tinalexander.github.io / notes / 2022 / 08 /
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Imported from Revue
The U.S. government made over 20 million doses of the updated COVID-19 booster vaccine available for pre-ordering prior to FDA authorization to enable jurisdictions, pharmacy partners, and federal entities to make sophisticated distribution and administration plans, should the booster be authorized by the FDA and recommended by CDC. All 50 states and the District of Columbia have pre-ordered doses.
11:00:39 AM PETER MARKS, FDA: First of all, we want to make sure that adults and the adolescents covered by this– this authorization are able to get the most up to date version of a booster vaccine. And that’s why we are no longer authorizing the monovalent, the original booster, for administration as a booster dose to those– those populations, despite the fact that they will remain, that original vaccine will remain what is given for the primary series, the first two doses of the mRNA vaccines.
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11:01:18 AM PETER MARKS, FDA: And the rationale for the two month window is that it’s– it’s two fold. First of all, if one tries to give too many vaccines right on top of one another, one may not have the kind of immune response than one would like to this– the additional vaccine. So this gives some space between vaccination And the second issue is that it also helps balance the risk benefit in terms of risk that may come from something like the uncommon risk of myocarditis, which can come if these vaccines are potentially– they seem to be associated with when they’re given closer to one another. And there are some other considerations as well, but I think that is– is probably some of two of the main ones.
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11:05:47 AM PETER MARKS, FDA: Now, another reason for getting this out there just is– in case you’re– you look at modeling, is that we are looking at a possible fall wave, with a peak around December 1st. And by giving the booster now, we will hopefully both control the current plateau that we’re in, even though we’re dropping off, we’re dropping off very slowly, as well as address this future potential wave that looms out there.
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11:11:55 AM PETER MARKS, FDA: So I mean that– I think Dr. Califf is right. We don’t want to– we want to make sure that when we make data available publicly, that we’re confident in those data, because a couple times during this pandemic, I personally have experienced where we went forward too quickly and had to double back. So I think we want to make sure that when we come out with data it’s data that we trust, and that will probably be– we’re probably at least one to two months off from having those data because of the time it takes to actually dose and then do the assays etc. That said, both manufacturers are diligently conducting the clinical trials that are needed to get this done.
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11:14:15 AM PETER MARKS, FDA: So this– what we’re doing here is what we do every year for influenza vaccine, which is we understand how the vaccine works really well, and that’s something I think we understand about the mRNA vaccine platform. There is a genetic sequence in the– and the– that is in, basically, that encodes a protein, and that is what we’re using here for vaccinations. So, we understand how the vaccine works. We understand from two different manufacturers, how they’ve three times over now, for three different variants besides original vaccine, have made– they’ve made boosters potentially because we thought we might need them for other variants such as Delta or Omicron BA.1. And they’ve shown that they produce very good immune responses in humans and they were safe, granted, in a small– small, number of individuals relatively, but in aggregate now, in enough people to feel comfortable on that when we change the sequence of these vaccines, we will produce– we will see an immune response to the protein that’s produced that will be robust. We have those data from humans, plus we have non-clinical data again, data from animal experiments, that that help bolster the– our impression that this should produce a better response. And that’s our expectation for these, and we’ll see whether that’s borne out. Again at no matter what, honestly, we get, in terms of incremental benefit here, it’s really important for people to think about getting boosted, because that– that prototype that original booster that’s there plus this will hopefully give us the kind of immunity we need right now to again tamp down the wave we have going through the country now, and hopefully bring us the protection we need through October, November, December, to prevent yet another wave that shuts down things like holiday plans, etc.
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11:16:32 AM ROBERT CALIFF, FDA: I’d like to emphasize the point made that people should remember, that this contains the prototype vaccine also. So the BA.4/5 component is additional to the prototype, and so people should have confidence that there will be a boost in immune status just like the previous boosters I’ve done. And again I’d emphasize, we’re not talking about trivial things here, we’re talking about prevention of death and hospitalization as an outcome. It’s just me, but I’ll also tell you, I’m turning 71 next month. I will be at the front of the line at the pharmacy getting my vaccination. I’m very confident about this.
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11:22:52 AM PETER MARKS, FDA: Let me take this second question because I know from the– I appreciate the letters from parents who are very interested in these, and I actually appreciate the fact that they’ve been very polite, actually. They want to know when they’re going to have their boosters. I appreciate that. They– these are– we are waiting for the companies to submit data from children on these. And we would expect, again, I can’t promise an exact timing, but we expect to start seeing the age range dropped down into the younger age ranges, within the next one to two months. And so as we get submissions from the companies, we will act on them with all due diligence, because we’re aware that there are, particularly in the slightly older age ranges of children, some children that are coming due for boosters. So that’s that situation.
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11:23:47 AM PETER MARKS, FDA: As for the issue of when we move to the bivalent type of vaccine for the primary series, we had a discussion of this at our vaccines advisory committee meeting, is this came– this topic came up. We’re considering this a transitional year where we feel like everyone needs to get this base of immunity that we understand really well, because half a billion people in the world have received it, and we believe that building on that is important. So those who have not yet been vaccinated, if they decide to go out and get vaccinated, which I hope they will– they will, you know, either get their two doses, three or four weeks apart, and then two months after that, they’ll be up to date as well when they go get their booster. So I think this makes sure that everyone has this good base upon which we build upon, which will help protect us against the unknown. Probably if I had to say what keeps me up at night most in this pandemic, it’s that we have seen lots of twists and turns that were hard to predict. So it’s the unknown unknowns that really are concerning, so we don’t know what may come up later this year. And by doing this, we’ve tried to mitigate against that by making sure that we understand the protection very well. The base level of protection that people have.
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11:25:24 AM Q: And can you clarify, in children down to six months, it’s administration of the BA.4/5 booster? That’s the data you’re waiting for? Not the BA.1? PETER MARKS, FDA: So it’s it’s a variety– there’s a variety of different data, and I can’t go into what might be in pending submissions, but there’s a variety of different data that may be coming in.
Imported from Revue
This is the first death in an presumed positive for monkeypox that we are aware of. However, the individual had various severe illnesses and until the investigation is complete, it is premature to assign a specific cause of death.
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CDC is aware of a reported death of an individual who had severe illnesses and presumed positive for monkeypox in Harris County, Texas. 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 Texas officials to investigate this situation. Until the investigation is complete, it is premature to assign a specific cause of death. To date, more than 17,000 people in the United States have contracted monkeypox. Currently, 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 and 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
2:06:33 PM BEL EDWARDS, LA: Several weeks ago, I called you to make sure that this event was on your radar, it already was, and in fact, you had already started communications with folks here in Louisiana. And so, I want to thank Dr. Walensky because she’s personally made calls into Louisiana and talked to some of our healthcare professionals. But also Dr. Daskalakis as well, who is no stranger to New Orleans, and he’s been helping us here for quite some times. And of course, I want to thank Secretary Becerra too. This is an example of, I think, a really solid example of what a federal state local partnership and then the community providers as well, because the public health folks in New Orleans have been tremendous, but also the community providers, and it has manifested itself in several, I think, significant ways. So for example, you all have sent down multidisciplinary teams to the New Orleans to help us to organize, to prepare, to better communicate and do outreach, and set up testing and vaccination sites in the community. They’re going to be convenient for the at-risk of population. And at our request, you sent down additional doses, so that we could administer more vaccines, both to residents, and to visitors around Southern Decadence festival. 6,000 doses, we thank you so much. And with respect to testing, you are going to pilot a mobile testing facility here around the Southern Decadence festival too, so we really appreciate that.
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2:10:58 PM XAVIER BECERRA, HHS: Our focus, every day, is making sure that those most at risk for monkeypox have the information and resources they need – vaccines, tests, treatment – to keep themselves and their loved ones safe. As Bob mentioned, our latest effort involves working with state and local governments across the country to set up vaccination clinics at key upcoming festivals. This is work that started a few weeks back when we allocated additional supplies of Jynneos vials to the pride festival in Charlotte, North Carolina. At that festival, local public health officials were able to vaccinate 540 people. Today, I’m happy to announce that we will be allocating an additional supply of the Jynneos vaccine vials to the Southern Decadence festival in New Orleans. Louisiana, and the Black Pride festival in Atlanta ,Georgia, which will allow up to 5,000 vaccinations at each event. We will also be allocating an additional supply of Jynneos vials to two festivals in Oakland, California, the Pride Festival, which is also this weekend, and Pride Fest, on September 11th.This allocation will allow up to 2,400 additional vaccinations and we’re not stopping there. I’m happy to report that we’re working with additional jurisdictions to assure that we’re able to set up vaccination clinics at other key festivals.
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2:15:17 PM DEMETRE DASKALAKIS, WHITE HOUSE: That’s exactly why today we’re announcing an equity innovation pilot that earmarks an additional 10,000 vials of vaccine for smaller equity interventions that are identified by jurisdictions. This is an exciting new program that is directly based on our conversations and collaboration with local leaders and groups on the ground about what they may need to reach their communities.. Jurisdictions that have used more than 50% of their delivered vaccine qualify for an allocation of vaccine to support up to five smaller equity interventions that reach populations that could benefit from monkeypox prevention. So what we mean by an equity intervention is: what works in your state, county, or city to reach people who we may not be reaching, especially people of color and members of the LGBTQI plus population.
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2:23:43 PM JENNIFER MCQUISTON, CDC: CDC has been in touch with Texas and Harris County and we are aware that they’re reporting a death in a patient that did test positive for monkeypox. It’s our understanding this patient also had underlying health conditions, and had a number of things going on, and I think that additional investigation is needed to know what role monkeypox may or may not have played in their deaths. So we’ll be reporting that out as soon as we have more information. I think it’s important to emphasize that deaths due to monkeypox, while possible, remain very rare. In most cases, people are experiencing infection that resolves over time. And there have been very few desks even reporting globally. Out of over 40,000 cases around the world, only a handful of fatalities have been reported. It’s serious and our hearts certainly go out to this family who have lost a loved one. And while we are doing further investigations to find out what role monkeypox may have played, it is important to focus that we have mitigation measures to prevent monkeypox: get vaccinated if you’re sick, go to a doctor, get tested, and if you have severe illness, there are treatments that are available.
