The Food and Drug Administration (FDA) pushed back a decision on whether to clear Pfizer’s COVID-19 vaccine for children under 5 because both arms of Pfizer’s clinical trial have a low number of COVID-19 cases, a Pfizer board member and former FDA commissioner says. “Since there’s a low number of cases overall in the clinical trial—most kids are not getting symptomatic COVID—one case in one direction or another can tip the perception of the vaccine’s overall effectiveness,” Dr. Scott Gottlieb, the former FDA commissioner who now sits on Pfizer’s board, said on CNBC’s “Squawk Box.” FDA officials analyzed data from when the trial gave children 6 months of age to 4 years old a two-dose primary regimen and determined the data was not enough for emergency use authorization. The trial includes approximately 8,300 children 12 or younger. “The data that we saw made us realize that we needed to see …
FDA Delayed Decision on Pfizer’s Vaccine for Children Due to Low Number of COVID-19 Cases in Trial: Gottlieb
February 15, 2022
admin
0 Comment