FDA Postpones Meeting with Pfizer to Approve Child Vax

Explanation Offered by Pfizer for the Delay Makes No Sense

From The New York Times:

“In a striking reversal, federal regulators said on Friday that they would wait for data on whether three doses of Pfizer-BioNTech’s coronavirus vaccine are effective in children younger than 5 before deciding whether to authorize a vaccine for the age group…

… Pfizer-BioNTech said that their three-dose trial for young children was moving briskly, and that the new timetable would allow the F.D.A. to get more data and thoroughly review it. Results are expected in early April.

“Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group,” the companies said.” ¹

This explanation makes no sense. The clinical trial is not “moving briskly” and “advancing at a rapid pace.” It is moving at the only pace it can after the company decided to try giving a third dose to children under five at least two months after their second dose. Pfizer presumably has been waiting for two months to pass, then giving the children their third dose, then measuring the antibody response. By Pfizer’s own admission, the trial is not big enough to measure the vaccine’s ability to protect against infection and disease. Antibody production is the only goal.

In any case, the FDA meeting that was originally scheduled for Tuesday, Feb. 15 has now been postponed until at least April.

Did our letters and emails slow them down, if not scare them off entirely? Are the children suffering escalating side effects with each dose? Are they experiencing negative efficacy while “partially vaccinated”?

I will have much more to say on this topic shortly.

1. Covid Live Updates: Vaccine and Mask Mandate News - The New York Times (nytimes.com)