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Imported from Revue
Given the combined proportion of COVID-19 cased caused by the Omicron BQ.1 and BQ.1.1 variants, the U.S. Food and Drug Administration (FDA) has announced bebtelovimab is not currently authorized for emergency use treatment of mild-to-moderate COVID-19 in adults and pediatric patients. Lilly and the FDA agree that it is not medically appropriate, at this time, to treat high-risk patients with mild-to-moderate COVID-19 with bebtelovimab in the US. Based on pseudovirus data, Lilly can confirm that bebtelovimab does not retain neutralization activity against the BQ.1 and BQ.1.1 variants, most likely due to an amino acid K444T substitution. Lilly will pause all distribution of bebtelovimab. Any unused bebtelovimab may be kept during the pause—please follow storage and handling as specified in the Fact Sheet. As we have seen over the last several months, prevalence of COVID variant sublineages vary by state, region and even country, and can change rapidly. Lilly continually monitors the global COVID-19 environment, assessing the neutralization activity of potential antibody therapies against a wide array of existing and emerging mutations and variants. Lilly will continue to search and evaluate monoclonal antibodies to identify potential candidates for clinical development against new variants. Allison Howell
The FDA determines blood donor eligibility policies in the U.S. using scientific data. These policies are intended to ensure the safety of the blood supply, for blood donors, and patients who receive blood transfusions. All blood centers are also regulated by the FDA and required to comply with all of the policies. The donor history questionnaire (DHQ) is part of a layered safety approach. Questions on the DHQ also help to determine a possible “window period” for infection, meaning a potential donor may be in the early stages of infection when the virus is present in their blood but the immune system has not yet made antibodies to the virus. During the “window period,” the infection may not be detectable by laboratory testing but may still be transmitted to others by transfusion. Regarding the study questions, we can’t share the specifics at this time, but the ADVANCE Study is examining if different questions could be added to the donor history questionnaire that are based on individual risk of HIV infection, and if these questions would be as effective as a time-based deferral in reducing the risk of HIV among gay and bisexual men who present to donate blood. Nick Gehrig
“America’s Blood Centers strongly supports a safe and available blood supply that treats all potential donors with fairness, equality, and respect. ABC supported the FDA change in 2020 that reduced the donor deferral period from 12 to three months for men who have sex with other men. Two of our member centers are now working as part of the ADVANCE study to collect the needed scientific evidence to further evaluate the current policy. ABC strongly supports this effort as a pathway to the establishment of donor-screening based on individual risk behaviors, not sexual or gender identity. The use of rational, science-based deferral periods must be applied fairly and consistently among all blood donors,” said Kate Fry, Chief Executive Officer at America’s Blood Centers.
On Wednesday, November 30, 2022, the U.S. Centers for Disease Control and Prevention (CDC) formally revealed their plan to strategically expand wastewater testing for poliovirus in select jurisdictions across the country. They explained that although preliminary discussions are underway with other state and local health departments, the Michigan Department of Health and Human Services (MDHHS) and Philadelphia Department of Public Health (PDPH) are among the first locations to explore plans to start collecting wastewater samples in specific communities for analysis at CDC’s polio laboratory. This plan is at the earliest stages and no specific date has been set for the start of testing. However, once it is underway, the findings from CDC’s strategic wastewater testing effort will help jurisdictions to prioritize vaccination efforts in identified communities of concern. Philadelphia Department of Health Commissioner, Dr. Cheryl Bettigole says, “we decided to move forward with wastewater testing for polio in Philadelphia because, although we have relatively high vaccination rates, there are epidemiologic links between groups in Philadelphia and in New York that could potentially increase the risk of transmission among the small pockets of unvaccinated residents of our city, given the known circulation of polio virus in New York state. While some parents who have not vaccinated their children may be absolutely determined not to do so, others may have opted out based on the very low risk of their child contracting polio in modern-day America. If we were to find a positive in our surveillance sampling, that might convince some of the latter group to agree to vaccinate their children.” Dr. Bettigole goes on to explain that “as far as the extent of testing is concerned, a wide net will be cast at the start, then, if we start to receive positive indications of the presence of polio, further investigation will need to be done and may warrant a need to undertake more focused testing to understand the areas of the city being impacted. We hope that the results of such investigations will convince those not yet vaccinated for the poliovirus to be vaccinated.”
The FDA remains committed to evaluating alternatives to the time-based deferral policy by helping to facilitate the generation of the scientific evidence that might support an individual risk assessment-based blood donor questionnaire. The agency has proactively sought public input to collect insights on how it might transition and implement alternative deferral strategies, such as individual risk assessment. The FDA is reviewing results from the Assessing Donor Variability And New Concepts in Eligibility (ADVANCE) pilot study as expeditiously as possible, using a thorough and science-based approach. While the study has concluded, the collective efforts of the FDA and the participating blood establishments continue. This FDA funded study, conducted at community health centers in key locations across the United States, has generated data that will help the FDA determine if a donor questionnaire based on individual risk assessment would be as effective as time-based deferrals in reducing the risk of HIV. Although we do not have a specific timeline for when our analysis will be complete, the agency believes the initial data from the study, taken in the context of other data available from blood surveillance in the U.S. and in other countries, will likely support a policy transition to individual risk-based donor screening questions for reducing the risk of HIV transmission. The FDA remains committed to gathering the scientific data related to alternative donor deferral policies that maintain a high level of blood safety. The FDA will determine next steps including when and how results of the study may be made public. We anticipate issuing updated draft guidance in the coming months incorporating key learnings from the ADVANCE study, as well as taking into account international developments in donor deferral policies. Carly Kempler (Pflaum)
It could be a few weeks before sampling begins. The wastewater testing for polio is really different for other things like COVID and so we need a different methodology, sampling sites, etc. We continue to work on identifying the right locations and the right partners.
