mention that we are generating data with booster doses in the pediatric population. Next slide. And then one more slide please. Our submissions of booster data generated in children 12 to 17 and 6 to 11 years of age are currently ongoing to the U.S. FDA. The original pediatric studies were extended to evaluate booster studies of mRNA-1273 in these populations, and similar to adults, where the booster is administered at half the dose of the primary series, adolescents receive a booster of 50 micrograms after a 100 microgram primary series, and children 6 to 11 years of age received 25 microgram booster after a primary series of 50 micrograms. We expect to complete these submissions by mid-September. Next slide. And then the youngest age stratum of children 6 months to 5 years of age, we’re evaluating a primary series with a bivalent BA.1 containing vaccine, and booster doses with both mRNA-1273 and the BA.1 bivalent vaccine. Results from this trial should be available by the end of the year. And we are also exploring ways to evaluate primary series and boosters with the BA.4/5 vaccines.
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1:13 PM JACQUELINE MILLER, MODERNA: Before taking any questions, there was a question stated earlier in the discussion around the presentation of booster vaccines. And so I’d like to say that the bivalent BA.4/5 vaccine will be presented in a two and a half mL vial. It’s intended to have a point five mL administration to adults over 18 years of age. And as we’re reducing the number of doses in the multi dose vial, we’re working towards the future looking for single syringe presentations.
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1:34 PM DARIN EDWARDS, MODERNA: Thank you, Dr. Miller. Yes, I think it’s highly relevant– two additional points are highly relevant. One, we now have two and a half years of experience with these animal models and how they do correlate to human immune responses. And we have seen very good correlation between effective doses and effective bivalent vaccines between mice, non-human primates, and humans to this point. One particularly relevant point, though, is we do measure in these animal studies the impact of variants on neutralizing titers. So, for example, a BA.1 neutralizing titer in a mouse vaccinated with 1273 is many fold reduced versus the original strain. And we see the same thing, recapitulated, when when we’re assessing human sera. So both from a immunogenicity standpoint and an impact of variants standpoint, these animal models have translated very well.
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2:17 PM ADAM (UNKNOWN LAST NAME), PFIZER: Okay, brilliant. If we could go to the next slide, please. Just to cover the first question related to the bivalent 30 microgram dose. I think this may be a slide build. If we could go to slide 38 please. Thanks very much. So the Omicron containing bivalent vaccine will retain the gray cap, as per the original vaccine. And the reason for this is the Omicron containing bivalent vaccine is essentially the same drug product, contains the same formulation as the original vaccine, albeit it contains the different strain, much like the flu vaccine. And the gray cap is to indication that the product is the same dose, requires the same storage conditions, and the same handling as the original cap presentation. And you can see from the information on the right hand side of the slide that we differentiate between the original primary series vaccine, for the original vaccine, and the BA.4/5 containing bivalent vaccine through the label, that is highlighted on the right hand side.
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2:48 PM SARA OLIVER, CDC: As you’ve heard previously, the EUAs are issued for the bivalent Pfizer vaccine in those 12 and over and the bivalent Moderna vaccine for those 18 and over. We’ll have votes for those specific vaccines and age groups specifically, but we’re also asking ACIP to consider the larger question: does ACIP support the use of updated or bivalent COVID-19 vaccine booster doses for those individuals and age groups already currently recommended to receive a COVID-19 vaccine booster? Next slide. On the left are the current recommendations, where the focus was on counting dose numbers. And those 5 through 49 years are recommended for three doses, and those 50 and over were recommended for four doses. On the right is, overall future proposed recommendations, where individuals recommended for a primary series and a bivalent booster dose, regardless of the previous booster doses given. Age and vaccines for this will be as authorized by FDA and recommended by ACIP and CDC. So this is not necessarily the recommendations today, but where we envision the future of the program going. We’ll hear from Dr. Hall later today around the details for the schedule, but I wanted to orient us to the broader discussion that we hope to have for today.
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2:52 PM SARA OLIVER, CDC: Then there COVID associated deaths, again throughout the pandemic, mortality rates have been higher, again among racial and ethnic minority populations. Again, they were more pronounced earlier in the pandemic. Then, as highlighted in the box, the recent mortality rates show less evidence of these disparities. Next slide.
