tinalexander.github.io / notes / 2022 / 10 /
Learn more about this site and how to get in touch.
Imported from Revue
While we’ve recorded 131 cases, we haven’t had outbreaks among people experiencing homelessness (PEH), and specifically no transmission among PEH in encampments or interim housing sites.
Q [00:52:15] My question to you is, over the past few years, you’ve been under a lot of scrutiny in the news media. What’s something important to you – an accomplishment, a mistake, a story – that hasn’t been covered as much in the career that you’ve had so far? ANTHONY FAUCI, NIAID [00:52:32] That that hasn’t been covered? Wow. I’ve been publicly colonoscopied mostly. (laughs) You know, I think what– you gave me a whole list of areas. I think the thing that hasn’t been fully appreciated is the importance of personal relationships, particularly my family, which has really been the core of what keeps me sane at a time, particularly lately, where I get attacked every single night on Fox News by crazy people. And a lot of– and a lot of politicians are running their campaigns on, you know, put Fauci in jail, hang him, kill him. Steve Bannon just came out yesterday with a statement that he is– wants everybody to attack me and my family. It was amazing. And I’m surprised he’s not in jail for that. Well, he is going to jail, hey. (audience applause) It’s– it’s personal interactions that are so important to me that don’t get– personal interactions with people like Peter.
ASHISH JHA, WHITE HOUSE [00;59] I do expect them to look a little different. They’re going to be well-controlled trials, larger samples, and so my expectation is that you’re going to see– and you see this in both the Ho and the Barouch study, you see a little bit of a difference, bigger difference about I think about 30% higher titers in the Barouch study – which I think is reasonably well done, though it’s small – I expect we’re going to see at least that size benefit, but probably bigger, in the Pfizer and Moderna studies.
…
ASHISH JHA, WHITE HOUSE [02;36] The other question you’re going to want to ask yourself is, you’re not getting this vaccine to protect yourself just for the next two, three, four weeks. You also want protection two months from now, three months from now, four months from now, six months from now. And, again, we can talk about XBB– the one I am paying most close attention to in the United States is BQ.1.1, which as you know, is a BA.5 derivative. And based on all of the things that we understand about immunology, your protection against BQ.1.1 is going to be significantly better after a BA.5 bivalent than if you got nothing at all, and certainly– and even compared to if you had gotten the prototype, the original vaccine, as a booster. So given all of that, I think getting this bivalent makes a whole lot of sense.
…
Q [03;51] For example, I’m sure you’ve seen, there have been suggestions of, we should go all in on a monovalent BA.5, or we should get a second booster of the bivalent. But it sounds to me like you thinks are just, like, not going to happen this fall? We don’t need a change or more boosters? ASHISH JHA, WHITE HOUSE [04;08] Correct, correct. For a variety of reasons.
…
ASHISH JHA, WHITE HOUSE [06;17] These studies are preliminary. They’re small. I see them as kind of, again with a lot of preliminary studies, you haven’t sort of gone through and done all of the steps of really getting a tight control group and making sure that your groups are evenly matched. Again, these are both terrific research groups. No critique of their scientific prowess. But I feel very comfortable saying that we’re going to want to make one of a policy decisions based on more definitive, larger studies, which are coming soon.
…
ASHISH JHA, WHITE HOUSE [16;48] I believe most scientists I know believe that the FDA made a bold, and smart, and really science-driven decision. One of the reasons why I continue to believe that this was clearly the right call is if you look at the BA.1 bivalent, the better done studies on BA.1 bivalent, like, for instance, the one that was published about two weeks ago in the New England Journal, and look at how the BA.1 bivalent does meaningfully better against BA.1 than the original prototype, and so then you think, well if that’s true for the BA.1 bivalent, why would that not be true again for the BA.5 bivalent? So there is a bit of like, all of the well done studies continue to point towards better immune response. And I, therefore, I feel like, we’ll wait for more definitive data, but even the preliminary data, I mean if you look at Dan Barouch’s study, 30% titers, that’s important. And so I remain very confident that the FDA made exactly the right decision. We’ll get more data soon.
We appreciate the early observations on small numbers of individuals regarding the immune response to the bivalent (BA.4/BA.5 + original) boosters. Data from larger, well controlled studies that are not subject to the same limitation of these smaller studies are expected to be available in the near future. That said, it is important to note that even the data from these initial small studies indicate that the bivalent vaccines are generally at least as good or better as the original vaccines in generating an immune response, particularly to BA.4/BA.5 and other newer variants. Additionally, even modest improvements in vaccine response to the bivalent boosters could have important positive consequences on public health. Thus, FDA continues to encourage eligible individuals to consider receiving an updated vaccine to help protect against the currently circulating COVID-19 variants and the wave of COVID-19 that appears to be coming. While we can’t comment on what the timing may be, the agency does plan to convene a meeting of the VRPBAC this winter to discuss the composition of COVID-19 vaccines for primary vaccination. Peter Marks
Imported from Revue
Jurisdictions officially report deaths to CDC through national case surveillance after a medical investigation has been completed. This often takes time because it may involve an autopsy or additional laboratory testing to establish whether there are other infections involved, particularly in immunocompromised people. The reports of deaths are just starting to make it into national surveillance systems. To our knowledge, many of the patients who have died of monkeypox contracted it during the summer and had a prolonged course of illness and treatment that in some cases was followed by a postmortem case investigation, which often takes weeks to complete.
The tiered approach allows states to create a coordinated, networked approach between state and local public health officials, in collaboration with hospital partners, to serve in one of the three suggested roles recommended by the CDC. In addition, Virginia with the CDC and the Dulles Quarantine Station have identified a transport rotation schedule between the airport quarantine station and the treatment facilities within the region. David Goodfriend
There are several hospitals within the region that rotate who would receive an individual from Dulles.
James R Moss
We are currently following 31 returning travelers. We make an initial contact and then we conduct follow-up calls or texts during their monitoring period. The Los Angeles County Department of Public Health does have the capacity to test and we can get same day test results. It is important to highlight that because the early symptoms of Ebola are indistinguishable from many other illnesses, especially travel related illnesses, the majority of patients who are tested for Ebola will have something else.
We do not have any individuals who we are following because of recent travel to Uganda.
Our health department forwarded your email to me. The responding hospital would be University Hospital in Newark. Anthony Puglisi
the OraQuick® Ebola Rapid Antigen Test can be used to detect Ebola infections caused by the Sudan virus
…
We make this product as the need arises and are currently in production now to help the CDC efforts. Amy Koch
We don’t typically comment on preprint studies we weren’t involved in. As for bivalent data, we recently shared the 7-day data and will have additional data in coming weeks: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-early-data-clinical
We will have our BA. 4/5 data by year end and ours will be statistically powered.
[11:23 AM] ANTHONY FAUCI, NIAID If that is the case, it’s not that disappointing. Because both of them work very well. I might comment that those studies, they came from very good institutions and very good investigators, both of whom I know well, but they’re still not peer reviewed and the numbers in those studies were small. What I’m really looking forward to, Kate, is the full data that we’ll be getting hopefully within the next couple of weeks at the latest from the FDA who will get the totality of the data that was submitted to them by the companies that did the study. So I think the jury is still out about that. But even if it turns out they’re equivalent, they both did very well, which means there’s no reason not to and a very good reason to get your updated booster shot.
ROCHELLE WALENSKY, CDC [00:48:43] If you look at all age groups, about 79% of people have received of primary series, about 49% had received one booster before we rolled out our bivalent campaign, and about 7% of people have received a fall booster. So we have work to do. Some cautious optimism here is that we are doing better with our higher risk populations. That we have about 93% with a primary series, about 72% have gotten a boost, and about 17% with our fall boost. But we have– we do have more work to do there.
…
ROCHELLE WALENSKY, CDC [00:41:59] And we’re watching very carefully BQ.1 and BQ.1.1. I’ll remind you that BQ.1.1 was the little icon there. And that is because we are following these very carefully. And those are of our greatest concern right now, both for the number of mutations, but also for the impact and the phenotype that we are worried that they may imply. So most recently, and these come out every week on Thursday, we are Nowcasting about BQ.1 being about 9.4%, BQ.1.1 at about 7.2%. Again, early on, with relatively small number of sequences, we have larger confidence intervals just to be aware of. The doubling time of these for both variants compared to BA.4 and BA.4.6 and BA.5 are increased. The doubling time for BQ.1 has been about ten days, for BQ.1.1 about six days. And both variants now are expected to have both of Evusheld and bebtelovimab resistance. There are no current data –and both of these stem from the BA.5 sublineage– there are no current data to suggest decreased vaccine effectiveness, but something we are watching, of course, very carefully. If we look at this by region, we also map our variants by region. You can see it is actually different across the map. In Region 2, you can see that about half of our variants are now predicted to potentially– or half of our sequences are predicted to potentially have Evusheld resistance. In Region 3 down here, you’re probably closer to 60% in your region. Region 10 only about 25%. So again, something we focus on carefully.
AHMED OGWELL OUMA, AFRICA CDC: The usual test kits we use in the field, when we use cartridges, do not work for this particular strain. And therefore, all the laboratory testing has to be done using PCR platform. In this way, it means that we are engaging much more of the established laboratories.
Imported from Revue
LISA GROHSKOPF, CDC [00:43:47] Definitely. We would definitely recommend that. In any given season, we don’t we don’t have just one flu virus circulating. We generally have sort of co-circulation, often we will have influenza A H3s and A H1s co-circulating. Often one predominates, but there will usually be some of the other as well. Most seasons we have both flu A and B out there, and people can of course, get infected with something that they didn’t see earlier in the season, later in the season. So it is possible to have this one twice in one year, in short. So even if you’ve had the flu, it’s definitely recommended to get the vaccine for this season, every season.
…
LISA GROHSKOPF, CDC [00:45:09] That’s a really good question and it is a complicated one. One of the difficulties with with flu is that it is seasonal, but we can’t predict exactly when the season is going to start, and also when it’s going to peak. Typically, flu activity peaks in December, January, or February, but it can vary quite a bit. Some seasons, as you pointed out, Dr. Schaffner, start a little early, some start later. So on top of that, it’s also been demonstrated in studies that– not every study and not consistently in every age group– that the immunity that you get from a flu vaccine can wane over the course of the season. It looks like it might be more of an issue among older adults than younger people. It might be also more of an issue with some viruses, for example H3’s than H1’s or B’s. But the studies vary in terms of what they’ve found, and it’s very difficult to tell any individual exactly what their situation is going to be. So the recommendation is based on the fact that, typically, flu activity can begin to pick up in the U.S. as early as October. Typically, the peak is not going to be until later, December, January, or February. We don’t recommend July or August vaccination for some groups, for many groups, actually, particularly for older adults, because they’re the ones that the waning literature seems to most support waning in. But September and October are generally considered, based on the data we have, good times to be vaccinated. And also importantly, as I think Dr. Gulati pointed out in her presentation, after October is not too late because, as we mentioned, it’s not going to peak likely until December, January, or February, as long as the viruses are circulating and we have an unexpired vaccine, it makes sense to get vaccinated.
“A select number of labs dispersed throughout the US are able to test, but we aren’t able to say the exact number. CDC is also working to bring on additional labs. The test being used by the LRN labs is a screening test that requires confirmation from CDC. So while it takes about an hour or so to run, we don’t know the actual turnaround time including receipt of the sample, confirmation by CDC, and then reporting a result. At this point the most important thing is that we have a test and several labs around the nation that are able to test.”
VICKI HERRERA, UNMC [00:21:54] So a big question is what diagnostic testing is even available for this? So, as Aneesh talked about earlier, there is differences between the Sudan and the Zaire strains. Of this current outbreak is, of course, as you know, Sudan, and the previous large outbreaks had been associated with the Zaire strain. And though– and that is why many of the laboratory diagnostic tests were developed to specifically detect that strain. So federal partners are actively working to increase the testing capacity across the nation for the Sudan strain, by deploying assays or testing kits to the public health labs that are part of the Laboratory Response Network, as well as the regional treatment centers. While they are working as quickly as they can to increase the number of laboratories that are able to test, as of today, that number is still very limited. So the best thing that you can do is to contact your local public health departments and they can help you determine what testing is available and where. And if you are part of the LRN network that is not able to provide that test right now and you are receiving phone calls for that, please reach out to the CDC as they will have a list of who currently is able to test and will help you determine where the specimens should go.
…
VICKI HERRERA, UNMC [00:23:23] Specimen types may vary depending on the laboratory and the test that is available, but currently most of the tests are requiring full blood collected in EDTA or purple top tubes. But again, as the testing increases, there may be other specimens that are requested. So please just contact your public health department or your testing facility.
