1. #ACIP, @CDCgov's vaccine advisory panel, meets today to study the data on Novavax's Covid vaccine and will vote on whether to recommend its use.
I'll be live tweeting the meeting.
If you want to watch the meeting yourself, it's viewable here: video.ibm.com/channel/VWBXKB…
2. Several members of #ACIP appear not to be attending today's meeting. Perhaps they'll join later but I think there are at least 4 of the 15 voting members not present.
3. Make that 3 missing members. I think.
#ACIP
4. This #ACIP meeting is about whether to recommend use of the Novavax vaccine in the US.
Matt Daley, chair of the ACIP Covid vaccine work group, notes that somewhere between 10.3M & 13.9M adults in the US haven't had a single dose of Covid vax.
5. @CDCgov's Katherine Fleming-Dutra is making a presentation to #ACIP on the epidemiology of the Covid pandemic in the US. Recently there's been a increase in hospitalizations and deaths, the latter predominantly in people 75 and older.
6. The pandemic is still taking a bigger toll on unvaccinated people than vaccinated people. In May, unvaccinated people were 3.5 times more likely to be hospitalized with Covid than vaccinated adults. #ACIP
7. And in May, unvaccinated adults were 9 times more likely to die from Covid than vaccinated adults. #ACIP
8. Slides are moving too fast for me to unpack these for you but there's interesting information here about who remains unvaccinated in the the US.
By age and ethnic group.... #ACIP
9. ... and by where people live.... #ACIP
10. ... and by socio-economic status. #ACIP
Clearly the point of displaying this information is to set the stage for discussion of how the Novavax vaccine might be used to make inroads in some of these under-vaccinated groups/areas.
11. @CDCgov's Tom Shimabukuro is presenting on myocarditis associated with Covid vaccines. He started by saying there's nothing new in his presentation; was presented to #VRBPAC recently. I'm not going to tweet this. #ACIP presentations are here: cdc.gov/vaccines/acip/…
12. Here's the sum up slide from Shimabukuro on myocarditis & Covid vaccines. #ACIP
13. Shimabukuro says @CDCgov will be doing enhanced surveillance for myocarditis after the rollout of the Novavax vaccine — if it is recommended.
#ACIP blew through a scheduled 20 minute break, so they're getting a 9 minute break now.
14. Novavax's Filip Dubovsky is presenting on the company's vaccine now. He's running through the studies done that were the basis of @US_FDA's decision to issue an EUA for the vaccine. So these data were also recently presented at #VRBPAC.
#ACIP
15. This slide could misleading as the Novavax study was done before the emergence of the Omicron variant, which has much greater escape capacity than previous variants. #ACIP
16. Interesting piece of information here. Though the Novavax vaccine has been authorized in many countries, there hasn't been a ton of use of the vaccine globally, likely because of how late it was so market. By the end of June, just over 1M doses have been used worldwide. #ACIP
17. Dubrovsky said Novavax hopes to have updated vaccine (including an Omicron strain) available in the 4th quarter of 2022, if the currently underway study shows it's effective. #ACIP
18. Someone asked if Novavax is seeking approval for single-dose vial format, because with a 10-dose vial at this time there's going to be a lot of wastage. Dubrovsky said the company is working on it, but it will require going back to @US_FDA. #ACIP
19. The public comment session is on now.
Fascinating to me that though commenters are drawn by lottery, it is often the case that most commenters on a given day are either anti-vax or pro-vax. Today is the former. #ACIP
20. @CDCgov's Evelyn Twentyman is presenting what is called the "evidence to recommendations" for the Novavax vaccine. This slide is busy, but contains a lot of data on who (by age group) has not received 1, 2, 3 or 4 doses of Covid vaccine. #ACIP
21. I don't know Twentyman, but she sounds like she's dealing with a respiratory infection herself.
22. A big argument in favor of the Novavax vaccine is that because it's like some licensed vaccines (ie isn't as novel as the mRNA vaccine), some people who won't take the mRNA vaccines will finally agree to be vaccinated.
Maybe.
#ACIP
23. A survey done by @CDCgov and the University of Iowa isn't exactly suggestive of a huge pool of people waiting to get this vaccine at this point.
(Caveat: This survey was small.)
#ACIP
24. Further to the issue of the 10-dose vials: vials have to be discarded six hours after first puncture if all vaccine hasn't been used.
Serious potential for a lot of wastage.
#ACIP
25. This seems like a potential irritant for people who administer vaccine. The expiration date of the Novavax vials isn't on the vial itself. People needing to check the expiration date will have to check on Novavax's website.
26. Evolving situations, evolving guidance: @CDCgov's guidance on co-administering the Novavax vaccine with other vaccines now includes guidance on whether you can give it at the same time as a #monkeypox vaccine.
27. For people who are immune competent, the Novavax vaccine can be given with a longer interval between doses — up to 8 weeks — rather than the standard 3. The extended interval should not be used in people who are immunocompromised.
#ACIP
28. Twentyman lays out what the situation — in terms of vaccine choices in the US — will be if Novavax is authorized for use.
She said the assumption is people who get the Novavax vaccine will need a booster down the road. #ACIP
29. This labeling issue — and its potential to create confusion and trigger errors — is a concern to some #ACIP members. Novavax's Dubrovsky says the company is working on this. I assume he means generating labels that actually have the expiration date printed on them.
31. I no longer am getting the #ACIP broadcast.
32. So the #ACIP meeting streaming has resumed. It's clear the discussion continued. So the members and the CDC staff clearly could hear each other. But people streaming the meeting lost a few minutes of it.
34. #ACIP member Sarah Long is not impressed by the fact that the expiration dates are not on the Novavax vials. She says it's unacceptable to ask providers to have to look online.
36. #ACIP votes 12 to 0 to recommend use of Novavax's Covid vaccine. It now goes to @CDCDirector who must sign off at this before the vaccine can begin to be used.
3 members missed this meeting: Beth Bell, Kevin Ault and Veronica McNally.
37. It's been a long time coming for Novavax, but its Covid vaccine has cleared the penultimate hurdle between its vaccine and the US market. Expect it to clear the final hurdle later today. statnews.com/2022/07/19/nov…
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