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01;01 BARBARA MAHON, CDC: So the data that are coming out today are going to– and this is a projection– they’re going to show that the XBB.1.5 is projected to make up 40.5 percent of variants nationally.
There is a probability interval on that. And it’s really important to stress that probability interval. That’s from 22.7 to 61 percent. Those intervals tend to be broader when a variant is growing in proportion quickly.
So we’re projecting that it’s going to be the dominant variant in the Northeast region of the country and that it’s going to increase in all regions of the country.
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02;10 BARBARA MAHON, CDC: We are constantly monitoring and reporting on the, right now, it’s what people have called the variant soup, but we’ve been for a couple of years constantly monitoring variants in the U.S.
And what we– we get those variants in through our national genomic surveillance as well as from public health laboratories. And we, as I know you know, we update the report each week. So the– we have been aware of– we’ve been tracking XBB for quite a while. So it was pretty prominent in Singapore, and we’ve been tracking XBB.1.5 for a number of weeks.
What we do is we actually split it out in the Nowcast once it reaches one percent. And so that’s why it’s popping up there this week, but it was lumped in with the with XBB as a whole last week in previous weeks when it was below one percent.
So we have been watching it and it reached that one percent threshold this week. And so that’s why it’s split out this week
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04;17 BARBARA MAHON, CDC: The weighted percentage that we use as the basis of the Nowcast as the basis to do the projection was less than one percent.
So that’s going back, two to three weeks, that the weighted– the weighted proportion of XBB.1.5 was less than one percent. So we weren’t reporting it. But now that weighted projection is more than one percent. And so we’re reporting it with the Nowcast, projecting forward with that probability interval that we’ve talked about.
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06;45 BARBARA MAHON, CDC: There’s been concern about respiratory viruses in general tend to be worse than the winter, and it certainly is the winter now. There is no information, there’s no suggestion of this point, that XBB.1.5 is more severe.
But I think it is a really good time for people to do the things that we have been saying for quite a while that are the best ways to protect themselves, so those really don’t change.
That means vaccination, getting the updated bivalent booster, if you haven’t already had it, staying home when you’re sick, improving indoor ventilation, masking, especially in areas where the COVID Community Level is high, that’s always an option for people testing before gathering is an option for people, so that that advice doesn’t change at all.
And this time of year is a really good time to be following that advice because, for the last couple of winters, we’ve seen increases and we have, in the last several weeks, seen some not not huge, but general, increases in COVID activity really across the country.
So XBB.1.5, no XBB.1.5, it’s just these are like the basic things that people should be doing to keep themselves safe.
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08;30 BARBARA MAHON, CDC: We’re tracking hospitalization rates and we are seeing them notching up. They have not notched up more in the areas that have more XBB.1.5 at this point, but we’re tracking it really carefully.
And if we do see concerning trends, we can– there are other levers that can be pulled. But at this point, we’re not seeing any indication of greater severity with XBB.1.5 then is sort of happening with other variants.
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09;29 BARBARA MAHON, CDC: The thing that I would really stress is vaccination, and that probably won’t surprise you.
At this point, we know that throughout, as we’ve been monitoring vaccine effectiveness throughout the whole Omicron period, vaccines have been quite effective in preventing hospitalizations and severe disease. And we just released MMWRs that I’m sure you’re familiar with a couple of weeks ago that show that the bivalent boosters are really doing a good job in protecting people from severe disease and hospitalization.
Unfortunately, the uptake has not been what we would hope. So more than 60 percent of people who are over 65, which is the age group at highest risk, have not yet received it and more than 85 percent of people over five in the population as a whole have not received the updated bivalent boosters.
So I really think, if I was going to winnow it down to one thing, the most important thing for people to know, it’s that we expect that the bivalent booster will provide protection against XBB.1.5 as it has against the other Omicron sub variants, and if people haven’t gotten it yet, this is a great time to do it.
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01;14 BARBARA MAHON, CDC: So we’ve been tracking XBB for weeks, as I said, and it was XBB and XBB.1 and they really weren’t taking off. They weren’t increasing rapidly in proportion.
I think what you were asking me about though is the increase in XBB overall over the last few weeks, not over the last several months, and you were correct that, yes, XBB.1.5 is primarily driving that increase over the past several weeks. And you can see that in the “Nowcast” now that it’s broken out.
You can see how it’s if you kind of add the XBB and XBB.1.5 in your mind, you could see that the XBB.1.5 is a major proportion of it.
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02;44 BARBARA MAHON, CDC: It could be that it is winter seasonality. It could be that it’s the specific spike of XBB.1.5. We’ll continue to monitor.
But, I think that it’s hard to say with certainty, as we’ve seen all of these variants go up and go down, what in any one case what specifically is driving it other than that there’s a combination of factors that’s leading to it kind of outcompeting its fellow variants.
Yes, Novavax plans to pursue licensure for its vaccine in the U.S.
With what we know so far, XBB.1.5 has not acquired any new mutations in the viral protein targeted by Paxlovid. The susceptibility of XBB.1.5 against Paxlovid should not change given the current data. Though we should continue to monitor sequence data.
Yes the XBB1.5 variant would look similar to the XBB we tested in our study. The R346T/I mutation within the spike increases the ability of the virus to evade antibodies more efficiently. Both the XBB and XBB1.5 have this mutation.
CDC is exploring all options to help slow the introduction of new variants into the United States from other countries. Previous COVID-19 wastewater surveillance has shown to be a valuable tool and airplane wastewater surveillance could potentially be an option.
Prof. Saeed forwarded me your message below. The NIH found that the research was not subject to the agency’s grants policy since the work was funded by BU.
Best wishes,
Colin Riley
Executive Director of Media Relations
Boston University
2:40:38 PM FEDERAL HEALTH OFFICIAL: Airlines must confirm the negative COVID-19 test result or documentation of recovery from all passengers before they board or do not– they will deny boarding to the passenger.
Other countries driven by the same concerns, including Italy, Japan, India, and Malaysia, have applied measures to slow the spread of COVID-19 during the current surge in China.
And as you all know, China has said it will continue to require travelers from the United States to demonstrate a negative COVID-19 test, 48 hours before the departure, the same policy we’re putting in place.
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2:51:01 PM FEDERAL HEALTH OFFICIAL: This is [FEDERAL HEALTH OFFICIAL]. I’ll go ahead and maybe just add on as well and, just reflect back on what [FEDERAL HEALTH OFFICIAL] said a little bit earlier in his opening remarks as well about the traveler-based genomic surveillance program. This gets to the part of your question around the viral sequence information.
And I think this is really an important piece of what else the United States is doing with CDC’s expansion of its traveler-based genomics surveillance program to two additional airports, bringing our total number of airports to seven and to additional flights, bringing the total number of weekly flights that are going to be covered by it to about 500 from across, at least, 30 countries around the world. This also it will include from the PRC and surrounding area, specifically about 290 weekly flights.
So we’re going to be able to gather through that voluntary genomic sampling program more data on variants that are potentially coming across into the United States, which could include variants that we already have circulating here, but also gives us a way to watch out for any new variants of concern that might be coming across so that we can then plan and look at our countermeasures against those.
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2:42:27 PM FEDERAL HEALTH OFFICIAL: CDC continues to recommend masking during travel, self-monitoring for symptoms, and testing for three days after arrival from international travel.
We know these measures will not eliminate all risk or completely prevent people who are infected from entering the United States, but taken together, they will help limit the number of infected people and provide us an early warning about new variants and improve protection for communities.
We’ll continue to monitor the situations and quickly adjust our approach as necessary.
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2:44:21 PM FEDERAL HEALTH OFFICIAL: So one of the reasons we’re putting in this policy is we have very limited information in public databases about variants that are circulating in China presently. In the past few months, only about a hundred sequences have been uploaded, and some of those recently, in the past week.
Among those sequences that have been uploaded are Omicron sublineages, including BA.5 and, for example. And so those variants are currently circulating in the U.S. as well.
What we’re concerned about is a new variant that may emerge actually in China, with so many people in China being infected in a short period of time, there is a chance, or probability, that a new variant will emerge and our traveler-based genomic surveillance, we’re expanding that hopefully to pick up variant that will emerge. But we’re also going to reduce transmission of any new variant by introducing this pre-departure testing program.
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2:45:38 PM Q: My second question was on how you’re going to decide when and how to end this policy?
2:45:40 PM FEDERAL HEALTH OFFICIAL: We will continue to monitor the situation in China. We hope that– the cases, I understand, cases, hospitalizations, and deaths are continuing to increase.
We’ll continue to monitor the situation on the ground and adjust as needed.
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2:56:34 PM FEDERAL HEALTH OFFICIAL: Operationally, it does take some effort by the airlines to make their data systems to put this all in place. And so we have to– we’re making the announcement today, but it will take time to implement the program. So there’s some operational implementation issues, and you need to get airlines some time to put everything in place.
I will say, while that’s happening, in terms of pre-departure testing, we continue to expand our travel-based genomics surveillance, and continuing to receive sequences through that program of travelers from China.
Attributable to US officials:
There are mounting concerns in the international community on the ongoing COVID-19 surges in China and the lack of transparent data, including viral genomic sequence data, being reported from the PRC. Without this data, it is becoming increasingly difficult for public health officials to ensure that they will be able to identify any potential new variants and take prompt measures to reduce the spread. Public health officials in the U.S. and countries around the world have been discussing their concerns about this and potential steps that can be taken to monitor the case surge effectively and identify any potential variants of concern. Our partners have expressed concern about the situation including WHO, Japan, India and Malaysia. Japan and Malaysia have announced public health steps in the last 24 hours to address the COVID-19 surges in the PRC. Japan will require a negative COVID-19 test upon arrival for travelers from the PRC and Malaysia has announced new tracking and surveillance measures. The U.S. is following the science and advice of public health experts, consulting with partners, and considering taking similar steps we can take to protect the American people.
Here’s some information for you. We continue to see an elevated number of pediatric iGAS cases with 6 reported so far in December 2022. From 2017-2021, we identified 0-7 pediatric iGAS cases in November and December compared with 14 so far in November and December of 2022. Below is a breakdown of total cases and pediatric cases by year. The 2022 year started off with cases lower than might be expected and is ending with cases being higher than in prior years.
| Total iGAS cases | Pediatric cases | |
|---|---|---|
| 2017 | 359 | 27 |
| 2018 | 367 | 26 |
| 2019 | 326 | 27 |
| 2020 | 271 | 15 |
| 2021 | 214 | 4 |
| 2022 | 283 | 28 |
Let me know if you have other questions.
Andrea
Thanks for your inquiry. Please see below:
Do you know how many Siemens Healthineers kits are being distributed for this round of covidtests.gov ordering?
The CLINITEST Rapid COVID-19 Antigen Self-Test is not included in this round of covidtests.gov ordering. The test is available for purchase on Amazon. Here is the link: https://www.amazon.com/CLINITEST-Rapid-Covid-19-Antigen-Self-Test/dp/B09QX4DWCD/ref=sr_1_3
How was the shelf life extended?
After commercializing CLINITEST Rapid COVID-19 Antigen Self-Test, stability data has continued to be collected on an ongoing basis.
This new stability data has been reviewed by the FDA. They found that it was sufficient to support using the product for a longer period after manufacture.
Have a good holiday!
Kind regards,
Kim
Here is what we have to share:
The number of infections involving pediatric patients under 18 so far this year is 17.
The number was apparently lower than normal across the United States in 2021 and Pennsylvania was consistent with the national trend, reporting seven (7) cases in 2021.