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2:34:21 PM DAWN O’CONNELL, ASPR: Thank you so much secretary. So our focus and priority remains making sure that we have the tools to end this outbreak as quickly as possible. And if we were to receive additional funding, among the things that funding might go to are additional purchases of vaccine, additional purchases of TPOXX, making sure that we have the antivirals and the vaccine available for those populations that might need it, and we can use these tools to end the outbreak as quickly as possible. So we’re continuing to look across what those budget numbers might be and– and plan accordingly,
[14;31] ROBERT CALIFF, FDA: There’s a term we use called totality of evidence, which sort of– what we just discussed, all these many people with expertise in different areas, come together, look at all the evidence, including the historical evidence. And in this case, we now have multiple versions of the mRNA vaccine, as it’s called, with two different companies doing multiple studies, showing that it’s been reliable, that if you induce an immune response, that is antibodies to the particular virus that you’re trying to take care of, that that translates into a clinical benefit. And of course, that’s always an extrapolation when you make it, but it’s what we do with the flu vaccine every year. So it’s not something new for us. It’s sort of the combination of multiple versions of this vaccine over time. And the consistency of the immune response, that’s being elicited by this vaccine, is giving us confidence. Now, of course, we’re still reviewing the data from that the companies have submitted, so we’re not ready yet to make that decision. But if it goes, as expected, according to pattern, we will make that extrapolation.
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[16;02] ROBERT CALIFF, FDA: One way I’ve thought about this, and, you know, I grew up in clinically, in my research career, and a glorious time in cardiology, where we did big studies, we proved the benefits and risk over the course of years, and then things came on the market. And we could implement their use in a very deliberate way, armed with really high quality data. In the midst of a pandemic, if you wait for all that data to come in, you’ve missed the boat. And so you have to be preemptive in a pandemic, which means that you have to take some of the steps that we’ve taken. But, I have great comfort in the community of experts that have looked at this and are coming to the conclusions that we’re in a time now where we can adapt the vaccine to the circumstance and take advantage of prior knowledge. And then of course, there’s post marketing surveillance and evaluation which will continue.
Imported from Revue
Today, the Biden Administration is announcing that it will suspend taking orders for free at-home tests through COVIDTests.gov as of Friday, September 2, because Congress has not provided the COVID-19 funding we need to replenish the nation’s stockpile of tests. As a result, we are suspending new orders through this program to preserve our limited remaining supply, so that we can ensure we have a limited supply of tests available in the fall, when we might face a new rise in infections and more acute need.
The Administration has been clear about our urgent COVID-19 response funding needs. We have warned that Congressional inaction would force unacceptable tradeoffs and harm our overall COVID-19 preparedness and response—and that the consequences would likely worsen over time. We were also clear that failing to provide resources to be prepared would mean that if a surge were to come later, the cost to the American taxpayer would be even higher. Unfortunately, because of the limited funding we have to work with, we have had to make impossible choices about which tools and programs to invest in—and which ones we must downsize, pause, or end all together. The Administration will continue to work within its limited existing resources to secure as many additional tests as we can.
We have already distributed over 600 million tests through COVIDTests.gov, and every household has had the opportunity to place three orders for a total of 16 tests. Notwithstanding this suspension of additional free at-home test distribution, Americans will continue to have other options for free testing, including at-home tests reimbursed by private health insurance, Medicare and Medicaid; over 92% of Americans are covered by one of these programs. In addition, the Administration continues to ensure equitable access to tests through a number of programs, including free tests distributed directly to long-term care facilities, schools, child care and early learning centers, community health centers, and food banks. And, there continue to be 15,000 federally-supported community-based free testing sites, including local pharmacies and libraries.
If Congress provides funding, we will expeditiously resume distribution of free tests through COVIDTests.gov. Until then, we believe reserving the remaining tests for distribution later this year is the best course.
[05;21] ROCHELLE WALENSKY, CDC: As we have updated these booster shots for the fall, the data that we’re looking at is related to very, very small changes in the mRNA sequence, and really shouldn’t impact safety at all. We’re not expecting it will impact safety. There’s always a question here of being too slow versus too fast. And I think one of the challenges is, if we wait for those data to emerge in human data, not just mice data, in human data, we will be using what I would consider to be a potentially outdated vaccine. And maybe it’s best, and I believe, it is best to use a vaccine that’s tailored for the variant that we have right now. So we do know that the very– over 88 percent of the sequences that we’re seeing right now are BA.5, over 98% are either BA.4 or BA.5. So the strategy now is to tailor vaccine for giving us the largest breadth of response, ideally one that would have less waning over time. And that is by targeting the– what I would say is the most proximal variant, the one that we have closest to us, which is BA.4 and BA.5. And I believe there’s significant upsides to doing that with this updated bivalent vaccine, and very little downside in doing so.
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[04;03] ROCHELLE WALENSKY, CDC: But if you are in a place where you feel like you’re at high risk of severe disease, if you’re over the age of 50, if you’re especially over the age of 65, and there’s a lot of infection in your community, you may want to go ahead and not wait for that booster– the information from that booster. Get the one that is available to you now and then we’ll have further recommendations about when you can get an updated booster in the fall. What I really want to avoid is somebody who was waiting two weeks and happened to get severely ill in that interim period of time, when they could have avoided that by getting the prototype booster now. So my party line is never a bad time to get a booster if you’re eligible. If you get one today, and you should if you’re eligible, that doesn’t necessarily mean you won’t– you won’t have a recommendation for another one in the fall.
[41;20] BRUCE FURNESS, CDC: So in my clinic, we see PrEP patients, so they are taking HIV prevention medicine. And we also have those that are affected that are on retroviral therapy. In my experience, I’ve not seen differences in the clinical manifestation of this particular atypical outbreak between those that are taking medicine to prevent HIV and those that are taking medicine to treat their HIV. That being said, we have seen one or two pretty bad outbreaks among HIV infected individuals that didn’t have good control. And when I say this, I’m talking, the pictures of these patients are similar to what you see about those with those really bad outbreaks in the Congo, and in the parts of Africa where this virus is endemic. So no– I– I believe that well, controlled HIV doesn’t lead to additional risk. But we have seen some pretty significant outbreaks among individuals that are HIV positive and not well controlled.
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[44;19] KATHRINE TAN, CDC: Currently, right now we’re watching very carefully the populations that are being most impacted by this outbreak. And considering the vaccine supply that we have right now, we’re trying to focus on those that were recently exposed to monkeypox. And so, for this outbreak, we don’t know and we have not heard of any cases of monkeypox among among those that are incarcerated. There was possibly one case, but there is no other transmission after that. And so for that reason, because we have not really seen monkeypox in this population. We are not recommending vaccination in general for those that are incarcerated at this time.
Imported from Revue
Pfizer/BioNTech has not yet fully reviewed the complaint but we are surprised by the litigation given the Pfizer/BioNTech COVID-19 Vaccine was based on BioNTech’s proprietary mRNA technology and developed by both BioNTech and Pfizer. We remain confident in our intellectual property supporting the Pfizer/BioNTech vaccine and will vigorously defend against the allegations of the lawsuit.
2:25:16 PM BOB FENTON, WHITE HOUSE: I’m also glad that we’ve seen significant progress in intradermal administration of vaccine in just the last two weeks. As of today, 75% of jurisdictions are already applying intradermal administration of vaccine and another 20% are working to move in that direction. This is important progress in a short period of time. As the– as the cumulative 1.1 million vials are delivered to jurisdictions, and as we get more supply, we are approaching the point where we can offer two doses of vaccine to the entire high risk population via intradermal administration.
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2:29:20 PM DAWN O’CONNELL, ASPR: Across all four phases of the national vaccine strategy, we have allocated approximately 1.1 million vials of Jynneos vaccine. We shipped about half of that number prior to the FDA issuing their emergency use authorization for Jynneos allowing for intradermal administration. So those first 600,000 or so vials were distributed when one vial equaled one dose. Since the FDA issued the EUA on August 9th, we have shipped approximately 188,000 additional vials of vaccine, which represents up to 940,000 doses using the intradermal vaccination method covered by the EUA. Combined, that comes to about 1.5 million doses already distributed in the field. Now on Monday, we launched the fourth phase of our national vaccine strategy, making the next 360,000 vials of vaccine available to states and jurisdictions for ordering and distribution. Using the intradermal administration method, jurisdictions can administer up to 1.8 million doses of vaccines from these vials. Taken together, by the end of phase 4, we will have provided enough vials to state and jurisdictions to provide more than three million doses of vaccines. Meaning we have supplied nearly enough vaccine to reach the entire at risk population.
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2:30:50 PM DAWN O’CONNELL, ASPR: Now, as supply continues to increase steadily and we ship out thousands of doses daily, it’s important that we make sure that things are going to the people in places that need the most, and that shots, like Bob said, are getting into arms, not sitting on shelves. As part of Phase 4, in order for a jurisdiction to order from its allocation, it must attest that it has utilized at least 85% of its current supply. Since Monday, 14 jurisdictions have attested to 85% utilization. And as soon as the jurisdictions let us know that they have used 85% of their supplies, we place an order more, the Strategic National Stockpile team immediately fulfills those orders and ships them out. Of the jurisdictions that have attested to this 85% utilization, since Monday, ASPR has shipped nearly 48,000 vials of vaccine, which represents up to 240,000 doses.