I can let you know that the diagnosis and death occurred in September. However, we are not providing any additional details.
The LRN has 22 labs that can diagnose Sudan Ebolavirus while four regional treatment centers can also diagnose the virus. I am not sure if they are using BioFire Warrior, but I am checking. The current average is about 140 passengers each day are funneled to one of the five airports for evaluation. You might want to check with Customs and Border Patrol on a more exact count.
Imported from Revue
ASHISH JHA, WHITE HOUSE [00:28:06] In the beginning of the new year, they will be. The U.S. government, we bought a good number of doses, because we thought it was very, very important for Americans to have – to continue to have free access. Congress has stopped funding the COVID response, now as of about six or seven months ago. So, we’ve been pulling resources out of many other programs to try to make sure we have enough vaccines and treatments. Next year, we will move to commercialization because we are out of resources. And that means it will start going through your health plan. Vaccines should remain free, because the Affordable Care Act, you know, Obamacare from many years ago, one of its stipulations was that preventive things like vaccines should be free, so vaccines should remain free. What we’re trying to do is figure out how do we make sure there are not cost barriers to treatments. But that’s all next year, and probably later part of next year. Right now, these vaccines are free, and I think in early part of 23, you’re going to see it continue to be free.
…
ASHISH JHA, WHITE HOUSE [00:34:07] There are no guarantees, right? Three years ago, if you had gone to that Thanksgiving dinner, people could have picked up the flu or RSV. So that’s always out there and a possibility. The key in my mind that you want to make sure that that Thanksgiving is as safe as possible without causing a lot of disruption. And the most important thing is obviously for you and your husband to make sure that you are updated on your vaccines with this bivalent vaccine. I think that’s sort of critical step number one. Number two is I think testing can be helpful. We actually know very good data that before gatherings, if people test, this dramatically reduces the risk of infection. These tests are widely available, actually free. If you are on Medicare or on private insurance, you can go to a CVS or a Walgreens and say, I would like my eight free tests per month. That’s something that the government has pushed the insurance companies to make available. So they are easily available. And I’ll tell you, is it necessary? Well, it just reduces the risk. So even if the risk wasn’t high, I think it just adds one more layer of protection. Not critical, but I’ll do– I’ll tell you, in my family, we’re getting together for Thanksgiving. My brother and his family, my wife and I and our kids, with my elderly parents, there will be about 12 of us. And my plan is we’ll just get everybody a test that first morning, just to make sure nobody’s got the infection. It just adds one more layer of protection.
MARY CHOI, CDC [00:46:54] Yeah, sure. So as I mentioned, with the Sudan outbreak, CDC has been very active on the domestic preparedness front and addressing exactly this issue of the lab testing has been a huge priority. And so we’ve been working very hard to get 28 LRNs the capacity to run the BioFire with the Warrior Panel, and that has been– and so they can test under CLIA as well, which is, of course, another beast in itself. And so, at the beginning, a couple of weeks ago, we had maybe 8 LRNs that had the ability. And at this point, we’re at 18 and rapidly scaling. There is a lot of cross collaboration between agencies and CDC to make this happen. And so, to the point of like sending loaner BioFires to facilities, having weekly calls with the facilities to really kind of help them ramp up. And so the idea is to be able to have the BioFires at many LRNs and potentially even expanding past that. I think there’s also work at CDC to provide more high throughput real time PCR assay as well. And so that work is ongoing and we are seeing progress from that.
…
MARY CHOI, CDC [00:50:00] As you know, returning travelers from Uganda being funneled to five airports. And at the airports, they get a screen to identify people who are ill and that sort of thing. And then once those individuals go back to the state that they live, they are also being contacted by the health departments. And the people who have traveled in the outbreak affected areas, the recommendation is that they’re followed twice a week. And then– I’m sorry, twice a week, for 21 days after they return. And then for people who are in Uganda, but not in the affected area, at a minimum of one week. I will say that, in terms of Uganda and the risk right now, it is different than in West Africa. In West Africa, it was three large countries. The outbreak affected travel hubs. It had affected the capital. And we had a lot of travelers coming because you have three countries, right? So you had potentially a lot of travelers coming through. With the Uganda outbreak, in Uganda, we don’t have that level of passengers coming to the United States. Obviously, first of all, there’s no direct flight from Uganda to United States. But also the number of travelers has been estimated to be about 140 a day. And so that’s pretty low compared to what it was in West Africa. But despite that, I do think that CDC and other agencies have been very forward leaning on that. And, it has initiated the funneling as well as the screening.
ELODIE GHEDIN, NIAID [00:02:37] And what’s interesting is that in many of these sub lineages that we’re seeing now, there’s convergent evolution, where you have certain positions that appear to mutate equally in all of these. And so, and now we were hearing in the news in the last couple of weeks, we have a recombinant, that XBB that’s at the top in blue, and the BQ.1.1 that is also one of these variants that are emerging. And we will continue to see a lot of these emerging variants occurring. And it’s a question of what impact they have on disease severity.
…
AMY KIRBY, CDC [00:35:09] It’s worth noting that wastewater has some interesting quirks that we need to consider. So as Elodie mentioned, just like looking at those minor variants, wastewater is going to be a mix of lots of different infections. And so we have to be very careful that we don’t overinterpret any of the data that we’re seeing here, and that we recognize that we’re actually seeing lots of different variants, and don’t make assumptions about how those pieces of the tiled amplicon necessarily go together. So to put that more bluntly, we can see all of the mutations associated with a variant like Omicron, but we can’t necessarily confirm that they are all present on the same genome. So wastewater sequencing will never be confirmatory for a variant. It will only be supportive of data that we’re seeing. And unfortunately, that is why wastewater is also a ‘no’ for variant prediction and forecasting. We cannot link it back to a single genome. Part of that is a technical problem with the methods, but more importantly, what we’re detecting in wastewater is largely decayed viruses, decayed and decaying viruses. So it’s already broken when it comes into the laboratory. And so we might be able to garner some insights of where it might be going, some hypothesis generation, but again, not confirmatory.
…
AMY KIRBY, CDC [00:41:16] Polio virus is a bit different. It is, of course, the grandfather of wastewater surveillance testing. It’s been done for many decades. But implementing it in a high vaccination, almost fully sewered population is very different. And so there we had to ask questions about, again, about the assays. So can we do molecular testing for polio virus and get data that is actionable? What scale of surveillance is appropriate? If a population is already 95% vaccinated, what are we going to do with a positive detection if the answer is vaccination? What frequency of testing is needed? We test for SARS-CoV-2 twice a week. That’s probably too frequent for polio. And finally, and most importantly, because polio is a target for eradication, there are very strong containment implications for detecting polio virus in a community. And so we want to make sure we understand how to interpret wastewater data for containment and how those containment policies feed back into our wastewater system.
…
AMY KIRBY, CDC [00:42:20] So we are expanding to other core targets as well. So not just response, but some of the things that have been with us pre-COVID: antibiotic resistance, Influenza A and B, Norovirus, Candida Auris, we expect these to roll out at the beginning of next year, so stay tuned for more information on that. We’re transitioning our test type.
…
AMY KIRBY, CDC [00:43:55] That’s a great question. So CDC is not supporting nationwide archiving at the moment, mainly because we want to have that ethical framework in place, and have a really solid guidance on how we make decisions about testing for those samples in the future. So a future use issue essentially, before we start having archiving in place. I think that’s really important for community support for this new type of surveillance.
…
AMY KIRBY, CDC [00:45:54] We were very worried about that when vaccination first rolled out that, if people are vaccinated, will breakthrough cases actually shed in feces the way non-vaccinated cases do? I will say we don’t have great data directly asking that question. However, we haven’t seen really a change in the way wastewater data relates to case data, when we add in vaccination coverage. So at least at that high level, it’s not looking like it’s making a big change. But that’s something that we really want to get better data on.
MEREDITH MASSEY, CDC [00:29:59] We tested questions on COVID and long COVID as part of a larger testing project. We went to L.A. in October of this year and conducted 50 in-person interviews, testing questions on a variety of topics. Next slide, please. First, these are the COVID related questions that we tested. Have you ever had or likely had coronavirus? Have you ever been tested for coronavirus? Has a test found that you had coronavirus or COVID 19? And how would you describe your symptoms? Next slide, please.
…
MEREDITH MASSEY, CDC [00:30:37] We also tested three versions of the long COVID questions: the NHIS version, the NHANES version, and the Office of National Statistics version. Although we would still like to collect more data on how respondents understand these questions, I will now share some of our notable findings from the interviews. Next slide, please. 17 respondents answered ‘yes’ to the question about having had coronavirus. The ‘yes’s included those who didn’t have a test or who tested negative, but assumed they had COVID due to symptoms ,and also included those who had no symptoms but positive tests. The ‘no’s included those who don’t believe COVID is real, and those who tested positive, but believed the test was faulty or fake. Three respondents answered, ‘don’t know’ or ‘refuse to answer’ because they didn’t have symptoms and weren’t sure if they had COVID, and those who don’t believe COVID is real. Next slide, please.
…
MEREDITH MASSEY, CDC [00:31:45] So we split the three long COVID questions among the 17 respondents who answered ‘yes’ to having COVID or likely having COVID. Looking at the NHIS version of the question, ‘did you have any symptoms lasting three months or longer that you did not have prior to having coronavirus or COVID 19?’ We had eight ‘no’s, and those included one whose taste took three months to return, but was back to 75% after one month. And other respondents who had symptoms that lasted one to two months, but not as long as three months or more. So it was clear that respondents were paying attention to the three month time frame. Next slide, please.
…
MEREDITH MASSEY, CDC [00:32:31] Looking at the NHANES version of the question – ‘did you experience any new recurring or ongoing symptoms four weeks or later after being infected with COVID-19 or suspecting to have been infected with COVID 19? These symptoms can sometimes appear after recovering from the initial infection’ – we had two yes’s and four no’s, and in our sample it seemed that respondents were mostly thinking of taste and smell, that being a hallmark symptom of COVID. Next slide, please? We also looked at several follow up questions to the NHANES long COVID question. First, ‘among all of the post-COVID symptoms that you experienced, which one bothered you the most?’ It is up to three different symptoms. We had one respondent who answered ‘severe body aches,’ and it seemed that this person was thinking of all COVID symptoms, and not just post-COVID symptoms. Next slide, please. Another follow up question that we asked was: ‘Do you still experience any of these symptoms now?’ One respondent answered, ‘I don’t know,’ again, thinking of taste and smell. This respondent elaborated, ‘Probably, I have no clue. I don’t know if my taste is back entirely because the memory of what my taste used to be like is not the same. I don’t have an active comparison.’ Next slide, please. Finally, we tested the Office of National Statistics version of the long COVID question. ‘Would you describe yourself as having long COVID, that is, are you still experiencing symptoms more than three months after you first had COVID-19, that are not explained by something else?’ We had six no respondents to this question, and we found that several respondents had not heard of the phrase long COVID. And again, others were thinking mostly of taste and smell as a symptom. Next slide, please.
…
MEREDITH MASSEY, CDC [00:34:36] I want to emphasize that respondents understood these questions in the context of their lives and their daily experiences. Their understanding of questions and their responses to the questions were highly influenced by their living circumstances, whether or not they had felt sick with symptoms, whether they had known anyone who had become very ill, or someone who had died from COVID, the context of their other life concerns, and their general beliefs about illness and about COVID specifically. Overall, they were not thinking about these questions on the basis of objective truths or reality. Next slide, please.
…
MEREDITH MASSEY, CDC [00:35:12] Finally, we plan to collect additional data to get a more complete picture of how respondents understand these long COVID questions. We have some virtual interviews planned for the fall and winter.
…
FARIDA AHMAD, CDC [00:37:36] So a little bit more about cause of death coding. In order to quantify deaths and compile statistics, NCHS codes death certificate data according to the International Classification of Diseases 10th revision, or ICD-10. NCHS takes the literal text written on the cause of death– in the cause of death section of the death certificate and codes those words and phrases to standardized ICD-10 codes. The code used U09.9 is designated for coding and reporting post-COVID conditions. It was approved by the World Health Organization in September 2020. However, it has not yet been adopted for use in U.S. mortality coding. Next slide, please. So why don’t we use U09.9? So implementing new ICD-10 codes requires developing coding guidelines and training for manual coders, developing coding logic for automated coding systems, and updates to downstream data systems to recognize that new code. But before that new code can be adopted and used, we need to understand what terms are being used. What are the literal text terms being written on the death certificate, and how often are those terms found? So this information will help us when we go to update our coding systems to implement the new code. Next slide, please.