The figure was 21 in 2020… 24 in 2019… 26 in 2018… 41 in 2017… and 25 in 2016.
Take care,
Mark
| Mark O’Neill | Press Secretary |
| Department of Health | Office of Communications |
In the five years prior to the pandemic (2015-2019) an average of 19.4 pediatric invasive group A strep cases were reported a year. An average of eight pediatric cases were reported a year during 2020-2021.
Report Year Total Cases <18
2015 27
2016 19
2017 11
2018 21
2019 19
2020 10
2021 6
Warm regards,
Paul Galloway
As of today (Dec. 22), we have ~12,500 results submitted through MMTC. This is the total number since the site launched a month ago (Nov 22 launch).
FOR IMMEDIATE RELEASE Wednesday, December 21, 2022
Readout: Secretary Becerra and Commissioner Califf Speak with Pediatric Medicine Manufacturers Amid Rise of COVID-19, RSV, and Flu This Winter
The call with medicine manufacturers is part of a series of ongoing HHS actions and engagements with key stakeholders amid the rise of respiratory illnesses this winter.
On Tuesday, December 20, 2022, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra and U.S. Food and Drug Administration (FDA) Commissioner Robert Califf convened conversations with senior leadership from major medicine manufacturers and distributors on the current production and distribution of over-the-counter pediatric medicines.
All the companies shared that they are running manufacturing facilities 24-7 to meet demand, supplies of these products are being replenished as quickly as possible, and there is no widespread shortage of pediatric medicines. Participants included the Consumer Healthcare Products Association, a trade association representing nationwide manufacturers and distributors of over-the-counter drugs, Perrigo, and Johnson & Johnson, among others.
Secretary Becerra’s call with medicine manufacturers is part of a series of ongoing engagements that HHS has held with key stakeholders amid the rise of COVID-19, RSV, flu, and other respiratory illnesses this winter. Last week, Secretary Becerra met with hospital associations. Participants included the American Hospital Association, America’s Essential Hospitals, the Federation of American Hospitals, the Physician Hospitals of America, the Catholic Health Association, and the National Rural Health Association, among others.
Today, Secretary Becerra announced that that in addition to giving states the flexibility to tap into their own state stockpiles for Tamiflu, HHS would also give them the flexibility to tap into the national stockpile for Tamiflu if they lack their own state stockpile of the antiviral. This announcement follows Secretary Becerra’s letter to states emphasizing that HHS stands ready to assist them with resources, supplies, and personnel in an effort to reduce the number hospitalizations and deaths due to flu and other respiratory illnesses in the months ahead.
PETER MARKS, FDA [00:19:50]
Probably sometime in the early part of the new year, there will be a discussion about, first of all, really what should the composition of these vaccines be? How should we, and what should be the timing of, when we select new vaccine strains? How often should we do so?
And that’ll be an important discussion because I think we are trying to get to some sense of normalcy with how we do vaccination. Right now for pharmacists, COVID-19 vaccination is quite complicated. There are lots of different vial sizes for Pfizer-BioNTech, lots of different sizes for and types for Moderna, and that creates challenges for essentially keeping things straight.
And so we’re going to hopefully be able to simplify things after some further discussion, and also then come up with a timing so that people can expect when they would be getting their vaccinations. I think hopefully it will mirror something like the influenza model, although, COVID-19 is not influenza, it doesn’t have quite the same seasonality. There are all sorts of caveats there.
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DANA DESHON, NAPNAP [00:21:48]
Your next question is, can a toddler who completed the Moderna primary series over the summer receive the Pfizer bivalent booster? I have a two year old and am eager to get her boosted, but cannot find a provider as pharmacies only vaccinate three and up and Vaccines.gov has no local result.
PETER MARKS, FDA
Oh boy. So the issue the issue would would be that that for these vaccines right now, unless a child is has essentially moved into a new age range, we generally recommend that if a child started the Pfizer vaccine and is under four years old, they complete out the series with Pfizer. And the same goes with the Moderna.
That said, once children are– essentially have moved into a new age range, then the ability to use a different booster kicks in. I don’t know whether you have a better– you may have a better answer to that question than I did, and I’m not I’m not sure I have a better one.
Any thoughts, Dana? Yes.
DANA DESHON, NAPNAP
Yeah. I mean, I go by what the recommendation is. I mean, there is the recommendation is still the stick with the same one to complete out the series. But you know what, the older ones, I know there has been that we can– they’re both mRNA vaccines so–
PETER MARKS, FDA
I just want to– this is actually a great question that circles back to the last answer I gave about the reason for having this advisory committee meeting. One of the reasons is this is one of the issues that needs some simplification, right?
Because ultimately we’d like things to be as simple as they are with influenza vaccine, where it doesn’t matter what manufacturers’ vaccine you’ve received. It would be it would be nice if we can get things– could get things so that we could have, essentially, swap– be able to swap out, and that’ll be something else that’ll be considered at that time.
So hopefully within a couple of months there’ll be some– some better guidance in that regard.
LYNNETTE BRAMMER, CDC [00:08:52]
This data shows some of our information on outpatient respiratory illness. The graph on the upper left side shows the percentage of outpatient visits for respiratory illnesses reported through the U.S. outpatient influenza like illness surveillance network or ILINet. During week 48, 7.2% of patient visits were for influenza like illness. This showed a slight decline from 7.6% the week before. But I’d like to note that that week, the– where we had the 7.6%, was the Thanksgiving week. And sometimes we see a little bit of elevation because of the holiday, because people are less likely to go to the doctor for routine issues, but still go when they’re sick. So it sometimes elevates our percent ILI a little bit during those holiday weeks.
If you look on the upper right hand side, you can see it’s basically the same data as the percent ILI, but by age group. You can see that for the most recent week we did see a slight decline in the percent of patient visits for influenza like illness for the 0 to 4 and 5 to 24 year age groups. But for all the adult age groups, we did see– continued to see increases.
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SUCHITA PATEL, CDC [00:43:44]
And then these data are just numerator data, but they tell us about where to places where vaccinations happen in pharmacies and in medical offices. We do not have data for workplace vaccinations and other vaccinations to kind of round out the picture.
But for these two settings, we are seeing 4.5 million fewer doses administered in physician medical offices this year compared to the same time last year. However, we’re seeing 2 million more administered at pharmacies. So either adults are not making it or not getting to see doctors, or staying away purposefully because there’s that they’re hearing that there’s a bad respiratory season going on. We really don’t know why, but we’re seeing lower– lower doses in medical offices so far. Next slide.
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LYNNETTE BRAMMER, CDC [00:56:07]
I don’t believe there are any early estimates in yet. Typically, we will put out the preliminary estimates usually in about February. So I would expect some– a similar schedule this year.
ASHISH JHA, WHITE HOUSE [00:09:26]
Now, let me add on this that there have been and again, I’m not talking about Dr. Offit specifically, but in general, there have been people who have been booster skeptics, or booster skeptics last fall, the evidence was overwhelmingly clear that people should get that booster last fall. And those 750 people that we heard about who passed away in Philadelphia, and the tens of thousands of Americans who died, almost all of them were people who had not gotten a booster. The data on this is overwhelmingly clear. In the spring and summer, there was a lot of skepticism about, kind of for older Americans, that second booster. The data was overwhelmingly clear from Israel, if you got that booster, you were dramatically less likely to die.
I think the scientists at the FDA, the career scientists at the FDA, made– they thought the data was very clear that these things should be recommended for every adult and now for kids as well. That’s where the CDC scientists are. I spent a lot of time talking to scientists across the country on an ongoing basis. I think the broad consensus is that people are better off with the bivalent booster. The broad consensus in the scientific community is that the bivalent booster is substantially better than the original booster.
And so, look, there are going to be individual people are going to have their individual views. My job sitting at the White House is to look at what all of the broad range of scientists, Dr. Fauci and the folks at the NIH, what do they think? What does FDA think? What does CDC think? What do the broader scientists think?
This is one where there’s actually a lot of consensus that this new bivalent vaccine is a clear improvement and that it is absolutely essential for people, especially if you’re at elevated risk, of getting this booster, it’s going to make an enormous difference in whether you get sick or not. That should be our message. That is our message. There’s actually quite a bit of scientific consensus.
…
ASHISH JHA, WHITE HOUSE [00:17:47]
You know, in terms of other investments, there are a lot of dollars that came out of the American Rescue Plan given to cities and states for investments in improving indoor air quality. I actually think this is probably the most important long term thing we can be doing for schools or office buildings or nursing homes.
Indoor air quality is sort of– has just not got the level of attention it deserves. Most experts believe that, if we make some basic investments in indoor air quality, we can reduce, in fact, all respiratory infections by 30 or 60 or even 80%. I mean, the notion that you could cut respiratory infections– there is no study in the world that shows that masks work that well. So you’re never going to get the kind of benefit from mandatory year round masking as you would from making substantial improvements in indoor air quality, plus it’s a lot easier to implement as well.
So this is an area where we’re doing a lot and trying to really encourage people to use the resources they have to make those investments and start really improving ventilation filtration.
Q1 (Jan-Mar) 2022 estimates are currently available at https://covid.cdc.gov/covid-data-tracker/#nationwide-blood-donor-seroprevalence-2022.
We are planning an update soon (no specified date) to include quarter 2 (April-June) 2022 estimates. Updates should occur approximately every 3 months after that.
Thanks,
LaKia Bryant, MPA
5:09:17 PM SENIOR ADMINISTRATION OFFICIAL: First, starting tomorrow, each household can visit COVIDTests.gov and order a total of four at-home tests to be mailed directly to their doorsteps for free. That’s four free tests per household, regardless of how many tests they’ve ordered previously, with tests starting to ship next week, the week of the 19th.
This adds another way Americans can access free tests this winter, including through their health insurance plan, which covers free eight free tests per month, per individual, as well as thousands of community-based locations around the U.S. like community health centers, schools, and long-term care facilities.
We’re able to reopen COVIDTests.gov for a limited round because, in the absence of congressional funding, we’ve acted within our limited resources to buy more at home tests for our national stockpile.
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5:13:07 PM SENIOR ADMINISTRATION OFFICIAL: Thanks so much for the question. This entire time as we’ve been fighting COVID, we’ve been talking about making hard choices given limited funding . And when we– sorry– and there remains an urgent need for additional COVID funding to help us stay prepared in the face of an unpredictable virus.
So at the end of the day, we had to repurpose some of our existing money to focus on this important initiative as we are seeing cases go up. These are always hard choices and we have to make trade-offs
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5:14:45 PM SENIOR ADMINISTRATION OFFICIAL: Thank you for that question. As you’ll see in our plan, we do reference masks. The administration has given out hundreds of millions of masks for free and they are widely available.
They were originally distributed to pharmacies and we are now ensuring that they are also being distributed to places where people who might have greater challenges accessing free masks can get them, including food banks, community health centers, and other locations.
And I think we view masks to be just one important tool in an arsenal of tools that is part of a multi-pronged strategy to combat COVID.
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5:18:29 PM SENIOR ADMINISTRATION OFFICIAL: Thanks, great question. So, just going to the first part of your question, first, we’ve been talking for months about being prepared for a winter surge.
Before Thanksgiving, we talked about the six week push for vaccinations, and we are constantly looking for ways to be ready. We are a few years into– we’re a few years into the pandemic, and we are prepared for this moment. We have the tools, we’ve learned from the past, and we saw an uptick in cases after Thanksgiving, and we believe that– that was expected when people gather indoors. We expect those sorts of things. We’re closely monitoring cases, post that. And we are standing ready and prepared with the tools that we have assembled to face this this winter.