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2:31:44 PM DAWN O’CONNELL, ASPR: DAWN O’CONNELL, ASPR: Looking ahead, we anticipate another 150,000 vials of vaccine from our supplier, which represents up to 750,000 doses. And all coming in as early as late September. In addition, last week, we announced that Bavarian Nordic reached agreement with Grand River Aseptic Manufacturing to establish the first US-based fill and finish for Jynneos in Grand Rapids, Michigan, Once up and running, this facility will fill and finish 2.5 million vials we ordered this summer. This is an important step in building our domestic capacity and in providing domestic jobs
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2:32:22 PM DAWN O’CONNELL, ASPR: It is also important to us that TPOXX is easily accessible for treatment to those at high risk for severe disease. That is why last week we announced that we would pre-position up to 50,000 patient courses. That’s three times as many treatment courses as there are monkeypox cases. Jurisdictions are able to start ordering those treatment courses earlier this week, and so far, the SNS has shipped out about 10,000 courses to 19 jurisdictions. That’s in addition to the more than 22,000 courses we’ve already shipped. This approach allows us to pre-position these treatment courses for quick and easy access for patients to qualify for them.
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2:34:24 PM ROCHELLE WALENSKY, CDC: Today, CDC is posting additional data that provide a picture of monkeypox vaccine administration in the United States. Our plan is to update these data on a weekly basis on the CDC website. It’s important to know that the data we’re releasing today reflect only 19 jurisdictions where data are flowing to CDC for analysis. But the data do provide us with an insight and understand where we are in our efforts to administer vaccine to those at risk. We’re actively collaborating with the remaining jurisdictions so that they can upload their data in response to our data use agreements.
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2:44:09 PM ROCHELLE WALENSKY, CDC: That’s a great question. So we have started to see globally that we may be turning a corner. We, in the United States, had our first case about two weeks after some of the European countries that we have also started to see turn around, and as you note– or turn downward, as you note, there’s certain jurisdictions New York Chicago, San Francisco that are starting to report that they’re at starting to see a downward trend. I want to be cautiously optimistic about these, not only because of the downward trend, but because of the AMIS data that Dr. Daskalakis just noted, that we’re actually seeing vaccine get out, behaviors change, harm reduction messages being heard and implemented, and all of that working together to bend the curve, if you will, That said, I also want to say that week over week our numbers are still increasing. The rate of rise is lower, but we are still seeing increases, and we are, of course, a very diverse country, and things are not even across the country. So we’re watching this with cautious optimism and really hopeful that many of our harm reduction messages and our vaccines are getting out there and working.
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2:51:09 PM ROCHELLE WALENSKY, CDC: Yeah, great, thank you for that question. So we have said that these vials may contain up to five doses. I do want to be clear that we recognize that not all vials will– providers be able to get five doses out of– as you note, three, may be some possibility. We also recognize that in some situations, they may be only able to use a single dose from that vial, either because it’s administered to a child, or just somebody who has a keloid reaction from sub-Q dosing. So we have built in a buffer as we’ve been allocating and distributing to rest assured that people who are getting the doses that they need without anticipating that every single one is going to get five doses out of the vial.
[01;42] PETER MARKS, FDA: We heard loud and clear from parents that they did not want us to see kids left behind. And so, we will make sure that, as we get submissions in, and have the data, that we expand the age range down.
Imported from Revue
[16;49] DEMETRE DASKALAKIS, WHITE HOUSE: So I’ll start with probably the most important thing: just know that the risk level in institutions of higher education is extremely low. With that said, we recommend that colleges and college students are really mindful of signs and symptoms and monkeypox and that– that you all are very aware of the populations who are overrepresented in this current outbreak, because those populations are also a part of your– of your campuses and your higher education institutions.
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[28;11] MARTHA MONTGOMERY, CDC: So if an IHE has not had a case of monkeypox, you can continue following normal operations to prevent the spread of infectious diseases. So the following steps are ones that your IHE should take, as part of normal operations, regardless of a disease outbreak in the community. This includes encouraging staff and students to stay home when they’re sick, providing access to hand washing and supplies– you know, it’s not a real public health presentation unless we remind you to wash your hands – regularly cleaning high touch surfaces, and disinfecting with when needed. Your IHE should also identify a space for students who are sick to be isolated when needed.
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[30;10] MARTHA MONTGOMERY, CDC: If someone has monkeypox, the school should make sure to clean and disinfect the areas where the person with monkeypox spent time. This includes surfaces, shared materials, etc. IHEs should also work with their health department to identify and monitor the health of any staff or students who might have had close contact with the person who has monkeypox. IHEs should provide fact based information about monkeypox to staff and students. The person who has monkeypox should isolate. If it’s a student who lives on campus, IHEs choose can use a dedicated section in the dormitory ideally with a dedicated bathroom and dedicated laundry. If that’s not possible, then the IHE can work with the health department to determine appropriate laundry and options. When possible, the IHE should arrange for virtual classes so that the person who has monkeypox can continue their education while in isolation.
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[36;14] LISA BARRIOS, CDC: So both Pfizer and Moderna finalized their submissions for emergency use authorizations for their new bivalent boosters to the FDA this week, and potential FDA authorizations are expected shortly. So following that authorization, CDC’s Advisory Committee on Immunization Practices will convene to discuss potential recommendations. In fact, a meeting of that advisory committee was just scheduled for the end of next week, and administration of any new booster can begin after CDC officially recommends that happen. But it’s possible that those new bivalent boosters will start shipping out to states next week.
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[40;25] DEMETRE DASKALAKIS, WHITE HOUSE: So it is so complicated. And we’re hoping that the WHO– that they move in a direction that breaks the tie. I’ll tell you, so, MPX has an issue because I think it conjures like other– another product that is, I think, a rifle? So some folks don’t like MPX because of that. MPV has a little complexity, I think we use it as well, but not very frequently, because I think sometimes though– it’s not a virus you’re worried about so much– I think that’s also the abbreviation for metapneumovirus, which is like a respiratory virus that can cause wheezing. So I think that it’s like tremendously complex and hoping that we get clarity if it’s renamed. But I think if people know that if you’re talking about MPV right now, we know what you’re talking about. And it’s probably not talking about metapneumovirus. So that’s fair, since that’s not a very common one. But definitely, all that viral taxonomy, all the sort of nomenclature is complex. And so we’re sort of watching WHO with a lot of interest.
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[51;16] DEMETRE DASKALAKIS, WHITE HOUSE: So that I know is a little bit medical, but it’s a part of the treatment strategy for monkeypox, not only thinking about using this investigational drug– and footnote, there are studies that are coming starting September 9 that folks may qualify for. So look out for that in your area as well. And maybe even in your academic institution. But then also, really close attention to recovery and symptomatic treatment is important.
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[01;03;53] MARTHA MONTGOMERY, CDC: I think, kind of as I mentioned earlier, because of that– the long potential duration of the need for isolation, the first thing to note is, you know, monkeypox is not COVID-19. So the number of bed spaces available that will be needed is not nearly the same thing. So, you know, you should sort of try to disassociate those two. Having that isolation space available is really important. But you can, this is kind of the good, better, both, best approach that I mentioned earlier. So, of course, the best option is if you can give somebody an isolated room with a door that shuts their own bathroom, their own laundry, I don’t know– that didn’t happen in my college. But, that’s kind of your ideal option. I will also note that multiple people who have tested positive can stay together, if you can figure out the logistics for that, they can stay in the same room together. So that might help to free up some space. The kind of next best option, people live locally, then I think they could go home to isolate, making sure that if there’s virtual options for learning, that those are made available. Another option is the– the sort of like least ideal approach is if people must be around others, or if they have to leave the isolation, make sure that students with monkeypox are wearing a well fitting disposable mask over their nose in their mouth, and that any lesions that are exposed are well covered.
The Florida Department of Health is no longer the middleman for federal vaccine distribution. Local providers order through Florida SHOTS, as they do with most immunizations. This ensures demand meets supply and avoids unnecessary excess. Providers have until Thursday, August 25, 2022, to pre-order. These doses will be delivered directly to providers who order.
[16;54] ASHISH JHA, WHITE HOUSE: So the– the antigen tests continue to work just fine. But then the question is, what are they working fine in? What are they doing? Antigen tests turn positive, when you have a high enough viral load that it’s going to cause you to be able to be contagious and transmit. So if you think about somebody who gets infected, there’s a period of time when they’re positive, and maybe on a PCR test, but they’re not yet contagious. During that period, the antigen test will be negative. So people say, “Oh, the antigen test isn’t working,” except it’s not really a test to know whether you’re infected or not. It’s a test to know whether you’re contagious or not, right? So once you get into that contagious period, where you have a lot of virus in your nose and your throat, that antigen test turns positive. And then, as that contagiousness goes down over time, you may still have symptoms, you may still be testing positive on PCR, but if you’re no longer contagious, the antigen test will turn negative. And so people often say “whoa, does that mean the test isn’t working?” If your goal is just diagnosis, yeah, sometimes the test will be negative when you actually have the virus. If your goal is contagiousness, the test is quite good.
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[6;20] ANTHONY FAUCI, NIH: Well, it’s remarkable transmissibility, Andy, because I have been compulsively careful about wearing masks and not, you know, being exposed in congregate settings. And I know exactly when I got infected. I had to go up to my 60th college reunion where they were honoring me by naming a building the Anthony Fauci Science Center, which was such a wonderful honor. And I went into the reception, and all of my classmates from the Class of 1962 were unmasked. They saw me, they got very enthusiastic, they came to give hugs. So I looked– I felt I looked so out of place with a mask on. I literally took my mask off for about 45 minutes, mingling with them and their family. Went back, put my mask on. Five days later, bingo, I was infected. (That’s all it took?) Yeah, it’s all it took. So that’s the first thing I learned. The second thing was the remarkable diminution of symptoms within 12 to 18 hours after I took my Paxlovid. It really made a difference. I mean, I was sniffling and a headache and – and a little bit aches, I took Paxlovid. In the first doses were the afternoon dose. By the following morning, I was completely asymptomatic, which tells me that it really does work as an antiviral.
