Pfizer’s coronavirus vaccine has received full approval from the Food and Drug Administration (FDA). The first coronavirus vaccine to receive the FDA’s approval outside of the emergency use authorization.
Pfizer’s full approval from the FDA applies to those 16 and over who receive the vaccination; based on over 44,000 people for six months, the report data shows the vaccine to be 91 percent effective in preventing infections. Pfizer’s use of the coronavirus vaccine for those 12-15 is still operating under emergency use.
The license application “included more than 340,000 pages, three times more than the earlier emergency use authorization submission at 110,000 pages, USA Today reports.
“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 FDA approval clears the way for Pfizer to market the vaccine, which was not permitted without full licenseure.
Now that Pfizer has been granted full approval, it is likely that many companies, schools, and other entities will require it.
The news follows as governors have begun making vaccine mandates for certain sections of workers in their states. In California, for example, vaccinations are required for health care workers. New York and Maine have moved in the same, as protests erupted.
Public health experts have already begun urging booster shots for coronavirus eight months after the second injection. Last month Pfizer met with public health officials to discuss the potential need.
All while citing a decline in vaccine efficacy, federal health officials in association with the Center for Disease Control and Prevention (CDC), FDA, National Institutes of Health (NIH), and National Institute of Allergy and Infectious Disease (NIAID) in a joint statement said they are “prepared to offer booster shots for all Americans beginning the week of September 20 and starting 8 months after the individual’s second dose.”
The concern looms over mandates and long-term side effects as polls show that most unvaccinated will not take the vaccine.
According to the CDC, over 92 million people in the U.S. are fully vaccinated with the Pfizer vaccine.