Imported from Revue
Q: Has WHO decided to change the name of monkeypox?
A new name for the disease has not yet been announced. We will share details once finalized.
Here is some background information on naming of the disease, the virus that causes the disease, and the virus variants or clades:
Naming the disease:
Human monkeypox was given its name in 1958, before the publication of WHO’s best practices in naming diseases was published in 2015. According to these best practices, new disease names should be given with the aim to minimize unnecessary negative impact of names on trade, travel, tourism or animal welfare, and avoid causing offence to any cultural, social, national, regional, professional or ethnic groups.
o Assigning new names to existing diseases is the responsibility of WHO under the International Classification of Diseases and the WHO Family of International Health Related Classifications (WHO-FIC) through a consultative process which includes WHO Member States. ICD is part of the WHO Family of International Health Related Classifications (WHOFIC).
o Following a broad-based public and national consultations with countries and advisory bodies on the name of monkeypox disease, the ICD unit of WHO has recommended a way forward.
o These recommendations were endorsed at the WHO-FIC annual meeting held on 17-21 October 2022, but a final decision has not yet been reached.
o Suggested names can be consulted here (see “ICD-11, Add proposals”). WHO have had received over 200 proposals on the platform.
While this guidance on best practices does not apply to existing diseases, the ICD consultation considered these principles in reviewing over 200 new name proposals for monkeypox.
· Naming of viruses: The naming of viruses is the responsibility of the International Committee on the Taxonomy of Viruses (ICTV). There was already a process underway to reconsider the naming of all orthopoxvirus species, including monkeypox. This will continue under ICTV leadership.
· Naming monkeypox virus clades: See WHO press release on naming of monkeypox clades
Q: Is the process to find a new name due to pressure from any particular country or region?
When the outbreak of monkeypox expanded earlier this year, there were instances of racist and stigmatizing language online and in other settings. In several meetings, public and private, a number of individuals and countries raised concerns and asked WHO to propose a way forward.
(See further details above.)
BRUCE TROMBERG, NIBIB [00:00:56] Ever since, even before we really officially launched RADx, I think it was pretty clear what we wanted to do with RADx was help drive a paradigm shift from laboratory testing to point of care and home. And I think this is now happened ,and people have spoken, and we and the community really has been able to really rally around the authorizations and in the production and distribution of tests, with the COVID dot gov website. So home tests are widely available. … BRUCE TROMBERG, NIBIB [00:01:57] When you transmit information from point A to point B and it should be in a standard format with data elements and a structure that allows any computer or any database or any receiver to be able to read and interpret it. So we found early on that home testing didn’t have that kind of standardized structure, selection of common data elements, and so we started working on that, and our team developed what is called the Mobile Application Reporting Standard, which you can take a look on our website, it’s RADx MARS – Mobile Application Reporting Standard – and there is a ton of information on RADx MARS that ranges from, you know, very understandable high level, to super detailed detailed, techy, nerdy, but the sort of the the bottom line is that this is the first standard that allows identification of the core or common data elements that you would need to have from a home test, regardless of the platform. And then allows you to put it in a structured language and then mobile health or actually in virtually any kind of health care reporting informatics, the standards are what HL7v2 and FHIR. … BRUCE TROMBERG, NIBIB [00:04:08] And we’ve done– there’s a process by which we identify the standards and then Micky’s office works with multiple stakeholders to kind of ensure and validate that all this makes sense and gives it their seal of approval. So this takes a while. And then we’ve also worked with the APHL, so the American Public Health Laboratories, they’re the ones who who sort of do the point guard work of the distribution of the information out to the various databases, including HHS Protect, the states, and for laboratories. So we started working with them very early on to help with this home tests. So they’re involved. So it’s really a big consortium that we brought together. The CDC, we have them involved. So there’s nothing different about this in terms of where the data goes, as compared to what’s going on right now with laboratory tests. So right now, the CDC will report the number of cases a day. And that same path is the same path that we’re following with this, it’s just it’s enabled by you, the user in your home, just pressing a button on the website. … BRUCE TROMBERG, NIBIB [00:10:14] So what we’re trying to do is get a sense for what’s going on in home testing. The number of home tests that we don’t really even know how many home tests are being performed. We know how many people get from the COVID dot gov website, but we don’t know how many are being used. So there’s– when you’ve got laboratory data and you’ll have this data, which in combination, gives you a totally different view of what’s going on in terms of prevalence of infection. And it’s not just the absolute number of tests that are reported. It’s also the frequency. Are they a lot of test results? It’s the geographic distribution. Are a lot of tests coming in? And at this time, in this month, and then are they going down in the next month? So it helps you. It’s just another data point. And I think this is one of those things that it’s really, really easy to say, ‘well, we don’t need that because we have laboratory tests.’ But the fact of the matter is, however you look at it, the laboratory test is a very, very small understanding of the total number of people who are taking tests, by a huge amount. … BRUCE TROMBERG, NIBIB [00:15:43] There is there is an FDA reporting requirement for point of care tests. And so what we’re hopeful is that, and we have some encouraging signs, that the manufacturers could just put this QR code on their box and say, ‘hey, you know, you can just report here’ and that it’ll be up to the regulators, but you know, I don’t think it’s inconceivable that might ultimately help with or you can become, take the place of the reporting requirement. And wouldn’t it be great? Because then for a company, we get 10 or 15 different tests out there, and different apps and everybody doesn’t want to download every manufacturer’s app or if you can use any at all. … BRUCE TROMBERG, NIBIB [00:16:37] I think it’s essential for us to build this highway. And there is a shift going on. The paradigm shift is not just that home testing has become the dominant COVID testing. It’s really that home testing and health care has the power to move out of hospitals, into point of care and into people’s homes. And so metrology, ways to measure your health in your home, and in point of care, will become increasingly sophisticated and powerful. Individuals need to be able to control that information, but not in a random sort of cacophonous way. It’s got to still be structured in data structures that can be received and interpreted by health care providers, insurance carriers, hospitals, point of care centers, all of that health care provider networks. So this gives us, for the first time, a way to connect and communicate. … BRUCE TROMBERG, NIBIB [00:19:00] So we’re pushing a Test to Treat like effort with ASPR that that will be very similar to our “Say Yes! to COVID Test.” Can you do test to treat in people’s homes and identify places where people don’t have access? This is an ongoing, it’s like a working project, that I think we’ll be able to roll this out fairly soon. And this backbone will serve and facilitate that project, that experiment, and which just like in “Say Yes! to COVID Test” we had no idea if people would test at home. So we were able to use this structure to really get to that conclusion. Test to treat, what if you could do a test at home and then transmit this information to your health care provider and then actually get your treatment delivered to your house? And so, for COVID, for flu, we have treatments– that could be really nice. And you need to have this kind of backbone. … BRUCE TROMBERG, NIBIB [00:20:55] So the CDC is increasingly interested and excited about it. And that’s a key thing. It’s the same– it will go to the same data collection place, what we call HHS Protect that the laboratory tests go to. So it’s up to the CDC what they do. But, they’re very interested in releasing that data to the public, and making it all available as they have been making all this other stuff and the other data that they make available.
Imported from Revue
PETER MARKS, FDA [00:00:34] So there are a variety of different groups looking at vaccines, exactly as you’ve noted, that might be able to provide the kind of mucosal immunity, that is the ability to zap the virus before it gets into the system at the portals of entry. And so those– the hope would be that in the coming year, we see those investigated and obviously we will be looking at them, helping them to come along, and reviewing them as quickly as possible. Even if we can get to vaccines that give us a year of excellent protection, that would be an advantage over where we are now. And obviously, the ultimate goal would be to have something that would be a multi-year protective vaccine against all the different types of COVID, SARS-CoV-2 that might come along. So I think we’re we’re optimistic on that front. And then the nice thing, if we could get this to a once yearly vaccine, are that a number of manufacturers are very interested in combining the COVID 19 vaccines with their influenza vaccines to make it simpler to immunize people, because most people would rather get one shot once a year rather than have multiple shots. So I think there’s a lot of work that’s going on in this area. I think we at FDA are trying to encourage additional work go on in this area as well.
SARAH DESPRES, HHS [00:06:31] I think flu vaccines are always a challenge because you got to get it every year, and you have to get it within a window. So I think that it’s one of those vaccines where, again, we need and we have a permanent infrastructure to just keep pushing it every year. But, currently, and I’m just sort of looking at the latest I’ve got from CDC, while the vaccine coverage looks similar to last year, there is a significant drop while– a 6% drop in coverage over pre-pandemic years. So I think you’re seeing that as a problem. We have for adults five million fewer doses have been administered compared to this time last year in pharmacies and physician’s offices. So it’s 15% lower compared to last season.
JOHN BARNES, CDC [00:31:47] We’ve had a lot of circulation of a lot of different zoonotic viruses in avian and swine populations. And in the last two years, we’ve had quite a number of different zoonotic influenza subtypes that have been been detected. And so please look out for any of those influenza A viruses that we cannot actually obtain a subtype, that has a influenza A target below 35, 35 or below, but reactivity for PD H1 or H3 subtypes, that’s a diagnostic specimen to CDC, please send those immediately. As I mentioned, also, we’re looking for these B/Yamagata viruses. We have not seen those in the last couple of years and most of the viruses that we have seen collected are actually LAIV cases, where we have live attenuated influenza vaccine that has persisted a little bit too long in the nose. And we’ve gotten a swab of somebody who has been treated with that. And so be aware that this is also a possibility. And that we may be reaching out to you all if we have a B/Yamagata potential case, if there has been exposure in the– actually a live attenuated vaccine has been given, or there was somebody else in a household in which this has been given as well.