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[11;14] ANTHONY FAUCI, NIH: A, it’s going to be available the first or second week in September, from Pfizer, and probably the end of September, beginning of October, for Moderna. Number two, if you are an elderly person with an underlying condition, and you have not been vaccinated in calendar year– boosted in calendar year 2022, you shouldn’t wait. Because given the degree of viral dynamics with BA.5 right now, as you and I are speaking, you’re in danger. So I wouldn’t wait. If you’re an otherwise healthy person, a young person, or even someone who’s a little bit older, but still very few if any underlying conditions, I would wait, because the chances if you’re vaccinated, but unboosted, of getting a severe illness is low. If you really want to get the updated booster of a BA.5, I would wait. And the third part of your question is, when it does become available, should you get it right away? Or should you wait? You know, one of the dangers, Andy, in waiting for an outbreak to occur, is that by the time you know it’s occurred, you may be one of the vulnerable people that got infected. So if I had not been boosted, in, let’s say the last six months or so, and it came out in the middle of September, I would probably get it right away, or try and coincide it with the influenza vaccine, try to get them both at the same time.
Audience: Clinical Laboratory Professionals Level: Laboratory Advisory To prevent false positive test results, CDC recommends that laboratory professionals perform repeat testing to verify positive diagnostic results for Orthopoxvirus or Monkeypox virus DNA in specimens with high Cycle Threshold (Ct) values from persons who do not meet identified epidemiologic risk criteria for monkeypox. Review laboratory test results (including raw data, PCR curves, etc.) carefully before you report results. Because molecular tests (e.g., real-time PCR tests) are very sensitive, cross-contamination is possible. If you obtain a high Ct value (generally ~34 or higher), CDC recommends to immediately re-extract and re-test to ensure there was no cross-contamination. CDC suggests this approach based on high Ct value alone, even in the absence of epidemiologic information. When possible, re-extract and re-test before you report results.
The Florida Department of Health is no longer the middleman for federal vaccine distribution. Local providers order through Florida SHOTS, as they do with most immunizations. This ensures demand meets supply and avoids unnecessary excess. Providers have until Thursday, August 25, 2022, to pre-order. These doses will be delivered directly to providers who order.
[39;04] PAUL CHAPLIN, BAVARIAN NORDIC: Yeah, so the dose sparing intradermal approach is a temporary approach. So in Europe, it’s actually written as a temporary measure while vaccine doses are low. And in the U.S., it’s governed by the EUA, which is only in place once this is– while there is a declared emergency. So, if and when the emergency is over, this is only a temporary measure, and it will revert back to how the vaccine is recommended on the label.
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[40;58] PAUL CHAPLIN, BAVARIAN NORDIC: So just so that we’re all on the same page. There– there is a substantial amount of bulk inventory that the U.S. has purchased over the last few years. That equates to approximately 15 million liquid doses, or around about 13 million freeze-dried doses. We’re already eating into that inventory with the five and a half million liquid doses that has already been placed. So that bulk would need to be replaced to fulfill the options that already began to be awarded earlier this year, which is– which is to create a stockpile of 13 million freeze-dried. So yeah, it will impact the timing maybe of the freeze dried, depending on what additional orders we get– we receive from the U.S. But as I said, the option to start manufacturing freeze-dried was $119 million. That was awarded, if I remember rightly, in early June. That has not been touched and it is still sitting there. And that is part of the larger option $299 million. But the exact timing (inaudible) now is a little unsure, because of course, we’ve also pushed out the tech transfer to (inaudible) as we’re manufacturing Jynneos liquid. But we do anticipate that any bulk that is utilized in the current manufacturing of liquid will be replaced. And that we will, at some point, revert to the manufacturing of freeze-dried.
[4;09] KRISTIAN ROTH, FDA: In the coming weeks, we will reach out to all antigen test manufacturers with additional information on this approach. We believe that it is critical for public health that these tests remain on market. We’ll work with manufacturers to ensure that tests remain available and any changes which are needed to the labeling are rolled out in a predictable and transparent manner. More information will be available soon. And we will provide updates on this call throughout this transition period.
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[25;17] KRISTIAN ROTH, FDA: Thanks for that. And sorry about the confusion. However, we haven’t kind of officially released our plan yet. Once we do, we plan to communicate with all antigen test developers at the same time to make sure that everyone who potentially could be impacted kind of knows what the strategy is, kind of, like I said, at the same time. So that, that as part of the communication plan. We’re still discussing what the path forward is for everybody. And once we have that finalized, everyone should know.
[16;54] AGAM RAO, CDC: And just an important point that I want to make here is that, if lesions from a person without epidemiologic criteria are tested, or also just a risk group that is not not really at risk too much as part of this outbreak, almost– I mean, more than 98% of cases or so are happening among men who have– and among those for whom we have information about gender identity, they are men who have sex with men. So I guess we would just say that ensure that the OPX positive test results are repeated and confirmed before taking action. We have heard of a good number of false positives that have occurred. And– and so it’s really important to ensure that that positive is truly a positive in an individual for whom there would otherwise be low suspicion. At this time, there have been very few cases in children and women. And there’s been no sustained transmission reported within those groups at this time.
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[20;10] AGAM RAO, CDC: And tecovirimat is firstline and cidofovir and brincidofovir just because of the adverse events that are associated with them would make them less advantageous and in most cases– most cases. Brincidofovir is not currently stockpiled at this time, although there is a plan to do so. Really the the indication for brincidofovir, once it becomes available, because it has so many serious adverse events or concerning adverse events associated with it, will perhaps be if a patient were truly not improving, had life threatening illness, and evidence of resistance to tecovirimat. Those are those are things that would have to be determined on a case by case basis.
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[29;24] AGAM RAO, CDC: My understanding is that health departments are, to the best of their ability, attempting to notify individuals when they are informed by a patient of places where that they might have visited where they might have been infectious. So workplaces, daycares, that sort of thing. We have not seen– we’ve actually had a number of people who have worked while they were ill, accidentally, not realizing they had monkeypox, and there has not been secondary cases associated with those activities. So the spread has been from predominantly to people who– with whom they’ve had close skin to skin contact, or household members occasionally. But in workplaces and all, we haven’t seen– we haven’t seen much of that.
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[36;04] AGAM RAO, CDC: I think first, I want to just point out the numbers that are being reported out about children– we are actively working to understand the true number, because some of– some of the cases that have been reported to us turned out to be false positives, and then were removed from certain case counts and not from others. And so we’re trying to– we’re trying to hone down on what the true full number is now. And there is a team working on this. So I guess, just to caution you on the numbers we are here– I mean– I think because health departments have– and we’ve not been saying differently until very, very recently, once you get positive OPX to a case, they’ve called that monkeypox until proven otherwise. And it’s been recorded on on health department websites. But I believe just yesterday, we sent an email out about the fact that we are seeing these false positives happen increasingly, not just among children, but also in women and just people that don’t have any kind of epi risk factors.
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[52;49] AGAM RAO, CDC: And so we’re we’re working on developing guidance for individuals who might have been vaccinated, for example, within the last 20 years. Perhaps they only need a booster dose, because their immune system would be boosted by that by that dose. Versus people who were vaccinated, you know, as children, in which case, we don’t know how much protection, if any, and we would recommend just get the two dose series if you are someone who’s going to need vaccination.
[48;21] ATHALIA CHRISTIE, CDC: Initially labs sent any specimen that tested positive for orthopoxvirus to CDC for characterization, but now labs are guided to send in about 10% of positive samples to CDC for genomic sequencing. This takes the burden off of labs, while still enabling CDC to monitor virus samples and their genomes for mutations that could affect spread or symptoms.
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[53;45] ATHALIA CHRISTIE, CDC: So we have not had very many pediatric cases, and each one is resulting in a pretty extensive investigation. But I just want to stress that, if any of you have children, parents spend quite a lot of time diapering, bathing, and holding up their children. So it’s not at all surprising to have a pediatric infection. Some children may be infected by a parent or caregiver, or possibly other family members.
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[56;29] ATHALIA CHRISTIE, CDC: I think we all know that, that surveillance is difficult. So there is definitely testing is being tracked. Vaccination is being tracked by local states and jurisdictions. We are only just beginning to put some of this information on the CDC website, because, I think hopefully, people are pretty familiar from COVID, it can take quite a lot of effort, and some time, for the data to make its way from the state and local jurisdictions to CDC. There’s been a process to clean the data and to ensure its accuracy, in discussions back and forth with our state partners. So we have a lot more data up on our web this week than we did last week. But I do want to say that it’s not that the state and locals aren’t tracking, it’s just that the data pipeline to CDC has some hurdles.
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[01;00;07] ATHALIE CHRISTIE, CDC: Well, having a long career in outbreaks, I have learned not to get too excited by the initial data. So I can’t say anything more than cautious optimism. I certainly hope that what– whoever the individual is who asked the question, what they’ve seen bears out to be true. But we all know that there’s lags in reporting, and– and that we may see additional waves and various outbreaks. So I will wait a few more weeks before saying anything about whether we’re bending the curve. (As a fellow infectious disease person, I feel like cautious optimism is a great phrase for us to use in this field.) I think when I worked in Liberia during the West Africa outbreak, we saw the last case about four times so stopped– stopped making any assumptions.
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[25;27] CHRISTY HUTSON, CDC: Thanks for that question. So this is something that we’re actively thinking about. CDC is able to test those specimens. So we have received some from some suspect pets. But we do want to work with our vet lab partners, and other partners that conduct animal testing. As far as changes, there shouldn’t be too many changes. Obviously, this would be run under non-CLIA, which makes it a little bit easier. We routinely run our PCR assays at CDC for animal lab studies. So you just have to change the internal control that you use, because like RNase T, obviously, that’s a human control, so we’d have to use a different control. So there are some, some small changes like that that would need to be done. And then biosafety would obviously need to be addressed.
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[28;56] CHRISTY HUTSON, CDC: This study we’re looking at is, it’s focused on with our D.C. public health lab partners, and it’s looking at people that are coming in for their first vaccine dose that are at high risk that they’re in the PEP plus plus group. So they’re not going to have lesions, but they could have some prodromal symptoms, they could have had an exposure. So for that, we’re looking at throat swabs and rectal swabs and blood. I do know that there are other public health law partners that are starting to look at saliva, compared to lesion. So just seeing if that’s another alternate site, or an alternate specimen, when lesions are present, which will also give us some really good data to understand if saliva might be a good specimen site.