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5:19:53 PM SENIOR ADMINISTRATION OFFICIAL: So in terms of where the funds came from, they are ARP funds. And we’ve had to think very hard about how exactly to make these trade-offs, in terms of how we use these funds. So it’s from ARP.
Procurements are ongoing and so I can’t give you exact numbers on how this is going to land, but we feel confident that we are going to have enough tests to get through this next round, four per household, in the coming weeks.
Can you clarify something: so new tests are being purchased for this round? Aka these aren’t old tests that were stockpiled earlier that might be near expiration?
The stockpile is being replenished with last procurement, so it’s a mix
As part of a previously announced purchase, we notified Congress in August that HHS would be procuring 3.7 million treatment courses of Paxlovid – one of the best lifesaving tools we have to treat those who are infected with COVID-19 and are at high risk of severe illness.
Wondering if you’d be able to clarify if/when NCHS is also planning to release updated guidance for completing long COVID death certificates? Apologies if this was already published and I missed it.
NCHS plans to release this guidance, but we do not have a release date yet.
Brian
FARIDA AHMAD, CDC [00:36:42] While previous presentations in this panel have looked at measuring the prevalence of long COVID illness, we have limited information about long COVID mortality. There are currently no estimates of the number of long COVID deaths in the U.S., and this is due to a number of challenges.
Long COVID diagnostic guidelines are evolving over time as we understand more about the condition, so there’s no simple diagnostic test for long COVID. Terminology has also changed over time. Additionally, we don’t have standardized guidance for listing long COVID as a cause of death on the death certificate. There’s also no cause of death code approved for coding long COVID on certificates, and this presents a challenge for quantifying how many deaths have involved long COVID.
Next slide, please.
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.
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.
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.
ELISHA HALL, CDC [00:20:06]
One question we’re already receiving a lot is that there is this bivalent booster on the schedule for children age five, who received a Pfizer primary series. Can a child who completes their primary series at the younger age group, six months through four years, and then ages up to five, can they get that bivalent booster when they turn five years?
The answer is yes. A child in the six months through four years age group who completes their three dose Pfizer series, but then ages up to five years, they can get this one bivalent Pfizer booster as long as it’s been at least two months since their last dose.
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ELISHA HALL, CDC [00:29:22]
This slide shows the percentage of nursing home residents who are up to date with COVID-19 vaccination using facility level level data. The National Healthcare Safety Network collects data on nursing home residents and staff who are up to date with COVID 19 vaccines for the purpose of surveillance. As of the week ending October 2nd, individuals are considered up to date if they received a bivalent booster or completed a primary series in the last two months or received their last monovalent booster in the last two months. These vaccination data can be reported at the person level or at the facility level.
Among the subset of facilities submitting person-level data, over 99% of individuals classified as up to date received a bivalent booster dose. Therefore, up to date can be used to estimate bivalent booster coverage.
So the take home on this slide is that, as of the week ending 11/27/2022, an estimated 45% of nursing home residents have received a bivalent booster dose. Next slide.
MICHAEL BELL, CDC [00:30:37]
The other piece of the PPE conundrum, and this is going to get more interesting as the months pass, because we’re in the process of revising the isolation guidelines, the old droplet versus airborne, very black and white, binary approach.
It was useful back in the day when people were just getting their their feet wet, as it were, with with infection control practices. And we needed some very concrete approaches.
But I think we as a society are ready to think a little bit more critically about what we’re doing. We want to be thinking about the very real issue of the area around other people having some amount of respiratory secretions floating around all the time.
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MICHAEL BELL, CDC [00:33:45]
We’re in the process, as I said, of trying to state this in a clear and useful way in the update of the isolation guideline. That is in progress right now. I hope to have a draft in the Federal Register for the public to look at and comment on, probably mid to late spring of this coming year.
That is going to be a document that says, here’s how we are describing infection transmission. And here are the things that we do about it. But then, it’ll be followed, probably over the course of a year and a half or two years, by the Appendix A section. Those of you who have looked at this know that there’s a big table that lists all of the different organisms and what we recommend for infection control.
And going through each one of those is going to be a very challenging but important exercise to start drawing the line between things like seasonal versus pandemic flu, COVID now versus COVID five years from now.
ASHISH JHA, WHITE HOUSE [00:13:50]
We got to get through this period of time. I don’t know how long it’ll last, what we’re going to see with this increase, but we’ve got to manage it. And that is acting.
In the background, and not so far in the background, we have a group of people on our team who are thinking about the transition. The transition to sort of more normal, as some people call it, commercialization, kind of the more normal way of doing business.
You know, the last three years, I think very much rightly so, certainly the last two years under the under President Biden, the U.S. government has been buying vaccines, has been buying treatments, has been buying diagnostic tests. We know at some point that needs to transition.
What is that point? Well, that point is driven by a few different factors, not the least of which is lack of congressional funding. Congress is not funding us buying these things, so we can’t purchase them if we don’t have the resources.
But also, we are moving to a different phase in this outbreak where– where I do think it will be reasonable to move a lot of this stuff into the normal health care market.
Our principle or values on this have been: make sure this transition happens in a seamless, non-disruptive way. We want to make sure that people don’t all of sudden wake up one morning and say, ‘Oh, I no longer have access to treatment.’ That would be a real problem. Got to make sure that that’s very (inaudible).
Second, have a very clear strategy for both– for cost issues around– you and I both know that while 92% of Americans are insured in America, there are still significant cost barriers for a lot of insurance. I do not want a low income senior unable to afford Paxlovid or unable to afford diagnostic testing, and therefore not be able to get treatments. That would not be okay.
So our values are that there should not be cost barriers, particularly for lower income people.
And then obviously there are 8-10% of people who are uninsured. Making sure that they have access. And that cost barriers are not a problem.
That is all work that has been going on in pretty vigorous ways, ready for the time when things transition. When will that be? The reason I can’t break news today is because I don’t know what I would answer even if I wanted to.
There will come a day when the secretary of HHS will decide to end the public health emergency. I don’t know what that day is, and there will be a set of factors that will go into it. The only thing I know the secretary has promised and we as an administration have promised that we’ll give everybody at least 60 days.
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ASHISH JHA, WHITE HOUSE [00:20:04]
One of the big, big difference is I do less predicting. As a colleague of mine said, I was in the business before I started this job of predicting where the fires were going to be, how big were the fires, and if they turned out not to be true, there was really no big deal.
I’m largely out of that business. I am now much more in the business of making sure we have a fire response plan, making sure that if it’s a large fire, we’re ready for that. If it’s a small fire, we’re ready for that. When we see fires, making sure that we actually go execute on all of that.
That necessarily changes the communications. And appropriately so. Right? It’s very different to be in a actual execution role and a coordinating role than as an academic, where you get to sit back and look at the world and say, I think this is going to happen.
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ASHISH JHA, WHITE HOUSE [00:29:00]
On masking, this has also got, I think, unnecessarily complex. Here’s how I think about masking.
Do masks work? Well, low quality masks don’t work that well. High quality masks really work much, much better.
Again, going back to my clinical experience, you know, I was struck by, I remember one day, this was in early January of this year, I was in the hospital taking care of patients. I had a really sick COVID patient, with COVID pneumonia, coughing up just a lot of like virus into the air. Walked into his room wearing my mask and also had an eye goggles, but other than that, like wearing a mask that is widely available.
I was listening to his lungs and in the middle of it, he had this coughing fit, and just coughed cough cough on my face. He felt bad. I was fine. I walked out and I took off my goggles and I said to my one of my residents, I said, ‘This is what I’m going to count on my vaccine and an N95 to get me through it.’
And it did. A high quality N95, that are widely available now, it was not some purposefully special fitted, I had literally bought it from a store and was wearing it protectively in a pretty high risk situation. I’m confident I was wearing a surgical mask or a cloth mask at that moment, that would not have been (inaudible).
What I say to folks is we have a whole series of tools we use for mitigation, preventing serious illness, preventing infections. Masks should be one of them. They shouldn’t be exalted. They should not be diminished. They are one of the tools we have. People should use them when they want to. We don’t ask and demand people use all the tools, but the more you use, the safer you will be.
I think turning down the temperature on this, remembering what masks are: one important public health tool. High quality masks clearly make a difference, and that if we see it in that context, maybe we don’t have to have so many fights about masks.
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ASHISH JHA, WHITE HOUSE [00:04:36]
I think in terms of COVID, specifically, the way I look at where we are today, I think again, with infections rising, there’s a series of things that we can do that will influence what happens next. And there’s a series of things that the virus is going to do that are largely outside of our control.
The virus continues to evolve. How it’s going to evolve, are we going to see some other major new variants, things that we don’t know, but things that we do know are that we are at a place in this pandemic where if people are up to date on their vaccines, people are getting treated, people are using basic precautions, wearing masks in super crowded, indoor, poorly ventilated spaces, where we are using testing for large gatherings, we do some basic things, we can make an enormous difference in terms of keeping infection numbers lower, certainly preventing serious illness.
That stuff is under our control and I think that’s going to be a truism moving forward. But there’s going to be more and more things that we can do under our control to manage things. But obviously, the virus continues to have its own X-factor.
It’s really hard to make predictions about exactly where the virus is going to go.
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ASHISH JHA, WHITE HOUSE [00:46:10]
So I report to the president, I meet with him, and he’s got a pretty full plate. I meet with them whenever there are sort of critical issues or we’re engaging him on something or he wants to be briefed up on something. And there are lots of ways of engaging the president, beyond just one on one meetings or in person.
And the day to day, a lot of it is my meeting with and spending time with Ron Klain, the president’s chief of staff. So that’s sort of kind of the mechanics of how a lot of this.
ANNALIESA ANDERSON, PFIZER [00:44:40]
Here’s just some preclinical data that we’re showing for the first time. And this is our data with our investigational modFlu vaccine, put in combination with our COVID bivalent vaccine. And on the left of the slide, you can see data for our COVID vaccine. And so what we did is we vaccinated mice with either the COVID vaccine alone, the investigational flu vaccine alone, or both of them together. The left shows neutralization data for the COVID component of the vaccine, both the vaccine alone, the COVID vaccine alone in blue or– and gray, actually, and then against the Wuhan strain, and the 4/5 variant.
And you can see there’s really very similar levels of neutralization when you have the vaccine as monovalent vaccines with just the COVID or when combined. And then on the right of the slide, you can see very similar data for the flu components where you have the flu vaccine alone, and then the flu vaccine with the COVID, tested against the four different hemagglutinin antigens. And we see little or no interference when we combine those vaccines.
So we’re currently in phase one with this study, and we’re looking forward to having a readout early next year, to then move that program forward.
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NAVIN KATYAL, PFIZER [01:22:06]
But just in terms of COVID 19, I think we know first and foremost, COVID is here to stay, unfortunately. So we do expect that there will be, moving forward, a sort of a durable business around standalone Comirnaty as well as the combo with influenza moving forward.
I think many countries around the world have already started to signal that they will move towards an annual recommendation for most of the population, or large parts of the population, and then for some, potentially those at high risk or maybe immunocompromised, maybe something somewhat more frequent.
But that is based– the basis for our strong view that this will be a durable annual business that looks like flu. I think as we think about the commercial potential, we also think about the influenza sort of paradigm, given all the reasons I just talked about. I do think that the adult market will quickly emulate the flu in terms of uptake. And I think the pediatrics basis, given what we’ve seen in terms of uptake to date, will take a little bit longer to mature, but over time, I think we do see that that will start to converge.