Imported from Revue
ROCHELLE WALENSKY, CDC [00:12:10] So what we’ve seen with RSV as well as with influenza is both that they are coming earlier. So we usually don’t see RSV until the winter, December and January, similarly for flu. And we have started to see in those areas that have been hardest hit by RSV, the South and South-Central region, that some of those regions are starting to come down in their RSV rates. That would be really good news. Similarly with influenza, much earlier than we generally see in the season, we haven’t seen those come down quite yet, but we have seen in the Southern Hemisphere, for example, where they get flu before us, that they had an earlier season but not a more severe season. So we are hopeful. It doesn’t always follow that that will be the case. We still very much recommend not only your COVID-19 bivalent vaccine, but also your flu vaccine, to really prevent those hospitals from being overwhelmed and to protect you and your families.
SARAH DESPRES, HHS [00:00:04] There are also supply chain issues that have come up over the course of this surge. There are several products that are in– that are in shortage that are used for response to this. And so ASPR and FDA are working to both monitor and mitigate those shortages in order to help health care providers respond. Q [00:00:28] Can you be specific about what some of those shortages are? SARAH DESPRES, HHS [00:00:31] Yes, there are four that I know of. But the problem with shortages is that sometimes they bubble up and can be– there can be a geographic shortage in an area that we don’t even– that doesn’t even rise to FDA’s visibility. But the ones that we– that are on my radar are certain pediatric formulations of amoxicillin, an antibiotic, certain formulations of albuterol, pediatric trach tubes, and then certain formulations of sterile water.
JOANNA PRASHER, CDC [00:06:21] But to be clear that, as of right now, there are no probable or confirmed cases of Ebola in the current outbreak outside of countries other than Uganda. The risk of Ebola in the United States does remain low. However, that being said, CDC is working, as I said, with our interagency and our state and local partners to make sure we are ready should there be a case present here in the United States. … JOANNA PRASHER, CDC [00:07:09] To date, so that’s through the 20th of November, CDC has screened 4,816 persons at these funneling airports. 69 required what are called secondary public health assessments, but none have been referred to hospitals, and there have been no high risk exposures identified through this process. … JOANNA PRASHER, CDC [00:07:28] CDC has been sending health information alert text messages to travelers that are arriving from Uganda. The messages asked travelers to monitor themselves for signs and symptoms, and to provide information of what they do– what they should do if they get sick, specifically to isolate, call the public health department, and share their travel history with their doctor. To date, that’s through the 17th of this month, we’ve utilized what’s called the CDC text illness monitoring or TIM system to send general Ebola health text messages to the 2,790 unique phone numbers of arriving international travelers from Uganda. We then have been supporting U.S. health departments by sharing contact information for these travelers so that health departments can conduct follow up risk assessment and management of travelers. … JOANNA PRASHER, CDC [00:08:14] Following CDC guidance, during the week of the 6th to the 12th of November, jurisdictions were monitoring 1,160 travelers. To give you some sense of the level of effort going on nationally here. To support that follow up, we’ve also started, with the help of the CDC Foundation, distributing cell phones to travelers from Uganda who arrive without a cell phone or U.S. cell phone service or U.S. phone number. This supports local and state health departments contacting these travelers to do that important follow up. To date, we’ve distributed over 240 cell phones to such travelers. … JOANNA PRASHER, CDC [00:09:34] As of this weekend, we have conducted 29 such Ebola related clinical consultations since the start of the response on September 20th. Only one to date has been referred for Ebola testing, in consultation with the jurisdiction and the treating health care facility. That person, I’m happy to say, tested negative. … MUKTHA NATRAJAN, CDC [00:20:26] Antigen tests have been widely used for diagnosis, screening and surveillance of SARS-CoV-2 across health care settings, including hospitals and physicians offices, and skilled nursing facilities. And so CDC is currently updating communications about testing, giving actionable information on testing decisions and streamlining our existing content. Therefore, it’s necessary for CDC to maintain and update this antigen testing guidance for health care providers. Next slide, please. The need to update this antigen testing guidance became clear as soon as FDA released their repeat testing guidance and CDC updated its new goals for public testing guidance. … MUKTHA NATRAJAN, CDC [00:27:24] So these updates have been cleared by CDC, and we’re just awaiting the actual web page rollout. We expect it any day now. It’s not officially online yet, though.