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[47;32] TIMOTHY STENZEL, FDA: So the FDA has already drafted a template of recommendations for test developers. It is going through the clearance process. The FDA has already drafted guidance that may be used if such a declaration is made. So this is all in preparation for the declared need of EUA authorities for tests. The templates with recommendations are going to be very similar to what the FDA was recommending early in the COVID emergency and that is that we recommend that 30 positives and 30 negatives be used to validate your tests. Because some labs and developers have a hard time accessing monkeypox samples, as they had a difficult time accessing COVID samples for many weeks, if not month, at the beginning of the pandemic, the FDA would allow the use of contrived samples, so plasmid constructs, other control materials, extracted DNA from monkeypox, things like that, can be diluted into negative patient matrix down to about two to three x LOD.
[6;20] ASHISH JHA, WHITE HOUSE: These vaccines are coming. As I said, early to mid September, all of course, FDA has got to authorize it, they’re going to look at the data. Assuming they do their job, CDC signs off on it, these vaccines will become available in September, and they’re going to be much more targeted to the version of the virus that’s out there. And that means my expectation is, based on the data we have, it should be better at providing protection against infection, preventing transmission, and then providing even more robust protection against serious illness and death. Again, we’ll see where the data lands, but I am very hopeful that that’s what these new vaccines are going to have. And they should be widely available as we get into September, October.
[0;21] ROCHELLE WALENSKY, CDC: As I think we all recognize, prior to this pandemic, our infrastructure within the agency and around the country was too frail to tackle what we confronted with COVID-19. To be frank, we are responsible for some pretty dramatic, pretty public mistakes, from testing, to data, to communications. As an agency, even with all the terrific work we do, we still suffer the consequences from these mistakes. After over 18 months serving in this position, learning and living the many lessons from our COVID-19 response and receiving feedback from many internal and external interested parties. This is the right time to take a step back and strategically position CDC to facilitate and support the future of public health.
Imported from Revue
HHS and CDC, through this Addendum, are requesting the same vaccine administration data elements, including monkeypox vaccine data available in jurisdictional immunization information systems prior to effective date of the Addendum, using the same data submission specifications, relevant systems, and technical architecture for monkeypox vaccine administration data as outlined in the DUA for COVID-19 vaccine administration data. All provisions of the DUA and its Appendices apply to this Addendum, except for as provided below.
There was a suspected monkeypox (MPX) case in a child whose initial testing for orthopox virus was “equivocal” (not able to be interpreted as positive or negative). Per protocol, the sample was sent on to the CDC. CDC testing then ruled out MPX.
While we have certain reservations, we are trying to find the best way to support the EUA by collecting additional data and aligning on the responses to assist state officials in the rollout. We are also investing in expanding the manufacturing capacity at both BN and external facilities, with likely more announcements soon to come. Lastly, we are testing the potency of older JYNNEOS batches stored at the SNS. In our in-house stability program, two-thirds of the batches we tested that were manufactured in 2014 are still within specification and so we are hopeful that many of the eleven 2014 batches (approximately 1 million doses) at the SNS will also still be within specification. We will know in the coming days and weeks and will work with the authorities to expedite the availability of these batches in the fight against monkeypox.
Further testing is necessary to confirm if this child’s result was indeed a false positive, however, we still consider this case positive until proven otherwise. The mother and infant are still in DC completing further tests to finalize the investigation.
2:06:02 PM GRETA MASSETTI, CDC: Other standalone guidance documents, such as the healthcare guidance, travel guidance, and guidance for congregate settings at high risk of transmission, will be updated by CDC in the coming week or so. Importantly, CDC will continue to follow the science and update our public health recommendations based on the data
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2:11:09 PM GRETA MASSETTI, CDC: So, to your first question, around the greatest impact, you know, there isn’t a lot in the– in our package of guidance that’s new. Really, what’s new is presenting it as a framework and how we’re messaging the updates, in that it’s really about kind of how people can understand how all of these components fit together. It starts with people understanding their own personal risk, for serious illness and that of their loved ones and their family members and the members of their household. And really, that information is vital in understanding what steps they might need to take, so very person to person based on who they are, based on their risk tolerance, based on where they are in their community. And so that’s where the recommendations are on protecting yourself come in. And then the recommendations around steps to take if you’re exposed or if you’re infected. So it’s about presenting a framework to help people understand how to access the information they need, what is the right fit for them based on their needs, and then how to use that information to take action.
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2:12:50 PM GRETA MASSETTI, CDC: Yeah, so to your question around stakeholder groups and partners we have involved. We continue to hold very closely that our partners, our public health partners, our educational partners, we have ongoing conversations and dialogues with them around kind of what is the current evidence. What are we seeing in communities? What are schools and community settings able to implement? And– and that has had multiple conversations around where we are now given the current state of the pandemic and high levels of population immunity and broad access to vaccination and treatments. And so we have been able to kind of have these engagements with our partners, to get that input on– to assess the– how these guidelines will be able to be implemented in schools. And in other settings as well.
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2:16:19 PM GRETA MASSETTI, CDC: So essentially, the key changes in the school guidance are, are in those sections that would would parallel the changes to the community guidance. So, for example, we are no longer, recommending quarantine. And so, in the school guidance, there is no more section on quarantine. Instead, the recommendations around what to do children, or students, or teachers, or staff are exposed are the same as what we recommend in a community setting. And similarly, because we’re no longer recommending quarantine, we’re no longer including a section on test to stay because the practice of handling exposures would involve masking rather than a quarantine and test to stay is an alternative to quarantine. There’s also a new section, or a shift in our strategy, in our recommended strategy for COVID-19 screening testing, for people who have no exposure and no symptoms. And that’s really where we’re focusing particularly on high-risk situations that schools can use screening testing at, when they are at high COVID Community Levels or in a response to outbreaks in the school settings. And so there’s a new outbreak section that helps schools understand kind of how to manage and outbreak. And again, those are– those are changes that mirrors some of the changes in the general community guidance.
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2:21:03 PM GRETA MASSETTI, CDC: Yeah, thank you for that question. So we are working also on updates to our guidance for healthcare settings. You may be aware that we do have a guidance and recommendations that are specific to healthcare settings and nursing homes. And those are getting updated and they should be released within the next week or so. And they will continue to rely– or we do continue to rely on community transmission, and the really– the main reason for that is that in a health care setting what is really important, is to be– pay attention to the level of disease in the community and to avoid any infections, because healthcare settings are often places where people who are vulnerable to very severe illness are accessing care. Such as places were people who have a cancer diagnosis or other immunocompromising conditions. And so in those settings, we do have to be a little bit more cautious in avoiding infections, but that– the specific updates to that infection prevention control guidance and the other health care guidance should be available in the coming weeks.
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2:22:39 PM GRETA MASSETTI, CDC: So, as we stated back in February, when we first released the COVID Community Levels, is we have an ongoing effort to reassess the performance of the COVID Community Levels. Both vis a vis how they are predicting the occurrence of serious outbreaks in areas, or more severe disease, as well as how well the metrics are performing in the combination of metrics, which include new hospitalizations, the proportions of inpatient beds occupied by COVID-19 patients, and new cases. At this time, the performance seems to be relatively stable, but we are doing a lot of analytic work to reassess how these metrics are performing in U.S. data specific to the Omicron, period, for example, in the last four to six months. And so that’s an ongoing effort. We have not gotten any results that suggest a substantial change is warranted at this time. But we may make some adjustments in the future if we find that the data no longer support the COVID Community Levels in their current form and some adjustment may be needed.
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[01;28;06] ANTHONY FAUCI, NIH: First, boosters are going to be extremely important, because we know, very clearly, that immunity, at least against symptomatic infection, maybe not so much against severe disease, wanes at about four months or five months. So right now, we’re concerned about there being a surge in the fall. We don’t know exactly when it’s going to occur, because the thing that surprised us is that everybody who saw a BA.4/5 come, we thought it was going to go down by the end of July, and essentially be none. But now we’re having still 400 deaths per day and 150,000 infections. So if we get BA.5 that goes into September, then you wouldn’t be thinking about a fall surge. You’re still in the summer surge before you think about a fall surge. But the short answer to your question is that we will very likely be using a BA.4/5 bivalent booster starting in the fall. Very likely, Pfizer will have it by first or second week in September and Moderna will likely have it by the end of September, the beginning of October. So everybody’s going to– you’re going to be probably hearing soon about a big push to get people who have not been recently boosted to get a booster shot as we enter into September and October.
[7;37] ROCHELLE WALENSKY, CDC: And even now, we are still at about 400 deaths a day. And that, we’ve become accustomed to saying it, but I don’t feel like that can be a number that we are okay with staying at. I think we really do need to continue to recognize that that is well too many deaths than we should be comfortable with. As you’ve been hearing in the news, we have the new BA.5 variant– perhaps not new anymore. This is an Omicron subvariant that accounts for nearly 90% of cases here in the United States. We’ve seen a doubling in the number of hospitalizations since April. We are hoping this week that it is first starting to plateau, if not trend down a little bit. And the largest percentage of deaths are really occurring among those over 65.
[01;00;28] ALLISON ARWADY, CHICAGO: What we actually did a press release this morning about this locally and said, you know, we expect in the next two weeks, give or take, one to two weeks, we will probably make an announcement that we’re switching over. But there may be some sites that can move before that. But we won’t just sort of say start. We will make sure people will have updated provider agreements, updated training requirements, all of this. And, you know, our first call with the CDC, about this, is on Friday, just to give you a sense of that this is a process. It’s not here’s the EUA, go. We’ve been getting a lot of behind the scenes information. But– and already, you know, like I said, we just went ahead and ordered syringes, but– I do think it’ll be, and across the country, I think it’ll probably take somewhere between one and three weeks, depending a little bit on how setup different sites are. And it could even be longer if some of these questions are not yet answered, or we have problems with accessing those syringes. So little more to come there. … [01;06;59] ALLISON ARWADY, CHICAGO: Yeah, actually, we wouldn’t expect anybody to be past due at this point because, in the first– I showed on that slide our timing: between June 3rd and July 22nd, we had only received 5,000 doses total. It was when we got that next big allocation, the 15,000, that we switched to the one dose approach, because it was just clear that with the speed,, the amount of vaccine that was available, and so people who were in that very first sort of cohort, we’ve said, if they already had second dose appointments available, they could keep them. And so if we’re able to get this going by around August 23rd, I don’t actually think anybody would have a delay. And if there are people who have a delay, I think it’ll be on the order of a few weeks. And so this is one of the reasons why certainly I am supportive of this strategy, just making sure that the questions get answered and the operational needs on the ground really get supported. But yeah, I don’t think it’ll be a lot of people who have a significantly delayed second dose. But if there are surprises along the way, that is an approach that we plan to continue to use in Chicago because I just– we’ve got to get as many people as protected as possible.