…
FARIDA AHMAD, CDC [00:39:07] So to get at those questions, we developed an exploratory analysis. The goal was to work to quantify long COVID in NVSS data using the literal text from death certificate. First, we needed to make a list of key terms so that we could use that list to find the death certificates and then quantify and summarize the results. Next slide, please. In making this list of key terms, we consulted with experts and literature. We ended up with a list of eight terms as seen in the brown box. These terms include ‘long COVID,’ ‘long haul COVID,’ ‘post COVID,’ ‘post COVID syndrome,’ ‘PASC,’ ‘post-acute sequelae COVID 19,’ etc.. Next slide. So we then had a few analytic considerations to make. First, we limited death to those with COVID-19 as a contributing or underlying cause. So even if ‘long COVID’ was written on a death certificate, we wanted to make sure that– or even some of those terms were listed, we wanted to make sure that those were coded to U07.1. And then in considering data completeness, we limited the study period to deaths that occurred through June 30th, 2022. So we had pulled these records in the summer of 2022, this past summer, and we wanted to make sure that we had the most complete information for the deaths that we would expect through June. And lastly, we wanted to compute. We wanted to be able to compute crude and age adjusted rates. So we needed a subset of data for a 12 month period. So we, in our analysis, we also chose a subset of data from July 2021 through June 2022 for that subset to create rates. So, our next steps, I know that was a bit of a teaser, so we don’t have the results published yet, though that is our– the next big step that we’ve got ahead of us, is to summarize and publish those results in a Vital Statistics Rapid Release Report. And then some potential future steps include updating the analysis with more recent data and maybe refining key terms if necessary.
…
FARIDA AHMAD, CDC [00:41:47] And then the last two bullets are for consideration after we have the results. First, we’ll look at the need to issue certification guidance to promote consistent and accurate reporting of long COVID on death certificates. And second, would be the potential implementation of the ICD-10 code U09.9 for cause of death coding. Next slide, please.
Imported from Revue
LYNNETTE BRAMMER, CDC [00:05:07] Just to summarize, influenza activity in the U.S. remains fairly low overall, but we are seeing an increase, particularly in the southeast and south central part of the country. The numbers are small so far, but H3N2 viruses are predominant in the U.S. and it is, of course, too early to tell what will be the predominant virus for the season. For the sake of time, I moved the slide to the supplemental slides for the Southern Hemisphere vaccine decision, but they did update the H1N1 component. It is within the same genetic sub clade that our vaccine is. So the components of our 2022-23 Northern Hemisphere vaccine at this time look appropriate for this season. In other words, similar to the genetic groups that of the viruses that we’re finding.
…
NIRAV SHAH, ACIP [01:22:05] One of the topics that states have been discussing is whether or if moving back to subcutaneous administration is something that ought to be considered. The initial move, as you’re aware, to intradermal was because of limited vaccine availability. The question on the table from an implementation perspective is now that our teams are used to intradermal administration, now that the population most at risk is sensitized to the benefits of it, whether it’s worth it to shift back or stick with the status quo. So we would appreciate any insights from the working group now or at the appropriate time, given that the hour is late. AGAM RAO, CDC [01:22:43] Thank you, Dr. Shah. This is Agam Rao. We are talking about that. We’ve been discussing the VE data that’s available. There’s going to be more VE data and safety data comparing the intradermal and the subcutaneous route. And so the work group will consider all of these things when we come back to present to the ACIP. PABLO SANCHEZ, ACIP [01:23:03] I just want to add that that we are discussing it and the question is, also, how practical it is to give the intradermal, how easy it is compared to the subcutaneous. So I think, as Agam said, I think that has come up and we’re hoping to also have some presentations about the effectiveness of both methods.
…
AGAM RAO, CDC [01:24:34] So we are actually trying to collaborate with some academic partners to evaluate like the immune response, after someone has monkeypox, the duration of protection, so that we can understand when they might need to be vaccinated, if they need to be vaccinated, and also the duration of the immune response from after having received the Jynneos vaccine. We do know from having presented, you know, the systematic review data, the GRADE data last year, that the subcutaneous route, we know that there is an anamnestic response, at least at two years after completion of the two dose series. And based on Dr. Fry’s data, we assume that the intradermal route is going to be similar. But, are going to follow it forward, not just at the two year point, but going beyond that to inform guidance in the future.
…
AGAM RAO, CDC [01:26:05] I was just going to say that we do have a CDC MMWR that is planned to be published the first week of November that characterizes the– it was under a hundred cases, I can’t remember how many cases, but it is the pediatric cases that we have been notified of since the beginning of the response up until a certain cutoff point. And it describes– it basically says that the youngest children seem to have acquired it from caregivers through contact and the adolescents, best we can tell, seems to be similar to adults, male to male sexual contact. We are trying to tease that out better. Actually, transmission is a really critical question, and I know in the work group, people have asked repeatedly that just for an explanation about the cases in women, the cases in pregnant women, the cases in children, just to understand, you know, what we can say about what type of exposure led to some of these cases where male to male sexual contact is not believed to be the cause. And so that is a priority for the response right now. And I did see some data earlier today that’s not yet ready for prime time, but will perhaps be presented to the workgroup next week to try to tease this out. But to answer your first question about the pediatric epi, that will be published very soon.
…
KATHLEEN DOOLING, ACIP [00:21:04] And for countries that have eliminated polio and only use IPV, such as the United States, the WHO Strategic Advisory Group of Experts recommends to respond to circulating vaccine derived polio virus with routine and catch up immunization with IPV, that should be continued. And countries should consider use of nOPV if IPV response does not stop the circulating VDPV. For example, if the outbreak spreads beyond a well-defined population group or geographic area, or if transmission persists.
…
NIRAV SHAH, ACIP [00:32:10] Which takes me to my last observation for Dr Brooks and Ms Bahta, which is a frequent question that’s come up among state health officials, is the why not switch to the novel OPV given the mucosal benefits of it? And so we look forward to reading and discussing what the working group comes up with there.
…
MATTHEW DALEY, ACIP [00:35:18] How does what we decide as a committee fit into the global strategy? And I guess I ask that in the context of use of oral polio outside the U.S. and risk of importation here, that kind of thing. And then I have a second question. JANELL ROUTH, CDC [00:35:37] It’s a it’s a great question with regards to how this fits into the global strategy. I think we have been talking to our global immunization colleagues about that very question. And I think it– the question for them is what does eradication actually mean, now in the context of these ongoing circulating VDPV outbreaks now that we found it in the United States? Does eradication mean no paralysis versus actually eliminating the virus from the environment across the world? And so I think it’s it’s something good to consider as we move forward with these nOPV discussions in the United States. I think it’s going to be an important factor to understand how they’re viewing eradication. And that probably will lend itself to to how we might think about using it here.
…
WILBUR CHEN, ACIP [01:23:27] This is actually piggybacking off of Dr. Shah’s question, which is I didn’t know what proportion of that 906,000 doses were given ID versus subcutaneously? And then kind of wondering, are we going to be able to assess, in some way, the durability of of protection by the two routes, kind of also trying to inform the route of administration for in the future? AGAM RAO, CDC [01:23:59] Thanks, Dr. Chen. So that actually does reflect a lot that was was given subcutaneous early on in the response and it actually reflects a lot of post-exposure prophylaxis and PEP plus plus or the expanded PEP. We are working to trying to break it down by how much has been given by both methods. And over time we’re, hoping that the the graphic will actually represent more pre-exposure prophylaxis and could provide you with that data in the future.
BRETT PETERSEN, CDC [00:11:08] Brincidofovir is another antiviral that has been licensed and approved by FDA for the treatment of smallpox disease in adults and children, including neonates. It is not yet available from the Strategic National Stockpile, but BARDA has awarded a contract to procure brincidofovir for the SNS and it’s expected to be made available via emergency investigational new drug application request to the FDA.
…
BRETT PETERSEN, CDC [00:13:49] Lastly, having a low threshold to use multiple medical countermeasures for people with these severe manifestations does make sense. The medical countermeasures available have multiple mechanisms of action, and there is some animal model to suggest that perhaps using tecovirimat and brincidofovir, for example, may provide synergy. So there is some evidence to suggest that multiple medical countermeasures may be a benefit in these people with severe manifestations or at high risk for progression to severe manifestations.
…
JUDY ABERG, MOUNT SINAI NEW YORK [00:18:07] Thank you for a very informative session. In light of the fact that we’re starting to see household contacts that are immunocompromised now coming down with monkeypox, any consideration now as a pre-exposure vaccination to immunocompromised individuals who live with high risk individuals? BRETT PETERSEN, CDC [00:18:28] Yeah. So, you know, I shared the updated recommendations for pre-exposure vaccination. This is something that ACIP is also looking at, so I think that is possibly something that they may weigh in on. I think certainly if they fall into that eligibility criteria, they should be vaccinated. Obviously, with immunosuppressed individuals, there’s always the concern about whether or not they’re going to mount a sufficient immune response to the vaccine. But if it– if there may be a good immune response, then it’s worth trying. And in terms of whether or not they should receive it, if they’re a household contact of people in that eligibility criteria, I think that’s something that’s still being discussed.
ANGELA LUKIN, PFIZER [00:27:01] Based on our current understanding, when we enter a traditional commercial model, anyone with commercial or government insurance who is eligible to be vaccinated should be able to access the vaccine without any out-of-pocket payments. This is assuming continued broad recommendations supporting annual vaccination. When this transition happens, the commercial price point for the vaccine will reflect its cost effectiveness. This will include increased cost as we transition to a single dose vial and commercial distribution. But more important, it reflects the value this vaccine has brought to society. We believe a potential U.S. list price between 110 and 130 dollars per single dose vial for adults reflects the value of the vaccine and is well below the threshold for what would be considered a highly cost effective vaccine.
…
ANGELA LUKIN, PFIZER [00:39:29] Encouragingly, we are seeing a positive trend in adult coadministration of flu and COVID vaccinations year over year. Just to kind of give you a sense, last year, same day administrations were in the teens. While this fall, coadministrations have increased to roughly 40%. So additionally, we potentially are looking at a launch of a flu and COVID combination product, and we expect that this will also help to improve uptake due to convenience for HCPs and consumer alike. So still early days and a lot of key variables that kind of have yet to be determined.
…
ANGELA LUKIN, PFIZER [00:40:08] Currently, the COVID-19 related contracts between Pfizer and the U.S. government continue through the end of this year. So the transition to a more traditional commercial model wouldn’t happen until the first quarter of 2023 at the earliest. And this transition will be triggered by the expiration of current contracts, depletion of government supply, and potential rollout of adapted vaccines to match any shifting strains.
…
ANGELA LUKIN, PFIZER [00:43:55] So in terms of the timing of the shift to the commercial model, really will be contingent on the COVID related contracts that we have with the U.S. government, as they’re going to continue into the end of the year. So the transition to that more kind of commercial model wouldn’t mostly likely happen until the first quarter of 2023 at the earliest. And this transition will be triggered by expiration of the contracts, depletion of government supply, and/or potential rollout of any adapted vaccines to match any kind of shifting strains that may appear.
Imported from Revue
SYBIL CINEAS, ACIP [00:32:24] The combined immunization schedule work group updates the child and adolescent and adult immunization schedules annually. The child, adolescent immunization schedules summarizes ACIP vaccination recommendations for persons 18 years of age or younger, and the adult immunization schedule summarizes ACIP’s vaccination recommendations for persons 19 years or older. The goal of the combined immunization schedule work group is to better harmonize the child, adolescent and adult schedules. No new policy is established by the schedule. Rather, it reflects a summary of ACIP recommendations.
…
SYBIL CINEAS, ACIP [00:33:47] I would like to remind the committee and the audience why we present the schedule for vote every fall. ACIP’s approval is necessary prior to publication of the schedule in February of the following year. In addition, ACIP approval is necessary before we have our partners from the professional organizations listed here to review and approve the schedule. Of note, this is the first year that the American Pharmacists Association will be listed as an approving organization for the adult schedule. We welcome them and their input.