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3:10 PM SARA OLIVER, CDC: So we’ve previously discussed immune tolerance and concerns for COVID-19 vaccine booster doses. As a reminder, immune tolerance is the concern that giving additional doses of COVID-19 vaccine would lead to lower antibody levels or a failure to restore antibody levels to what was seen after a previous dose, or T cell exhaustion. However, again, we aren’t seeing data at this point to suggest that this is occurring. Bivalent vaccine is able to improve vaccine titers in individuals without prior infection, and also provided robust boosts in antibody titers for individuals with prior infection. As you can see here on the right, we continue to see high antibody titers from vaccine prior to (inaudible) As you can see here on the right, the high antibody titers that we see for this bivalent vaccine plus prior infection could lead to slower waning and prolonged protection against COVID-19 and severe disease. Next slide. We also had discussed imprinting previously. Imprinting, sometimes known as the original antigenic sin concern, is the concern that the initial exposure to one virus strain primes B cell memory and limits the development of memory B cells and neutralizing antibodies against new strains. However, data suggests an improved, diverse response, obtained with bivalent vaccines. Antibody titers to all SARS-CoV-2 variants tested, were higher with the bivalent vaccine compared to the monovalent ancestral vaccine.
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3:24 PM SARA OLIVER, CDC: So in summary, the benefit of– the balance of benefits and risks for these bivalent vaccines. We know that for both Maderna and the Pfizer BioNTech vaccines, the bivalent vaccines increased the immune response for those who have completed a primary series and previous booster. We saw similar reactogenicity profiles. We know that the myocarditis risk is unknown, but anticipate a similar risk to what’s seen after the monovalent vaccines. We know that the modeling projects more hospitalizations and deaths would be averted when booster doses are recommended broadly for persons 18 and over, compared to those 50 and over and when the booster campaign began – would begin in September, compared to beginning in November. We also know that the benefits and harms for the U.S. population are best assessed when the clinical trial and study populations are optimally representative of the U.S. population. Next slide.
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3:25 PM SARA OLIVER, CDC: This slide shows survey data from an online survey conducted in partnership with CDC and the University of Iowa. We’ve seen results from this partnership frequently over the course of several ETRs. This survey was conducted recently over the month of August and showed that 72% of eligible respondents said that they definitely or probably would get an updated booster that protects against Omicron. Next slide. Among people who said that they were unsure about getting a booster, people both felt that they have enough protection from their prior dose, Or that the booster may not be effective. Next slide.
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3:34 PM SARA OLIVER, CDC: While many have received a second booster in the past six months, you can see comparatively few have received a dose in the past eight weeks. You can also tell that, overall, the numbers have declined with each of the booster recommendations as we’ve progressed. Next slide. This actually shows that, based on– that in September, based on the total number of persons eligible, which includes those who have completed a primary series, but not received a COVID vaccine in the past two months, consistent with the language in the EUA, is almost 210 million individuals, while the number ineligible, which would be those who had a vaccine dose in the past two months, is less than 5 million. Next slide. Overall, the U.S. government has purchased approximately 171 million bivalent mRNA vaccine booster doses for the fall and beyond, with the options to purchase additional doses as needed. Based on this, there will be a sufficient but finite supply of these vaccines. We do not anticipate limited supply settings overall. However, jurisdictions have been given considerations for selecting sites to receive the initial doses based on their ability to rapidly use the vaccine. These considerations were in the operational planning guide provided to jurisdictions, with the link at the bottom, and they include location and access to a range of populations to ensure equitable distribution, the ability to reach those at highest risk of COVID, the ability to handle the large product shipments, and the ability to administer the vaccines. Next slide.
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4:02 PM ELISHA HALL, CDC: We are changing the way we’re thinking about these vaccines, from dose counting monovalent boosters, to one bivalent booster for everyone eligible. So this table just reinforces that regardless of whether you’ve had zero, one, or two monovalent boosters, one bivalent booster is now recommended next. So since some people may have already had three, four, or even five doses, for those who are immunocompromised and had a second booster already, we want to emphasize we’re no longer looking at total number of doses. If eligible, meaning age 12 and older, have completed at least a primary series, and are two months out from the last dose, a bivalent booster should not be denied based on the number of total doses the person has received.
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4:11 PM ELISHA HALL, CDC: Our current timing guidance for vaccination in persons with current or prior SARS-CoV-2 infection also applies to bivalent boosters. If a person has current or prior SARS-CoV-2 infection, at a minimum, vaccination should be deferred at least until recovery from acute illness and criteria to discontinue isolation have been met. This is the minimum. Additionally, these people may consider delaying vaccination longer, by three months from symptom onset or positive test, if infection was asymptomatic. Individual factors, such as risk of COVID-19 severe disease, community level, or characteristics of the predominant strain, should be taken into account when determining whether to delay getting a COVID-19 vaccine after infection.
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4:21 PM TOM SHIMABUKURO, CDC: I don’t have the exact timeframe off the off the top of my head, but we’ve– there’s actually a couple of studies, which aren’t which aren’t published yet, one looks in v-safe data, and it looks at it looks at people who report having a vaccination – and I’m not sure how they define it – But I suspect it’s on the order of within several months, but based on that information, self reported reactogenicity appears to be, and that’s things like systemic reactogenicity, fever, fatigue, muscle aches, that type of thing, is reported with higher frequency if you’ve had a recent infection. But again, there’s there’s no evidence– or there’s a lack of evidence that that that places you at increased risk for myocarditis.
