Wow. FDA is keeping its cards close to its chest...Just saw the...

Wow. FDA is keeping its cards close to its chest...

Just saw the question set by FDA for the Vaccines and Related Biologics adcom members to vote on today (their time) i.e.

" Do the safety AND effectiveness data from clinical trial CV (Pfizer/ BioNTech) support a COMINARTY booster dose administered at least 6 months after completion of the primary series for use in individuals 16 years of age and older?
Please vote 'YES' or 'NO'. "

By wrapping safety and efficacy up together in one indivisible vote, FDA gets maximum bang for its buck - two shots on target (at least) - and exposes the Pfizer application to maximal scrutiny & reservations.

And, at the same time, they're tightly limiting adcom's input to the decision & not giving adcom members any of the opportunity to influence the outcome that they did with views on 'benefits' e.g. on the Janssen C-19 vaccine on Feb 26 2021. The question asked of adcom members then was simply:

" Based on the totality of scientific evidence available, do the benefits of the Janssen COVID-19 vaccine outweigh its risks for use in individuals 18 years of age and older "

Playing hardball with Pfizer, & reserving its options with the White House is the way I see it atm.