…
MATTHEW DALEY, ACIP [00:52:07] We’ve received comments from the public that are concerned about adding COVID-19 to the routine schedule– to the routine childhood schedule. And I just want to address that directly. This doesn’t represent new recommendations. This represents sort of a summary of existing recommendations. But I will acknowledge– I appreciate that there is symbolism in adding COVID-19 to the childhood immunization schedule. And that symbolism is that we view this as routine, and that we view this as COVID is here to stay. And so, when I think about the routine immunization schedule as a practicing pediatrician, I think about it as an opportunity in my patients to prevent serious disease and death. That’s what I view that as. And if something is added to the schedule, it’s because I feel like the benefits continue to strongly outweigh the risks. And so I just want to make those points. The other point I will make is that this does not constitute a mandate. But there are mandates. But those are really state board of health, largely, decisions. And this doesn’t represent a mandate. But then I appreciate that if parents are concerned about COVID-19 vaccines, then they’re concerned that this could be turned into a mandate.
…
NIRAV SHAH, ACIP [00:55:22] This discussion today around adding the COVID-19 vaccine to the recommended childhood immunization schedule does not constitute a requirement that any child receive the vaccine. That decision remains where it did before. This is rather a codification of a pre-existing recommendation. We recognize that there is concern around this, but moving COVID-19 to the recommended immunization schedule does not impact what vaccines are required for school entrance, if any. Indeed, there are vaccines that are on the schedule right now that are not required for school attendance in many jurisdictions, such as seasonal influenza. Local control matters, and we honor that. The decision around school entrance for vaccines rests where it did before, which is at the state level, the county level, and at the municipal level, if it exists at all. They are the arbiters of what vaccines are required, if any, for school entry. This discussion does not change that.
The New York State Department of Health (NYSDOH) is in communication with both the federal Centers for Disease Control and Prevention (CDC) and the New York City Department of Health and Mental Hygiene (NYCDOHMH) regarding two New York City residents who tested positive for Monkeypox and have recently passed away. Both individuals had underlying conditions that placed them at high risk of severe outcomes from monkeypox infection. The causes of death remain under investigation. For more information about this ongoing investigation, please contact NYCDOHMH directly.
We are deeply saddened by the two reported deaths and our hearts go out to the individuals’ loved ones and community. Every effort will be made to prevent additional suffering from this virus through continued community engagement, information-sharing and vaccination. Out of respect for the confidentiality of these patients, additional information will not be provided at this time.
AGAM RAO, CDC [00:15:44] Persons experiencing homelessness, this is something where vigilance is required. There have been cases identified, several hundred actually, including severe cases. Anecdotally, those seem to be in people experiencing unsheltered homelessness. And we are working to try to understand the exposures that have occurred to those individuals and whether transmission has occurred from from person to person.
…
AGAM RAO, CDC [00:21:41] No, but there are cases that have dragged on. So when people are severely immunocompromised, then they don’t have the ability to clear the virus on their own.And tecovirimat, TPOXX as people call it, that slows down the replication. But the immune system still needs to be the one to clear the actual virus. And so there are patients that have prolonged illness because of that, because their body isn’t capable of clearing the virus. But we have not heard of a recurrence.
…
RUTH LINK-GELLES, CDC [00:32:08] So what about VE against hospitalization, which I think we all agree is probably the most important outcome we could look at, and then VE in children under five, which is something that I think we’ve all been interested in since those vaccines were finally authorized a few months ago? So it’s not a great story, mostly because we can’t measure it, because kids aren’t getting vaccinated. So here, I’ve shown coverage of one dose on the left and two doses on the right over time, by age group. Again, the kids are shown in the yellow. And so you can see just this huge drop off, even from adolescents going down to the 5 to 11 year olds. And then you can hardly tell that the under five year olds are getting vaccinated. It’s really abysmal, and I think at this point, is kind of a sad public health failure. And then on the flip side, the other thing that contributes to whether or not we can measure vaccine effectiveness is whether cases are accruing in our data sets. And so here I’ve shown, this is from the VISION Network, SARS-CoV-2 negative but symptomatic kids in blue, and positive kids in red. And you can see here that we’re just not accruing very many positive kids. There just haven’t been a lot of hospitalizations over the last year or year and a half in this age group. But more importantly, there haven’t been a lot of vaccinated hospitalizations. And so if we look at this sort of descriptively, I think it’s good evidence that the vaccine is probably doing what we want it to do. But the numbers are just too low for us to get any real vaccine effectiveness estimates.
…
RUTH LINK-GELLES, CDC [00:47:09] And then to your second point about the different study designs, I agree. I think the test negative design has held up really well so far, but I think it’s going to continue to have issues. And I think the biggest bias that we’ve seen so far has been the increase in at home testing. We really don’t have a good concept of who has a prior infection. And we know that prior infection affects your risk of future disease. And so we know that, now we have a whole sort of naturally immunized population as our unvaccinated comparison group. And so we’re really biasing ourselves towards a lower vaccine effectiveness. I think there’s no gold standard at this point. I think we do need creative solutions. Even the fanciest, well designed cohort test that does serology of all their cases, and figures out who’s got prior infection and who doesn’t, can’t tell you when they had prior infection, what variant they had prior infection with. And that’s the piece that really matters. And so I think that there’s a number of these sort of big problems with with the way that we are used to measuring vaccine effectiveness in the real world against diseases like measles, where you just don’t have a second infection. And I agree, we need creative solutions, and I don’t have a silver bullet for it– for you today, unfortunately.
…
AGAM RAO, CDC [00:17:33] So this is something to keep a look out for. I think we– that there are three cases, I believe, that where monkeypox– death was due to monkeypox. There are others under investigation where death might have been associated with monkeypox.
MDH is currently investigating the potential death of a Maryland resident and is awaiting final documentation. MDH encourages Maryland residents to follow the recommended prevention steps and to get vaccinated if exposed to monkeypox or are at higher risk of being exposed to monkeypox. Vaccines are available throughout the state and the following are eligible: Anyone of any sexual orientation or gender identity who has had multiple or unknown sexual partners in the past two weeks, including those considered higher risk: gay, bisexual, and other men who have sex with men, and immunocompromised individuals; or Anyone of any sexual orientation or gender identity who are aware that one or more of their sexual partners from the past two weeks has been exposed to MPX. More information, including pre-registration for the vaccine, is available at https://health.maryland.gov/phpa/OIDEOR/Pages/monkeypox.aspx Chase Cook Acting Director of Communications Maryland Department of Health
Imported from Revue
Q [00:01:37] Now, let’s start with that big statement by President Biden. The pandemic is over, he declared. Do you agree with that view? ANTHONY FAUCI, NIAID [00:01:46] Well, certainly if you’re talking about the pandemic as a widespread disease throughout the world, it’s not over. What the president was referring to– but it’s understandable how there could have been some varied interpretations of that– he was referring to the very fulminant phase of the outbreak, when, for example, in the United States we were having about 800 to 900,000 infections a day and up to 3 to 4,000 deaths per day. We are not at that point now. We’re much better off. But technically speaking, we still are in the middle of a pandemic. As you mentioned correctly in the beginning, we’re having about 400 deaths per day, which is an unacceptably high level of deaths of any infectious disease, certainly any that we have experienced recently. And so we really have a ways to go before we can say we’re comfortable enough to feel that we’re really out of this. We’re not there yet.
…
Q [00:02:46] I just wonder whether you think President Biden’s words are helpful? Because it seems to me that many people, and I would have to say maybe even at times you, have consistently underestimated COVID’s staying power. And maybe that’s a recurring problem. ANTHONY FAUCI, NIAID [00:03:00] Well, it is. And that’s one of the problems we’re having, is that we don’t want that statement to be interpreted by people to say that we have to let, and can let, our guard down. We still have to do much better with vaccinations. You know, as a rich country, an enlightened country, we’re not doing very well. We only have about 68% of our population has been vaccinated and only one half of those have gotten their boost. We need to do much better than that.
The Boston University Institutional Biosafety committee, Boston Biosafety Committee and Boston Public Health Commission (BPHC) approved this research protocol in March 2020 after full review of the proposed research and under the condition that the lab follow all applicable safety controls, including CDC guidelines for handling COVID-19 and those imposed by the Boston Biological Laboratory Regulations to protect public health and safety. BPHC is in the process of reviewing all application materials related this study to confirm that the research was conducted in conformity with protocols, and that they were properly overseen.
Following FDA’s emergency use authorization, the CDC director signed a decision memo today allowing Novavax (non-mRNA) COVID-19 boosters in limited situations for people ages 18 years and older who have never received a COVID-19 booster, and who cannot or will not receive mRNA vaccines.
ASHISH JHA, WHITE HOUSE [1:37 PM] And there was a lot of pressure. And the U.K. did it. A lot of European countries did it. And the FDA said, nope, we’re not going to look in the rearview mirror. We’re going to look ahead. We’re going to make some bets on what’s coming. And we’re going to ask companies to make a BA.5 bivalent. And it was bold, and there were a lot of people who were critical. And I have to tell you, it was the best decision I have seen in a long time by anybody. Because, again, BA.5 represents still 70% of infections out there. BQ.1.1, the one I’m probably most worried about in terms of taking over the U.S., it’s a BA.5 derivative. And so, if you got a BA.5 bivalent, the preliminary data says you should have a very high degree of protection. Even XBB, which is the one in Singapore that’s a problem, it’s a BA.2 derivative, much closer to BA.5 than BA.1. A little technical here.
…
ASHISH JHA, WHITE HOUSE [1:25 PM] Couple of key things to understand. One, is our immunity is very robust, and our ability, our T cell ability to identify and deal with these variants, especially if you’ve had multiple vaccine doses or if you’ve been vaccinated and have had prior infections, is quite robust. So I remain convinced that we are not heading to a period of time again where we’re going to see 3 or 4,000 deaths a day. Something very extraordinary would need to happen, and I can’t even quite figure out what that is. That said, because of the rapid viral evolution, if we do not keep up, if we take a pure laissez faire like, ‘eh, I got vaccinated last year, I got infected in January, I’ll be good.’ We’re going to see a pretty significant wave of infections, because these are highly immune evasive.
EVELYN TWENTYMAN, CDC [01:34:49] As a further update, Centers for Disease Control and Prevention has signed off on recommending use of the Novavax monovalent COVID-19 vaccine as a single booster dose in those ages 18 and above, as outlined in the authorization from the Food and Drug Administration (crosstalk) Following these recommendations, you will see our interim clinical considerations for use of authorized and approved COVID 19 vaccines updated, along with all accompanying schedules and clinical guidance materials.
…
SARA OLIVER, CDC [02:49:46] As we’ll be discussing today and tomorrow, incorporation of the COVID-19 vaccines in the immunization schedule and the Vaccines for Children or VFC program is an important step towards inclusion of COVID-19 vaccines in a routine vaccination program. We’ll hear more about the VFC vote next, but I want to highlight the details of the implementation for the COVID-19 vaccine VFC program will require ongoing work, but the ACIP vote allows the progress to begin. So it’s not the finish line, it’s the start line. And then we’ll hear more from Dr. Santoli about vaccine next, but I just want to highlight that the point of the VFC vote is to allow for un- or underinsured children to have access to COVID-19 vaccines at a time in the future for when the vaccine transitions to a commercial market. We know that both now and in the future, equitable access to COVID-19 vaccines for all ages and populations remains critically important. Again, this includes now while the vaccines are being supplied by the federal government, and in the future when we one day move to a commercial program.
…
CAMILLE KOTTON, ACIP [02:53:00] I had a question about children who are over the age of 12 who are getting basically full dose vaccines. And for the immunocompromised, they’re supposed to get usually three doses of mRNA in the primary series, but it’s recently come to my attention that many pharmacies no longer have monovalent mRNA vaccine, and– or at least some of them in my region have shipped monovalent vaccine back. So then, what is the– what would the recommendation be in order to give them a full primary series of monovalent, if it isn’t available, and if only bivalent vaccine is available? SARA OLIVER, CDC [02:53:42] Thanks Dr. Kotton. So right now, the– the primary series is only authorized to be monovalent product. But we’re aware that this kind of is emerging as an issue, as we’ve transitioned to a lot of the bivalent supply. We are trying to work with a lot of the vaccine deliveries, both pharmacies and kind of health departments, to make sure that there aren’t pockets where there’s no monovalent vaccine. So I think we would say, if you run into that in an issue, potentially contact the health department or, you know, if it may not be at that local pharmacy, hopefully it’s still at one in the area. But we are conveying to jurisdictions to please keep some supply of the monovalent on hand, because there is absolutely people who still need that for right now.
…
SARAH LONG, ACIP [02:54:50] Is it anticipated that there will be a bivalent primary series? Because, although, you know, there are fewer adults getting immunized initially, all the children are. So it would seem it would be way better if we could get the right dosing in a bivalent, that would be very beneficial. Do we know anything about that or a timeline? SARA OLIVER, CDC [02:55:18] Thanks. I don’t have a specific timeline, but I know that studies are ongoing. And so we look forward to a time when we can hopefully bring that data and have those discussions. So it is on the list of things that we’re continuing to talk about. And as soon as we have data available, we will absolutely bring it.