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4:25 PM SARAH MEYER, CDC: We have hundreds of thousands of doses being delivered around the country today, and by the end of the holiday weekend, millions of doses will be in the field, with more arriving every day. So we anticipate that we will quickly be able to have an authorized available booster product out there over the next couple of days.
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4:49 PM JEFFREY DUCHIN, ACIP: Your state and local health department colleagues are now in their third year, as well as our health clinicians, are in the third year of COVID pandemic response, as well as trying to respond to monkeypox outbreak and vaccination campaigns, on top of other local infectious disease outbreaks. Many areas are also grappling with climate related health emergencies like heat, flooding, wildfires. And the work of achieving optimal vaccination coverage and equitable vaccination coverage requires significant investment in building relationships with community partners, empowering community partners, and developing trust. And that trust requires consistency. And that consistency and the adequacy of the response overall requires funding. We have not received additional COVID funding. We have not received any monkeypox funding. And we are very much running on fumes after such a long outbreak response that is being now multitasked, with all the other overlaid responses by the same staff and healthcare providers.
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5:26 PM GRACE LEE, ACIP: I also want to emphasize that I feel strongly about reducing and mitigating any potential risks, if at all possible. And so, I am going to put out there that my personal preference is to anchor on three months, as a minimum interval, from either infection or a prior vaccine dose. That is what I will recommend to individuals who ask me. But I recognize that there is an authorization out there. I just– I just feel like we’ve seen benefits and reductions in harms by a longer interval.
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5:34 PM SARA OLIVER, CDC: Yeah. So I mean, I– we absolutely– the work group talked about this, as well. I think there are distinct reasons that it is– it is really helpful for the ACIP recommendations, in the current setting that we’re in, for the recommendations to match the EUA. If ACIP were to vote on a different recommendation, then that would be different than the authorized interval, and it would cause significant confusion and potentially legal issues with the provider agreement that there would be different intervals recommended by FDA and ACIP. So that’s why we’ve really tried to emphasize that we have in clinical considerations some considerations for longer interval, especially around those who have had prior infection. And that, for kind of the population that is at risk for myocarditis, the nearly every one of those individuals is six months, if not longer, from their last dose. I will say that this is not meant to imply that people need boosters every two months moving forward. As we said, this is a transition point for the program, where we’re moving hopefully forward. Where we’re not kind of counting doses with minimum intervals, but may be able to get on kind of a more regular schedule. I fully agree with Dr. Bell that we have to follow the data. And that could change. But that’s the plan. And so hopefully, the future interval is considerably longer. But this is, if we’re recommending a time based program, that we think everyone should should who’s eligible should go get this vaccine this fall, the minimum interval is two months since your last dose, but most people are longer than that. And it legally is– you need– needs to be in line with FDA. Thanks. 5:36 PM GRACE LEE, ACIP: Dr. Oliver, was there any objection to taking out the words at least two months? It could just be just 12 and older, after receipt of a primary series, with additional clarification on the wording. 5:36 PM SARA OLIVER, CDC: I mean, that it’s– the interval that matches the EUA, I think, is important here. 5:37 PM GRACE LEE, ACIP: I don’t quite understand that. But I mean– I understand that, we would say that at least two months has to pass. But it would allow us more flexibility to actually provide that information that’s needed for both clinicians and patients to understand, if they just got had an infection, perhaps more leeway or something along those lines. I just– there’s a lot of people who have had recent infection, and I read this as they should be getting it two months, even though it says at least two months. So this is a legal issue, we cannot change the wording of the recommendation? 5:37 PM SARA OLIVER, CDC: It’s it is a PREP Act liability if the ACIP recommendations are different than the EUA recommendations around specific things like time intervals. 5:38 PM BETH BELL, CDC: But I– just to push this just a little bit more, and ask if we’re not making a different recommendation if we simply are silent on the issue of the interval and the recommendation. It’s not exactly the same as contradicting the EUA language of the FDA. Again, we maybe or not– this may or may not be a very fruitful avenue. But I do wonder if the lawyers might look a little bit differently on this specific issue, which is not contradicting the FDA, it’s just being silent on the issue in the language of the recommendation. 5:38 PM MELINDA WHARTON, CDC: This is Melinda Wharton. I appreciate the concerns about this issue. I will remind you all that there are very few people who are within two dose– within two months of getting a recent dose. There’s– we’re just not talking about many people who are in the age groups that that are eligible for this. And– and realistically, as this goes forward and moves toward public– publication, program implementation, it will have to be in alignment with the EUA. I certainly appreciate the concerns, though, that you all have articulated. I think you absolutely have have expressed concerns about those groups of people for whom this may be the most– a more important consideration. And we do have, in the clinical considerations, guidance about people with recent infection. And I’m sure the conversation today has increased the visibility and awareness of those issues and, hopefully, people can make decisions about timing of vaccination accordingly. So I don’t think we can take it out in the vote. But you know, it’s– it’s not a– it’s not a requirement for a strict two month interval, it’s at least two months. And again, there’s very few people who are within two months of getting vaccinated anyway.
