Day 742: The FDA Backs Off

The FDA, after egging Pfizer on in their premature submission of an ineffective COVID vaccine for toddlers, has now punted the advisory board meeting until Pfizer has tested their third dose. It's unclear why they backtracked so suddenly; the least likely explanation is the one they gave about always following the science:

Since the early days of the pandemic, we have always followed the science in this ever-changing situation. Given the recent omicron surge and the notable increase in hospitalizations in the youngest children to their highest levels during the pandemic so far, we felt it was our responsibility as a public health agency to act with urgency and consider all available options, including requesting that the company provide us with initial data on two doses from its ongoing study. The goal was to understand if two doses would provide sufficient protection to move forward with authorizing the use of the vaccine in this age group. Our approach has always been to conduct a regulatory review that’s responsive to the urgent public health needs created by the pandemic, while adhering to our rigorous standards for safety and effectiveness. Being able to begin evaluating initial data has been useful in our review of these vaccines, but at this time, we believe additional information regarding the ongoing evaluation of a third dose should be considered.

Vinay Prasad is strangely disappointed in this good news:

Now, facing the prospect of a negative advisory vote, the FDA walks back the meeting itself.

What are they thinking? We have far more at stake than just this vaccine— we have the fate of all vaccines on the line. What will the American people think about this vaccine with these flip flops? If a vaccine is ultimately approved at these ages, a huge chunk of Americans may never trust it. Worse, many may stop trusting all the vaccines we have had to protect from childhood illnesses for many years. Already some states are floating regulations to remove all vaccine mandates. That would not be good. Finally, trust in the FDA may crater entirely as it appears the White House is controlling the day to day decisions of the agency.

If a kids vaccine is someday approved, what will the uptake be? We currently have ~20% uptake in 5 to 11, this vaccine is poised to do even poorer given all this drama.

We agree that flip-flopping is bad, but what's the alternative at this point? Surely not crapshots in arms?

P.S. Massachusetts cases were up a sixth of a percentage point today.