The Food and Drug Administration (FDA) took the unusual step of requesting data from Pfizer and BioNTech on how its vaccine has been doing in a clinical trial because of the surge in pediatric COVID-19 hospitalizations and wanting to prepare for the next “twist” in the pandemic, an FDA official said on Feb. 4.
“As reports of pediatric hospitalizations increased in association with the Omicron-variant surge in late December, FDA requested Pfizer to provide more detailed data for our review as data became available,” Dr. Dorian Fink, the official, told a Centers for Disease Control and Prevention (CDC) vaccine advisory panel during a virtual meeting on a different subject.