[6;04] JENNIFER MCQUISTON, CDC: So we’ve seen an interesting shift over time in this outbreak in terms of race and ethnicity data. So if you look at the early days of the outbreak, so that started MMWR week 20, there, you can see that the majority of cases that were being reported to us were occurring in persons who had a white race. But as the outbreak has progressed, you can see that we have other races rising in terms of the percentage that are impacted. Some of this might be that, in those early cases, they were travel associated. And I think there are certain socioeconomic differences in people who can afford to travel to Europe. And it might– that might be reflective of that. But what this really illustrates is that there are some significant health equity concerns that we need to think about with this monkeypox outbreak, making sure that those individuals are having access to treatment and to vaccine, and really thinking more about how we deliver those– those activities to the populations that need it.
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[12;21] IAN WILLIAMS, CDC: As I mentioned, we have high levels of vaccine and infection induced immunity in the country, we have highly effective treatments and prevention tools, we’ve greatly reduced the risk of medically significant illness, hospitalization, and death from SARS-CoV-2 infection for most, not everyone, but for many people. And really, this is about pivoting towards our public health focus on sustainable efforts to minimize the impact of COVID-19 on health and society. So as part of this, we are refreshing our guidance, really focusing on the four main core areas you’re seeing up here on the slide, to make it easier for people to know the risk, know how to protect themselves and others, what actions they need to take if you’re exposed to the virus that causes COVID-19, what actions to take if you have symptoms or test positive for the virus. These updates to the guidance will again help people better understand their personal risks or COVID-19 and help make them informed – make informed decisions to layer prevention strategies as needed. These prevention strategies will all be tied to the COVID community level that I showed you previously, launched earlier this year, again, trying to help provide people information about when they want to take additional actions and may want to layer on additional prevention strategies. As part of this streamlined guidance refresh, CDC will be updating, consolidating its COVID-19 website, amplifying messages through a partner outreach, and conducting proactive media and social outreach. A timeline for this is, hopefully, we’ll be moving forward on this in the next couple of days to a week or so. No definitive timeline yet.
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[16;53] IAN WILLIAMS, CDC: So how have we done this? Well, here’s a chart that shows basically sort of the transition or progress over time in terms of the number of activities, the little circle on the right shows you that we identified 800 different activities that needed to get transitioned as part of this. We sort of successfully transitioned about half of those so far, a number of them are slated to be transitioned, whenever we continue to wind down the response sort of even further. And there’s a number of functions, which are going to have to be maintained after the response completely unwinds.
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[6;22] IAN WILLIAMS, CDC: As you all are well aware, we are tracking variants. Most recently, we have started tracking BA.4.6 separately from BA.4 to see if it exhibits any positive growth rate relative to the other variants. And we’re very interested in this because BA.4.6 has an additional spike substitution at position 346, which might impact the performance of monoclonal antibodies. So we continue to watch variants, watch for the next variant, collaborate very closely with our partners around the globe to sort of see what is happening there.
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[12;44] JENNIFER MCQUISTON, CDC: What will be announced later today, there’s a press briefing, is moving to an intradermal strategy, which would be a way to use a single subcutaneous dose in up to five patients with an intradermal dose. So that would dramatically increase the availability of vaccine and the coverage that could be achieved.
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[8;26] JENNIFER MCQUISTON, CDC: I think that we probably are also now on the cusp of going to a pre-exposure vaccination strategy, if more vaccine can become available to accommodate that. So we’ll likely see another shift in that effort shortly.
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[13;08] JENNIFER MCQUISTON, CDC: So ACAM 2000 is a much maligned and misunderstood vaccine. It is an excellent orthopoxvirus vaccine. It provides strong protection with one dose. It is a replicating virus, which has means it has an adverse event profile, which can be challenging if somebody is immunosuppressed, has eczema, or an underlying skin condition that predisposes them to vaccinia infection, and could potentially be spread to others if somebody’s not careful with a site of inoculation. And the other challenge is its available under an EA-IND. But there are millions of doses of ACAM 2000 in the system. And some of our modeling here at CDC suggests that it could play an important role in bringing this outbreak to a close if it was used carefully.
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[5;11] JENNIFER MCQUISTON, CDC: Right now, I actually have an update on pediatric cases, too, I’m aware of four pediatric cases in the United States, one confirmed, one probable, and then two prior that were classified as probable, but I am labeling them under investigation, because further attempts to characterize the virus have shown that those might be false positives or inconclusive results. And that really does highlight an issue, that when you start expanded testing outside of the population that has a high incidence, the positive predictive value of that test drops. And it requires us to really think a lot when we do see a positive case, for example, in a pediatric patient or pregnant woman, and they’re not– they don’t have a strong connection to someone who’s known monkeypox case, that you need to take a step back and say, maybe we should repeat this test and make sure.
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[1;14] JENNIFER MCQUISTON, CDC: So we have been in an agency level activation with our emergency operations center since June 28th. But we’ve really been responding to this emergency, as I said, since May 17th. We are still operating under a containment goal. Although I know many states are starting to wonder if we’re shifting to more of a mitigation phase right now, given that our case counts are still rising rapidly.
NIAID is planning to gather additional information about intradermal delivery of Jynneos in a trial expected to start in the coming weeks. We will provide more information about the trial once details are finalized.
4:12:32 PM BOB FENTON, WHITE HOUSE: What Dr. Califf just laid out is a game changer when it comes to our response and our ability to get ahead of the virus. It’s safe. It’s effective. And it will significantly scale the volume of vaccine doses available for use across the country. As Secretary Becerra mentioned, we’ve distributed over 670,000 vials of vaccine already to jurisdictions across the country and we have 400,000 vials in the Strategic National Stockpile that have been allocated to jurisdictions ready to be ordered when jurisdictions use 90% of their current supply. With today’s announcement, those 400,000 vials have the potential to write up to two million doses to Americans. We encourage jurisdictions to utilize alternative dosing method as quickly as possible and we’ll be your partner in this step every step of the way.
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4:14:14 PM BOB FENTON, WHITE HOUSE: We also will be reviewing the current allocation and distribution timeline for vaccines we put forward in light of today’s announcements to make sure that jurisdictions have sufficient vaccine supply to meet demand and also make sure that jurisdictions aren’t receiving more vaccine than they can store or use in a given time period.
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4:15:56 PM ROCHELLE WALENSKY, CDC: As Dr. Califf described, this strategy would change the method of administration for the Jynneos vaccine from subcutaneous to intradermal to allow vaccine providers to use an existing one dose vial of the vaccine to administer a total of up to five separate doses. Intradermal injections are often used for TB skin tests and have been used for other types of vaccines before. Some health care providers may not be as familiar with intradermal administration, where you deliver the vaccine into the layer of skin just underneath the top layer, compared to the more traditional subcutaneous administration which goes into the fat layer underneath the skin. For this reason, CDC will be providing information and educational materials to vaccine providers. To help ensure this new strategy can be implemented quickly and as seamlessly as possible.
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4:20:46 PM PETER MARKS, FDA: I think first of all, we want to make sure we get it right, and we don’t have the data in children that we have in adults. But second of all, as a practicing physician, and though I’m not a pediatrician, I’ve treated pediatric patients at times. We have had to give this vaccine to the youngest of children and it’s just giving a intradermal injection to a baby is actually just a little more challenging at times. And so, this I think from an operational perspective, this is just the more familiar and simpler thing to do
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4:29:26 PM ROBERT CALIFF, FDA: Bob, I want to comment on the strength of the data, just to make the point, I mean, there has been a lot of midnight oil burned over the last few days because one advantage we had is that study that we’re using was submitted with the data for the approval. So the data was actually available and we were able to talk with the investigators. Dr. Marks really led the charge on doing that, so I’ll let him speak to it, but it will be publicly available that the basis, and you’ll see that the immunologic responses, it’s super impossible with the two intradermal doses at that dose versus subcutaneous dose.
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4:30:11 PM PETER MARKS, FDA: The only thing I want to add is that just for those who might think that, giving this particular vaccine modified vaccinia ankara, is something new that by the intradermal route. It’s not at all new. In fact, the reason why the Bavarian of this equation comes from the fact that in Germany, this vaccine was given intradermally originally in an effort to replicate the original version of the smallpox vaccine. It’s been given the thousands of people intradermally. So this isn’t the first time it’s been done. It’s obviously a little different here. We have a vaccine that’s being used for smallpox and monkeypox, but just so you understand, we look at the totality of the available scientific evidence and we bring that together to try to do the best by public health.
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4:38:05 PM DEMETRE DASKALAKIS, WHITE HOUSE: I– just sort of commenting on the last question about eligibility, I think that this is potentially also a question for Dr. Walensky. The current eligibility remains the same as vaccine supply increases. So, I think there’s not a change there yet.
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[50;34] MEG SULLIVAN, ASPR: The U.S. government will continue to send out supply of the product over the next couple of weeks, but we’ll stop at the end of August, with our last full week being the week being August 22nd. We will talk about how there will be information about how states and territories and providers can order directly through AmerisourceBergen. And again, are working closely with our CMS partners around reimbursement questions. And again, expect to have a lot more information coming in the next few weeks. The other thing that is really important to us is to ensure ongoing access for individuals who are uninsured and so we’re working on different options for that.
