Thread by @HelenBranswell

1. #ACIP is meeting now to vote on a recommendation that some severely immunocompromised people be given a 3rd dose of mRNA vaccine in their primary series, because they do not get enough protection from 2 doses. FDA cleared the way for this LATE last night.
I will be tweeting.

2. Here's the story we published last night about this change to the EUAs for the Pfizer and Moderna vaccines. The 3rd dose should be given at least 28 days after the 2nd dose in the series.
No change was made to the 1 dose Johnson & Johnson vaccine.
statnews.com/2021/08/12/fda…

3. #ACIP has a new chair today. Grace Lee from Stanford takes over from José Romero, Arkansas' health secretary.
The committee is down 3 members today. The term of 3 previous members expired but 3 replacements haven't yet been "onboarded" -- which I think is a paperwork thing.

4. The #ACIP meeting is being broadcast live. These meetings are really interesting if you are interested in how decisions about vaccines are made.
Today's will be pretty short; expected to be over by 2:30 pm.
You can listen here: video.ibm.com/channel/VWBXKB…

5. @US_FDA's Peter Marks explained why FDA amended the Pfizer & Moderna EUA's to allow for a 3rd dose for severely immunocompromised individuals. He noted even a 3rd dose only offers moderate protection & these people need to be cautious & surround themselves with vaxed people.

5. @US_FDA move left immunocompromised people who got the J&J vaccine in a quandary. What are they to do? "CDC and FDA are actively engaged to ensure that immunocompromised recipients of Janssen COVID-19 vaccine have optimal vaccine protection" said CDC's Kathleen Dooley.

6. @CDCgov's Dooley said immunocompromised people should get a 3rd dose of the vaccine they originally got. If that vaccine isn't available, they can get the other mRNA vaccine.

6. Immunocompromised people are more likely to have severe #Covid, more likely to infect others, more likely to have prolonged infection, which raises the risk of mutation generation. Preventing Covid in this population is good for them & good for everyone. #ACIP

7. (repeating to fix thread) I'm not going to tweet details of the data on which the decision was made. The studies have been published; details are in the public domain.
Upshot: A 3rd dose helps some immunocompromised people & no serious side effects were seen in a small trial.

8. These are the questions #ACIP is being asked to explore today.

9. #ACIP member Kathy Poehling, a pediatrician, said it's important to let children 12-17 who have immunocompromising conditions be included in this 3rd dose policy. Only the Pfizer vaccine can be used in 12 to 17 year olds.

10. #ACIP member Wilbur Chen raised the $64M question: What about the immunocompromised people who got J&J vaccine? Shouldn't they be given additional doses?
@CDCgov's Amanda Cohn says there aren't data yet to answer the question about J&J — but the question is being worked on.

11. @CDCgov's Cohn said very few people who are immunocompromised likely got the J&J vaccine. They were near the front of the line for vaccine and the J&J vaccine wasn't being given in the earliest phase. It wasn't yet authorized.

12. @US_FDA's Marks said the FDA hopes to have a solution for the immunocompromised people who got the J&J vaccine soon.

13. #ACIP Camille Kotton, who runs a transplant clinic at Mass General, said she weekly sees patients in hospital who are immunocompromised & fully vaxed but are in hospital with severe Covid because 2 doses aren't enough. She supports allowing kids down to 12 to get a 3rd dose.

14: But #ACIP member Sarah Long, also a pediatrician, is worried about exposing 12-17 yos to a 3rd dose of mRNA vaccine because of rare side-effects seen in some young people, mainly males. Some develop mild myocarditis or periocarditis after getting mRNA vaccine.

15. #ACIP chair Lee wonders if the risk of myocarditis or periocarditis might be lower in teens who are immunocompromised.

16. #ACIP member Keipp Talbot says her concern about a 3rd dose for the immunocompromised is that it will make them safer, but not safe. They will still be at significant risk from #Covid & need to be counseled about their risks, she said.

17. Yvonne Maldonado, the #ACIP representative from the American Academy of Pediatrics, says the risk of myocarditis after mRNA vaccination is low, but the risk from Covid for this population is not.

18. Sean O'Leary, from the Pediatric Infectious Diseases Society, agrees, but says enhanced safety surveillance for adverse events in this population would make sense after a 3rd dose of mRNA vaccine. (12-17 yo immunocompromised children)

19. At this point, the #ACIP meeting is running about 1 hour late. These people take the decisions they make very seriously.