Imported from Revue
PETER MARKS, FDA [00:24:21] I think we do need a better generation of vaccines for SARS-CoV-2, much the same way as we need better generation of vaccines for influenza. But in this case, the reason why it’s so urgent, at least for me, to SARS-CoV-2, is we see that this virus continues to surprise us. And I just worry that so far, thankfully, the surprises have not led to loss of T cell mediated immunity in the general population. Perhaps it’s made it more challenging in the older population, and that’s the more sensitive population. But if we get to a place where somehow the virus evolves far enough that we lose that T cell mediated protection that we’re getting, or lose even a significant portion of it. That could be quite troubling. So I do think we need to be thinking about trying to keep ahead of this virus. It’s a hundred nanometer particle that seems to be able to move at a very, very fast pace. … PETER MARKS, FDA [00:25:30] One effort needs to be to go further along understanding correlates of protection that go with immunity to SARS-CoV-2. I think we’ve obviously settled on antibodies as the best tool we have. But antibody levels are not telling us about what the long term protection of a vaccine will be. And right now, in order to understand that, because we don’t have a formula that helps us there, we’re going to have to rely on clinical studies. They’re going to go on for a while. It’d be nice to have better correlates as we move forward. … PETER MARKS, FDA [00:26:05] And the second piece is going to be to have what I would consider a platform-agnostic search for the best vaccines that might actually provide us with that long term broad immunity. I think it would be a mistake to get very wedded to the technologies that have served us early on, or to prior technologies. I think we need to have another open-minded search for what might best protect us here. And it might be combinations of vaccines, too. So I think we have to be very open-minded here because, ultimately, if we don’t, I worry that this virus will get ahead of us. … PETER MARKS, FDA [00:27:26] I mean, part of this is that we try to look at the best available science, and our scientists are constantly looking at what we believe to be immune correlates of protection. Some of them, we have our own laboratories which do applied scientific research, that are looking at correlates and trying to understand them better. We’re very open to working with our partners at NIH and CDC and, for that matter, academic partners to look for the best tools to understand the immune response. And so I think, ultimately though, when we settle down on a correlate, it’s going to have to be something that we can feel is well validated. So that we’ll feel comfortable using it for approvals, which is a tall order, because it means we have to feel comfortable that it’s going to really correlate with the clinical outcomes. And some people find that a little challenging, because it’s not just enough to have a study and 10, 20, or even 100 or 200 people. We need to feel really comfortable that the biomarker is going to really correlate with what we’re going to see in terms of effectiveness in the real world.
Imported from Revue
IAN WILLIAMS, CDC [00:03:58] Back when I started in the response as a principal deputy incident manager last spring, we had about 10 task forces with 60 different teams. So very large incident management structure, close to 2,000 people deployed at the response at that time. And over the course of the last 6 months, we’ve now slimmed down to 2 task forces and 10 teams. This really involves taking about 400 different activities, figuring out where they belonged, working with the National Center for Immunization and Respiratory Diseases to stand up a new division that’s going to be the ultimate home of a lot of this activity. … IAN WILLIAMS, CDC [00:07:14] Deaths, again, have declined quite dramatically here, but there’s still lots of, too many deaths happening, still between 300 to 350 deaths a day happening from COVID. There’s been a lot of work and activity focusing on what’s going on with who is currently dying from this. And there will be actually some additional information coming out from CDC, hopefully later today, sort of examining in more depth a little bit of who these people are that are still dying. To give you just a little sort of hint, looking forward, a lot of these people tend to be older. They tend to have multiple underlying conditions. So they tend to be sort of the most medically fragile. So there still needs to be some efforts of focusing on thinking about vaccination for these folks and post-exposure prophylaxis, with Paxlovid. But more on that later in my presentation. … IAN WILLIAMS, CDC [00:09:35] One of the things to say is that one of the things we’re doing is we’re watching quite carefully all around the world, talking with our public health partners to watch for what’s emerging in other places. And the overall sort of good news is it doesn’t look like there’s any place in the world where there’s a new variant that’s sort of driving surges. Where we’ve seen surges, they’ve seen mostly it be driven by seasonality, people coming inside, spending more time around one another, but not being specifically being driven by the emergence of a new variant. However, there’s a lot of worry that a new variant could emerge and start us all over again. So there’s a lot of work focusing on making sure we’re prepared and thinking about that and watching if it emerges around the world, so we can become prepared here. … IAN WILLIAMS, CDC [00:13:09] There’ll be some data released in the next couple of weeks really sort of looking at the vaccine effectiveness. But the preliminary look is that the bivalent boosters actually do work relatively well for hospitalizations and deaths, and probably pretty well for infection as well. But more to come in the coming weeks. … IAN WILLIAMS, CDC [00:13:57] Another big focus here is again, talked about preparing for a potential fall-winter surge of COVID here. A lot of this is around making sure we’re watching variants, what’s happening not just in the United States, around the world. There’s a very robust system through an interagency group across HHS and the U.S. government where we’re constantly talking to one another. We have robust discussions with our public health partners around the world. So we’re we’re watching this very carefully. And again, the good news is, even though this variant soup is sort of happening, it doesn’t look like there’s sort of a new really bad variant of concern that’s sort of emerging and driving any place in the world so far. So fingers crossed and hopefully it keeps that way. … IAN WILLIAMS, CDC [00:15:59] We need to continue to look forward to a transition of where we move and go in the longer haul. I think where we are is, in terms of the transition of the CDC response, we’re about where we’re going to be, I think, for at least the foreseeable future, until we really understand if there’s going to be a variant surge or not. We don’t, I think, want to go too much further in transitioning things. The stuff that we’ve really retained