Thread by @kavitapmd

Moderna initiating eua for under 6 will potentially be part of a larger eua app related to their under 18 cohort which has not yet had action (likely due to concerns about safety signals in 12-17) - so what does this mean potentially ?
/1

Means that moderna has more data than their interim analysis announced March 23 but still not sure if they have 2 month follow up on half the patients yet /2
investors.modernatx.com/news/news-deta…

So the initiation means that the process of submitting full data could take 1-2 weeks and then fda needs to read through hundreds if not thousands of pages to prepare its assessment for vrbpac /3

Then vrbpac is scheduled (seems to be in June which feels an eternity away) but then it’s not clear where the advisory cmte members land on this in light of 2 tensions /4

1. Sense that while immunogenicity targets met/ pre established clinical efficacy endpoints might be <50% and deemed not sufficient

2. Recent cdc data indicating 75% children have been infected

/5

Add to this growing sense that the “pandemic is over” and vaccine mfrs are working on next generation vaccines the worst outcome would be a very close vrbpac vote that sends a signal that under 5 is not needed to meet the eua threshold of “known benefits outweigh the risks” /6

Recall that eua threshold is benefits outweigh risks versus full approval which deems vaccine safe and effective /7

But what is difficult to convey is that the very same vaccines that breezed through vrbpac earlier would also likely not meet efficacy targets due to omicron yet we have now allowed for 12+ to get 1-2 boosters in light of waning efficacy yet under 5 have had nothing /8

So what does this mean? Key dates:
Tomorrow moderna initiates eua

Pfizer submits data and also initiates eua sometime in may

Ba2++ rise peaks and declines in parallel

Vrbpac meets and vote is close/agency has to decide

Acip quickly meets (this has to happen) /9

This continues to prolong what can only be described as systematic calculated torture for parents who at this point absolutely should be allowed to choose in consultation with their pediatrician whether to get vaccinated. /10

EUA benefit calculation must factor immunobridging data as well as some acknowledgment that clinical efficacy of <50% is STILL BETTER THAN ZERO. If advocates wonder where to target efforts it is this point they should drive home. /fin
#ImmunizeUnder5s @ImmunizeUnder5s