19. @CDCgov's Neela Goswami gives a rundown of the people whose immunocompromising illnesses would qualify them for a 3rd dose of mRNA vaccine as part of their primary series. #ACIP

20. In Goswami's presentation, she noted the Covid vaccine work group suggests that when possible, people who are going to get immunosuppressing therapies be given 3 doses of mRNA vaccine BEFORE therapy starts.
#ACIP member Sarah Long questions how well that would work.

21. @CDCgov's Dooling (I think I called her Dooley earlier; apologies) says that the group of people who are immunocompromised are incredibly varied and there may not be a 1-size-fits-all (my words, not hers) approach for the timing of delivering a 3rd dose. #acip

22. One of the #ACIP affiliates (non-voting members) asks a great question: If immunizers see immunocompromised patients for vaccination going forward, should they recommend they get an mRNA vaccine rather than the J&J? In her community, a lot of people are getting J&J.

23. Another #ACIP affiliate worries about how this will play out in the real world. He's getting asked by patients for letters saying they are immunocompromised, even though they aren't, because they want a 3rd dose. Will proof of immune status be required?

24. Molly Howell from the Association of Immunization Managers says that #ACIP & @CDCgov should be as clear as possible about who qualifies for a 3rd dose, because it's going to be up to individuals to self-identify & seek the 3rd dose.
(Me: this isn't going to be easy.)

25. @CDCgov's Dooling says it is not anticipated that doctors would have to give people notes to get a 3rd dose. The idea is that people who qualify can go to seek it.
(Me: Stampede ahead?)

26. There's a short break. I believe the public comment section will be next.
FYI: I can't listen to the meeting, live tweet AND monitor my feed for queries. So I won't be answering in real time.

27. Public comment period is over.
#ACIP is now going to discuss and then vote on this language about a 3rd dose for people who are severely immunocompromised.

28. #ACIP member Kotton is wondering about the nuts & bolts of how this change will be put in place, because she expects eligible people to be seeking 3rd shots this weekend. Honor code or screened?
@CDCgov's Cohn said it will be "a patient's attestation."

29. @CDCgov's Cohn acknowledges that the lack of advice right now is very challenging for immunocompromised people who got the J&J vaccine. But she said the hope is data will be available soon to advise these people.

30. One of the #ACIP affiliates noticed that the wording of the recommendation looks like a 3rd dose is being recommended for all immunocompromised people — thought the FDA EUA language states its for people who are moderately or severely immunocompromised.

31. Now going to the vote. #ACIP.

32. #ACIP votes 11-0 to approve a 3rd dose in the primary #Covid vaccination series for people who are moderately or severely immunocompromised & who got one of the mRNA vaccines.
This policy change applies to people 12 years & older who got either the Pfizer or Moderna vaccine.

33. The #ACIP meeting continues with discussions about variants (now) & the state of evidence related to the need for #Covid boosters for the general population. There will be no vote on general boosters today.

34. Sara Oliver, @CDCgov data presenter extraordinaire, is now presenting on what's known about whether people are going to need #Covid boosters. These would be additional shots at a later time, not a 3rd shot in the primary series, as it recommended for immunocompromised people.

35. Oliver says this is how @CDCgov is thinking through whether/when #Covid vaccine boosters for the general public are needed & whether they are of benefit & are safe.

36. To figure out whether Covid vaccine coverage is waning, it will be important to monitor these populations, who are among the first people vaccinated in the U.S., @CDCgov's Oliver said. #ACIP

37. The #Covid work group that advises #ACIP raises the issue of global equity (👏🏼). Getting more people vaccinated around the world will reduce the risk for all.

38. #ACIP is meeting again on Aug. 24 to future work on the evidence around #Covid boosters, @CDCgov's Oliver says. She closes by asking ACIP to give the work group advice on the questions in the screen shot.
And now there are technical problems.

39. Maldonado says people who were in the first clinical trials of #Covid vaccines a year could give answers about how well the vaccines work a year out. Stored blood samples can be studied to try to establish correlates of protection. Vax companies should do this work, she said.

40. "This concludes the meeting."
Next #ACIP meeting currently scheduled for Aug. 24.
End thread.