Thread by @HelenBranswell

1. #ACIP is meeting this afternoon to discuss the recently @US_FDA authorization of Covid boosters for youths aged 12 to 15. I'll be live tweeting. The agenda is here cdc.gov/vaccines/acip/… and the meeting can be monitored here: video.ibm.com/channel/VWBXKB…

2. Slide presentations for today's #ACIP meeting can be found here, though most of them aren't yet up: cdc.gov/vaccines/acip/…

3. At present there are 13 of the 15 #ACIP voting members in attendance. Chair Grace Lee says others may join later. This meeting was set up at short notice and members have had to scramble — as they have multiple times through the pandemic — to clear time for this meeting.

4. Peter Marks, director of @FDACBER, (and subject of a @statnews Q&A yesterday) is going to address #ACIP. statnews.com/2022/01/04/pet…

5. Before he does, Amanda Cohn, former secretary to #ACIP, is speaking. Gist: There are going to be fewer ACIP meetings going forward. So far in the pandemic, ACIP members have met a total of 24 days to address #Covid vaccine issues. (They typically meet between 9-12 days a yr)

6. Cohn said going forward, some of the changes to the vaccine authorizations and authorizations that @US_FDA pushes out will go directly to @CDCDirector for her approval (or not, but that's not super likely). Cohn didn't explain which types of decisions would skip #ACIP...

7. ... but 2 changes @US_FDA authorized this week (a change of the interval for the Pfizer booster to 5 months from 6 months & a 3rd dose for children 5-11 yo who are moderately to severely immunocompromised) may serve as an example. Walensky signed off without asking #ACIP.

8. @US_FDA doesn't consult its vaccine advisory panel, #VRBPAC, on everything. Perhaps this is moving #ACIP more towards that model.
The workload on this panel has been crushing over the past couple of years. All these people have jobs where they're needed.

9. So now there are 14 of 15 #ACIP members present.
And Peter Marks is up now. Saying it makes sense to boost sooner in the face of Omicron, which has some capacity to evade immunity and requires higher antibody titers to fend off.

10. Sharon Alroy-Preis, from Israel's health ministry, is now presenting data on Israel, which is ahead of the US on administering boosters.

11. There seem to be technical problems. The sound has been cutting in and out. #ACIP

12. Alroy-Preis said the data from Israel on myocarditis after Pfizer vaccine is really reassuring for booster shots in young teens. They've given +41,000 doses and have recorded only 2 cases of myocarditis.
attn: @matthewherper

13. @CDCgov's John Su is presenting data on adverse events reported to VAERS after vaccination in kids 5-11 yo.

14. Su says of 18.7M doses of Pfizer vaccine given to kids 12-15 yo, there were 265 cases of myocarditis.

15. Data moving quickly. Bit hard to keep up.
In children aged 5-11 yo, there have been 12 cases of myocarditis out of 8M doses administered.
But it's early days still in vaccination of this age group, Su says.

16. Here are the reporting rates for myocarditis among children and teens.

17. @CDCgov's John Su says most of the cases of myocarditis seen in after vaccination are mild. But he acknowledged that one patient died. In this case the myocarditis was only diagnosed after death & it's not yet clear what caused the death & how/if myocarditis contributed.

18. #ACIP member Sarah Long cautioned against drawing too many conclusion about the rate of myocarditis after boosters (ie that there are few) in children 12 to 15 yo because it's still very early.

19. @CDCgov's Anne Hause is presenting data from CDC's Vsafe program now. Seems like side effects are pretty mild in younger children.

20. Ironically, I just got a text from Vsafe asking me to do a weekly check in on how I feel after my booster shot.
I can't do it because the links Vsafe has sent me for the past 3 weeks don't work.

21. Nicola Klein of Kaiser Permanente Northern California is now presenting on myocarditis or pericarditis seen in the KPNC system in children aged 12-17 after Pfizer vaccination (doses 1 and 2).

22. Klein says most of the cases were admitted to hospital; all were later discharged. Most were released in 1-3 days.

23. Klein says so far there are no safety signals that have come to light for children 5-11 yo. For teens aged 12-17, the myocarditis risk is almost exclusively after dose 2, when it appeared at a rate of about 70 cases per 1M doses administered.

24. Klein said there were no deaths recorded among the children in the KPNC system who developed myocarditis following Covid vaccination.
#ACIP is now on a 10-minute break. Reconvening at 2:50 for the public comment session. The meeting is running a little late.

25. I took down a previous post in this thread. I had tweeted that I could not report to Vsafe — the links haven't worked for me recently. It turns out it's because I am out of the US at present. So, my bad, not Vsafe's. Apologies.

26. Getting rid of my earlier tweet required me to zap several and repost them so as not to break the thread. Sorry for the confusion this may cause.

27. #ACIP is back. @CDCgov's Evelyn Twentyman is now presenting on the interim clinical consideration for use of #Covid19 vaccines.
The move to a 5 month interval for the Pfizer booster was motivated by the threat of Omicron, she said.

28. Wow. This must be making things complicated at sites where booster shots are being administered.
3 vaccines, 3 different booster intervals.
To say nothing of the fact that J&J recipients are so far only eligible for a 2nd booster, not a third.

29. #ACIP member Kathy Poehling asks if kids 5-11 who are immunocompromised (& now eligible for a 3rd dose in their primary series) will be eligible for a 4th shot 5 months later, ie a booster.
CDC's Twentyman notes that kids aged 5-11 aren't currently eligible for boosters.

30. #ACIP member Camille Kotton notes that while the discussion has been about myocarditis after vaccination, there should be consideration of the risk of myocarditis after #Covid infection. Kotton runs a clinic for transplant patients a& immunocompromised people at Mass General.

31. Kotton said that while everyone is talking about how mild #Omicron infection is relative to earlier variants, she's seeing lots of life-threatening infections in immunocompromised patients, for whom Omicron is a nightmare.

32. @CDCgov's Sara Oliver is now presenting. This it the presentation that will lead to the vote on whether to recommend boosters for children 12-15 yo.

33. Oliver's presentation includes this slide, which shows that as with older groups, vaccine efficacy in 12-15 yos (red line) declines over time.

34. Here's data on myocarditis after Pfizer vaccination from Israel, broken down by age group and by dose. The rates are highest (so far) among dose 2 recipients.

35. Oliver said a study that will be published later this week in @CDCgov's MMWR suggests that vaccination is protective against MIS-C — a multi-system inflammatory condition in kids.

36. Interesting (to me, anyway) to see the reasons parents give when asked to explain their concerns about getting their teens vaccinated against Covid. It's much more vague — too new, I don't know... — than about specific risks.

37. #ACIP's discussion on whether to recommend that 12-15 yos be offered boosters, and whether the recommendation should be a permissive one (they *may* get one if they want) or a stronger one (they *should*) is coming up soon.

38. #ACIP member Kathy Poehling says her hospital is currently full, with sick kids waiting in the Emergency Dept for up to 18 hours before they can admitted because of the crush of cases. "I'm leaning towards should." Lynn Bahta said she too is leaning towards should.

39. Pablo Sanchez points out that the recommendation for 16 & 17 yos is a *may*, not *should.* @CDCgov's Oliver says if #ACIP wants to vote *should* for 12-15 yos, then it would have to be for 12-17 yos, to harmonize the recommendations.

40. #ACIP member Sarah Long says given the rising rates of infections among children in the #Omicron wave, she favors a *should* recommendation for boosters for kids 12-15 yo.
But Keipp Talbot says the stress needs to be on getting more unvaxed kids dose 1 & 2.