FDA Fully Approves Pfizer’s Coronavirus Vaccine

Michael, a 16-year-old teenager, receives a dose of the Pfizer-BioNtech COVID-19 coronavir
JACK GUEZ/AFP via Getty Images

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.

“I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity,” he added.

The news comes as governors across the country begin to make vaccine mandates a reality for certain sects of workers in their respective states. In California, for example, healthcare workers are required to be vaccinated. New York and Maine made similar moves, triggering protests.

It also comes as public health experts emphasize the need for coronavirus booster shots eight months after initial inoculation. Pfizer met with public health officials last month to discuss the possibility.

Citing a decline in vaccine efficacy, federal health officials associated with the Centers for Disease Control and Prevention (CDC), FDA, National Institutes of Health (NIH), and National Institute of Allergy and Infectious Diseases (NIAID) said in a joint statement they are “prepared to offer booster shots for all Americans beginning the week of September 20 and starting 8 months after an individual’s second dose.”

Concerns over mandates and long-term side effects loom as polls show a majority of the unvaccinated indicating they will not get the jab.

According to the CDC, over 92 million people in the U.S. are fully vaccinated with the Pfizer jab.


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