in the IM structure has been those things that are really cross-cutting. So those are things like the chief science officer, the chief health officer, and the two task forces we retained are cross-cutting. They’re the data analytics and visualization, and making sure the data is good in our STLT task force. So making sure that those pieces work well are going to be an important part for the next couple of months at least. And we’ll sort of see, as we get through the winter, sort of how things go. … JONATHAN MERMIN, CDC [00:29:11] Actually, it’s just– we are in the works of actually looking at what– is there any difference in immunity from the second dose? In other words, the prior studies has indicated that in both the strength of immunity and the length of how long you have immunity will be a benefit from a second dose. And also looking at whether there’s any difference between intradermal and sub-q routes of administration. … JONATHAN MERMIN, CDC [00:30:22] So even though we estimate that there are about 2 million people who would potentially benefit from mpox vaccination, we’ve only had first doses for a little less than 700,000. So we still have people who are potentially vulnerable to infection. They just may not be being exposed at the current time. So we need to expand vaccination and we need to respond to the outbreaks. … JONATHAN MERMIN, CDC [00:31:02] And this map is just showing counties, so you can see that even within states, it’s not the entire state. So of the 3,143 counties in the United States, only 168 had any cases in the past two weeks. Of those 168, 80 had only one case. Presumably then, close to ending their transmission and then of the other counties, very few had more than ten cases. So again, the idea that if we can bring assistance to those geographic areas and those health departments in particular, we should be able to more rapidly reduce transmission. And we’ve been having communications and calls and support for some of these health departments over the past week– actually two weeks. … Q [00:45:00] I was really asking about the the non-COVID excess deaths. And I mean, I think from a general perspective of, as from disaster epi, we already know we’re really terrible at measuring mortality and disasters. I mean, we usually end up getting data from the media for a while to do that. And so, I was more talking about those non-COVID excess deaths, if that’s part of the data? IAN WILLIAMS, CDC [00:45:29] The stuff that we’re going to (inaudible) is more focused on those people that are basically being reported as dying with COVID as a primary or underlying cause within the sort of death certificates. So that’s the big focus. There is, has been, a big look sort of at that sort of other chunk. We’re not– it’s a tough thing to get the data to wrap your sort of arm around. And it’s something that I know that we’re continuing– the response is continuing to sort of look at. … JONATHAN MERMIN, CDC [00:57:14] But there are complexities that come up. One is that the vaccine itself is available only through the Strategic National Stockpile. There have not been ACIP, you know, kind of formal recommendations yet. The tecovirimat is still being administered under an EA-IND and there’s an ongoing randomized controlled trial called STOMP, which has enrolled a bit over 30 people because it got rolling as the epidemic started– outbreak started to decrease. And so I think that’s something that is just– hopefully they’ll develop enough cases to be able to answer some of these questions. But there’s there’s some issues that come up in terms of just our normal way of approaching things and getting information may not be enough for us to kind of move forward. … IAN WILLIAMS, CDC [00:59:54] But I want to point out what Jono said. Part of this is thinking about transitioning to sort of a longer term program, that COVID’s going to be around for a period of time. We need to not just be one and done. We need to have community based programs. We need to build this into the primary public health care system. We need to educate physicians on when Paxlovid needs to be prescribed. We need to make sure it’s accessed. So it’s building all the stuff that Jono sort of said, thinking about how to bake this sort of in this community writ large.
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ANTHONY FAUCI, NIAID [00:07:50] I’d have to be perfectly honest with you, and with our viewers and listeners, that there is always the possibility that we will get a variant that’s very, very different than the current variants. And let me explain what I mean. So right now, we, up to a few weeks to a couple of months ago, had a predominance of BA.4/5 variant, which was a Omicron variant. Then we now have the creeping in of BQ.1, BQ.1.1, BF.7, BA.4.6, things that are meaningless to your viewers and listeners, but they are sublineages of Omicron. And so although they are variants, they’re not so far off that the protection that you have from vaccines and boost won’t help you at all. It will help you a lot. There is a possibility – I don’t know what the likelihood of it is, it is difficult to predict – that there will be a variant that’s very, very different, that we will have to get everybody vaccinated out of the sync of a yearly type of a vaccine. So when you talk about a yearly, seasonal, similar to flu, that’s to get people into a reasonable cadence. That doesn’t mean that there aren’t going to be some people, particularly people who are immune compromised, who are transplant or cancer, chemotherapy, they may need that updated boost more often. But for the broad general population, something like once a year seems reasonable.
ASHISH JHA, WHITE HOUSE [00:21:23] So, first of all, this is a decision that the secretary makes. And what I will tell you, in terms of how long, is right now, I think it’s through January 11th or 12th, I can’t remember the exact date, the secretary has been very explicit and clear that he will give everybody at least a 60 day notice before pulling it down. That is an ironclad commitment. And so you can do the math of where we are, but that 60 day commitment is there. Why is there a 60 day commitment? Because there will come a time when the public health emergency will end. The secretary will make that determination and the secretary make that determination when he believes that the tools that PHE gives us are no longer necessary for protecting American lives. And obviously, giving people at least a 60 days notice is a really good thing to do, because it lets everybody plan for it. There are a whole set of things that flow from a public health emergency around data, around how we’re thinking about EUA products, I mean, just there’s a set of things, and we want to make sure that all of that transition happens in a very orderly way, again, with the goal of making sure that, when that public health emergency ends, whenever that ends, that Americans continue to have access to vaccines, treatments and tests. That we are not sort of unable to respond to a surge. Like there’s just a bunch of things that we need to be able to do. And the secretary has determined that that is still necessary right now.
