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Notes for 08/24/2022

From Alexander Tin (@alexander_tin)
From Alexander Tin (@alexander_tin)
Notes for 08/24/2022 from a podcast interview, from a CDC lab advisory, from a Florida health department spokesperson, from Bavarian Nordic, from an FDA town hall, from an NFID webinar, from a NACCHO webinar

From a podcast interview
[6;20] ANTHONY FAUCI, NIH: Well, it’s remarkable transmissibility, Andy, because I have been compulsively careful about wearing masks and not, you know, being exposed in congregate settings. And I know exactly when I got infected. 
I had to go up to my 60th college reunion where they were honoring me by naming a building the Anthony Fauci Science Center, which was such a wonderful honor. And I went into the reception, and all of my classmates from the Class of 1962 were unmasked. They saw me, they got very enthusiastic, they came to give hugs. 
So I looked– I felt I looked so out of place with a mask on. I literally took my mask off for about 45 minutes, mingling with them and their family. Went back, put my mask on. 
Five days later, bingo, I was infected. 
(That’s all it took?)
Yeah, it’s all it took. So that’s the first thing I learned. 
The second thing was the remarkable diminution of symptoms within 12 to 18 hours after I took my Paxlovid. It really made a difference. I mean, I was sniffling and a headache and – and a little bit aches, I took Paxlovid. 
In the first doses were the afternoon dose. By the following morning, I was completely asymptomatic, which tells me that it really does work as an antiviral. 
[11;14] ANTHONY FAUCI, NIH: A, it’s going to be available the first or second week in September, from Pfizer, and probably the end of September, beginning of October, for Moderna. 
Number two, if you are an elderly person with an underlying condition, and you have not been vaccinated in calendar year– boosted in calendar year 2022, you shouldn’t wait. Because given the degree of viral dynamics with BA.5 right now, as you and I are speaking, you’re in danger. So I wouldn’t wait. 
If you’re an otherwise healthy person, a young person, or even someone who’s a little bit older, but still very few if any underlying conditions, I would wait, because the chances if you’re vaccinated, but unboosted, of getting a severe illness is low. If you really want to get the updated booster of a BA.5, I would wait. 
And the third part of your question is, when it does become available, should you get it right away? Or should you wait? 
You know, one of the dangers, Andy, in waiting for an outbreak to occur, is that by the time you know it’s occurred, you may be one of the vulnerable people that got infected. So if I had not been boosted, in, let’s say the last six months or so, and it came out in the middle of September, I would probably get it right away, or try and coincide it with the influenza vaccine, try to get them both at the same time.
From a CDC lab advisory
Audience: Clinical Laboratory Professionals
Level: Laboratory Advisory
To prevent false positive test results, CDC recommends that laboratory professionals perform repeat testing to verify positive diagnostic results for Orthopoxvirus or Monkeypox virus DNA in specimens with high Cycle Threshold (Ct) values from persons who do not meet identified epidemiologic risk criteria for monkeypox.
Review laboratory test results (including raw data, PCR curves, etc.) carefully before you report results. Because molecular tests (e.g., real-time PCR tests) are very sensitive, cross-contamination is possible. If you obtain a high Ct value (generally ~34 or higher), CDC recommends to immediately re-extract and re-test to ensure there was no cross-contamination. CDC suggests this approach based on high Ct value alone, even in the absence of epidemiologic information. When possible, re-extract and re-test before you report results.
From a Florida health department spokesperson
The Florida Department of Health is no longer the middleman for federal vaccine distribution. Local providers order through Florida SHOTS, as they do with most immunizations. This ensures demand meets supply and avoids unnecessary excess. Providers have until Thursday, August 25, 2022, to pre-order. These doses will be delivered directly to providers who order.
From Bavarian Nordic
[39;04] PAUL CHAPLIN, BAVARIAN NORDIC: Yeah, so the dose sparing intradermal approach is a temporary approach. So in Europe, it’s actually written as a temporary measure while vaccine doses are low.
And in the U.S., it’s governed by the EUA, which is only in place once this is– while there is a declared emergency.
So, if and when the emergency is over, this is only a temporary measure, and it will revert back to how the vaccine is recommended on the label.
[40;58] PAUL CHAPLIN, BAVARIAN NORDIC: So just so that we’re all on the same page. There– there is a substantial amount of bulk inventory that the U.S. has purchased over the last few years. That equates to approximately 15 million liquid doses, or around about 13 million freeze-dried doses.
We’re already eating into that inventory with the five and a half million liquid doses that has already been placed. So that bulk would need to be replaced to fulfill the options that already began to be awarded earlier this year, which is– which is to create a stockpile of 13 million freeze-dried.
So yeah, it will impact the timing maybe of the freeze dried, depending on what additional orders we get– we receive from the U.S.
But as I said, the option to start manufacturing freeze-dried was $119 million. That was awarded, if I remember rightly, in early June. That has not been touched and it is still sitting there. And that is part of the larger option $299 million.
But the exact timing (inaudible) now is a little unsure, because of course, we’ve also pushed out the tech transfer to (inaudible) as we’re manufacturing Jynneos liquid.
But we do anticipate that any bulk that is utilized in the current manufacturing of liquid will be replaced. And that we will, at some point, revert to the manufacturing of freeze-dried.
From an FDA town hall
[4;09] KRISTIAN ROTH, FDA: In the coming weeks, we will reach out to all antigen test manufacturers with additional information on this approach. We believe that it is critical for public health that these tests remain on market.
We’ll work with manufacturers to ensure that tests remain available and any changes which are needed to the labeling are rolled out in a predictable and transparent manner.
More information will be available soon. And we will provide updates on this call throughout this transition period.
[25;17] KRISTIAN ROTH, FDA: Thanks for that. And sorry about the confusion. However, we haven’t kind of officially released our plan yet.
