FDA Fully Approves Pfizer’s Coronavirus Vaccine

The Food and Drug Administration (FDA) has fully approved Pfizer’s coronavirus vaccine, marking the first coronavirus injection to receive the FDA’s full approval outside of emergency use authorization.

The FDA’s full approval of Pfizer’s shot, which applies to the vaccine given to those ages 16 and older, is based on a study involving over 44,000 people for six months, with data showing the vaccine to be 91 percent effective in preventing infections, per reports. Pfizer’s vaccine for those ages 12-15 will still operate under emergency use.

USA Today reported that the license application “included more than 340,000 pages of material, three times the earlier emergency use authorization submission, which weighed in at 110,000 pages.”

“Based on the longer-term follow-up data that we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” Pfizer chairman and CEO Albert Bourla said.