And then I think to your point on combination, you know, we’re very bullish on combination because we know that the adult vaccination market is getting a bit more crowded and there is a lot of interest, particularly amongst the health care system, but also amongst consumers, for something that’s more convenient.
And I think that will have a synergistic effect in terms of driving uptake both for flu as well as for for COVID moving forward.
So we’re know, I think we’re very confident and we definitely are continue to invest given the large and durable business that we see moving forward.
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NAVIN KATYAL, PFIZER [01:32:16]
Something we’re spending a ton of time on, because we think there’s an opportunity both for Comirnaty and for COVID rather, but also for flu, to do have better strain match. And so what we are going to be doing and we’re already doing is actively having discussions with regulators around the world, institutions like the CDC, WHO, to make sure that we have a fit-for-purpose strain selection that allows us to get closer.
And then as you highlighted, it’s going to be complex, because you are going to have potentially shifting strains both for flu and for COVID. But I think, as we’ve spent a lot of time meditating on this, I think we at Pfizer, we’re going to be uniquely and I think, really well positioned, for sort of working through all of those different sort of moving parts.
Imported from Revue
JOSE ROMERO, CDC [00:48:21]
National trends for RSV activity suggest that the peak of seasonal activity has passed in nearly all regions. So that’s good news.
RSV-associated emergency department visits among people of all ages appear to have plateaued and are decreasing, though RSV associated emergency department visits remain at or above the level typically seen during the peak of RSV activity during the winter.
The slide shows ED visits for RSV and RSV like illnesses such as bronchiolitis from our National Syndromic Surveillance Program, which captures data from approximately 75% of emergency departments nationally. So it’s a very robust system. This graph shows that data as of November 26th, and goes back to 2019. So we can compare the 2019-2020 winter RSV season with what we’re seeing today from the National Respiratory Enteric Virus surveillance System, we’re seeing that RSV activity remains elevated, but is beginning to decrease in all regions except the mountain region. That’s HHS Region 8. Test positivity is decreasing in the south and southeast, HHS Regions 4 and 6, and has plateaued in New England, Midwest, mid-Atlantic, Mideast, Northeast, and Pacific West, specifically HHS Regions 1, 2, 3, 5, 7, 9, and 10.
We are also seeing some cold circulations and co detections of viral infections this year compared to previous seasons. Most of these are due to rhinovirus enteroviruses. We’re not seeing increased severity of disease this year, even when accounting for co-infections compared to previous years. On preliminary analysis, the length of hospital stay, the proportion requiring ICU admission or mechanical ventilation, are similar to previous RSV seasons.
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JOSE ROMERO, CDC [00:52:40]
Most recently, we’ve been involved with an outbreak of measles in Ohio. This is– I’d like to give you a brief update on this.
Following cases with reported travel from Kenya, between June and October, two community cases without known links to the prior cases or international travel were confirmed on November 5th. As of December 6th, there have been 58 reported cases, nearly all of which from the city of Columbus, with just one outside in the surrounding Franklin County– another in Ross County, and the final one from Richland County.
All these cases are younger, with a median age of 2 years and range from 6 months to 15 years. 55 cases, or 95%, are among individuals that are unvaccinated, and the remaining 5%, or 3 cases, had only one dose of MMR vaccine.
For those with known exposure setting, the majority were infected in a healthcare setting. That’s 23 patients. 6 had household infections and 5 were from daycare settings. 22 individuals, or 38% of cases, have been hospitalized. This is higher than the 20% that’s typically seen. These stays are larger in the short duration, and are for dehydration and diarrhea.
2 had pneumonia. The first case admitted to the ICU followed reaction to intravenous gamma globulin used for the treatment of presumed Kawasaki disease before measles was confirmed. And as a pediatrician, I can tell you that the most common misdiagnosis is that of Kawasaki disease. We don’t think of this clinically.
We reached out to the American Academy of Pediatrics, the American Academy of Family Practitioners, to issue a reminder to think about measles in a rash and febrile illnesses. CDC has been requested to provide technical aid to Columbus Public Health and the Ohio Department of Health through an epi aid. 3 staff, 2 EIS officers, were deployed to support the effort.
CDC has also facilitated the procurement of 1,200 adult and pediatric MMR 2 doses, with a 317 funding, and completed phylogenetic analysis of the measles cases. All of these occurring were found to be of genotype of B3. They’re also related to an outbreak that occurred in Minnesota and are closely related.
CDC is supporting Columbus Public Health and the Ohio Department of Health with the following response priorities: first, improving MMR vaccine coverage among families with low vaccine confidence, leveraging associations, working with affected community, and provider outreach with patient recall for those unvaccinated or behind in their immunization schedule.
Limiting measles transmission in health care settings with early detection, isolation, and cohorting, rapid contact tracing, and provision of post-exposure prophylaxis or PEP or daycare school exclusion for 21 days. Triangulating immunization information systems, school entry, and nationwide children’s hospital MMR vaccine data to improve the accuracy of zip code level coverage estimates.
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JANELL ROUTH, CDC [00:12:33]
In 2022, we have 30 confirmed cases, consistent really with what we’ve seen in other non-peak years. Next slide.
So I think the question on everybody’s mind, and the question that outlines our work moving forward, is to why there was no increase in AFM despite this apparent increase in EV-D68 circulation in 2022. This is the first year we’ve really seen this discordance. And I think there are many hypotheses that are being floated, but there’s going to be additional research, and certainly surveillance, needed to help answer this question.
We’ve been asked, is there a change in the virus? Is there somehow a change in EV-D68 that caused it to be less neuroinvasive or neurovirulent? We do know from sequencing efforts both in academic centers and also at CDC, that the clade that is circulating this year is B3, which is the same clade that circulated in 2016 and 2018. We also know that minor changes in those antigenic loops of enteroviruses, including polio, are frequent. We expect these enteroviruses to mutate at a rate of about 1% per year. But we do know at least from polio, that vaccines remain effective. So this does suggest no major changes in the virus structure or its infected properties.
I think one important task moving forward will be to see if the 2022 strains cause paralysis in mice, just like the other outbreak strains have done. And certainly our academic colleagues are working on that.
The second hypothesis could be changes in the host. So pinging off of Dr. Hannah Kirking’s great presentation yesterday regarding the pediatric hepatitis investigation, which I think has many similarities to AFM, we need to better understand how host co-factors in these patients with EV-D68 infection bring that patient to develop paralysis. What is it about the host that causes paralysis in just a few cases, where most infections with EV-D68 resolve with no further sequelae?
Attempts to understand host co-factors have been done through hypothesis, generating questionnaires and interviews, but thus far none of these have returned any signal. But certainly, given the immunity gap that exists over the past three years, there may be changes in host immunity that have impacted the virus’s ability for neuroinvasion and pathogenesis. We’ve also been discussing this concept of viral interference, I think with many respiratory viruses circulating, a nonspecific immune response to one respiratory virus might block, for example, the pathway for EV-D68 to infect the nervous system.
So again, these are just hypotheses, but trying to think certainly about the reasons why we did not see AFM, although I think we’re all incredibly grateful for that.
ASHISH JHA, WHITE HOUSE [00:22:38]
Yeah, it’s a– it’s a great question. Nursing homes have, in fact, suffered so much or people in nursing homes have suffered so much.
We’re doing a lot to try to encourage nursing homes to make sure that every resident is being offered the vaccine. It’s actually a requirement that every every resident should be getting offered it. To Len, what I would say is make sure that your father’s being offered that COVID vaccine. Single most important thing for your father’s health protection this winter is making sure he’s gotten that updated bivalent vaccine. So that’s number one. If the nursing home isn’t offering it, get a family member, a loved one, to help them go to a CVS or a Walgreens or a Walmart and get that vaccine.
And the second thing I will add, which we I think often don’t talk enough about, is if he does end up getting an infection, if anybody in the nursing home or anybody at elevated risk, getting treated as critical. We have so many good treatments now. They’re widely available, they’re free, and people should be getting treated as well.
ANTHONY FAUCI, NIAID [00:23:35]
You might want to add one other thing to get that extra level of protection. You’re vaccinated, you’re family members vaccinated, you might want to test yourself before you go in and visit, just to make doubly sure that you may not have gotten infected and you have no symptoms. If you put that together with vaccination, you really have a really good confidence that you’re going to be safe.
Imported from Revue
ROCHELLE WALENSKY, CDC [00:03:09]
Another one of those authorities is our hiring authorities and how we hire. If we’re going to be a response agency, can we provide hazard pay?
I have people on the front lines in Uganda working on Ebola. I can’t provide them hazard pay or overtime pay.
So those are some of the authorities that other agencies enjoy that we have not had the capacity to enjoy, and that if we really want to be response ready, we’re going to have to have.
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ROCHELLE WALENSKY, CDC [00:03:55]
I have been doing a lot of work on the Hill. I was there today, to say there’s this assumption that we have those authorities. And in fact, there have been numerous pieces written about ‘CDC is not sharing the data on X.’ And I just say, ‘boy, would I love to share the data on X, I’d love to have the data on X so I can share it with you.’
So that’s actually the thing– I think people just anticipate that we have the authority, that those data are coming in. Our first, during mpox, we had 23% race data on cases. And we were working towards trying to get testing data coming in. So those are the kinds of things that have been really hard for the Ebola response. We’re now funneling folks who have been in in Uganda to five different airports.
I think people know that. It’s about we’ve– we’ve been working with about over 6,000 people over the last several months who’ve traveled to Uganda recently. We don’t have the authority to ask that their final destinations, to give us the data on how they’re doing. It’s very hard to run a public health response that way.
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ROCHELLE WALENSKY, CDC [00:06:52]
So I’ll say before the pandemic, at the bedside every January and February are tough years. So the ICU are full of flu and patients with the flu, and those are tough years. And should COVID 19 settle out to be another one of those hard respiratory pathogens that we have in respiratory virus season, that may be where we land.
Certainly one of the things that worries me from a public health standpoint, from the public health emergency, is the data that we may not get because of the context of the public health emergency allows us a little bit more flexibility to see those data. We have the potential to extend those authorities, right after the public health emergency ends. So we’re hoping that we will continue to get them.
But in two years, will I be able to report on COVID 19 community levels? I can’t tell you that.
TREVOR SHOEMAKER, CDC [00:17:59]
And to date, there have been just over 6,000 entry screenings. 95 of those included secondary screening. Those are probably people who either maybe were ill or maybe had a bit more questions that needed to be asked, in terms of their risk assessments, when they arrived. And then– but none of them had been referred to hospitals and there have been no high risk exposures, people having had contact with a known or probable case or otherwise.
And since the start of the response, CDC has conducted 32 Ebola related clinical consults. It probably is now 33, including the one my colleague Dr. Choi took today. And two of those patients out of those 32 were referred to testing, and both were negative both at the LRN labs and CDC labs. But one had– did have an alternate diagnosis of malaria.
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JONATHAN MERMIN, CDC [00:39:15]
And there needs to be continued research on answering some of the most important questions for mpox on treatment, on vaccine effectiveness, mode of administration of vaccine, because we have recommendations for both subcutaneous and intradermal administration.
We need to continue to understand the animal reservoirs and the zoonotic risk in the United States, which at this point we have not identified any animals that have become infected, but it’s a potential risk that needs to be evaluated.
We need to continue to better understand the viral shedding and transmission dynamics and then expand the diagnostics and continue surveillance.
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JONATHAN MERMIN, CDC [00:57:15]
The other point, you said, ‘it’s like when do you know you’re done?’ And I think it’s interesting. So there’s one way, which is just case based. Have we gotten to where mpox cases are very rare and we’re able to respond rapidly? Essentially, and then the other is to say, ‘well, do we have enough immunity to prevent resurgence? Or new clusters in cases, if it’s reintroduced in either from one jurisdiction to another or from outside the United States back to the United States?’