…
JEANNE SANTOLI, CDC [03:01:49] So COVID-19 vaccines will not be available through the vaccine program immediately following the passage of this resolution, because they remain available for all Americans under the national COVID 19 response. But following the passage of this resolution, we will begin some additional necessary steps to awarding contracts for COVID-19 vaccines. And then once the vaccines are commercialized and therefore no longer available under our national COVID-19 response, then VFC providers will be able to order vaccines through the VFC program. And the timeline for commercialization of COVID-19 vaccines in the U.S. has not been finalized.
…
JOSE ROMERO, CDC [03:02:52] I just wanted to make sure that everyone understood that this is not a policy change, nor is it a mandate for the use of the vaccine. It is a way to ensure access to this vaccine for those individuals, those children that don’t have insurance. So I really wanted to make that clear. Thank you.
…
JOSE ROMERO, CDC [03:04:23] Let me state the second part of what I said, which is this is an access issue. This is an issue to allow children that don’t have insurance to gain access to this vaccine. It’s particularly important, as we move on to commercialization of the vaccine. It is not– it is not listing this as a routine vaccine for children to enter school. And it is not a change in our policy for these vaccines– routine vaccines in children. And as as Dr. Cohn is telling me, and again, reminding me, which you should all know, is that CDC doesn’t make state recommendations for vaccination. That is a state issue about what vaccines are required for use in school, for school attendance. Right? So that’s that’s another issue totally separate from this.
…
MELINDA WHARTON, CDC [03:05:43] So the VFC vote does not impact inclusion in the Countermeasures Injury Compensation Program. There’s specific steps that have to be followed for a vaccine to be added to the Vaccine Injury Compensation Program, and inclusion in VFC is not part of those that process.
…
SARAH MEYER, CDC [03:07:03] So we do know that a large proportion of our monovalent mRNA vaccine stock would be expected to expire over the next couple of months. However, there there are some unknowns here, like we mentioned, the unknowns about the availability of bivalent mRNA vaccines for primary series, whether these expiration dates could be extended. And just several things that are currently unknown, but that we expect to be able to work through in the next couple of months. So right now, as was mentioned earlier, we do still have– we do still have sufficient supply of the monovalent mRNA vaccines. As Dr. Kotton brought up, we are aware that in some locations people are having less and less of that. But the vast majority of people in this country still live within five miles of a site that carries the mRNA vaccines. So over the next couple of months, we will continue to work through these issues, but appreciate you bringing them up.
…
GRACE LEE, ACIP [00:54:02] This vote now passes with 15 yes’s, and 0 no’s.
…
OLIVER BROOKS, ACIP [04:52:41 PM] So since this outbreak occurred in New York, it was determined that we need to revisit polio. It’s really that simple. And so we have, as a work group have met once, only. And we’re looking to the ACIP as a whole to look at the terms of reference that we have determined, and offer any suggestions or comments regarding this. So we have these four. So whether more specific guidance on adult vaccination, which was addressed in the presentation, I believe that goes back 20 years, so it hasn’t been addressed in a while, including the use of adult booster doses can be provided in the context of circulating polio virus, which we now see. Whether adults who are immunocompromised should be recommended an additional adult booster dose of a polio containing vaccine. Whether we use fractional, which you see WHO said, but we do not, as pre-qualified by the (inaudible) should meet polio vaccination requirements, including for people emigrating to the U.S. And consider criteria under which novel oral polio vaccine might be used in areas with outbreaks or persistent circulation of polio virus.
…
JANELL ROUTH, CDC [04:56:03 PM] I think it’s an excellent question and we’ve been getting a lot of public inquiries as well about older adults who have lost their vaccination records, can’t remember whether they were vaccinated. I think, in general, we say unless there are specific reasons to believe an adult was not vaccinated as a child, adults who are born and raised in the United States likely did have a polio vaccine as a child. Given the fact that vaccination started back in the late 1950s and early 1960s, it’s most reasonable to expect that they were vaccinated. Large campaigns were made and to get all schoolchildren vaccinated, and so we’re really trying to have a conversation with those folks about how they are most likely to be vaccinated, even though those vaccination records aren’t available. I think if somebody is particularly concerned, or again, might live or work in an area where polio virus is circulating, I think the safety of IPV suggests that they could go ahead and get an additional booster. But at this time we are not recommending it widely.
…
JOSE ROMERO, CDC [05:04:11 PM] I think it’s also important to keep in mind the epidemiology of the disease, wild type disease, prior to the vaccination period. And that is, prior to vaccinating the United States in general, prior to 1955, because that’s when the vaccine was introduced, and we worked with IPV at that time, prior to that, this was a widely circulating virus. And most individuals were exposed during childhood. And most individuals of that age group probably have natural immunity to wild type polio virus. And, they were boosted with the vaccine. So they– the older individuals probably have natural immunity that exists. Now that we can get that those numbers specifically, I don’t think we can get them for you, but we will look.
…
JANELL ROUTH, CDC [05:12:22 PM] But for the most part, I think we have the most data around EV-D68, which I think we all know is what we now think is likely responsible for those every other year outbreaks of AFM until 2018, was our last outbreak. And interestingly, this year, even though we did see an uptick in EV-RV respiratory illness over the summer and at many sites that was due to EV-D68, we did not see a concurrent upswing in AFM cases, which brings on additional questions but also a lot of relief.
…
JANELL ROUTH, CDC [05:14:02 PM] This again, is why I think we’ve really adhered to the global guidance that, in countries that have eliminated polio, the maintenance of polio elimination is really around good surveillance for acute flaccid paralysis, which we have with AFM, and strong vaccination coverage, which again, we know that there are pockets of under vaccination, but for the– for the majority of the United States, we have good IPV3 vaccination coverage. And that wastewater testing should be used judiciously to understand the size and the scope of an outbreak around a polio case. I would say there are a number of critical considerations that are needed to think about before rolling out wastewater testing. First and foremost is containment issues. So again, polio virus type two is under containment. If it is found in the wastewater, there are a series of requirements that go into place, not just with wastewater samples, but with all samples that could potentially contain polio virus, and that includes clinical specimens like stool, respiratory swabs, etc. The second issue is response. So if a polio virus of public health importance is detected in wastewater, it behooves the jurisdiction then to roll into response, which means essentially improving vaccination coverage in those areas. And– and that’s an effort, right? That takes resources. It takes the acquiring of vaccine and the mobilization of of access points to get vaccines into arms. The third point I want to make is just communication around these potential detections of polio virus in wastewater and and how to communicate that to communities. I think, again, it is challenging. There’s a lot of worried well out there that hearing the detection of polio virus in wastewater can spur them to go and want vaccination where it might not be the best use of resources. And so, again, just thinking very critically about how we communicate what we’re looking for and what we’re going to use with that information if we find it.
FDA’s research is to facilitate the development and evaluation of live attenuated viral vaccines. In this case, we are interested in understanding viral genes or factors or mutations that attenuate SARS-CoV-2 so that we can use the knowledge to design live attenuated viral vaccines. The research work was approved by FDA’s internal research review committees. The work was not subject to review by P3CO as it is not deemed P3CO research.
Imported from Revue
We want to address the false and inaccurate reporting about Boston University COVID-19 research, which first appeared in the Daily Mail. First, this research is not gain-of-function research, meaning it did not amplify the Washington state SARS-COV-2 virus strain or make it more dangerous. In fact, this research made the virus replicate less dangerous. Secondly, the research was reviewed and approved by the Institutional Biosafety Committee (IBC), which consists of scientists as well as local community members. The Boston Public Health Commission also approved the research. Furthermore, this research mirrors and reinforces the findings of other, similar research performed by other organizations, including the FDA. Ultimately, this research will provide a public benefit by leading to better, targeted therapeutic interventions to help fight against future pandemics. We fulfilled all required regulatory obligations and protocols. Following NIAID’s guidelines and protocols, we did not have an obligation to disclose this research for two reasons. The experiments reported in this manuscript were carried out with funds from Boston University. NIAID funding was acknowledged because it was used to help develop the tools and platforms that were used in this research; they did not fund this research directly. NIH funding was also acknowledged for a shared instrumentation grant that helped support the pathology studies. We believe that funding streams for tools do not require an obligation to report. Secondly, there was no gain of function with this research. If at any point there was evidence that the research was gaining function, under both NIAID and our own protocols we would immediately stop and report. All research at Boston University, whether funded by NIAID or not, follows this same protocol. We are in continued conversation with NIAID leadership and program officers.
Q [00:01:00] And beyond that, you also have what is– what some are naming a twindemic, or if you include RSV, three pandemics essentially, or three concerning outbreaks at the same time. How are you coalescing around that in terms of whether or not you might advise for a return to certain stricter mitigation measures? Is that on the table for– for this winter? ASHISH JHA, WHITE HOUSE [00:01:20] So again, if you take that step back, and think back to the fall and winter of 2020, we didn’t have vaccines. We didn’t have treatments. We barely had enough tests around. At that point, masking, social distancing, shutting down large gatherings, that all made a lot more sense. I just don’t think that’s where we are as a country anymore. Right now, we do have widespread availability of these brand new bivalent vaccines that are free, widely available. Pretty much everybody is eligible for it. We have treatments. We have lots of testing capability in that context. Yes. I mean, obviously, we’re looking at the flu, we’re looking at and worried about we might see with COVID or RSV, but I don’t think we’re going to need to do anything that resembles what we had to do in previous winters. I really do think we’re in a very, very different place.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, did not review nor issue awards for experiments described in a pre-print article on SARS-CoV-2 research at Boston University’s National Emerging Infectious Diseases Laboratories (NEIDL). NIH is examining the matter to determine whether the research conducted was subject to the NIH Grants Policy Statement or met the criteria for review under the HHS Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens (HHS P3CO framework). More information about the history of oversight on research involving enhanced potential pandemic pathogens is available in this fact sheet.
Imported from Revue
There are no suspected Ebola cases in the U.S. at this time. Regards, Bert Kelly CDC Media Office
To date, no suspected, probable, or confirmed cases of Ebola have been reported in the United States and the risk of Ebola domestically is low. The City of Chicago does not currently have anyone with Ebola virus under isolation and no individuals with quarantine orders. The Chicago Department of Public Health (CDPH) initiated the evaluation of the developing situation in Uganda on September 20th, 2022 after the World Health Organization (WHO) identified a localized outbreak of Sudan-Ebola virus (EVD) within the Central and Western districts of Uganda. The Department of Homeland Security (DHS) initiated funneling of travelers on October 6th, 2022 to (5) airports in the United States: New York (JFK), Chicago (ORD), Newark (EWR), Atlanta (ATL), and Washington, D.C. (IAD) with an average of 145 travelers in total returning to the United States daily. In coordination with Customs and Border Protection (CBP) and the Division of Global Migration and Quarantine (DGMQ) onsite teams began actively assessing travelers returning to US from Uganda who have flight/ passport or visa’s originating in Uganda within the previous 21 days. Entry screening for symptoms and potential exposure to EVD is part of a layered process that includes exit screening in Uganda. CDPH follows up with all travelers returning from Uganda to confirm travel and exposure histories, and to enroll travelers for symptom monitoring for 21 days after their departure from Uganda.
Q [00:57:35] So there’s a question about– is it expected that the COVID-19 vaccine will be added to the Vaccine for Children program? So, Dr. Meyer, do you have a crystal ball on that one? SARAH MEYER, CDC [00:57:49] Well, what I would say is, stay tuned for next week’s ACIP meeting that will be discussed about the COVID-19 vaccines appearing on the child, and adolescent– child, adolescent, and adult schedules, as well as discussion around use of the vaccine in the VFC program. So I would encourage people to tune in next week to the ACIP meeting.
MARC LIPSITCH, CDC [00:50:08] And so from from the CFA perspective, we’ve been releasing what are known as– what we’re calling technical reports on monkeypox. We’re working on our fourth, and we did one on– we’ve done a few other such activities. The idea is to be on a fairly regular schedule and to be putting out, not just a lot of facts and figures, which of course is very important, but also an assessment of what we think is the trend and the big picture, even though we know that predicting the future is an imperfect science. So we’re clear about what we know, we’re clear about what we think is going on, and we’re clear about what we’re not sure yet about, and what we’re trying to do to understand that. And I think helping people understand the scientific process and the constant effort to narrow uncertainty will be one contribution to improving understanding.