LOVISA ROMANOFF, CDC [00:37:25] And last but not least, as a result of Jim Macrae’s report that was published this summer, the CDC’s scientific and programmatic review, we have developed priority action teams. So as part of Jim’s report, there were 24 priority action areas, and they were divided into 21 groups. And they are individually looking at each of those recommendations and making plans for how we can implement those. Earlier, we talked about leadership and the importance of training and the importance of providing our staff with the resources to be successful. That is one of the recommendations. And there’s an implementation plan being developed for that, as well as emergency response staffing, which we’ve also talked about today, which is a priority. So the timeline for these recommendations or implementation plans, they are expected to be delivered to the Moving Forward team by early December for further implementation. Next slide, please. So just wanted to show a quick timeline. So on the right here, you see the strike teams that were implemented. They produced their initial recommendations to CDC leadership. Then we had about a month of engagement and discussion across staff and leadership team. And we’re currently pending the final decision from Dr. Walensky on those recommendations that were made to her. So we have– we know that there’s a commitment that, by the end of the calendar year, there will be a proposed reorganizational package that is put forward by Dr. Walensky. And we just heard last week that we are still on schedule for that. So, aggressive but doable timeline to get all of these activities done. But there are a lot of things happening across the agency, and we’re engaging both internally and externally on all those. … CHRIS BROWN, CDC [00:03:32] I will spare you what I think has been several straight DC updates of numbers about calls coming in to the EOC and the number of people we’ve sent out to the field. And we’ll just say that that that continues to be the case across the multiple responses that we’re supporting. At one point a couple of weeks ago, we were up to eight concurrent responses across the three levels of the graduated response framework. So several at the agency-wide level and a handful at the center-led and program level. With a little breathing room, perhaps, we’re down to six as of a couple of days ago. So six today. Still ongoing is the level three response that carries over its old designation from before we enacted GRF for the polio response, that’s an agency-level response, plus COVID, monkeypox, and the ongoing center-led Ebola response. Across all of those, we’re providing the normal suite of services and support that we provide via the EOC at the agency wide level. So things like deployment support, emergency travel, equipment issuance, SME connections via the EOC, back to programs, when we get calls and requests from state partners and others. But we’ve also had quite a bit of activity in the way of things like emergency risk communication support. COCA Calls, HAN products that have come out. There have been several around the Ebola response and the monkeypox response of late, so that’s been keeping our risk communication apparatus very busy, as well as just ongoing support for things like data and data analytics and visualization work, our situational awareness products, and the continual training and planning we’re always doing to help make sure that folks across the agency are ready to roll into response roles when they’re needed. … CHRIS BROWN, CDC [00:09:01] We realized not just in the COVID response, but over the course of responses that have happened really over the last decade or so, and that was underscored again in COVID and Ebola and monkeypox now, and several other responses, that there is this big need at the agency that is being unaddressed by the voluntary opt-in system that we have for pulling people into emergency responses right now. … CHRIS BROWN, CDC [00:11:13] What we’re envisioning here is setting up a response ready cadre that we’ve since started calling CDC Ready Responder program. Our aim is to get to pre-identified, ready to go workforce, at all times, who can help us, not just with the start up but the sustainment and the feeding and care of long term public health emergency responses, which, in contrast to other types of emergencies, tend to last for a really long time. They’re protracted, they’re complex, and they have a lot of positional needs to sustain them. What this will do for us is really shift us away from what’s a pretty arduous, very time consuming process for recruitment during responses. So we hear time and time again that people could go on to CDC emergency responses feel like they spend an inordinate amount of time recruiting for their backfill, looking for somebody who has the right skill set to come in behind them when they’re ready to roll off. This will get us away from that, so that we know at all times who’s ready to go, who’s willing to go, who’s able to go, who’s on leave, out of pocket, and who has the skill set to meet the epi positions, the laboratory positions, the operations coordinator positions, the clearance management positions, the whole gamut of people who we need during an emergency response. … CHRIS BROWN, CDC [00:15:50] We hope to be in a much better spot of being able to say, I need an epi who speaks French, who has experience working with pediatric populations, who’s done vaccination in the field before, or who’s supported vaccination studies in the field before, or a clinician maybe who’s done the vaccinations in the field before. We’ll be able to search, once we have a uniform picture of who’s at the agency, and say this person is 100% match, this person has a 95% match. We can do some of that in CDC responder now, but giving ourselves the capability to actually tap those people, and have an expectation that CIOs will plan to make them available for responses, and be able to place upon to response needs when they’re needed, instead of hunting for them during a response, will be a much more efficient approach. And that’s what we’re really envisioning. … CHRIS BROWN, CDC [00:17:35] We’ve also started to partner with HRO, the human