And I think that’s where this idea of having a robust vaccination program while we can, for at least a period of time, where we can see what happens to the global outbreak, will be very beneficial. So we are moving, continuing to move full steam ahead, on trying to have people who are– would benefit from vaccine getting it. But I also– it is an ongoing question because people are already starting to think about other priorities for either their public health departments or their community based organizations or your agency.
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DAVID FITTER, CDC [01:04:27]
Preliminary DNA sequencing results indicated that the current circulating strain is the same as that of the 2010 outbreak. This was– you may have seen this in NEJM. The MGH put out a letter. This does suggest that despite no cases having been reported in the country in several years, the cholera strain may have remained in an unknown reservoir in Haiti or reintroduced from elsewhere.
Sequencing from a geographically representative set of reference samples from 2016 to 2019 is in process currently at CDC and we are waiting with bated breath for the results from that to come back.
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DAVID FITTER, CDC [01:12:58]
I was fortunate enough to be in the CDC office in Haiti from 2016 to 2019. And certainly after 2019, we’ve seen sort of an increase in insecurity. It has really affected the ability of movement, and mainly of population movement as a whole, and then movement of any of the partners around as well to support, in essence, public health interventions and health interventions. I still have several people in the office and elsewhere that I speak with.
Often they send around WhatsApp messages to each other to say, ‘Can we move today? Like, are there blockades?’ Physicians are not going into their offices. They check to see what the roads are looking like. It’s– a lot of it’s concentrated in the Port au Prince metropolitan area, but other cities are also seeing this. There was a big crisis in the southern claw, where they burned down at the airport. They took out a plane as well. It’s causing huge effect.
And so there’s cholera, and I went through it quickly, is really in the context of a very humanitarian crisis that’s happening right now. And it is amplified by that. I think, you know, having spoken with a lot of the Haitian colleagues and we’ve gotten on with the minister of health, Haiti knows how to respond to cholera. They had to do it for years, but they’re impeded because of what’s going on right now.
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HANNAH KIRKING, CDC [00:16:47]
So moving forward, we are we are doing a U.S. based case control prospective evaluation here. And the goal is to answer these objectives: is adenovirus infection more commonly detected in children with hepatitis of unknown etiology relative to healthy controls? And are there other exposures, pathogens or risk factors, more common in children with hepatitis compared to healthy controls?
We are matching healthy controls with our PUIs by age, time, geography, and blood specimen type, doing very detailed collection for all the cases and controls.
And then lastly, I’ll say to date, our case control has launched and the timing of that has coincided with a scale back of our surveillance, as well as a decline in case reporting. And so we are continuing to try to keep this investigation going,
Whereas respiratory adenoviruses don’t necessarily have strong seasonality, enteric adenoviruses do. And so it could be that this upcoming winter, which is the typical time we would see an increase in adeno-40 and 41 may actually allow this to continue to move forward, and or enroll more quickly. Next slide.
Okay. So overall, just to summarize. Identification, reporting of U.S. pediatric cases of acute hepatitis of unknown origin has dropped. It currently is low, but we don’t think this is over. I’ll just qualify it with that, because I think there’s some surveillance bias in there.
We do think there is an association between adenovirus infection and pediatric hepatitis of unknown etiology. Adenovirus type 41 is more frequently implicated compared to other adenovirus types, but the exact pathophysiology remains unknown. A large proportion of our PUIs here in the U.S. had co-infection. And so there’s this question, does co-infection increase their risk of hepatitis? That makes good clinical sense. And I think many of us think that that could definitely be part of this.
Similarly, I think we need more data on which host factors could be co factors with adenovirus infection, that could relate to the clinical outcome of acute hepatitis. And then finally, I just wanted to kind of state explicitly that the findings from our ongoing epidemiologic investigations definitely will help direct and focus the future research around this. And so I think our goal is to get from a public health standpoint, to get to a point where then it probably moves more into a clinical or research setting and to to work out the finer details.
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JOSE ROMERO, CDC [01:11:22]
The polio group had already come up with back of the envelope calculations as to the number of cases of polio we would expect in that community, based on immunization. That number was 8 to 12, right? We have not seen any. And I argue– I posit that the reason we’re not seeing it is because we have a well-defined public works system in this country. That the poop that’s coming out of the house, down the road, is not getting contaminated into the potable water that goes back into another house. That’s why we’re not seeing the 12 cases.
And again, I will I will again say that I think that we’re better spent– we’re better off spending the effort, the money, the time to get people vaccinated because of this.
Secondary, there’s a book called “Dirt and Disease,” it was published about three decades ago, that talked about the decrease in polio virus that occurred prior to even the advent of the vaccine. Paralytic polio, and that had to do with the infrastructure that I’ve been talking about it.
The last comment I want to make is about is about this wastewater– this is my bias on wastewater. Also, why I think we need to spend more time vaccinating.
I think that not finding the virus in a community with low vaccination is a reinforcer. It’s a negative reinforcement, because it makes people say, ‘See, it’s not here. I don’t worry about it. You just keep going.’ Right? And I think that that that could be a downside of us doing it.
The last comment on that is that if you look, you will find it, right, Because we’re a global society. And when we start looking, we’re going to find it. The question is, first of all, is it vaccine strain? Not not such a big problem. Is it a vaccine derived polio virus? More of a problem. Is it circulating? The biggest problem, and I think educating the public about those three different things is going to be difficult, because finding OPV, you’re going to find it. Finding vaccine derived, so it’s there, but how do you convey to the general public that that is not a big, big threat as long as we get everybody vaccinated? So there’s a lot involved in this.
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JOSE ROMERO, CDC [01:01:58]
We are conducting discussions with state health officers regarding the implications of finding a virus, that is the cost, the duration of screening, and the required response, etc. of the wastewater testing. We’re preparing to deploy a pan-polio virus assay for those partners that are interested. These are– this is developed and validated here at the CDC.
In addition, we’re drafting– CDC is drafting guidance for jurisdictions. This guidance will be entitled focused on wastewater testing to determine the presence of polio virus in selected areas of the United States, as well as guidance on containment implications in the event of polio being detected. And those are significant and I can discuss later if you so desire. Next slide.
So a slide to the site selection is summarized here to identify those communities of concern.
So first and foremost, the communities with low polio virus vaccination are identified and these are determined by zip code level IPV coverage for data for the last 5 to 10 years. High risk communities are defined as those below 80% of herd immunity, for a threshold, or if there’s a history of measles outbreaks, that can also be used as a proxy for vaccine coverage.
The second point would be potential for importation. So communities with travel to areas with circulating polio virus, these include Africa, Eastern Europe, the Middle East and Israel. So these are communities that would have large refugee populations and areas with diaspora communities.
Thirdly, the National Wastewater Surveillance System coverage. So sites participating in the NWSS are where RNA extracts can be obtained for testing and sequencing can be used. And so the site is selected.
Other considerations to keep in mind are the size of the sewer shed, so keep in mind that the Global Initiative for Polio Eradication has determined that their wastewater sewersheds are about 300,000. New York City, for example, is 1.2 million. So that has significant implications in the dilution of samples, and needs to be taken into account as you decide where to sample.
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BARBARA MAHON, CDC [01:23:56]
So here we’re showing the uptake of the bivalent booster coverage, and I think the uptake has been woefully slow. I think the best thing that we can say here is that the uptake has been highest in the age groups that are at highest risk. So that purple line is for adults 65 and older, who are just over 30%, and that certainly is the age group that needs to be paying the most attention to getting vaccinated. But obviously, 31% is way, way, way below where we would like it to be.
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BARBARA MAHON, CDC [01:28:44]
So first, uptake in monitoring of bivalent boosters continues to be very important priority. We have plans to highlight, and are highlighting, post authorization safety and effectiveness data to encourage uptake. We’re also anticipating several upcoming policy discussions around boosters and use of bivalent vaccines in children under five years of age, and regarding transition of the primary series from monovalent to bivalent COVID 19 vaccines.
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BARBARA MAHON, CDC [01:34:08]
We have also been working on trying to develop, as rapidly as possible, metrics that would be useful at state or regional levels for being able to visualize the level of overall respiratory viral activity. And so hopefully that will be ready to come out soon.
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JOSE ROMERO, CDC [00:48:21]
National trends for RSV activity suggest that the peak of seasonal activity has passed in nearly all regions. So that’s good news.
RSV-associated emergency department visits among people of all ages appear to have plateaued and are decreasing, though RSV associated emergency department visits remain at or above the level typically seen during the peak of RSV activity during the winter.
The slide shows ED visits for RSV and RSV like illnesses such as bronchiolitis from our National Syndromic Surveillance Program, which captures data from approximately 75% of emergency departments nationally. So it’s a very robust system. This graph shows that data as of November 26th, and goes back to 2019. So we can compare the 2019-2020 winter RSV season with what we’re seeing today from the National Respiratory Enteric Virus surveillance System, we’re seeing that RSV activity remains elevated, but is beginning to decrease in all regions except the mountain region. That’s HHS Region 8. Test positivity is decreasing in the south and southeast, HHS Regions 4 and 6, and has plateaued in New England, Midwest, mid-Atlantic, Mideast, Northeast, and Pacific West, specifically HHS Regions 1, 2, 3, 5, 7, 9, and 10.
We are also seeing some cold circulations and co detections of viral infections this year compared to previous seasons. Most of these are due to rhinovirus enteroviruses. We’re not seeing increased severity of disease this year, even when accounting for co-infections compared to previous years. On preliminary analysis, the length of hospital stay, the proportion requiring ICU admission or mechanical ventilation, are similar to previous RSV seasons.
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JOSE ROMERO, CDC [00:52:40]
Most recently, we’ve been involved with an outbreak of measles in Ohio. This is– I’d like to give you a brief update on this.
Following cases with reported travel from Kenya, between June and October, two community cases without known links to the prior cases or international travel were confirmed on November 5th. As of December 6th, there have been 58 reported cases, nearly all of which from the city of Columbus, with just one outside in the surrounding Franklin County– another in Ross County, and the final one from Richland County.
All these cases are younger, with a median age of 2 years and range from 6 months to 15 years. 55 cases, or 95%, are among individuals that are unvaccinated, and the remaining 5%, or 3 cases, had only one dose of MMR vaccine.
For those with known exposure setting, the majority were infected in a healthcare setting. That’s 23 patients. 6 had household infections and 5 were from daycare settings. 22 individuals, or 38% of cases, have been hospitalized. This is higher than the 20% that’s typically seen. These stays are larger in the short duration, and are for dehydration and diarrhea.
2 had pneumonia. The first case admitted to the ICU followed reaction to intravenous gamma globulin used for the treatment of presumed Kawasaki disease before measles was confirmed. And as a pediatrician, I can tell you that the most common misdiagnosis is that of Kawasaki disease. We don’t think of this clinically.
We reached out to the American Academy of Pediatrics, the American Academy of Family Practitioners, to issue a reminder to think about measles in a rash and febrile illnesses. CDC has been requested to provide technical aid to Columbus Public Health and the Ohio Department of Health through an epi aid. 3 staff, 2 EIS officers, were deployed to support the effort.
CDC has also facilitated the procurement of 1,200 adult and pediatric MMR 2 doses, with a 317 funding, and completed phylogenetic analysis of the measles cases. All of these occurring were found to be of genotype of B3. They’re also related to an outbreak that occurred in Minnesota and are closely related.