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[18;43] JAY BUTLER, CDC: I know one of the burning questions, because I asked it myself, is what do we do with people who are due for that next reduced dose of the booster? That is people over age 50 that have received one booster. Do we give them– do we boost them now? Or do we wait for the BA.4/5 vaccine that will be coming out, we think by mid-September, certainly sometime this fall? At this point in time, there’s really no definite recommendation on that. So it is a nuanced decision that needs to be made based on the likelihood that someone will be back in to receive a booster dose in another month, month and a half, as opposed to the opportunity to immunize them right now. I would also tend to lean towards providing the booster dose as soon as possible, given that right now we are seeing moderate to high levels of community activity of COVID in that are impacting the majority of the U.S. population.
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[30;04] JAY BUTLER, CDC: When will it be available? It will be sometime this fall. I’ve heard September, I’ve heard October. I do not want to over promise and under deliver. But I know that everyone is aware of the importance of getting these vaccines available as soon as possible.
The FDA has been working closely with vaccine manufacturers over the past several months to ensure that modified COVID-19 vaccines are available this fall, following FDA’s review for safety and effectiveness. The agency will work expeditiously to review submissions once received in order to make modified COVID-19 vaccines available for booster vaccination in this time frame.
Pfizer and Moderna have indicated that they anticipate the modified vaccines being available as early as September. Given this timeline, at this time the FDA is not considering authorizing a second booster for otherwise healthy individuals 18 through 49 years of age with the original formulation of the COVID-19 mRNA vaccines. Individuals over 18 years of age who have not received their first booster dose with the current COVID-19 mRNA vaccines, especially those who are at high risk, should consider getting one now as cases of COVID-19 are on the rise. After modified boosters containing a BA.4/5 component become available, individuals may consider getting one following an appropriate interval after their prior dose.
If you are 50 years of age and older and you have not received a second booster dose with one of the current COVID-19 mRNA vaccines, consider doing so now. You can still benefit from existing booster options and leave time to receive an updated booster in the fall.
Receiving a booster now will not preclude individuals from receiving an updated booster after the FDA reviews the variant-specific vaccines and authorizes them for use.
For any questions on the firms’ timing updates, please refer to the firms.
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[0;59] SAMEER VOHRA, ILLINOIS: Governor Pritzker and I are in touch with the White House. And we are happy to report that President Biden’s staff have been incredibly responsive. We are pleased that, at our request, the FDA – the Food and Drug Administration – has authorized use of the vaccine for anyone under 18 without jumping through the normal hoops in the process. That means that anyone, with their guardian’s approval, will be vaccinated today. Pediatricians are on site, as we speak, to screen children for cases and there are mobile testing and vaccines for the parents.
ASPR’s Strategic National Stockpile has quality control procedures in place to ensure proper temperature and storage of Jynneos vaccine both in the warehouse and in transit. The federal government monitors temperature of the product until it is signed over to the jurisdiction. To date, we have not lost any Jynneos vaccine to spoilage or temperature excursions during transit.
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2:31:47 PM XAVIER BECERRA, HHS: I want to make an announcement today that I will be declaring a public health emergency on monkeypox. We’re prepared to take our response to the next level in addressing this virus. And we urge every American to take monkeypox seriously and to take responsibility to help us tackle this virus.
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2:35:38 PM DAWN O’CONNELL, ASPR: I’ll just take a moment to briefly provide an update on our vaccine strategy. In total, we have made more than 1.1 million doses of Jynneos available to our state and jurisdiction partners under our national vaccine strategy. And we have secured 6.9 million doses in total. Of those, we have shipped, as both the secretary and Bob just mentioned, more than 602,000 doses to states and jurisdictions. This is an increase of 266,000 since just last week. Also last week, we announced the allocation of 786,000 doses of Jynneos, significantly increasing the supply of monkeypox vaccines available to states and jurisdictions. We opened the first round of ordering against those 786,000 doses on July 29th, and began shipping the first ordered doses earlier this week. We continue to ship these doses out as states are ordering them, and we’re doing so quickly, in most cases within 30 hours of receiving the order. We plan to open the next round of ordering on August 15th. And as an important, reminder, states and jurisdiction that have used 90% or more of their current allocation will be allowed to order additional doses sooner than August 15th. It’s important for us to get these vaccines out as quickly as possible to those places that are using them.
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2:37:01 PM DAWN O’CONNELL, ASPR: And we continue to work with our supplier, Bavarian Nordic, to accelerate delivery of doses to the greatest extent possible while also ensuring high quality and safety standards. Along these lines, I’m pleased to share that we will receive another 150,000 doses in the Strategic National Stockpile in September. We expedited those doses. They were previously scheduled to arrive at October. We anticipate continued delivery of additional doses in October, November and December. In summary, we continue to do everything we can to make as much vaccine available as quickly as possible.
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2:37:47 PM ROCHELLE WALENSKY, CDC: Today, I will speak to how the public health emergency declaration will enhance our nation’s response to the monkeypox outbreak. A PHE strengthens capabilities at all levels, particularly locally. It may provide access resources and flexibilities, enabling personnel to deploy to the outbreak, and potentially increase access to care to people who need it most. Importantly, the declaration will also help us continue to expand public health’s ability to expedite data sharing so that we can have comprehensive and timely data available to inform public health decisions. We’re grateful to the jurisdictions that have already agreed to share data on monkeypox. 51 have already signed data usage agreements with CDC, which will make vaccine administration data available, as part of their allocation. The public health emergency may provide the justification that the remaining jurisdictions need in order to sign their agreements. Additionally, it enables CMS authorities that can provide us with more detailed data around both testing as well as hospitalizations.
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2:44:30 PM ROBERT CALIFF, FDA: The goal has always been to vaccinate as many people as possible, and for our part, HHS has been working closely with the manufacturer to accelerate the availability of additional doses as quickly as we possibly can. In the meantime, we’ve identified a potential solution that would allow us to significantly increase the number of doses available to administer. To help close this gap, we’re considering an approach for the current doses of Jynneos that would allow healthcare providers to use an existing one dose vial of the vaccine to administer a total of up to five separate doses. This approach, which we’re referring to as dose sparing, would change the method of administration for Jynneos, which is currently administered subcutaneously. Under the proposed approach, a fifth of the current vaccine dose would be administered intradermally. There’s some advantages to intradermal administration, including an improved immune response to the vaccine. It’s important to know that overall safety and efficacy profile will not be sacrificed with this approach. Please know, we’ve been exploring all scientifically feasible options, and we believe this could be a promising approach. It’s important to note that we’ll not be sacrificing the high quality regulatory standards that Americans have come to expect. Our ability to continue allowing safe, high quality products for communities nationwide has and will always be top of mind. And we will continue working with impacted communities to ensure they have all the information they need to make informed decisions. Importantly. If you have the opportunity to get the Jynneos vaccine, please consider getting your dose first immediately. Addressing the monkeypox outbreak is a top priority for FDA. We’ll look forward to sharing more information on the dose sparing approach in the days ahead.
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2:47:24 PM ROCHELLE WALENSKY, CDC: So when we look at the population at highest risk, we’re looking at both those who are living with HIV, who are men who have sex with men, as those who are high risk for HIV by virtue of the fact of their eligibility for pre-exposure prophylaxis for HIV. Summing those two populations together, we estimate that there are about 1.6 to 1.7 million people who are at highest risk for monkeypox right now. And that’s the population we have been most focused on in terms of vaccination.
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2:48:05 PM ROBERT CALIFF, FDA: You know, I’m a cardiologist by training, I I’m used to sticking needles in people. But when we first talked about the cutaneous and intradermal administration, it worried me a little bit that people might not be able to do it, but then Dr. Walensky reminded me that the PPD tests which is routinely used, in public health clinics, and many other settings, is administered by many, many health care workers every day. So it really means basically sticking the needle within the skin and creating a little pocket there into which the vaccine goes. So this is really nothing highly unusual. It’s done in other situations routinely. So we’re very confident about the administration of the dose.
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2:49:31 PM ROBERT CALIFF, FDA: Across the FDA, drugs, devices, and biologics, we’re talking to all the manufacturers who might have options that could be used. We don’t have anything in the immediate future, other than the options that we’re talking about here, which as you can see, are becoming much more available. With regard to TPOXX, I know there’s been a lot of discussion about it. It’s really important and I think you asked the question because you’re well aware of this. This drug was approved for smallpox for emergency use, you know, with the disease with a mortality of 30 to 50% based on the animal rule, which means it’s never been tested in human beings, or in people with disease. We think it’s going to be effective in monkeypox, but we have no proof of that yet. And so it’s critical, as we roll it out through expanded access, and make no mistake, our goal is to make it available without excess bureaucracy and paperwork, but it’s critical that we collect data, because we don’t know about the risk of the drug, or the potential, how effective it will be. So I appreciate the question, we definitely going to collect data. And we are planning a clinical trial, which we think is essential to lead to its eventual full approval.
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2:53:17 PM ROBERT CALIFF, FDA: I’ll just add quickly that we’re feeling very good about the intradermal approach and probably, within the next few days, short period of time, we’ll make a final decision about it, but it’s looking good right now. And at that point, a 564 declaration would be needed to make it available because it’s not the standard previous route of administration.
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2:53:43 PM ROCHELLE WALENSKY, CDC: You know, two things are happening at once that I think can account for the rise in cases that we’re seeing. One is more widely available testing and two is potentially more infections that are actually happening or a result of infections that happened to two or three weeks ago. So, it’s hard to just entangle those right now. We do expect cases will continue to rise, as we’ve had more access to testing, people had more access to testing, before they go down again. And as we follow that, we will have more models available. Thanks.