Once we do, we plan to communicate with all antigen test developers at the same time to make sure that everyone who potentially could be impacted kind of knows what the strategy is, kind of, like I said, at the same time.
So that, that as part of the communication plan. We’re still discussing what the path forward is for everybody. And once we have that finalized, everyone should know.
From an NFID webinar
[16;54] AGAM RAO, CDC: And just an important point that I want to make here is that, if lesions from a person without epidemiologic criteria are tested, or also just a risk group that is not not really at risk too much as part of this outbreak, almost– I mean, more than 98% of cases or so are happening among men who have– and among those for whom we have information about gender identity, they are men who have sex with men.
So I guess we would just say that ensure that the OPX positive test results are repeated and confirmed before taking action. We have heard of a good number of false positives that have occurred. And– and so it’s really important to ensure that that positive is truly a positive in an individual for whom there would otherwise be low suspicion.
At this time, there have been very few cases in children and women. And there’s been no sustained transmission reported within those groups at this time.
[20;10] AGAM RAO, CDC: And tecovirimat is firstline and cidofovir and brincidofovir just because of the adverse events that are associated with them would make them less advantageous and in most cases– most cases. 
Brincidofovir is not currently stockpiled at this time, although there is a plan to do so. Really the the indication for brincidofovir, once it becomes available, because it has so many serious adverse events or concerning adverse events associated with it, will perhaps be if a patient were truly not improving, had life threatening illness, and evidence of resistance to tecovirimat. Those are those are things that would have to be determined on a case by case basis. 
[29;24] AGAM RAO, CDC: My understanding is that health departments are, to the best of their ability, attempting to notify individuals when they are informed by a patient of places where that they might have visited where they might have been infectious. So workplaces, daycares, that sort of thing.
We have not seen– we’ve actually had a number of people who have worked while they were ill, accidentally, not realizing they had monkeypox, and there has not been secondary cases associated with those activities.
So the spread has been from predominantly to people who– with whom they’ve had close skin to skin contact, or household members occasionally. But in workplaces and all, we haven’t seen– we haven’t seen much of that.
[36;04] AGAM RAO, CDC: I think first, I want to just point out the numbers that are being reported out about children– we are actively working to understand the true number, because some of– some of the cases that have been reported to us turned out to be false positives, and then were removed from certain case counts and not from others.
And so we’re trying to– we’re trying to hone down on what the true full number is now. And there is a team working on this. So I guess, just to caution you on the numbers we are here– I mean– I think because health departments have– and we’ve not been saying differently until very, very recently, once you get positive OPX to a case, they’ve called that monkeypox until proven otherwise. And it’s been recorded on on health department websites.
But I believe just yesterday, we sent an email out about the fact that we are seeing these false positives happen increasingly, not just among children, but also in women and just people that don’t have any kind of epi risk factors.
[52;49] AGAM RAO, CDC: And so we’re we’re working on developing guidance for individuals who might have been vaccinated, for example, within the last 20 years. Perhaps they only need a booster dose, because their immune system would be boosted by that by that dose. Versus people who were vaccinated, you know, as children, in which case, we don’t know how much protection, if any, and we would recommend just get the two dose series if you are someone who’s going to need vaccination.
From a NACCHO webinar
[48;21] ATHALIA CHRISTIE, CDC: Initially labs sent any specimen that tested positive for orthopoxvirus to CDC for characterization, but now labs are guided to send in about 10% of positive samples to CDC for genomic sequencing. This takes the burden off of labs, while still enabling CDC to monitor virus samples and their genomes for mutations that could affect spread or symptoms.
[53;45] ATHALIA CHRISTIE, CDC: So we have not had very many pediatric cases, and each one is resulting in a pretty extensive investigation.
But I just want to stress that, if any of you have children, parents spend quite a lot of time diapering, bathing, and holding up their children. So it’s not at all surprising to have a pediatric infection.
Some children may be infected by a parent or caregiver, or possibly other family members.
[56;29] ATHALIA CHRISTIE, CDC: I think we all know that, that surveillance is difficult. So there is definitely testing is being tracked. Vaccination is being tracked by local states and jurisdictions. We are only just beginning to put some of this information on the CDC website, because, I think hopefully, people are pretty familiar from COVID, it can take quite a lot of effort, and some time, for the data to make its way from the state and local jurisdictions to CDC.
There’s been a process to clean the data and to ensure its accuracy, in discussions back and forth with our state partners. So we have a lot more data up on our web this week than we did last week. But I do want to say that it’s not that the state and locals aren’t tracking, it’s just that the data pipeline to CDC has some hurdles.
[01;00;07] ATHALIE CHRISTIE, CDC: Well, having a long career in outbreaks, I have learned not to get too excited by the initial data. So I can’t say anything more than cautious optimism. I certainly hope that what– whoever the individual is who asked the question, what they’ve seen bears out to be true. But we all know that there’s lags in reporting, and– and that we may see additional waves and various outbreaks. So I will wait a few more weeks before saying anything about whether we’re bending the curve.
(As a fellow infectious disease person, I feel like cautious optimism is a great phrase for us to use in this field.)
I think when I worked in Liberia during the West Africa outbreak, we saw the last case about four times so stopped– stopped making any assumptions.
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From Alexander Tin (@alexander_tin)
From Alexander Tin (@alexander_tin)

Reporting on COVID-19 and some other public health topics for @CBSNews in DC. Email, call 202-381-7107, or DM for @signalapp number! He/him.

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