1. Good day. The Advisory Committee on Immunization Practices, #ACIP, is meeting today to review and vote on whether to recommend Pfizer's #Covid vaccine for children 5-11 yo.
The meeting is starting. It's expected to wrap about 5 pm ET today.
I'll be live tweeting.
The meeting is starting. It's expected to wrap about 5 pm ET today.
I'll be live tweeting.
2. The meeting opens with remarks from @CDCDirector, who called today a momentous day.
She acknowledges #Covid's risk to children is lower than adults, but it is not nil. 745 children under 18 have died; 94 were in the 5-11 age group.
School & childhood has been vastly changed.
She acknowledges #Covid's risk to children is lower than adults, but it is not nil. 745 children under 18 have died; 94 were in the 5-11 age group.
School & childhood has been vastly changed.
3. @CDCDirector tells #ACIP that pediatric vaccination can help put kids' lives back on a normal track.
4. #ACIP member Kevin Ault, from the University of Kansas Medical Center, is not able to attend today's meeting. So there will be 14 voting members today.
5. If you want to listen to the #ACIP meeting, you can do so at this link: video.ibm.com/channel/VWBXKB…
Here's the agenda for today.
Here's the agenda for today.
6. Alejandra Gurtman, Pfizer's VP for vaccine development, is presenting data on the company's pediatric vaccine now.
This slide shows the basics of the trials Pfizer conducted to find the dose for children 5-11 yo & to test the safety efficacy of the vaccine.
This slide shows the basics of the trials Pfizer conducted to find the dose for children 5-11 yo & to test the safety efficacy of the vaccine.
7. So far the data Gurtman is presenting has been presented elsewhere — most recently, at last week's VRBPAC meeting.
8. Gurtman said @US_FDA asked Pfizer to break out data showing the vaccine's efficacy against Delta and non-Delta viruses. None Delta = blue. Delta = green.
9. #ACIP member Pablo Sanchez asked what should happen if a child turns 12 between dose 1 & dose 2; should they get the 5 to 11 dose or the 12 & up dose as their 2nd shot. Gurtman said in the study, they gave all kids 2 x 10 micrograms (ie 2 kids' doses) but deferred to ACIP.
10. Gurtman described the symptoms of 3 children in the trial who were vaccinated but developed #Covid anyway. They didn't experience fevers, she said, & most had only coughs & sore throats. Milder symptoms than the children in the placebo group that contracted Covid.
11. There is a lot of interest in what to do for children who turn 12 between dose 1 & dose 2. @US_FDA's Doran Fink says giving either a 2nd pediatric dose (ie 10 mcg) or an adult dose (30 mcg) would be OK, but he suggests #ACIP should probably make a recommendation.
12. The vote today is set for 4:15, but the meeting is already running ~20 minutes late.
13. The public comment period is now underway. First speaker pleaded with #ACIP to say children "may" be vaccinated, not "should" as a way of averting vaccine mandates for kids.
I am guessing "may" will not be the outcome today.
I am guessing "may" will not be the outcome today.
14. Listening to the pubic comment period, I'm struck by the fact that people don't understand the fundamentals about developing a new vaccine.
Rare side effects are rare. No clinical trial is ever going to be large enough to capture something that happens at a rate of 1 in 100K.
Rare side effects are rare. No clinical trial is ever going to be large enough to capture something that happens at a rate of 1 in 100K.
15. Public comment period is over. #ACIP is on a break till 1:17 pm ET.
16. #ACIP is hearing seroprevalence data in kids — ie what blood testing suggests is the rate of children who've already had #Covid. For kids 5-11 yo, it's estimated to be 38%.
17. It's important to note these data are generated from blood tests done on kids who presented for some kind of care. It's important to note those kids may not represent all children in the community.
18. Another important caveat: Evidence of prior Covid infection isn't proof of protection.
18. Most of the current presentation, from @CDCgov's Jefferson Jones, was presented last week at VRBPAC. Such as this slide Covid and flu in children 5-11 yo. #ACIP
19. For the year Oct. 3, 2020 to Oct. 2, 2021, #Covid19 caused 66 deaths in children aged 5-11, making it the 8th leading cause of death in that time. @CDCgov's Jones notes that if Covid mitigation measures had not been taken, the death toll would likely have been higher.
20. Observation from me: The data from Wuhan early in the pandemic really created some false ideas about Covid & kids. Kids there were on lockdown — of course Covid wasn't spreading among them in the way it would have if they'd been living prepandemic lives.
21. #ACIP member Kathy Poehling asks if there's been a decline in MIS-C rates among kids 12-17 since vaccination in that group has become more common. A CDC MIS-C expert says CDC doesn't yet have data showing that yet; there's a significant lag in MIS-C reporting.
22. Presentation now is about myocarditis. It contains updated information, says CDC's Matt Oster. #ACIP
23. Oster says @CDCgov has heard of 9 deaths that might have been vaccine-related myocarditis. After full evaluation, none appear to be vaccine linked.
24. Important to remember there are multiple causes of myocarditis. It's often caused by infections.
These classic causes of myocarditis seem to peak in boys around the age of 15. #ACIP
These classic causes of myocarditis seem to peak in boys around the age of 15. #ACIP
25. @CDCgov is working on assessing the long-term effects of vaccine-related myocarditis. Of ~250 patients they've followed up, about three-quarters report symptoms have alleviated by about 3 months.
