The U.S. Food and Drug Administration (FDA) approved Comirnaty — the COVID-19 vaccine co-developed by Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) — for use in people aged 16 and older on Monday. The news drove shares of Pfizer and BioNTech up 2.5% and 9.6%, respectively. Fellow vaccine maker Moderna (NASDAQ:MRNA) also saw its stock price surge 7.6%.
The decision marks the first time the FDA has granted full approval for a COVID-19 vaccine. Previously, Pfizer’s and BioNTech’s vaccine was being administered under an emergency use authorization. Moderna’s and Johnson & Johnson’s drugs have also received an EUA.
The approval comes at a time when COVID-19 cases counts are surging, driven in part by new coronavirus mutations such as the delta variant.
“Based on the longer-term follow-up data that we submitted, today’s decision by the FDA affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” Pfizer CEO Albert Bourla said in a press release. “About 60% of eligible Americans are fully vaccinated, and infection, hospitalization, and death rates continue to rise rapidly among unvaccinated populations across the country.”