CDC is supporting Columbus Public Health and the Ohio Department of Health with the following response priorities: first, improving MMR vaccine coverage among families with low vaccine confidence, leveraging associations, working with affected community, and provider outreach with patient recall for those unvaccinated or behind in their immunization schedule.
Limiting measles transmission in health care settings with early detection, isolation, and cohorting, rapid contact tracing, and provision of post-exposure prophylaxis or PEP or daycare school exclusion for 21 days. Triangulating immunization information systems, school entry, and nationwide children’s hospital MMR vaccine data to improve the accuracy of zip code level coverage estimates.
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JANELL ROUTH, CDC [00:12:33]
In 2022, we have 30 confirmed cases, consistent really with what we’ve seen in other non-peak years. Next slide.
So I think the question on everybody’s mind, and the question that outlines our work moving forward, is to why there was no increase in AFM despite this apparent increase in EV-D68 circulation in 2022. This is the first year we’ve really seen this discordance. And I think there are many hypotheses that are being floated, but there’s going to be additional research, and certainly surveillance, needed to help answer this question.
We’ve been asked, is there a change in the virus? Is there somehow a change in EV-D68 that caused it to be less neuroinvasive or neurovirulent? We do know from sequencing efforts both in academic centers and also at CDC, that the clade that is circulating this year is B3, which is the same clade that circulated in 2016 and 2018. We also know that minor changes in those antigenic loops of enteroviruses, including polio, are frequent. We expect these enteroviruses to mutate at a rate of about 1% per year. But we do know at least from polio, that vaccines remain effective. So this does suggest no major changes in the virus structure or its infected properties.
I think one important task moving forward will be to see if the 2022 strains cause paralysis in mice, just like the other outbreak strains have done. And certainly our academic colleagues are working on that.
The second hypothesis could be changes in the host. So pinging off of Dr. Hannah Kirking’s great presentation yesterday regarding the pediatric hepatitis investigation, which I think has many similarities to AFM, we need to better understand how host co-factors in these patients with EV-D68 infection bring that patient to develop paralysis. What is it about the host that causes paralysis in just a few cases, where most infections with EV-D68 resolve with no further sequelae?
Attempts to understand host co-factors have been done through hypothesis, generating questionnaires and interviews, but thus far none of these have returned any signal. But certainly, given the immunity gap that exists over the past three years, there may be changes in host immunity that have impacted the virus’s ability for neuroinvasion and pathogenesis. We’ve also been discussing this concept of viral interference, I think with many respiratory viruses circulating, a nonspecific immune response to one respiratory virus might block, for example, the pathway for EV-D68 to infect the nervous system.
So again, these are just hypotheses, but trying to think certainly about the reasons why we did not see AFM, although I think we’re all incredibly grateful for that.
At this time, we do not have clinical data in this age group for a fourth (booster) dose of the original vaccine following the third primary series dose, and thus we cannot yet extrapolate the effect of a third primary series dose of bivalent compared to a booster (fourth) does of bivalent. We are continuing to study dosing regimens of primary series and boosters in this age group and will share these data as soon as available.
Cohen, Julia Michelle
Thanks for reaching out. We’re aware of the FDA authorization and the next step is CDC review of the data before the shots can be made available to children.
Kristen Nordlund
ASHISH JHA, WHITE HOUSE [00:04:42]
This is our third winter and obviously we are in a way better place than where we were the first winter, where we were the second winter. But as you said, we’re not out of the woods. We still have significant challenges in front of us.
We are facing probably the worst flu season of a decade, probably one of the worst RSV seasons at the same time, though, I do think, by the way, that RSV looks like it is peaked and maybe starting to come down. So that’s good news. But that is not true yet for flu. And then, as we expected, we are seeing a clear uptick in infections of COVID pretty much in every region of the country, up about 40% over the last couple of weeks.
So three challenges all arriving at the same time. There’s going to be some bumpy days ahead.
Now, the good news here is what happens, how this all plays out, how disruptive is it, how many people are going to get sick, so much of that is dependent on us. And the key here is we’ve got great vaccines against two of the three viruses. We’ve got great treatments against one and pretty good treatment against the second one. And so if we do the things that we know works, Stephen, I am actually very confident we can get through it.
I think the biggest issue is making sure that people use those tools, people do the things that are necessary to get through the winter that’s in front of us.
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QUESTION [00:22:47]
What is being done to ensure that health insurance carriers cover related and necessary treatments for folks experiencing long COVID syndrome?
ASHISH JHA, WHITE HOUSE [00:22:56]
That’s a great question. So this is an area where CMS – Center for Medicare and Medicaid Services – is doing a lot. It begins sometimes with some simple things like just creating the right billing codes. Because if you have a building code for it, you often can’t bill for certain services and that has negative effects. So there’s a lot of work happening there.
CMS is sending out guidance. Look, we need to make sure that while we sort out the details of the science of long COVID, that while we sort out what can we can use to treat it, we’ve got to take care of people. And we’ve got to make sure that whatever they’re suffering from, that the health system takes care of it. And so that is a very important priority, not just of CMS or of mine, but of the president, who was basically tasked us to really make sure we’re on this.
So you’re going to see more guidance and more clarity from CMS to make sure that private insurances are doing this as well.
Imported from Revue
QUESTION [00:23:12]
Having been associated with seven presidents and all of these activities that has happened, that you’ve kept something of a diary, and perhaps that could be turned into a book? Well, if you did that, I want to tell you that would be a bestseller.
ANTHONY FAUCI, NIAID [00:23:34]
Well, Bill, you’re right. I think one of the ways I can hopefully inspire people to get into our fields, the one that you and I have pursued all our professional career, would be to tell the story. And you could tell a story a number of ways. One of the ways is a book. I haven’t made any arrangements to do that, but I certainly would seriously consider it.
ROBERT CALIFF, FDA [00:42:00]
As I was going through nomination this time, I can’t tell you the number of calls I got saying, ‘you got to do something about the food side of the FDA.’ There, it’s been under supported, under resourced, maybe the commissioners have all been medical people, so not so interested in that.
Then, of course, the day I was confirmed was the Abbott recall on infant formula. So we went right into crisis mode. And the changes that I wanted to make had to be put on hold, because it’s not a good time to change an organization when you’re dealing with a crisis like that.
But just yesterday, the Reagan Foundation put out its report on the evaluation of the food side of the FDA, and it’s a pretty clear set of things that we need to do there.
But that’s sort of dealing with the FDA. The thing that’s really exciting and I think critical to our future. It’s not just the medical use of food, given climate change, international strife, supply chain disruption, I don’t think most people realize the effect the Ukraine war has had on the global ability of people just to get food, much less many of the excipients that are part of our supply chains for the foods that we eat, including of a formula.
And so you look at the threat that’s there. If we don’t do something different in food, it’s going to be an even bigger problem coming up, just in terms of making sure people are fed.
JAY BUTLER, CDC [00:16:43]
So let’s start with some of the changes at the agency level. This is the org chart that I think many of you are familiar with, with the office of the director and the four communities of practice as well as the NIOSH group.
So starting with changes within the office of the director, Mr. Kevin Griffiths is now the permanent associate director for communications. Kevin comes to us with HHS experience as the assistant secretary for public affairs in HHS under the HHS Secretary Sylvia Burwell. So Kevin has experience going back to the 2009 flu pandemic, as well as some of the other infectious disease challenges that we had in about a decade ago.
Dr. Jim Pirkle, who we’ll be hearing from later, who you may know from his time, many years leading the the laboratory at the Center for Environmental Health, is now the permanent associate director for laboratory safety and science. And Laurie Ishak has taken on the role of acting associate director for policy and strategy.
Within the infectious disease centers, there’s also been a number of leadership changes. The community of practice lead for public health service and implementation, that’s Dr. Nate Smith, has left CDC. Nate, of course, is best known in his role in HIV prevention, particularly globally. Nate also has a very intense interest in not only the care of the physical health, but also spiritual health. And he has spent some time working, since leaving his role as deputy director in the global HIV program, where he finalized his work to get a doctorate in ministries and he is now associate pastor at an Episcopalian church in Atlanta and is focusing on physical as well as spiritual needs of people living with HIV.
Denise Cardo is now acting director for the Center of Global Health, as we continue to complete the search for a new director for global health, we’ll hear more from Denise later today. I think everyone’s aware that Denise’s day job has been director of the Division of Health Care Quality Promotion in the National Center for Emerging Infectious Diseases Emerging and Zoonotic Infectious Diseases.
Celeste Philip, who was my my counterpart as deputy director for non-infectious diseases, has now become the acting director for the Center for State, Tribal, Local and Territorial Support. Dr. Jose Montero, who was in that role, has moved over to the OD and is leading some of the health equity efforts as part of CDC “Moving Forward.”
Within the deputy director of public health and surveillance, Jen Layden, who’s joined us recently from the health department in Chicago, has become acting deputy director. And I’ll get to what Dan Jernigan is up to in just a minute. Also, Dr. Les Dauphin is now the permanent director for the Center for Surveillance Epidemiology and Laboratory Science, also known as CSELS.
Finally, Patrick Breysse has announced his retirement. I’ll have to miss his retirement party this afternoon for more important things. And that’s where Robin Ikeda, who is the acting– was the director– associate director for policy and strategy has gone and she’ll be the acting director for NCEH while that search occurs. So let’s go to the next slide.
Some of the changes in the office of the deputy director for infectious diseases. As Jim mentioned, we welcome Dr. Laura Hughes Baker as the federal official for the DDID board of scientific counselors, and she is stepping into the role of scientific advisor and has been a fabulous help to me over the past several months, as well as to Wendy Kuhnert, who’s with us here in the room, and has now– has been designated– accepted the position of the associated deputy director for infectious diseases. But is detailed the other roles which I’ll get to in just a minute. It’s hard to keep track without a program, folks.
So let’s move on to the National Center for Immunization and Respiratory Diseases. Very pleased to welcome Dr. Jose Romero to CDC as the permanent director of NCIRD. Most recently, Dr. Romero served as the Arkansas secretary of health, actually stepped into that role when Nate Smith left it to come to CDC, which is kind of interesting twice I’ve talked to the governor of Arkansas about stealing his staff.
Jose has also served as the chair of CDC’s Advisory Committee on Immunization Practices, and certainly got to know I was a very well during a lot of Saturday and Sunday meetings during the rollout of the COVID vaccines. And you’ll be hearing from Jose later in the meeting as well. I want to recognize and thank Sam Posner, who served as acting director while the search took place over a prolonged period of time. Other changes in NCIRD, Georgina Peacock, who I think has one of the greatest names in the world, has been named the permanent director of the Immunization Services Division.
And Dr. Barbara Mahon, that we’ve heard from, I think in some of our telephonic meetings previously, the COVID IM– incident manager, is serving as acting director of a newly proposed division: Coronavirus and other Respiratory Viral Diseases Division, which some of us like to shorten to CORVD.
So moving on now to NCEZID. I mentioned that that Dan Jernigan has taken on another role. As many of you know, Dr. Rima Khabbaz retired earlier this year. So really pleased that Dan was willing to step into the role as acting director.
This helps us after Chris Braden served in this role for more than six months, and did a fabulous job. He has moved on to a detail with the National Security Council helping to lead the domestic response to the Ebola Sudan outbreak in Uganda.
Wendy, that I mentioned earlier, Wendy Kuhnert, is now been detailed as acting deputy director of NCEZID. As I think many of you are aware of, our friend and colleague, Dr. Marty Cetron, retired this past summer. Lisa Rotz is serving as acting director of the Division of Global Migration and Quarantine while a search for that position goes on.