SEYMOUR WILLIAMS, CDC [00:08:16] So as of the 17th, we have a total of 78 cases, 58 confirmed, 20 probable. There are 41 deaths, 21 confirmed, 20 probable. There have been about 10 or 11 infections among healthcare workers with about 4 deaths. There are 32 recoveries. Contact tracing is is going very well. They are reporting a 93% follow up rate among 514 active contacts. Just a brief on our global efforts. We’ve been actively working to get deployers. As of October 16, there were 18 CDC responders in Uganda. 7 epis, 3 lab, 3 ecology. We’re working closely with the CDC office that’s there and with the Ministry of Health and the WHO and other non-governmental partners in-country. As some of you know, we, CDC, has been in Uganda since 1991 and we have a country office since 2000.
…
SEYMOUR WILLIAMS, CDC [00:10:43] So currently there are no rapid diagnostic tests for detection of Sudan Ebola virus. And there are some discussions that are ongoing to determine how Sudan Ebola virus RDTs could be approved, manufactured, and made available in the future.
…
SEYMOUR WILLIAMS, CDC [00:19:50] Jasmine. I just spoke to Joel, and the BioFire panel does pick up five targets, including Sudan Ebola virus. They would have to unlock it to find the others, but yes– find out the specific one. But Sudan Ebola virus is included.
…
NATALIE THORNBURG, CDC [00:22:55] And then last week, we had an update where we added three additional sublineages to the data tracker. And just a reminder, when we decide the reason we decide to break things out, sublineages out on the data tracker, we have a couple of criteria. One, it has to reach at least 1% prevalence nationally. Two, it has to have medically relevant substitutions. So it has to have substitutions that could show a reduction in neutralization titers, have some effect on– we haven’t really seen diagnostics, but have some effect on diagnostics or therapeutics. But what we’ve really seen most– most often is substitutions that could affect neutralization. And then of course, we need a method for identifying those sublineages. So early last week, Pango, which is our software that we use to call lineages, released an update that allowed us to call BQ.1 and BQ.1.1 sublineages of viruses, as well as BA.2.75.2.
…
NATALIE THORNBURG, CDC [00:28:47] So it’s really that the numbers are too small. With only– it’s really only emerged over the past couple of weeks. We have not seen any increase in hospitalizations or deaths, and we haven’t seen an increase in case counts, including in the regions where they’re sort of higher prevalence, Region 2, Region 3, Region 6, they’re kind of hovering there– kind of plateaued in those regions. And we’re not seeing increases in cases, increases in hospitalizations or deaths.
…
NATALIE THORNBURG, CDC [00:29:27] XBB is a– is a chimera. And I think there have been a couple of sequences identified in the United States. But it’s way, way, way, way below that 1% threshold. I mean, it’s really like a handful of sequences identified in the United States.
Imported from Revue
From Dr. Anthony Fauci [00;38] ANTHONY FAUCI, NIAID: Whenever you evaluate the impact of the appearance of a new variant, there are at least two, maybe more, but at least two elements that we take under serious consideration. The first is whether or not it has a growth advantage over the existing prevalent variants that are out there. And for us in the United States and elsewhere, the dominant one has been BA.5. So when you get a new variant, like the BQ.1 or BQ.1.1, when you get variants like that, you look at what their rate of increase is as a relative proportion of the variants, and this has a pretty troublesome doubling time. Because it’s progressively becoming more and more prevalent, and it varies different regions of the country, like it’s more prevalent in the Northeast than in other parts of the country.
…
[02;51] ANTHONY FAUCI, NIAID: That’s the reason why people are concerned about BQ.1.1, for the double reason of its doubling time and the fact that it seems to elude important monoclonal antibodies.
…
[03;55] ANTHONY FAUCI, NIAID: So you would expect that, if you get the updated shot or the boost as it were, with the BA.5 bivalent, you would almost certainly get cross-protection, at least to some degree, against BQ.1.1, which is all the more reason why people should be going out there and flocking to get their BA.5 bivalent booster shot. Because the bad news is that there’s a new variant that’s emerging and that has qualities or characteristics that could evade some of the interventions we have. But, the somewhat encouraging news is that it’s a BA.5 sublineage, so there are almost certainly going to be some cross protection that you can boost up with the BA.5 bivalent.
…
[5;50] ANTHONY FAUCI, NIAID: Because history is something you should learn from. And if you look historically, and what has happened in the United States, it’s seems to rather consistently follow with a lag of about four weeks or so, what our colleagues in Europe in the U.K. experience. And that is, that they are starting to see, after they saw a diminution, the way we did, they are starting to see an increase in cases and an increase in hospitalizations. So, as much as you want to feel good about the fact that cases are down, hospitalizations are down, we don’t want to declare victory too prematurely. And that’s the reason why we’ve got to keep our eye out on these emerging variants.
…
[06;53] ANTHONY FAUCI, NIAID: But more importantly, we have interventions that can counter them. That’s the thing that’s so frustrating for me and for my colleagues who are involved in this, is that we have the capability of mitigating against this. And the uptake of the new bivalent vaccine is not nearly as high as we would like it to be.
Thanks for reaching out. CDC constantly monitors for and reports on current and new covid-19 variants. CDC identifies these variants by sequences received through national genomic surveillance as well as additional public sources, such as public health laboratories, and updates these reports each week. While BQ.1 and BQ.1.1. represent a small but fast-growing subset of the Omicron variant, BA.5 remains the dominant lineage in the United States. The updated COVID-19 booster helps restore protection that has decreased since previous vaccination and may provide improved protection against newer variants. CDC scientists continue to monitor both variants and work with partners to evaluate the impact of genetic changes on treatments and make any updated clinical recommendations. Background BQ.1 and BQ.1.1 are sublineages of the BA.5 lineage of the Omicron variant. The BQ.1 and BQ.1.1 sublineages of Omicron were represented in previous updates to the Variant Proportions tab of the COVID Data Tracker but were aggregated with their parent BA.5 since they were circulating at less than 1% in the empiric data. When a variant that has public health implications (such as changes in the spike that may impact mitigations) begins to circulate at more than 1% nationally, CDC lists that variant separately. In the most recent report, which is posted publicly, CDC NOWCAST estimates project that Omicron sublineages BQ.1 and BQ.1.1 each comprise around 6% of circulating viruses nationally for the week ending October 15, 2022.
We do not currently have data on Evusheld and BQ.1. We will stay in touch with any updates.
Imported from Revue
“NIAID researchers have compared the environmental stability of the outbreak virus with historic (2003) monkeypox virus, and have not observed great differences between the strains. In combination with epidemiology, which shows a decline in cases, NIAID researchers think that the contribution of fomites in the current outbreak is limited, and that the environmental persistence of monkeypox plays a limited role in the current outbreak. The results of this research are currently being prepared for publication.”
From a Smithsonian NMNH event AGAM RAO, CDC [00:43:47] As far as people beyond that, the Advisory Committee on Immunization Practices or ACIP is the group that provides federal guidelines about vaccine use. And you all may have heard of the ACIP, and their role in COVID vaccine guidance. They are assembling actually to consider who the monkeypox vaccine should be expanded to. So within the next few months, perhaps by the end of this calendar year, we’re hoping to have more information about who the vaccine should go out to beyond what is already already stated and beyond what is on state health department websites, beyond what is on the CDC website.
…
AGAM RAO, CDC [00:36:23] I think we’re investigating this. There’s nothing to report from the U.S. right now. There was a report internationally– a report or two internationally, and some questions raised about some of the testing associated with that, and whether those are false positives or not, or whether one of them there were– two out of– there’s still some uncertainty there. The reassuring thing I want to convey is that a lot– there have been a lot of cases in the United States, and despite some CDC teams trying to evaluate whether some pets have had monkeypox, we’re really not seeing a signal there. So it’s possible we might see a case or two or three here and there, but we are not seeing any sort of signal. And, yeah there’s– that’s good news. We’re not seeing our pets– our lovely little pets– I mean, I have my own pet that I’d be very concerned about as well. We’re not seeing them infected on any large scale.
MARY CHOI, CDC [00:18:46] So even though the risk of importation of disease is low, CDC has been very active on the domestic preparedness front to ensure that we are prepared to respond. CDC has activated its emergency response structure at headquarters and has dedicated staff focusing on responding to and managing this outbreak. We are also working to stand up the CDC Ebola response team, a team composed of subject matter experts, including medical officers, epidemiologists, infection control specialists, and laboratorians who can mobilize anywhere in the United States in response to a domestic case of EVD. We are also working to update guidance on the management of patients with suspected EVD and outlining a process for accessing the experimental Sudan virus monoclonal antibody therapeutic. Next slide. CDC is also coordinating with the ten regional special pathogen treatment centers. These facilities have specialized high level isolation units equipped with infrastructure, laboratory capabilities, and staff to care for patients with highly hazardous communicable diseases. On the laboratory front, we are also working to expand testing capabilities for Sudan virus at 28 Laboratory Response Network facilities and laboratories at the ten regional Emerging Special Pathogen Treatment Centers. Finally, CDC is communicating with public health departments, public health laboratories and healthcare workers to raise awareness about this outbreak.
…
DGMQ OFFICIAL, CDC [00:38:13] That is correct. So exit screening being done in Uganda, as well as entry screening done in the United States, is part of a layered strategy in addition to the other recommendations provided on today’s call for what providers can do. So it is possible that people will be missed during the screening processes, but the idea is to have many layers of intervention and screening.
…
TREVOR SHOEMAKER, CDC [00:46:34] As I mentioned, we currently have multiple CDC staff there assisting the ministry of health as well as there’s a very large ministry of health response, an international partner response. They’re doing a very good job, as I mentioned, increasing the case contact follow up and investigations. So in that– in that sense, we may still identify a few additional cases that had been infected. But I think there’s a very good chance that those cases will be recognized early and put into isolation. It’s very hard to predict at this time how much longer this outbreak will go on. It just really depends on how well they can quickly identify cases and put them in isolation, so they don’t cause additional secondary cases. But I’ll just stop there. But there’s a very good chance it will be under control. But as I said, there’s– it’s very hard to predict. So I don’t want to make any predictions, but there’s a lot of very experienced people working on this.
…
DGMQ OFFICIAL, CDC [00:54:10] So we can start with the numbers. Based on historical information, we expect that there are about 145 travelers that arrive from Uganda into the United States daily, and those passengers have begun being funneled to five U.S. airports starting at the end of the day, on Monday, on October 10th, to the Atlanta airport, Chicago O’Hare, Newark, JFK in New York, and Washington Dulles airport. So all of the passengers from Uganda arriving in these airports undergo a fever check, as well as a risk assessment questionnaire upon entry. Now, this is in addition to the exit screening process that’s done in Uganda.
…
NICOLE COHEN, CDC [00:55:48] And so we have posted guidance for state health departments who will be following up with these travelers. We are also providing health departments with contact information for these travelers, and the contact information is being sent securely to the states where travelers have their final destination.
For both age groups (18-55 and 55 and older) the BA4/5 adapted vaccine increased the neutralizing antibody response above pre-booster levels. These are the first data coming out of the trial and currently only a comparison in the above 55 age group was completed to the original vaccine. We don’t have data yet on the 18-55 year old adults. More data will be released soon.
CAMERON WEBB, WHITE HOUSE [00:51:17] And I want to just remind folks, we had COVIDtests.gov, that was where we got a lot of tests to families, about 700 million tests out. We don’t have that site available, because it ran out of funding. But people can, if they are insured, still get tests– eight tests per month, per covered individual, sent to their home. Talking about keeping kids safe, making sure testing is a part of that routine, when there are those typical upper respiratory infection symptoms, really making sure that folks have tests in the home and are ready to take advantage of that. And certainly we’re checking to see what’s happening in stores all over in communities all over the country to make sure our supply is there and we’re trying to maintain the ability, if need be, to serve some tests to folks If that becomes a challenge later in the fall like it did last year. But again, taking advantage of the resources you currently have.
Imported from Revue
We expect to have single dose vials available by 2023.
