Thread by @SarahKarlin

#FDA's vaccine advisory committee about to discuss COVID-19 vax approvals and emergency use authorizations in children. Key thing will be whether they think EUAs are OK for younger children.

pink.pharmaintelligence.informa.com/PS144444/US-FD…

FDA's Dorian Fink emphasizes they are asking the committee to focus on safety for this panel (agency feels confident with their established efficacy process).

CDC now presenting some data on inital safety surveillance of use of $PFE vaccine in adolescents.

also on myocarditis and pericarditis w/ mrna vaccines.

some inital VSafe data in adolescents.

some preliminary myocarditis/pericarditis data from VAERS
(remember this does not mean causality has been attributed to vaccine or FDA/CDC even verified info yet)

Interesting question from NIH's Michael Kurilla (FDA advisory panel member) to FDA's Fink about use of immunobridging (not clinical efficacy data) for pediatric vaccines when vaccine is based on virla sequence dervied well over year and half ago and virus has changed.

FDA's Fink says right now they are at least comfortable with current vaccines against circulating strains.

(also a note- FDA already indicated they mostly want safety advice from this panel ---they seem more set on their efficacy apporach for pediatrics.)

another interesting immunobridging question from Dr. David Kim - FDA is suggesting used 18-25 year olds as comparison --- would we not use 12-17 year old data we have now for younger children?

FDA's Fink says have considered this but downside is 12-17 data was also immunobridged

.@Public_Citizen's Sid Wolfe, a frequent advisory panel public speaker is the first commenter today.

@Public_Citizen Peter Doshi - arguing against EUAs for kids but said expanded access could be one way to make product available early.

Done w/ open public hearing and into committee questions and then discussion. Eric Rubin asks for COVID case rate in children to be put in context of the many viral diseases we immunize children from. ...making point that we vaccinate children against diseases that are rare now.

CDC's Hannah Kirking said sort of hard to compare because have better idea of trajectory with these other infectious diseases. says good analogy but pokes a handful of holes as well...doesn't really give any data.

On to offical discussion questions now.

1st panelist to speak Cody Meissner seems pretty clear he doesn't want these vaccines cleared for kids on emergency use basis. wants at least 12-18 months maybe even more in follow up. I do not feel we can justify an EUA he says. Burden of disease is small & risks not clear.

Messiner: I think caution should rule the day here.

Also clarifies this is for all children under 18.

I believe during $PFE inital EUA he may have opposed the 16-17 EUA.

Ofer Levy - seems slightly less conservative on topic than Meissner.

emphasizes need for dose-ranging studies to find right dose for mRNA vaccines for children. wants FDA to work with companies to find "sweet spot" where beenfit and potenitally less adverse events.

Eric Rubin: I agree w/ all of Meissner’s suppositions & come to the opposite conclusion. Says we use a lot of vaccines for which there is very little disease for public health purposes.

Rubin: We are willing to make tradeoff from individual to public health benefit. We don’t know what will happen - that’s why we want in our arsenal in case we need to use it. notes fall and winter may be worse.

Amanda Cohen and Paul Offit bring up the issue is not about duration of follow up - the issue is size of study to pick our certain safety events.

this may throw interesting wrench into what FDA has been thinking abot re EUA vs BLA and centering that around months of follow up.

Archana Chatterjee also chiming in saying size of safety database likely needs to be largely.

aso wants concominant administration data with other vaccines.

FDA's Marion Gruber weighs in: difficult balance to strike - if wait too long, prolong studies or add more people may not have tools when we need them. also asking the committee to weigh in on how they view specific age ranges.

Lori Dodd a statistician weighs in pointing out some of the safety numbers committee is throwing out may reap much gains so need to think about what you want to gain and then figure out sample sizes.

Chair asks FDA - how important is it for us to weigh in on EUA versus BLA, really haven't talked much about that.

I'm not FDA -- but this is pretty key :)

Ok moving on to discussion question TWO!

so that was the fastest discussion I've ever seen. they are basically OKing FDA approach here as laid out in guidance and preview documents for meeting.

on to question THREE

range of answers here from greater look at myocarditis in older children before look at younger children, vaccine enhanced disease,

FDA's Peter Marks jumps on for the very end of meeting and is taking a moment to acknowledge and remember the deaths of children who died from COVID-19.