Another retirement, and again, let’s– if we can go stick with the slide that was up. There’s another retirement that occurred during the past couple of months was a twofer. That was sort of a double whammy. Dr. Inger Damon, who has been director of our Division of High Consequence Pathogens and Pathology, retired along with her husband, Dr. Greg Armstrong, who’s been director of the advanced molecular diagnostics group. So these are huge vacancies that we’re working to fill.
Dr. Jennifer McQuiston, who has served in for a number of months as the incident manager for the monkeypox response, has now stepped into the role of acting director of the Division of High Consequence Pathogens and Pathology. Mike Bell is serving as the acting Director of the Division of Health Care Quality Promotion, while Denise Cardo is acting director of the Center for Global Health.
Maybe, maybe an Emmy is appropriate with all this acting going on.
Mike Bell is actually– I mentioned Mike Bell– Peggy Honein, who I think we’ve heard from before in her role as incident manager of some of these responses or deputy incident manager is now been named as the permanent director of the Division of Preparedness in Emerging Infections in NCEZID to fill the void created by Dr. Henry Walke’s departure to become director for the Center for Preparedness and Response.
And we’ll be hearing later in the agenda from Duncan MacCannell, who is serving as acting director of the Office of Advanced Molecular Detection in the wake of Greg Armstrong’s retirement. Now, if we could go to the next slide.
So the Center for HIV, Viral Hepatitis, STD and TB Prevention, Dr. Jono Mermin is on detail as now the incident manager for the monkeypox response. Dr. Deron Burton has stepped in as acting director. While John, I was away and is doing a fabulous job, will be hearing from Deron later in the agenda.
Finally, Dr. Robyn Fanfair is serving as acting director of the Division of HIV Prevention, while Dr. Demetre Daskalakis is serving as the White House National Monkeypox Response Deputy Coordinator.
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DEBRA HOURY, CDC [00:42:34]
And so as part of CDC Moving Forward, we are prioritizing improving public health infrastructure for the long term. And I’m actually speaking to an all-hands right after this around public health infrastructure and how we’re going to start standing that up at CDC more.
But also, how do we have a strong and diverse public health workforce, modernizing public health data systems, and advancing global health security. So really, where we can have a lot of the cross-cutting functions.
We’ve really sought input from staff, partners, leaders. We’ve conducted approximately 120 interviews to identify ways to improve and institutionalize how we deploy our science.
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DEBRA HOURY, CDC [00:43:16]
We had ten strike teams that looked at structural changes, and they ranged from data, global health, lab preparedness and more. And this was established to inform the structural reorganization process. And then we’ve had 21 priority action teams that looked at sustainable solutions to drive results.
The strike teams have presented to the senior leaders and developed a memo. Those have been finalized. The priority action teams’ near final, but my understanding is they’re presenting, I believe, tomorrow, and then we will have their recommendations after that.
So we’re excited to share more information as it becomes available. The goal is to submit the reorganization package this month, and I’m aware we’re already a week into December, but that is the goal prior to the holidays.
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DEBRA HOURY, CDC [00:54:22]
And with the reorganization, we received external input from several different partner organizations and then each strike team was able to do it when they saw fit. A lot of it was on internal structure.
So for some of the priority action teams, that’s where there was more external input. That external input that was given. We do not want to create more bureaucracy or barriers or silos. The goal of this reorganization is to break those down more.
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JIM MACRAE, CDC [01:11:55]
So what you see on this slide is from the report itself, we worked to identify what were the first tier actions that we wanted to focus on. And what we have basically done is we’ve created 21, we call them priority action teams, to focus on these specific actions that were identified, to flesh this out and to begin to implement these recommendations and these actions to actually begin to change how the organization delivers its science and its products to the American people. You can go to the next slide.
So the second big area that came up quite a bit was the whole policy process within the agency. And what became very clear is that there needed to be a more standardized policy development process that included front end feedback from partners, included a feedback loop, but also focused on issues of implementation in terms of developing guidance that provided information to public health practitioners out in the world.
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JIM MACRAE, CDC [01:03:59]
There were a series of strike teams that were identified focusing in these core areas: public health data, global health, external affairs, lab science, safety and quality, public health readiness and response, communications policy science, public health infrastructure, and advancing equity. And these teams were organized to look at the structure to see how the organization could better support these core functional areas.
And these teams had been meeting for the last several months, presented their proposals to Dr. Walensky in late October or early November. She is making some final decisions about how the structure can be, as I said earlier, set up to better support these areas and make sure that there is nothing in the structure that could be limiting the impact of what CDC is doing in each of these different areas.
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JIM MACRAE, CDC [01:17:49]
So just to give you a status update. So as I mentioned, we have 21 priority action teams that are currently working on their projects. They actually have submitted their first drafts of their proposals. We have identified, as I mentioned before, in terms of some of our principles, people from across the organization to participate in these teams.
One of the things that we then required was that they conducted listening sessions with all of the staff to get input from across the organization. In addition, we asked each of them to have partnership conversations to get feedback from our key partners about what is it that they wanted to see so that it could be informed as we develop these recommendations.
So we are currently reviewing the initial proposals. We hope to have more of this solidified by the end of this month, and to begin further implementation by early January.
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JIM PIRKLE, CDC [00:12:58] [DDID 2]
When we look at a CDC role, we are regularly expected to have a diagnostic test ASAP so that one rises really high to us. So a lot of the things that I mentioned were to say, how can we have that test with high assurance it’s going to be a test, How can we be sure it’s high quality and it would be timely? Those are big challenges and so those are the big priorities there. But the other things you’re mentioning, certainly important.
We’ve got to think about integration. One thing I did not mention was interaction with federal partners, but we have a standing regular meeting with FDA, the head of their in vitro diagnostics. It’s just a standing meeting where we meet every 4 to 6 weeks and just talk over how can we work better together. And that’s been going on for a year and a half now. It’s just a standing meeting just to talk about that one thing.
Imported from Revue
MARY CHOI, CDC [00:14:42]
For Sudan virus, there is no FDA licensed therapeutic. There is an experimental two antibody cocktail that is available and has demonstrated efficacy in preventing mortality due to infection with Sudan virus, Ebola virus, and Bundibugyo virus in non-human primates.
The product, MBP134, has been used during the current Sudan virus outbreak under a compassionate use protocol. For Sudan virus, there is no FDA licensed vaccine. However, there are three candidate experimental vaccines that will undergo evaluation in Uganda.
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MARY CHOI, CDC [00:17:48]
In general, the risk of importation, whether it’s to the United States or to the U.K. or Europe, really has to do with what is the status of the outbreak in Uganda. And so, we– the last case that was reported, which was a couple of days ago, was a stillborn infant born to an Ebola survivor. Although unfortunate, it’s not unexpected. And so prior to that, the last case was in mid-November. And so we’ve had now a couple of weeks now where we haven’t had cases that have been reported, which I think is a good sign.
With regards to the risk of importation to neighboring countries, obviously that is always a risk. But again, if the situation is well controlled in Uganda, then that obviates some of that risk. And so I think that right now we’re in a current state of cautiously hopeful that that the outbreak activities have been successful. The pedal is still to the pedal per se. I mean, it’s not that there are no cases right now and people are starting to relax. There’s still a lot of activity being done in the field to identifying additional cases, to do active case finding, both in the community and in the hospital.
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MEREDITH MCMORROW, CDC [00:48:13]
We’re also seeing increased acute respiratory illness across emergency departments.
And you’ll note specifically that, while the trend in the under ones, which is commonly a large peak that we see with RSV increases, that in addition to that peak, we are also seeing some increased activity at or above the pre-pandemic levels in the 2 to 5 year old and the 5 to 10 year old age group– or 11 year old age group. And again, we’re starting to see declines.
The gray bar over the end dates does indicate a period of potential lags in reporting. So, hopefully starting to see a downward trend over the last couple of weeks. And we will hope that that trend continues moving forward.
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TIM UYEKI, CDC [01:04:44]
So for Influenza A viruses, we’re seeing about 80% Influenza A subtype H3N2 viruses, and then about 20% influenza A H1N1 pdm09 viruses. And we look at those two subtypes, the matches looks pretty good, at least antigenic. So we would expect clinical vaccine effectiveness to be quite good, but we won’t know that until sometime in the early part of next year, depending upon how these vaccine effectiveness studies enroll.
And influenza B viruses, although we see very little influenza B in the U.S. so far this year, there is some, but what we would typically see in influenza season is influenza B viruses tend to start increasing once influenza A viruses have peaked already. And then towards the end of the season is when we see a peak of influenza B viruses. So just because we haven’t seen a lot of influenza B so far, it may be coming, if this is a typical influenza season.
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MEREDITH MCMORROW, CDC [01:06:40]
We are seeing similar levels of hospitalization to prior seasons, just earlier than a typical season. So where we would normally have RSV peaking in January or February, we’re seeing that peak happening in November more recently. But to date, certainly in the older adult population, we don’t seem to be experiencing much higher hospitalization rates.
Again, it’s unclear if this is because of lack of testing, or because– but I suspect that we’re seeing just similar rates compared to prior seasons, because I do actually think there may be more of a testing availability. So I think in general, the data coming out on adults and older adults in particular seem to be relatively consistent and relatively reassuring.
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ALEX KALLEN, CDC [01:33:05]
First of all, the community transmission doesn’t include hospitalizations etc. and it’s much more closer– a lot closely aligns with what you see in the hospital with the community. So community goes up, hospital goes up.
So, you know, testing not being done aside, it is a fairly good metric in that regard.
What we really need is a metric that’s pan-respiratory virus, and there’s a lot of interesting work going on that at CDC to try and develop a pan-respiratory virus kind of metric that we could use. That’s not going to come anytime soon, I don’t think.
So for now, I think people– I know it’s uncomfortable for people and I know it cause a lot of anger and hostility, etc. but I think people do have to think about their setting, adapt, you know, what Dr. Rhee and Baker said and try and adapt the recommendations as best they can to their setting.
And I know there’s lots of disagreement about that, which I’m seeing in the Q&A.
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QUESTION [01:08:22]
I think one of the questions that clinicians are asking here today is the practicality of even prescribing or using CCP is seeming pretty hard, if you even wanted to. A couple of clinicians have written in that their local banks– blood banks aren’t actually taking these in anymore, donors, and without government funding, they’re really saying they really can’t. Are you aware or do you know of any efforts to try to make this more available out in the community settings? Sounds like maybe medical centers in large medical centers have their own– if they have their own donation facilities, may be able to do it, but otherwise, you may be out of luck.
CARLOS VILLA, FDA [01:09:03]
Thanks. And certainly I appreciate the question.
As I mentioned, there are hundreds of licensed and registered blood establishments in the United States, ranging from hospital based donor centers to large regional blood collectors. And each of them have taken different strategies towards qualification and collection of convalescent plasma. I’d encourage those who are interested in using the product to engage their blood suppliers, to discuss with them, and to speak to blood collection organizations, such as AABB, America’s Blood Centers, and their blood suppliers.
We do– we do receive feedback from those organizations, and we engage them to get an understanding of what’s happening and try and do what we can to to make sure that– to make sure that the hospitals and blood suppliers have all the available information, and that the blood collectors have all the available information to be able to initiate those collection programs if they feel that there’s a sufficient demand for it.
The final thought I would leave with respect to the availability of the product is that things change. We’ve seen that the– we’ve been paying attention to the collections. We saw that there were a large number of collections in the early pandemic, and then those dropped off recently. But we are paying attention, and I understand it’s not frequently collected now, and I recognize that those challenges that places have.