resources office at the agency, and we took a big systematic look across all the CIOs to figure out where vacancies were so that, as we rebuild from COVID, we didn’t miss the opportunity to backfill in a way that would allow us to tap people for emergency responses. Very few people outside of CPR have emergency responses as a core duty of their positions. We identified and are working to place people into 600 vacancies across 7 or 8 different CIOs who participated, where emergency response is now a core duty on the position description, and those people who applied through the vacancy announcement that correspond to those PDs and vacancies know when they come in that they’re expected to maintain a CDC responder profile, and that they will be tapped, and the supervisors know that it will be tapped, when emergency response needs arise and we need a particular skill set. So that’s doing– it’s a small number of people in the relative percentage of staff at the agency, but it’s doing a lot to give us a model for how we should be backfilling positions to make sure that a whole workforce, with few exceptions, is emergency response ready. … CHRIS BROWN, CDC [00:18:42] We are working on updating the operational policies that lay out how CDC manages emergency responses. And we’re trying to shift ourselves away from the totally voluntary opt in nature of those policies, so that there is an expectation that we can tap people in the centers, and the centers will plan to support them. And we’re also working on developing emergency response participation performance standards for staff across the agency. We finalized that for executives. So every senior leader in centers across the agency will have an expectation that they have a CDC responder profile, that they participate in responses, that they make staff available for responses, and that they ensure that their staff have CDC responder profiles as well. And I want to mention that we are working through bargaining unit negotiations, and are making sure that we comply with all of those obligations, as we work to roll this out. But we anticipate that that’s coming ideally by the end of the calendar year, if not shortly thereafter.
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CHRISTINA HUTSON, CDC [00:20:10] Because of these findings, from the start of the outbreak, we have been monitoring the F13L gene within sequenced isolates. At this time, CDC has analyzed sequence data for more than 4,000 specimens from across the United States, of which 11 were found to have genetic changes in the F13L gene during those sequence surveillance efforts. When tested within the lab, using a cell culture based sensitivity assay, those 11 isolates were sensitive to tecovirimat, showing no evidence of resistance. We’re currently working on a health advisory related, in part, to development of tecovirimat resistance virus during prolonged tecovirimat treatment. We wanted to let everyone know that this would be coming out soon, and there’ll be more information for providers about the potential for tecovirimat resistance. And we hope to have that HAN out by the middle of next week. … NATALIE THORNBURG, CDC [00:27:45] And so we’ve shown lineages of viruses here in this table with substitutions that are in these different lineages of viruses. The bolded sublineages are currently expanding, and the ones that are not bold are no longer expanding. And notably, one– there is one labeled with an asterisk, XBB virus, and that lineage is less than 1% of weighted estimated viruses in the United States and therefore is not currently on the data tracker. We don’t add viruses until they meet a 1% threshold of weighted estimate of circulating viruses. … NATALIE THORNBURG, CDC [00:29:57] So one sublineage of virus that we have separated, just for the first time yesterday, is BN.1, which is an alias for BA.2.75.5.1, and it is growing and predicted to account for about 4% of circulating viruses this past week. The mutations it has in its spike receptor binding domain, relative to the BA.2 parental viruses, are listed there in that sub bullet below BN.1. And that includes one that we see in a lot of the circulating viruses right now, in R346T substitutions. … NATALIE THORNBURG, CDC [00:33:10] As I mentioned before, BQ.1, BQ.1.1, have a positive growth rate. BQ .1.1 is a little faster than than its parental lineage, with a doubling time of about 14 days, although that’s slowing down. Last week it was about nine days, so its growth is slowing down. And BQ .1.1 slowed from about 13 days to 26 days, so its growth is currently slowing down. BA.2 lineage viruses that, BN.1 that we just added this week, has a doubling time of also about two weeks, 14 days, although the uncertainty in that doubling time is a little higher because the absolute number of sequences is low, because the proportions are low, so has much larger confidence intervals. And XBB, which is a recombinant virus, two different BA.2 lineage viruses, it’s still below a 1% threshold, so it is not on the data tracker yet. Its growth is increasing, with a doubling time of also about 14 days, although it’s been sort of trending on the lower side of the predicted growth rate for the past several weeks. But it’s also increasing with a doubling time of somewhere around two weeks. … NATALIE THORNBURG, CDC [01:19:13] So the bivalent vaccines, as a reminder, have the original spike sequence of the ancestral virus of the virus that circulated early in 2020. And then it also has a spike that is the BA.4/5, same spike sequence as the other spike protein encoding gene in the vaccine. Most of the lineages, and I’ll have to do a little back of the envelope math here, while other people answer some questions, but the vast majority of circulating variants are either BA.5 – that’s still 30% of circulating viruses match the vaccine perfectly, or are BA.5 and 4 lineage viruses with either one, two, or three changes in the spike receptor binding domain. That is very similar. Spike is a very large protein, so that’s still very similar to what what the vaccine looks like. So we expect the VE to be high, but we don’t have real world data yet. Our epi colleagues are working on on getting VE, so we hope to have that very soon.