DEMETRE DASKALAKIS, WHITE HOUSE [00:37:00] And so from the very beginning of this outbreak, we really took a lesson from the HIV playbook, which was to focus on exposures and to talk frankly about risk. And so I think if you look at the sort of history of the way that messaging has happened, it started by saying that this is the way that monkeypox can transmit. As we learned more about this outbreak, and saw that it was really moving in a way quite differently than it would be expected, it became pretty clear that we said the way that this is most likely transmitted is through close, intimate, physical contact, often related to sex. There’s other ways that it can be transmitted, such as objects or respiratory through close, prolonged contact. But it’s really always important to sort of say clearly like what the mechanism of transmission is, without pinning it to a population. And so that, I think, is something that that that governmental public health in sort of this outbreak did a really good job on. And I think definitely the goal is whenever we see such things in the media to be proactive about correcting it. So, you know, it’s possible that someone gets monkeypox from contacting an object that has contacted someone who has had monkeypox lesions. But the reality of this outbreak is it’s not the most common way. And so I think that just being very clear about transmission, and being very intentional to not fall into the trap of saying this is a disease that’s associated with the population, but rather this is a population in which this virus is being experienced, is really important and not just semantic, but really creates a framework of communication that the media will emulate, at least the good media will emulate. And then folks who aren’t doing a good job, we need to sort of be aggressive to correct. And I think we– I can say from– I can speak from the White House perspective, that we definitely make those phone calls if we see something sort of expressed in a way that is damaging or potentially stigmatizing.
…
JONATHAN MERMIN, CDC [00:45:26] Everyone has comments about the state and local relationship and the ability to get resources to where they’re needed. It’s a– a really important issue. I was just going to say that we who work in the federal government can’t speak specifically or about lobbying for more resources for our work. What we can say is that this– that monkeypox virus will be with us for a long time. And, if we’re going to reach our goals, we’re going to need to be working on it for a long time. And as Demetre highlighted, this syndemics cause overlapping issues that we need to be able to address for the long run.
…
DEMETRE DASKALAKIS, WHITE HOUSE [00:47:12] This is a really interesting one because of the fact that both TPOXX and the vaccine live in the Strategic National Stockpile. So nobody had it on their bingo card that a infection that requires vaccines and treatments from the Strategic National Stockpile would be an outbreak among MSM. So the Strategic National Stockpile was actually never really optimized to do that. So it used to be that the SNS, the Strategic National Stockpile, could ship vaccine to five locations in the state that they could then distribute differently. So based on this, a new contract was negotiated by the ASPR who owns the SNS, and now 2,500 locations across the country can actually have vaccines shipped to them. So what’s happening is that one of the lessons learned from this is that SNS needs to be more flexible to be able to get vaccine and other countermeasures like TPOXX closer to people. So that’s one thing. The other part, really listening to what the problem was, CDC doing fabulous work in terms of reducing the paperwork for the EA-IND that was required. The other thing that we did from the White House, with the support of ASPR that owns the SNS, is we prepositioned TPOXX, 50,000 doses out in the world, so there wasn’t the same issue of trying to get it shipped from the SNS person by person. So this new contract will also allow more flexibility. So what’s in the future? I don’t know. Like, will the drug be commercialized? It depends on what the studies show. Will the vaccine be commercialized? That’s not something that’s going to happen for a while. And so I think that really trying to build in the flexibility in the SNS to be able to get vaccine and drug closer to people faster is what we’ve got today. But I think we hear you, for sure, and that’s really important feedback in terms of what we can have tomorrow, if either of these agents become commercialized.
…
DEMETRE DASKALAKIS, WHITE HOUSE [00:55:16] I’ll just add one thing, which is also there’s an NIH study that’s happening that actually not only looks at subcutaneous versus intradermal, but also at intradermal at one half the dose asking a couple of questions, which is, if you were to even go lower on the dose, do you have equivalent immune responses? And could you potentially have fewer of the side effects? And so I think everything is always on the table. I can tell you that that one of the really important innovations that happened based on community feedback is that on the ASPR– on the HHS landing page for monkeypox, there is a box that you can click, and it shows you what the vaccine strategy according to supply looks like. And you can actually track what we think we’re going to get, versus what we actually have. And so our current estimates of what we need is based on an intradermal dosing strategy. And that’s based at actually, like we may sit at three doses per vial, to be a bit more saucy, than the four doses per vial that most people can get out of the out of the vial, to be a bit more conservative. So I think that though it’s relative non-scarcity, there still is a level of scarcity in terms of what we have to do.
ASHISH JHA, WHITE HOUSE [01:06 PM] So I’m a hospitalist physician, and before I took on this job, every winter, December or January, I would spend a month on the hospital wards as a hospitalist. And here’s what I experienced every winter, pre-pandemic. The hospitals would be stretched, stretched to their limit during the holidays. We’d have patients waiting in the emergency room for days because there were no beds on the wards, largely due to influenza and other respiratory viruses. That was pre-pandemic, right? And influenza is not going away. And we know COVID is not going away. And so as we look forward to this fall and winter, I think it is reasonable to assume that we are going to see a level of influenza that we saw pre-pandemic. Throw in COVID on top of that, think about RSV and para-influenza and all the other respiratory viruses, and it becomes harder and harder to imagine how our health care system is going to possibly manage the burden of respiratory diseases that are all around us. And so we could take two strategies. We could take strategy number one, where we go out and build thousands of more hospitals, train millions of doctors and nurses, and accept hundreds of thousands of more deaths every year. We could take that strategy. I would argue that’s not the strategy we should be taking. We may need to do some work on thinking about our health care capacity. We have to bring the burden of respiratory pathogens down. And the single biggest structural change that we can make as a society is to do for indoor air what we’ve done for water quality. And that’s why this administration has made improving indoor air quality a key priority.
…
ASHISH JHA, WHITE HOUSE [01:08 PM] Today, we’re launching a new website, whitehouse.gov/cleanindoorair, where businesses and schools can visit to learn more about the Clean Air in Buildings Challenge. They can make their pledges, get a badge that you can show on your website or download and put up.
Imported from Revue
11:38:46 AM ASHISH JHA, WHITE HOUSE: I will again, sort of, iterate a point I made to Alex, which is, if you look at– if you start with, well, okay deaths are down 90% since the president took office, are we comfortable with that? Absolutely not. It’s great, but we got to do a whole lot better. We’re always driving towards lower and lower number of deaths. What is the number of boosters that we want to make sure people get, what is that rate? It is as high as we think is possible because we want more and more Americans protected. Obviously, a lot of our efforts are going to be particularly focused on higher risk individuals, older Americans, people with substantial chronic diseases. That’s where a lot of our resources and efforts are going to go. But we think every American over the age of 12 is better off with the bivalent vaccine than they are without it. So we really haven’t set targets. There is no number that if we hit it, we think, ‘oh boy, that’s great.’ Our goal is get as many people protected as possible, drive deaths down as low as possible, and every day keep plugging away at improving those numbers.
…
11:33:52 AM BEN SOMMERS, ASPE: Now, at the end of our our study period, 2021, the initial boosters, there was some uptake. It was still relatively low. It’s not separately analyzed. So we don’t have a separate number that says here’s the primary series versus the boosters. But it is probably true that part of the benefit here was the smaller number of people in the Medicare population who had received boosters. In terms of the treatment and the therapeutics, those – they came online during the course of the year, those are part of the of the baseline. Essentially, we’re looking at what would have happened with vaccinations versus without. Now, without vaccination, we still assume that those treatments are available. And so we are looking at the overall kind of changing pattern of hospitalization and death rate during the year, which would factor in those other issues. But what we’re focusing specifically on here is the vaccine association reduction in mortality. But it’s a great point that vaccinations are critical, but they’re not the only tool in our toolkit to try to improve health among Medicare beneficiaries and the population as a whole. And the therapeutics remain a key part of that equation as well.
…
11:32:17 AM ASHISH JHA, WHITE HOUSE: Let me be clear. It’s interesting. We have no internal goals. We have not talked about any goals externally. Because the way I look at it is our job is to save lives and our job is to protect the American people. And as far as I’m concerned, every single American who is eligible should go get this COVID vaccine because it will– it’ll be important. It’ll help them. It’ll reduce serious illness. It’ll reduce deaths. And so every day we are working to increase the number and make it easier for people to get it. And then trying to build a coalition of people who understand that, like our job as a country, is to put this virus behind us and get us into a better place. And so in none of that conversation, has it ever felt useful to identify a specific number, just as we don’t have a number for how many deaths we’re willing to accept. We are going to keep driving deaths down lower and lower and lower, with the goal– with the hope they’ll just drive deaths to as a low a number as possible. So we are in a very different place than where my predecessor was a year ago with vaccines, testing, treatment, all of it. The virus is in a different place. We have different level of population immunity. I’m obviously not going to speak to what my predecessor did or didn’t do, but I feel very clear that our goal is every American who’s eligible should get vaccinated and we’ve got to do everything we can to both share that information, share the benefits of that, and make it as easy as possible for Americans to get it.
…
11:30:30 AM ASHISH JHA, WHITE HOUSE: And let me just quickly add, I mean, look, as you all know, a lot of states have shifted pretty significantly on this. There are days of the week where you get four, five states out of 50 reporting. And so– which creates a whole lot of unevenness in the data, creates a whole lot of unevenness in kind of daily reports. And so what I think CDC is doing is moving to a weekly cadence that reflects where states are across the country, because CDC is– obviously this is a partnership with states and is dependent on states for sharing data. That said, the work of of the COVID team at the White House, the work of the CDC on looking at data, and analysis, that continues seven days a week. And wherever we have daily data available, we look at that. But in order to create kind of consistent, even information for the American people, given that a majority of states are now doing this weekly, it makes a ton of sense for CDC to start compiling this and updating its– that– those data on a weekly basis as well.
…
11:22:52 AM ASHISH JHA, WHITE HOUSE: So let me start by saying it is obviously harder to run a campaign when Congress decides not to fund it. And, you know, we have been again, the secretary’s leadership here has been extraordinary, we have gone back, we have looked at other critical programs, and where can we pull dollars from other critical programs. These are very, very hard decisions that nobody likes to make. And I’m grateful for the secretary’s leadership and willingness to make some very tough calls. We’ve been able to put some resources in. Obviously, our media campaign, our campaign with community based organizations, all of that is going to be more limited because of congressional inaction and Congress really just walking away from the American people at this moment. We continue to press Congress on on funding. They will obviously come back after the election. There will be an omnibus. We think that the needs of– of addressing COVID saving lives will not have gone away by then. And so the need for more resources remains. But we are running the best campaign we can and we think quite an effective campaign. But no doubt about it, it has been substantially hampered by the lack of funding from Congress.
…
11:19:48 AM ASHISH JHA, WHITE HOUSE: I actually see it a bit differently, Michael. I think we’re off to a good start. These are different vaccine campaigns. This one started about a month earlier, right, that these vaccines were authorized for use at the end of– the end of August, early September, right around Labor Day. We know that most Americans, when you think about when people get their flu shot, they tend to get it in late September or early October. It stands to reason, the weather is starting to get colder, people are starting to think about the holidays, that is often a natural time people to go get their flu vaccine. So I think that’s one issue. Our estimate is that, by the end of this week, between 13 and 15 million Americans will have gotten their bivalent vaccine. About half of that going to seniors. We think that’s a really good start. Also, let me be very clear. We need to continue and up that pace as we get into October. We think it’s a really smart idea for people to get their flu shot and their COVID vaccine at the same time. That’s what I did, it’s totally safe, it’s a very reasonable thing to do. And we have a very, I would say, a very kind of broad and set of efforts designed to make sure that we’re getting the word out and helping people get vaccinated this month, coming up. Working with trusted messengers, we have a media campaign that’s going to be specifically targeted in areas where building vaccine confidence is going to be important, we’re working with medical societies across the country, so I expect us to have a very good month ahead in terms of vaccinations. But I know that HHS is really the lead on this, and is doing so much– so much more. So I’m going to turn it over to the secretary to see what he wants to add to this.
…
11:10:29 AM XAVIER BECERRA, HHS: It says that between September 2020 and December 2021, vaccinations probably helped save about 300,000 Americans from the prospect of not being with us, 300,000 deaths likely saved between 2020– September 2020 and December 2021. This is all focused on seniors and the Medicare program, and so you can understand how important it is that so many of our older Americans can be with us today to learn the results of this report. Vaccinations also helped prevent about 650,000 hospitalizations, is the estimate from this report, for the same older American population, the same period of time. That’s a big deal. That represents about a 40 to 45% decline in severe COVID-19 outcomes compared to if those individuals have not been vaccinated.
The below response can be attributed to: Jefferson Jones MD MPH FAAP CDR, US Public Health Service Beginning in 2022, methods for the national blood donor seroprevalence study were substantially altered and estimates have taken more time to generate. Estimates up to December 2021 were published in JAMA (https://jamanetwork.com/journals/jama/fullarticle/2793517) and available on CDC’s Covid Data Tracker. Results for 2022 are being generated for each 3-month period of 2022, and we hope to release estimates for Jan-Mar 2022 soon and subsequent estimates soon after that.
