1. Good day. #ACIP is meeting today to vote on recommendations about who should receive a booster shot of the Pfizer #Covid vaccine. The meeting starts at noon ET. I will be live tweeting.
@US_FDA's EUA for the Pfizer booster is veeeeeery broad. statnews.com/2021/09/22/fda…
@US_FDA's EUA for the Pfizer booster is veeeeeery broad. statnews.com/2021/09/22/fda…
2. The meeting is underway. Doran Fink of @US_FDA is now explaining FDA's EUA for the Pfizer booster, which was issued last night.
My observation: The group of people eligible for a booster under this EAU is very broad. 16-17 yos are excluded but many over 18 will be eligible.
My observation: The group of people eligible for a booster under this EAU is very broad. 16-17 yos are excluded but many over 18 will be eligible.
3. @CDCDirector is addressing #ACIP. She acknowledges that the committee has to make decisions, sometimes with a huge amount of data, sometimes with "a paucity."
She mentions pregnant people.
My observation: Oddly, there was no mention of them in the FDA EUA.
She mentions pregnant people.
My observation: Oddly, there was no mention of them in the FDA EUA.
5. Today's meeting is going to start with the public comment period, which will be 35 minutes long. Then the various presentations will begin and the debate/vote will take place. Meeting is to conclude around 3 pm. Maybe later.
6. People who get to speak during #ACIP's public comment period are drawn by lottery. During many ACIP meetings, the comment period is packed with anti-vax speakers.
Today's draw is substantially different. Lot of support for Covid vaccines & evidence-based decision making.
Today's draw is substantially different. Lot of support for Covid vaccines & evidence-based decision making.
7. @CDCgov is running through modeled benefit/risk analyses of a 3rd dose of the Pfizer vaccine.
Lots of data flying by here, broken down by age and gender.
Lots of data flying by here, broken down by age and gender.
8. having trouble keeping up here, but it's clear that the benefits outweigh risks, but the benefits accrue to a far greater degree to people 65 and older. #ACIP
10. Vaccine efficacy appears to be waning over the past couple of months, though this includes all infections. #ACIP
11. But the declines in vaccine efficacy are smaller when the yardstick is protection against infection requiring hospitalization. #ACIP
12. On the issue of waning, it seems that not all vaccines are created equal. Check the difference between Pfizer and Moderna. #ACIP
13. @CDCgov's Sara Oliver just noted that if the amount of transmission of Covid drops in the US, there's less clarity about the benefit vs risk for younger adults. Especially younger males, I think, who have a higher risk of myocarditis after mRNA vaccination.
15. But among unvaccinated people, the need for a booster could further erode willingness to get vaccinated. #ACIP
16. This I do not understand. If we need a booster at 6 months, how is this NOT a 3-dose vaccine? Why does receipt of 2 doses still qualify as fully vaccinated? #ACIP
17. This is what the #ACIP Covid vaccine work group thinks. The WG typically tells the wider panel: Here's what we think you should do.
18. @CDCgov's Kathleen Dooling is running through various populations potentially eligible for a booster. She started with people 65 and older and then people living in long-term care. No accident she started there. #ACIP
20. Question 2 relates to whether people 18 to 64 with risks from exposure or medical conditions should be boosted.
22. #ACIP member Keipp Talbot says boosters aren't going to wind down the pandemic. Hospitals are full of people with #Covid who aren't vaccinated, she said. "I feel like we're putting lipstick on hogs. This is not going to solve the pandemic."
23. Sounding like #ACIP is likely to vote Yes to Q1.
More questions about Q2. It may be broken up, I would think. Or maybe ACIP's support for it will take a different form than Q1.
More questions about Q2. It may be broken up, I would think. Or maybe ACIP's support for it will take a different form than Q1.
24. I was prescient! Two questions have become 3!
25. Not clear to me where votes for Q2 & Q3 are going to land. Not tons of enthusiasm for them based on the data. Sounds like some of the #ACIP members think Q1 could be approved, & they could just let doctors vaccinate other people who want a booster off label. #ACIP
26. But CDC's Amanda Cohn warned that because the vaccine is owned by the gov't, that isn't really possible.
Gotta confess I'm a bit unclear on what Cohn was saying. #ACIP
Gotta confess I'm a bit unclear on what Cohn was saying. #ACIP
27. #ACIP members HATE that this is only about the Pfizer vaccine. "We just cannot continue to ignore the Janssen (ie J&J) product," said Pablo Sanchez. "I just don't think we can continue to ignore that population."
People who got the J&J vaccine got only 1 dose.
People who got the J&J vaccine got only 1 dose.
28. #ACIP member Sarah Long: I just don't understand how we can tell people 65 & older 'You're at risk but only half of you can do anything about it right now.'
Long says she may vote against Q1 just because it's only for people who got the Pfizer vaccine for doses 1 & 2.
Long says she may vote against Q1 just because it's only for people who got the Pfizer vaccine for doses 1 & 2.
29. Long also questioned whether pregnant people need to be boosted right now. She doesn't believe they do. #ACIP
30. So #ACIP chair Grace Lee just said there's a break coming up during which the language of the voting questions will be adjusted.
When ACIP debate makes clear something might not pass, but amending it might get it through, they do alter the language before calling a vote.
When ACIP debate makes clear something might not pass, but amending it might get it through, they do alter the language before calling a vote.
31. Number of speakers are pointing out how difficult implementing the booster campaign is going to be, especially with only 1 of the 3 vaccines available to boost with.
32. Serious question: Why is @US_FDA pressing hard for giving boosters to a huge number of people despite the fact there's little or no data that currently supports the need but they are dead set against recommending mix-&-match use of the vaccines? ie Pfizer boost after Moderna?
33. @US_FDA won't sign off on mix & match use of the vaccines because of the lack of US generated data on efficacy. Why does the lack of data impede this but not impede boosting broadly? #ACIP
34. #ACIP breaks until 3:45. 13 minute break.
39. "We are not voting on mix and match today," #ACIP executive secretary Amanda Cohn tells the committee. Sounds like Sarah Long may vote against all these votes because these only allow getting a Pfizer booster after getting 2 doses of the Pfizer vaccine.
40. Vote for Q1 is going to happen now.
41. Question 1 passed 15 to zero.
43. Question 3:
This one is a bit different. "Individual benefit & risk" means not everyone may choose to get it but they can. Sometimes described as "shared decision making between doctors & patients" or a "permissive" recommendation. #ACIP
This one is a bit different. "Individual benefit & risk" means not everyone may choose to get it but they can. Sometimes described as "shared decision making between doctors & patients" or a "permissive" recommendation. #ACIP
44. #ACIP ex secretary Cohn explains that under the PREP Act, because this is vaccine purchased by the US govt, the vaccine cannot be used in any way other than as laid out in FDA EUAs and ACIP's recommendations. I think she's saying these vaccines cannot be used off-label.
48. An observation: There was zero discussion today about the global vaccine supply situation or how use of boosters in the United States might affect getting first doses to billions around the world.
Not. One. Word.
#ACIP
Not. One. Word.
#ACIP
49. Because of the way the votes were structured today, #ACIP has voted not to recommend boosters for health care workers at this point.
I'm not sure if HCWs had been in a different group or grouped by themselves that this would have been the outcome of the vote.
I'm not sure if HCWs had been in a different group or grouped by themselves that this would have been the outcome of the vote.
50. #ACIP member Keipp Talbot wanted to propose a 5th vote, I suspect to address health care workers. But the people leading the meeting decided not to hold another vote today. There are multiple meetings in these folks near future.
Meeting adjourned.
Meeting adjourned.
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