Ahead of Dec. 10 hearing, FDA confirms Pfizer efficacy/safety claims for COVID-19 vaccine candidate

The Food and Drug Administration today released a briefing document on Pfizer’s BNT162b2 COVID-19 vaccine candidate that confirms the drug maker’s claims of the vaccine’s efficacy and safety. The document is among a host of materials released in advance of the key Dec. 10 meeting of FDA’s vaccine advisory committee in which Pfizer’s request for an emergency use authorization for BNT162b2 will be considered. FDA mirrored Pfizer’s application in its findings, stating that there are no specific safety concerns across key categories of race, age, ethnicity, medical co-morbidities or prior COVID-19 infection.

However, the agency notes that more data is needed to understand the vaccine’s efficacy against asymptomatic infection, which FDA says is possibly lower than its effectiveness against symptomatic infection. FDA also would like to see additional testing on the vaccine’s effectiveness in preventing the virus’ transmission.