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2:58:47 PM DEMETRE DASKALAKIS, WHITE HOUSE: I think that from the LGBTQ perspective, this is a very clear statement of the value of the lives of people who are in the LGBTQ community. So I think along with moving forward and accelerating some of the work we’re doing, I think it also represents an important commitment by the administration to the community. And I think, since my first day doing this job, the president is so committed to making sure that we are engaged with gay bisexual other men who have sex with men. And I think all of the folks on this call who represent agencies really are on the same page. So it’s an opportunity for us to really be clear and to leverage the emergency to move faster and also work, as we have been, to make sure our messaging is tight and is intentionally designed not only to be stigma free but to counter stigma.
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3:02:40 PM XAVIER BECERRA, HHS: Let me just say that we gave a lot of thought to how we were going to proceed, how– what we were going to do in terms of vaccines, the outreach, trying to expand the number of testing sites available, how we make sure we distribute the treatment, the TPOXX treatments. All of this has taken a lot of thought and consideration and work with the White House, our other partners around the federal government, and of course, state and local. So the same consideration will be given to how we proceed with regard to whether there is a declaration on 564 or whether we do something with PREP. And so what I would simply say to you is that we are going to do what we believe is necessary, working with the White House coordinator, to make sure that we’re addressing the needs in the country on monkeypox.
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3:03:47 PM ROCHELLE WALENSKY, CDC: I was going to circle back to the testing question, if that’s okay. So, since May, we’ve seen a significant increase in the number of testing performed week over week. In late May, we were at about 500 specimens tested per week to nearly 8,000 specimens tested per week, in the week ending July 29th. With the number of specimens being tested increasing by about 3,000 from the week prior. As testing has increased, our capacity for testing has increased, and far outpaces demand with our current capacity about 80,000 tests per week. So right now, we’re really only testing in about 10% of the capacity we have and we are encouraging anyone who has a suspected rash that could be monkeypox to present for testing and then, of course, encouraging providers to go ahead and send that test.
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3:04:39 PM ROCHELLE WALENSKY, CDC: I want to caution on the interpretation of percent positive, and that is because we are encouraging providers to take more than one sample per patient. And there’s probably not a standardization in terms of how many patients, which patients, get how many samples. We’re encouraging at least three samples per patient. Of course, you test the rash for this, you swab the rash. So there is not necessarily consistency in the number, in the percent positivity, because patients have a different number of samples that are tested.
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ARPA GARAY, MODERNA: Now turning to slide 21, we’re also happy to see that as we continue to scale globally around the world, that Spikevax’s market share in the booster market, defined as a third or fourth booster dose, continues to show substantial market share. As Stéphane has already mentioned, we see on slide 22, our new U.S. government contracts for the fall of 2022. Specifically, the agreement initially was for 66 million doses for bivalent COVID boosters to be delivered in 2022. Earlier this week, the U.S. government informed us that they exercised an option for 4 million doses for the pediatric age group. This brings the total contract value to approximately 1.8 billion. Our U.S. government order includes the options to purchase an additional 230 million doses, bringing the total to 300 million doses if all options are exercised.
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STEPHEN HOGE, MODERNA: FDA has also asked us, as you referenced to run, a phase– an additional study, really to support future deployment, because we do want to understand the performance of the 222 vaccine if there’s further variant evolution, for instance, in December or January, as has unfortunately happened every year in this pandemic. And we want to have samples that allows us to inform that– those sorts of decisions about deployment of vaccine. We expect to enroll that study really in August, but the data wouldn’t be available for a few months, because you would follow until approximately a month to get the boosted samples, collect them, and then test them in the relevant assays. We do not at this point expect nor, has the FDA suggested, that that data would be required prior to authorization. In fact, we will be authorizing based on the prior clinical data for 211.214, preclinical data, manufacturing data. But we will have that those samples in hand. Now as to the specific timing of when we would be able to share 222 data, other than later in the fall, I don’t think we have any other specific guidance today, except to emphasize again, that it’s really not required for the authorization based on recent FDA guidance. It really is to support future deployment decisions that are in the later part of winter.
DEMETRE DASKALAKIS, WHITE HOUSE: But I do want to highlight that we are– we have our guidance for sexually active people, our safer sex guidance and, and safer gatherings. It’s going to evolve over time. So keep an eye on it. It is coming up for a revision, like imminently, so expect to see some revisions to safer social gatherings and safer sex very soon. Next slide please.
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ALEXA OSTER, CDC: Thank you for the comment about schools. We’ve definitely been hearing a lot of questions about schools and children and people who are looking for resources on that. I will just say that it is a high priority for us. We know, for example, in the school district I’m in, school started today. So we know that it’s a particularly time sensitive issue. We have materials in the pipeline, and we’re hoping that we’ll have something to share soon
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DEMETRE DASKALKIS, CDC: So knowledge is power. So the first step is to get informed. We’re really excited that we have some good harm reduction approaches, to reduce stigma and prevent discrimination, while giving people very clear advice. You’ll see some great examples of folks who have amplified us. One of the ones that I’m the most proud of is my friend Shea, who was very kind to share with two million people our guidance. So thank you Shea Couleé,, sorry about the drag race finale. But the long and the short of it is that we have an opportunity to get people really good advice. And it really is multidomain, not just one thing, lots of things. So one thing that we’re really clear on saying is that having multiple or anonymous sex partners may increase your chances of exposure to monkeypox. So it’s a good plan to consider limiting the number of sex partners and could reduce the possibility of exposure. This is not a forever thing, it is a for now thing, in terms of the advice. We’re waiting to ramp up vaccine. And as that happens, our advice will change.
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DEMETRE DASKALAKIS, CDC: I mean, we do actually have things already, that we have guidance around congregate settings, which actually ends up being very similar to sort of like to also lots of other guidance. So I think that important lessons from COVID, is that we don’t necessarily need to have different guidelines and guidance for different environments, because that tends to be confusing.
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[27;23] JOHN BEIGEL, NIH: Yeah, we’ve had some preliminary discussions with the FDA. We anticipate to get it started within the next four weeks, ideally, sooner, but we’ll see.
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[25;13] JOHN BEIGEL, NIH: So the way we’re thinking of a dose sparing study, and the caveat is that this is still in development, is to do a first do an immunogenicity study. It’s a healthy volunteer, that includes risk groups, but not limited to risk groups, three arms, the intradermal, again the one fifth dose, the one dose, arm two is the one dose, and arm three is a comparator, which is the two doses. That, the analysis would be to compare the titers of intradermal sub-q to both in terms of immunogenicity and in terms of adverse events so you can really understand the trade off. I mean, there is going to be a trade off of reactogenicity and immunogenicity and trying to understand if that’s an acceptable trade off. And then compare that to the standard dose and to say, are we actually within range of the standard dose? Are we in range to what you would expect for ACAM 2000?
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[1;05;18] ELISSA MEITES, CDC: The CDC has already initialized several studies to answer key unknowns related to monkeypox, including seroprevalence studies, clinical studies, and laboratory studies. One example is an ongoing technical assistance that is a collaboration between CDC and the D.C. Department of Health, which will include collection of data to be used for early VE evaluation.
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[1;06;40] ELISSA MEITES, CDC: Additional opportunities to assess monkeypox VE are being actively explored. Opportunities may exist to leverage existing CDC surveillance platforms that are already well established in STD clinics or LGBTQ plus health clinics, meaning lesbian, gay, bisexual, transgender and queer communities. And these are already engaged in gay bisexual and other men who have sex with men and transgender people to provide data and specimens for research and surveillance on sexually transmitted infections. So some examples listed here include existing HIV, STD, gonorrhea, syphilis, and human papillomavirus surveillance platforms.
The referenced vaccine doses were delivered to the SNS for potential use for a smallpox response and would only be able to be used under a potential Emergency Use Authorization. The last doses of Imvamune (name of product before FDA licensure) arrived at the SNS in 2015 and the last doses expired in 2017. The vaccine was not approved for smallpox and monkeypox until 2019. The SNS continues to store the expired doses in quarantine. While it is highly unlikely that these doses remain viable, we sent sample vials to Bavarian Nordic for stability testing. If testing confirms retained potency, which we believe is unlikely based on experience with similar vaccines, we will work with FDA to see if these doses can be made available for the response; however, HHS’ current response does not rely upon these doses.
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[YouTube 19;06] ROBERT CALIFF, FDA: I’m going to assume that everyone on this call knows that, if the user fees are not enacted, the greatest suffering with be from the American people because our public health mission will be injured if we don’t have the money to pay employees. And I think we’ve been through this sort of situation before. Now, I do want to say that we’ve been, and you’ve heard the public statements from all of the elements of the Congress, that there is an intention to pass legislation that will fund the FDA before the money runs out. But it’s also the case that, by about the first week in September, unless we have great assurance that it’s either passed or it’s about to be passed, we’ll have to start notifying employees who are paid by user fees of impending personnel action because we’re really required to. And it’s— I’ve worked in all the industries, and you owe it to someone to give them due notice of problems are going to occur.
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[YouTube 39;26] ROBERT CALIFF, FDA: With regard to infant formula, we’re already inspecting foreign plants. It does turn out, if you look at the enforcement discretion decisions that we’ve made, there’s still a limited number of manufacturers, including the foreign ones. Some of the incumbent manufacturers in the U.S. had foreign plants that have gotten enforcement discretion. And so we fully intend to inspect those plants just as frequently as the U.S. plants, because this is— if there’s one thing we’ve all learned from this, it’s infant formula is a critical medicine basically. It’s a sole source of nutrition for a lot of infants. We can’t have a system which is so dependent on just a few plants making most of the formula. We have to have a resilient system and they have to be very high quality. You know that there’s funding at stake right now in some of the legislation. We do need more people. But we’re just going to beg, steal, and borrow from parts of the FDA until we get this one right, including the foreign plants, so there are inspections going on right now in some of those plants.
… we began pharmacist assessment/prescribing in a limited number of stores this week. Beginning this week, a small number of stores in Florida and Kentucky will have trained, state-licensed pharmacists on site available to perform a clinical screening and assessment, prescribe and dispense Paxlovid to eligible patients who have a tested positive for COVID-19. We have prioritized access to patients living in socially vulnerable and medically underserved communities and will continue to do so as we expand the service.