But by way of engaging your blood suppliers, we recognize it may change, and we try and stay on top of that.
Thank you for your request. BioNTech is continuously evaluating and preparing for the expansion of their authorizations. As soon as there are any updates, the companies will inform the public in the usual manner.
Alexander Siebert
The Red Cross is not experiencing a national blood shortage. We were able to overcome the blood crisis last February thanks to outpouring of support from donors. The Red Cross also do not have any data to show that a policy change would result in more blood donations. However, in general, if more individuals donated on a regular basis it would help eliminate seasonal shortages. Each year, an estimated 6.8 million people in the U.S. donate blood. While the demand for blood is constant, the number of donations can fluctuate based on a number of factors, which can sometimes lead to seasonal shortages. Only about 3 percent of the U.S. population donates.
ROCHELLE WALENSKY, CDC [12:18:13]
We, of course, look in real time as to how well we think the flu– the influenza match is to what’s circulating. And right now, the good news is that that looks like it is a very good match. We’ll have more definitive data later in the season, of course, in the spring as to how we did. But I also want to emphasize, even an imperfect matching season, we see 35% decreased rates of hospitalization even when we don’t have a good match, which really just emphasizes when we do have a good match, how much more effective it will be.
And of course, so much of what we can anticipate in the season ahead, we do know so far that we have seen an early season both for influenza as well as for RSV. We do know that if we do a lot of the work now, and people roll up their sleeves to get vaccinated, there is a lot that we can do to prevent severe disease. What we don’t know is what will happen in the weeks ahead.
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ROCHELLE WALENSKY, CDC [12:03:43]
CDC also continues to closely track COVID-19 activity. In the past week, we have started to see the unfortunate and expected rise of COVID-19 cases and hospitalizations nationally after the Thanksgiving holiday.
This rise in cases and hospitalizations is especially worrisome as we move into the winter months when more people are assembling indoors, with less ventilation, and as we approach the holiday season, where many are gathering with loved ones across multiple generations.
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ROCHELLE WALENSKY, CDC [12:04:13]
Additionally, RSV continues to remain high nationally, with variations in activity levels regionally.
We have seen signs that RSV may have peaked in some areas, like the south and southeast, and may be leveling off in the mid-Atlantic, New England, and Midwest.
And while this is encouraging, respiratory viruses continue to spread at high levels nationwide and even in areas where RSV may be decreasing, our hospital systems continue to be stretched with high numbers of patients with other respiratory illnesses.
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ROCHELLE WALENSKY, CDC [12:06:13]
Second, take your everyday prevention actions, such as covering your coughs and sneezes, staying away from people who are sick, and staying home if you yourself are sick, washing your hands and improving ventilation in your home and workplaces.
We also encourage you to wear a high quality well-fitting mass to prevent the spread of respiratory illnesses, most especially for those in the five percent of the population currently living in counties with high COVID-19 community levels.
CDC continues to recommend masking for anyone choosing to travel by plane, train, bus or other form of public transportation, or for anyone who may be immunocompromised or at increased risk of severe disease.
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ROCHELLE WALENSKY, CDC [12:12:16]
Maybe I will start and then pass it over to subject matter experts on my team and just say we have seen some outbreaks of streptococcal disease as well. And those tend to be more localized, but maybe defer to my team to see if they have anything more to add.
BARBARA MAHON, CDC [12:12:40]
We do have surveillance ongoing for invasive group A strep infections. These are the most severe infections that are found in the bloodstream or– not just in the throat.
And as far as I’m aware, we have not heard of any notable increase. But we can check on that and confirm that with you.
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QUESTION [12:22:29]
You mentioned earlier how, if you’re in a high community level, COVID 19 community level jurisdiction, you should consider masking. I’m wondering, is it time to revisit the community levels, which are focused on COVID? And to make it more holistically, to look at respiratory viruses overall? If you’re in a community without much COVID-19 in hospitals, but there’s a lot of RSV and flu, isn’t that reason to be wearing a mask?
ROCHELLE WALENSKY, CDC [12:22:58]
Yeah, I appreciate that question. It’s something that we are actively looking into at CDC.
In the meantime, what I do want to say is, we– one need not take– wait for CDC action in order to put a mask on. So we do know that five percent of the population is living in places with a high COVID-19 community level. We do encourage people to mask.
We know that 32% of jurisdictions are populations have to areas with medium COVID-19 community levels. And so we would encourage all of those safe preventive measures – hand-washing, staying home when you’re sick, masking, increased ventilation – during respiratory virus season, but especially in areas of high COVID-19 community levels.
And we are exactly looking into the question you asked.
The Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) provides advice to HHS on a range of policy issues related to blood and blood products, as well as tissues and organs. This committee has played, and will continue to play an active role, in deferral policies. At the spring ACBTSA meeting next year, the committee will likely vote on a recommendation, after reviewing the data from the Advance Study.
Since 1997, the National Blood Collection and Utilization Survey (NBCUS) provides data on blood collection and utilization in the United States. The NBCUS is performed every 2 years and the survey is used to develop reliable estimates of demand, as well as to inform future needs and actions. HHS is currently analyzing the 2021 survey results, but data from 2021 NBCUS suggest blood collection and transfusion in the United States has remained stable. The preliminary findings of this survey were presented at an AABB meeting in November 2022. We anticipate that blood collection will keep pace with blood utilization requirements.
The U.S. Food and Drug Administration (FDA) regulates the blood supply in the United States and enforces standards to ensure the safety of blood donations. Please contact FDA regarding their alternative deferral policy decision.
Additional Background:
A steady supply of blood and plasma is essential to the health of our nation. This is why HHS created the Giving = Living campaign because when you give others can live. The campaign encourages Americans to create new, regular donation habits and features personal stories that stress why donation is important. On the campaign website, you can find fact sheets and information about eligibility, answers to common questions, and an overview of the donation process. The website also directs users to a locator to help them find a donation center in their area.
Can FDA clarify what questions were tested in the ADVANCE study?
The ADVANCE study looked at similar risk factors that have been addressed by other countries as they moved to individual risk assessment approaches. In an effort to maintain neutrality, objectivity and impartiality throughout the study, the questions used as part of the study remained confidential. Further information will be available once FDA’s analysis of the study results are complete. Until then, FDA does not have any additional information to provide.
Will the HHS ACBTSA play any role in FDA’s draft guidance?
The U.S. Food and Drug Administration (FDA) regulates the blood supply in the United States and establishes and enforces standards to ensure the safety of blood donations. The FDA remains committed to gathering the scientific data related to alternative donor deferral policies that maintain a high level of blood safety. The FDA will determine next steps including when and how results of the study may be made public, and will consult the Advisory Committee on Blood and Tissue Safety and Availability as appropriate. We do anticipate issuing updated draft guidance in the coming months incorporating key learnings from the ADVANCE study, as well as taking into account international developments in donor deferral policies.
HEIDI MOLINE, CDC [00:32:19]
Many of the older children with RSV this year have co-infections, and some of those co-infections are with rhinoviruses and enteroviruses. And so it’s– there are multiple viruses circulating, and recognizing that we still have a lot to learn, but also that the season does seem to have a higher amount of older children affected by RSV as well than we would typically see.
QUESTION [00:32:46]
Thank you. Do we know why that is? Why we’re seeing older children?
HEIDI MOLINE, CDC [00:32:52]
Right. So I think part of it is because we did have kind of a wider season last season, so some children that may have been affected in a typical intense RSV season, were kind of spared last year. And so now we’re seeing a little bit of that now.
But also playing into this, the multiple viruses circulating. So many of the older children we’re seeing with RSV are presenting with more asthma-like symptoms. And those are often seen with rhinoviruses and enteroviruses, the co-infections that are happening alongside RSV in those older children.
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HEIDI MOLINE, CDC [00:34:55]
No, I agree. And I think the only thing I will add is that, particularly for young infants, this may be a time of year where we’re especially careful about the groups and gatherings that a brand new baby will be exposed to.
So if people are sick at a large gathering, to make sure that you are doing those preventative measures to protect the ones that are most at risk of RSV, which again, are those young infants, particularly those less than two months.
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HEIDI MOLINE, CDC [00:51:17]
You know, I think that’s a great question. And I work in our RSV surveillance. And so we’re often wondering, are we really seeing more or are we testing more? And I think it’s a little bit of both.
And so right now, we are doing– there is just broadly more testing for RSV than five years ago, not just in kids, but also in adults as well. And so the testing piece, whether you’re at an urgent care or you’re in the hospital, those have shifted a bit to where we are just having a – we’re more likely to be testing for RSV now than we were in the past. That being said, we are seeing more virus as well this year.
Imported from Revue
TOBY LOWE, FDA [00:07:28]
So as we’ve discussed here and in the guidance document, there is currently an EUA declaration in place under Section 564 of the FD&C Act, which declares that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection or diagnosis of monkeypox. We cannot anticipate when that declaration may be terminated.
It’s important to note that EUA declarations have historically been open for quite a while to ensure that public health needs are addressed, and this is seen with several previous public health emergency declarations, including Zika, Ebola, and obviously COVID-19, which has not been terminated to date.
And we at FDA are committed to help ensure that the public has access to appropriate testing options for monkeypox. And we will continue to review EUA requests as needed to address public health needs.
STEPHANE BANCEL, MODERNA [00:05:54]
As we’ve shown this summer, it took us 60 days from the FDA telling us with Peter Marks later at the VRBPAC on June 28, ‘I want BA.5,’ to get product in pharmacies.
So, I had a chance to meet with Peter in September, and he’s like, ‘I noticed you guys can do 60 days. And Pfizer too. So, I’d be happy for flu.’ Which will be interesting, in terms of competitive dynamics with the protein guys, which just technology cannot do that.
And I even think from a technology standpoint, we should be able to shrink that time even further. I think us going down to 30, 45 days, in a few years is not crazy. It will require work, but it is doable.
NAVIN KATYAL, PFIZER [00:21:04]
So as you noted, we have a contract with the U.S. for over 100 million doses and we expect to deliver all those doses, or the vast majority I should say, by the end of this year. So that’s the first piece.
And then I think in terms of impact to next year, early days, right? But we do expect that we’ll likely move into an environment in which we have a sort of a recommendation for a broad based vaccination campaign again in the fall. And the U.S. government has sort of signaled this numerous times in the past few months. And so that will sort of approximate the flu model is the expectation.
We also have seen, right, that COVID is evolving very, very rapidly. Even within the Omicron space, we’ve seen all these new mutations with escape potential. And so we’re expecting that there’s going to likely be another strain change that’s going to be needed. And so, even if you have significant amount of doses, there’s not going to be a scenario in which every dose needs to be sort of drawn down before we sort of have to shift into that new model.
And so we’re expecting that combination of the strain change and then sort of the flu type model, where we have a fall campaign, we’ll likely have, I think, a strong business.
Q [00:22:23]
So Navin, what you just said is very interesting. Governments are not forcing you guys to swap the old vaccine? So if I’m like a country in Europe, and I’m sitting on 50 million courses, and I’m not using them, am I not saying, ‘hey, give me the new one and I already paid for this?’
NAVIN KATYAL, PFIZER [00:22:37]
So every individual country is different, right? But in the U.S., for example, you know, we’re going to be– we’ll have satisfied our contract by the end of this year.
So in the U.S., we’re going to be moving into a commercial market, so that won’t be the case.
And then you just have to look at country by country. But I think, bottom line is we’re expecting right, that where we have contracts moving forward, we’re just going to shift into the new variant as they (inaudible).