CLAUDINE KAVANAUGH, FDA [00:27:20] So I kind of covered some of this in my opening remarks. We’re really continuing to work on increasing the availability of infant formula on the market. And some of the data that I discussed in the opening remarks really show that we have– we have had an increase in products, more infant formula products on the market. And actually recent retailer in-stock rates show that there are most products there’s over an 80% in-stock rate now. And I think when it was the lowest, it was around 67%, and it’s been maintaining over 80% for several weeks. So, while I think we’ve helped, there’s still more work to be done.
…
Q [00:25:45] How is FDA handling pending enforcement discretion requests for infant formula? Are you still reviewing them? CLAUDINE KAVANAUGH, FDA [00:25:53] So, thanks Janesia. So we are still reviewing infant formula enforcement discretion requests. I know I saw a question as well come in: ‘can people still submit new enforcement discretion requests?’ The answer to that is yes. We are prioritizing the review of products that are available immediately for store shelves and have an established distribution plan. FDA will notify their requestors receiving enforcement discretion, as we have in the past, and we have noted on our website formulas that have received enforcement discretion. Manufacturers not receiving a letter of enforcement discretion are encouraged to pursue a new infant formula submission. We really do– are encouraging to try and diversify the market. So folks, definitely if you don’t get enforcement discretion, certainly going to become a new notified formula, that’s certainly an option for you.
ASHISH JHA, WHITE HOUSE [00:10:49] Yeah, it’s a great question. I have the I have this sort of mirror image situation of you. I have got two over 12, and then one under 12, at home. And my 10 year old, I was about to say my 10 year old is excited to know about when he’s going to be able to get the bivalent. Actually he’s not excited, his parents are excited to know when he’s going to be able to get the bivalent. And the short answer is the companies, both Moderna and Pfizer, have submitted their applications for 5 to 11 year olds to FDA. FDA is evaluating it. FDA is the gold standard on these things. They take their time. They do it very carefully. They are– as soon as their evaluation is done, we will have an answer. My expectation, again, we don’t– I don’t know any specific details. My expectation is that we’re going to get an answer sometime around the middle of this month. And if everything goes well, and if FDA feels like it meets their high bar, I suspect later this month of October, kids 5 to 11 will become eligible for a bivalent vaccine.
At the September 1, 2022 meeting, ACIP had the opportunity to review and discuss data about updated (bivalent) COVID-19 boosters for all age groups for which monovalent COVID-19 boosters had been previously recommended. These groups included people ages 12 years and older, as well as children ages 5 through 11 years. Before ACIP can vote to recommend any specific vaccine product, however, FDA needs to issue an emergency use authorization (EUA) for that product. The day of the ACIP meeting, EUAs were available for updated (bivalent) boosters for people ages 12 years and older, but not for children ages 5 through 11. This was due to ongoing work in manufacturing and production of products for the younger age group. Since ACIP has already reviewed the relevant data—and in order to avert delays in providing updated boosters for children ages 5 through 11 years—once manufacturing and production are complete and EUAs are available, we anticipate CDC will make a recommendation for use of these products, and help make them available to children ages 5 through 11 across the United States.
Imported from Revue
9:06:37 AM PATSY STINCHFIELD, NFID: This year, NFID commissioned a nationally representative survey of over a thousand U.S. adults to understand their knowledge and attitudes about influenza and pneumococcal disease and vaccines. And we’re pleased today to share those results with you. Just a few high points are: We were alarmed to learn that only 49% of U.S. adults plan to get their flu vaccine this season. That is not good enough. And nearly one in five U.S. adults who are at high risk for severe influenza disease say they are not planning to get vaccinated. That is a dangerous risk to take. And on a positive note, a majority of U.S. adults, 69%, said they recognize that annual influenza vaccine is the best prevention, the best tool that we have, against flu related deaths and hospitalizations. So most people know what to do. We just need to do it.
…
9:15:48 AM ROCHELLE WALENSKY, CDC: During the 21-22 flu season, 51% of the overall U.S. population six months and older received a flu vaccine. This overall coverage is similar to that which we have seen in the previous two flu seasons, and prior to the pandemic. However, we did see drops in coverage among certain important groups. Pregnant people and children who are at higher risk of serious flu complications experienced some of the greatest drops in flu vaccination coverage over the last two seasons. Vaccine coverage for children six months to 17 years last season was 58%, a nearly six percentage point decrease from the 2019-20 flu season and the lowest flu vaccination coverage we have seen in children in the last eight seasons. During this time, we also know many children missed checkups and recommended childhood vaccinations. We need to remind parents and caregivers that flu can be dangerous for children, especially children younger than five years old, and children of any age with certain chronic conditions who are at higher risk of developing serious flu related complications.
…
9:17:03 AM ROCHELLE WALENSKY, CDC: We also know that pregnant people saw the most dramatic drops in coverage this past season, with about 50% of pregnant women getting their flu vaccination, a five percentage point decrease from the previous flu season and nearly eight percentage point decrease from the 2019-20 season. Getting a flu vaccine during pregnancy is crucial to help protect pregnant people and their babies against flu. Pregnant people are at higher risk for serious flu related complications due to changes in the immune system, heart, and lungs during pregnancy, that may make them more prone to severe illness from flu, including illness resulting in hospitalization. A flu shot during pregnancy has been shown to reduce a pregnant person’s risk of being hospitalized with the flu by an average of 40%. Also, when pregnant people get vaccinated, they pass antibodies to their developing baby, which can help protect their baby from flu in their first few months of life.
…
9:19:00 AM ROCHELLE WALENSKY, CDC: So these drops in coverage are troubling. And preliminary estimates also suggest that longstanding racial and ethnic disparities in vaccination coverage persist in the United States. Last season, disparities of up to 16 percentage points were seen in flu vaccination coverage between white adults and adults with certain racial and ethnic minority groups. CDC will release vaccination coverage data by race and ethnicity, as well as more information on how CDC is working to address barriers to vaccination, on October 18th in a Vital Signs report in the MMWR. This is an area CDC has committed to making progress to address these eight racial and ethnic disparities in flu vaccination coverage. These types of disparities cannot and must not persist.
…
9:45:20 AM ROCHELLE WALENSKY, CDC: So thank you for that question. Maybe I will just start and say our data are still really early and the data that come in are only from insurance claims. So we are still collecting those data. We have had over 4 million people– over 3 million people, I believe, get their flu vaccine. And we just started putting the COVID updated– updated COVID vaccine data up on our website as well. We’ve had over 7 million people get their updated COVID vaccine. But again, these are very, very early data. And so we are really looking forward to getting more of those data in and seeing those numbers rise and rise quickly.
…
9:46:12 AM ROCHELLE WALENSKY, CDC: So we generally– October is a really heavy month, where we’re going to see I think a lot of vaccination, both for COVID-19, the updated COVID-19, as well as for influenza. So this is the heavy lifting month. This is why we’re doing this at the beginning of this month, because we really do anticipate that this will be the month where most of those vaccinations happen. I do want to articulate that given that flu season started last year, pretty early, early November, that we really do want to get those vaccines into arms, if we can, in October. However, if you didn’t quite get to it, if it was on your to do list and you didn’t get there, you should still get vaccinated after October into November and December, because as also noted, we have had longer flu seasons over the last year or two, and so we do want to make sure that you get that protection. It’ll start a little bit later if you get your vaccine later, but it will continue through the full season. So now is where we expect people will start really moving forward and getting both your updated COVID-19 vaccine as well as their flu vaccine, and ideally before the end of October.
…
9:47:49 AM ROCHELLE WALENSKY, CDC: I think that it will take us some time, a couple of months, for us to see the match here. But the thing that I really want to emphasize is something that Dr. Schaffner said, which is we don’t need to see a good match necessarily. We always like to see a great match, but we don’t need to see a perfect match in order to get protection from the flu vaccine. So what we do know from last year is there was a lot of media reports that it was not a perfect match, but even those data demonstrated a 35% reduction in serious illness presenting to the doctor with influenza. Even in a season where the reported match was imperfect. So we will have updating and we will continue to update our data about how good that match is. It’ll take us a couple of months into the season, but I do want to articulate that we shouldn’t wait for those data to go ahead and roll up your sleeves and get that vaccine, because it doesn’t even need to be perfect to work.
[02:06:53 PM] ANTHONY FAUCI, NIAID: There’s no doubt the cases, and I was on the phone with colleagues in health departments throughout the country just two nights ago, and everyone is having the same experience: considerable diminution in the number of cases, the number of hospitalizations, and requirements for intensive care down, as well as the fact that deaths, even though they are trailing a little bit more slowly than I would like to see, they too are coming down. However, I think it would be a bit cavalier to all of a sudden say we’re completely through with it, because remember, we were going in the right direction in the summer of 2021 and along came Delta. Then in the winter, November and December of 2021, along came Omicron, and since then we’ve had multiple sub lineages of Omicron. So let me put it this way a little bit more long winded than most of my answers, but it really requires that Dan. Right now it looks like we’re going in the right direction. However, we are entering into the winter months where, no matter what the respiratory disease is, there’s always a risk of an uptick in respiratory diseases. Number two, even though BA.5 is still the variant that is the one that’s dominant, you have the creeping up of variants that are sub lineages like BA.4.6. We don’t have much of BA.2.75.2 yet, but there are other countries that do have that. So although we can feel good that we’re going in the right direction, we can’t let our guard down.
…
[02:11:35 PM] ANTHONY FAUCI, NIAID: Well, it really depends on the situation. For example, I don’t go to indoor dinners where you sit down in an indoor setting for a significant period of time. I would go to a reception, most of them outdoors, and I would not wear a mask. But if I’m in an indoor setting for a considerable period of time, I would keep a mask on. It really varies. It’s not like I always wear one or I never wear one.
…
[02:28:01 PM] ANTHONY FAUCI, NIAID: Well, EcoHealth puts in has grants that have nothing to do with what we’re talking about that are looking at surveillance in different countries. And when they put a grant in, and there are administrative issues related to another grant, not the grants that are getting ready to be funded, and the administrative structure of the NIH, which is fundamentally in NIH central, gives a list of administrative things they need to address, and they adequately address it, there is really no mechanism to say arbitrarily, we can’t fund you even though you’ve been peer reviewed and highly recommended for funding, because someone doesn’t like you. I mean, if they ever brought that in court, they could sue us and win that in a microsecond. So you’ve got to be careful. It’s kind of like saying that there is a grant from an institution in the United States. That’s something really bad about that grant. And therefore you shouldn’t give any funding to any other element of that institution. You’ve got to be fair and you’ve got to go by process, not arbitrarily deciding whether you want to fund something or not. You go by, as an established NIH process, if something is peer reviewed, gets a high recommendation for funding, you can’t arbitrarily decide, I just don’t want to fund it because people don’t like them.
…
[02:29:52 PM] ANTHONY FAUCI, NIAID: If they call me, of course, I have no problem. I am a big believer in oversight. And I have testified before Congress literally hundreds of times. I have no problem testifying before Congress.
The US FDA has updated the Emergency Use Authorisation (EUA) Fact Sheet for Evusheld to reflect new variant data.
Evusheld has retained in vitro neutralisation activity against all dominant SARS-CoV-2 variants to date and a substantial body of real-world evidence support its continued effectiveness in immunocompromised patients through previous Omicron waves.
The new variant data show that Evusheld maintains neutralising activating against BA.5, the current dominant variant globally, accounting for about 85% of current infections.
The in vitro pseudovirus neutralisation data conducted by an FDA laboratory showed that Evusheld is unlikely to be active against BA.4.6, which currently represents 6.2% of infections globally and growing slowly; it is not expected to become a dominant strain.
Based on the low prevalence of BA.4.6 and Evusheld’s activity against the dominant variant, Evusheld should continue to provide protection to the vast majority of intended recipients.
The US FDA continues to recommend Evusheld as an appropriate option for pre-exposure prophylaxis to prevent COVID-19, in combination with other preventative measures like getting vaccinated and boosted as recommended, as Evusheld still offers protection against many of the currently circulating variants and may offer protection against future variants.
The FDA also updated the Fact Sheet to broaden the patient population that may benefit from Evusheld, especially among people with blood cancers regardless of treatment status.
The COVID-19 variant landscape is dynamic and location dependent, with different variants and subvariants coming and going, with only a few becoming dominant. Variants are rarely dominant for more than a few months - they tend to either evolve further into different subvariants or are replaced by newer variants.