#ACIP
#ACIP
26. And based on cardiac testing of kids with vaccine related myocarditis, the results are quite reassuring. #ACIP
27. @CDCgov's Oster was asked if there are data on the risk of vaccine related myocarditis in kids with congenital heart conditions.
He said they've seen no increased risk of myocarditis from vaccination, but that these kids are at increased risk of severe Covid if they catch it.
He said they've seen no increased risk of myocarditis from vaccination, but that these kids are at increased risk of severe Covid if they catch it.
28. @CDCgov's Oster was asked about the risk of myocarditis after Covid infection and what the rates of those are compared to vaccine related myocarditis.
"Getting Covid is much riskier to the heart," he said.
#ACIP
"Getting Covid is much riskier to the heart," he said.
#ACIP
29. #ACIP member Sarah Long is stressing how much milder vaccine linked myocarditis is compared to classical myocarditis or even myocarditis that followed MIS-C triggered by Covid infection. She makes this point a lot. Likens them to apples, oranges and avocados.
30. @CDCgov's Oster says he "believes" there will be a lower risk of myocarditis in the 5-11 age range, but it's an expectation & will require followup.
Says in his opinion, any risk of vaccine related myocarditis is lower than the risk of having Covid for kids 5-11. #ACIP
Says in his opinion, any risk of vaccine related myocarditis is lower than the risk of having Covid for kids 5-11. #ACIP
31.@CDCgov's Tom Shimabukuro is explaining the various tools CDC & FDA will use to surveil for adverse events after vaccination in kids 5- 11. I'm not going to be tweeting this.
32. #ACIP is hearing about how jurisdictions plan to vaccinate kids aged 5-11 yo.
Looks like multiple approaches will be used.
Looks like multiple approaches will be used.
33. There's been talk about whether kids who've had #Covid before need 2 doses of vaccine. Sounds like the operating approach will be give all kids in the 5-11 yo age group 2 doses.
34. So now @CDCgov's Sara Oliver — data explainer extraordinaire — is wrapping up the presentations. She'll go through risks and benefits and then this is going to go to a vote.
35. @CDCgov modeling suggests that vaccinating 5-11 yos will reduce transmission of Covid in this country by 8% between Nov and next March, Oliver said. It will help to mitigate the impact of a new variant, should one emerge, but would not block its spread. #ACIP
36. Oliver makes a really important point: Even with substantial evidence of infection-induced antibodies in the pediatric population, it wasn't enough to curb the big wave of hospitalizations in kids seen during the Delta wave. #ACIP
37. Oliver gives some estimates of the benefits of vaccinating 5 - 11 yos. For every 1 million children vaccinated, hundreds of hospitalizations will be averted. #ACIP
38. But Oliver noted that the estimates above are based on Delta-wave transmission rates and will be an over-estimate of benefit in a time of lower transmission. Looking at the pandemic more broadly, with various transmission rates, benefits are still there. #ACIP
40. Parents whose kids who don't get sick from #Covid don't have to take time off to look after kids who are sick with Covid, Oliver notes.
Just saying....
#ACIP
Just saying....
#ACIP
41. Several groups that send non-voting representatives to #ACIP are making statements in support of recommending use of the Pfizer vaccine in kids 5-11. "There is an urgency to act," says Patsy Stinchfield of NAPNAP. Covid is still sending kids to ICUs, she said. #ACIP
42. NAPNAP is my absolute favorite acronym ever.
(Short for: National Association of Pediatric Nurse Practitioners.)
(Short for: National Association of Pediatric Nurse Practitioners.)
43. Sarah Long has no questions. That's unusual.
She's strongly supportive of recommending this vaccine in children 5-11.
"We have one more vaccine that saves the lives of children. We should be confident to use it to the maximum," she said. #ACIP
She's strongly supportive of recommending this vaccine in children 5-11.
"We have one more vaccine that saves the lives of children. We should be confident to use it to the maximum," she said. #ACIP
44. #ACIP member Matt Daley says the decision to vaccinate kids 5-11 should be made based on the benefits & risks for them. But he's convinced the vaccine hurdles that bar.
Note from me: No one so far has expressed any reluctance to vote to recommend vaccinating kids 5-11.
Note from me: No one so far has expressed any reluctance to vote to recommend vaccinating kids 5-11.
45. Michael Hogue, the American Assn of Pharmacists' non-voting rep to #ACIP, warns that parents who want to vaccinate their kids at pharmacies should expect to have to make an appointment & to wait. Hogue said pharmacies, like other workplaces, are experiencing staff shortages.
46. There hasn't been a motion made yet, but it sounds like #ACIP is moving towards a vote soon.
None of the voting members or non-voting members have voiced anything remotely like a negative view. This meeting's discussion has a much different tenor than last week's VRBPAC.
None of the voting members or non-voting members have voiced anything remotely like a negative view. This meeting's discussion has a much different tenor than last week's VRBPAC.
47. Going to a vote now.
49. #ACIP votes to recommend the Pfizer vaccine for children 5 - 11 yo by a vote of 14 - 0.
50. The final tweet of this thread. Read my story on the #ACIP vote here. Thanks for spending the afternoon with me. statnews.com/2021/11/02/cdc…
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