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5:50 PM PABLO SANCHEZ, ACIP: I voted no because I really feel that we need the human data. And that’s really, to me, really important. It’s a new vaccine, it’s a new platform, there’s a lot of vaccine hesitancy already, we need the human data. And at the same time, I think that the vaccine will be will have similar safety, as we’ve already seen with the other methods, with the previous vaccines with messenger RNA. And, you know, I, personally, am in the age group where I’m at high risk. And I, I’m almost sure that I will receive it. And I will take it. So I just feel that– that we really– that this was a bit premature. And I wish that we had seen that data. Having said that, I am comfortable that the vaccine will likely be safe like the others.
As it has been throughout the pandemic, Walgreens goal is to ensure COVID-19 vaccines and boosters are accessible to the public as new options become available and as eligibility expands to help provide better protection against COVID-19. Following additional guidance from the CDC, Walgreens will offer COVID-19 Pfizer and Moderna updated boosters to eligible individuals at select Walgreens locations, with vaccination appointments highly encouraged. Individuals will be able to schedule appointments following CDC approval by visiting Walgreens.com/ScheduleVaccine, the Walgreens app or calling 1-800-Walgreens.
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We plan to offer the Pfizer-BioNTech and Moderna bivalent COVID-19 booster vaccines once authorized by the CDC and once we have received supply. Following FDA authorization, the government’s distribution of the bivalent boosters started immediately. We expect our pharmacies to begin to receive supply on a rolling basis over the next few days and appointments will be made available at CVS.com and via the CVS Pharmacy app. We continue to provide our communities with convenient access to vaccines at CVS Pharmacy including the approved COVID-19 primary series, as well as flu and a number of other vaccinations, such as pneumonia and shingles. As announced by the FDA yesterday, the emergency use authorization (EUA) of the Moderna and Pfizer-BioNTech COVID-19 vaccines has been updated to remove the use of the original monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines for booster administration. Our vaccinating locations will continue to offer it as a primary series.
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As we have since the beginning of the pandemic, Walmart and Sam’s Club administers and dispenses all authorized vaccines and treatments related to COVID-19. Our pharmacists stand ready to administer bivalent boosters as supply allows. Visit our digital scheduler at http://www.walmart.com/CovidVaccine to make an appointment and find a location near you. Walk-in appointments are available as well. We have not stopped offering the primary vaccine series, which is administered as supply allows. We continue working with the CDC and other governmental agencies to help anyone seeking the primary vaccine series.
Novavax is anticipating US emergency use authorization (EUA) following completion of FDA’s review of data for our prototype COVID-19 vaccine as a booster in adults age 18 and older, and we are working to quickly bring it to market for this use upon authorization. As we continue to explore best practices for managing COVID-19 long term, we are conducting ongoing trials further evaluating our vaccine’s effectiveness and safety as a booster and preclinical data has indicated that our vaccine induces immune response against Omicron variants, including BA.4/5. This will be vital moving forward as we don’t know what variant(s) will be next.
Audience: Clinical Laboratories Level: Laboratory Alert CDC is aware of three Monkeypox virus (MPXV) cases in California in which preliminary data show a significant deletion in the tumor necrosis factor (TNF) receptor gene. This gene is the target for the CDC West African MPXV and Generic MPXV real-time PCR tests. At this point, the TNF receptor gene deletion is rare. Molecular laboratory developed tests (LDTs) designed using the CDC published primers and probes that specifically target Monkeypox virus did NOT detect the virus because of the TNF receptor gene deletion in these specimens. These cases were still correctly diagnosed because they were also tested with an LDT that was developed based on CDC’s published non-variola Orthopoxvirus (NVO) test. To prevent false negative results: If your laboratory is using a MPXV-specific LDT, refer highly suspicious Monkeypox virus specimens that result as negative to your public health laboratory, or to CDC, to confirm results. Public health laboratories and select commercial laboratories use the CDC FDA cleared NVO test, which can correctly identify Orthopoxvirus when the TNF gene deletion occurs. Use a multiplex assay that targets multiple viral genes, or an assay that targets an essential viral gene which is unlikely to mutate, or an assay that detects non-variola Orthopoxvirus. CDC will update the published primer and probe sequence information to alert test developers of this TNF receptor gene deletion.