The U.S. Food and Drug Administration has given full approval to Pfizer’s COVID-19 vaccine for people 16 and older.
“The public can be very confident that this vaccine meets the high standards of safety, effectiveness and manufacturing quality the FDA requires of an approved product,” acting FDA Commissioner Janet Woodcock said in a statement Monday.
In a speech given hours after the approval, U.S. President Joe Biden urged Americans to get vaccinated, reiterating the safety and efficacy of the shot.
“Let me say this loudly and clearly — if you’re one of the millions of Americans who said that they will not get the shot until it has full and final approval of the FDA — it has now happened,” Biden said.
“The moment you’ve been waiting for is here. It’s time for you to get your vaccination.”
The vaccine produced by Pfizer-BioNTech was approved for emergency use last December. Experts have stressed that this approval requires the same scientific evidence and number of clinical trials proving the safety and effectiveness of the vaccine, but only skips some steps and technicalities concerning labeling and distribution.
How Does FDA Approve Vaccines?
Experts stress that 3 major COVID vaccines have already been proven safe and that full FDA approval is largely a formality involving logistics issues
Still, some experts are hopeful that the full approval will encourage more vaccine skeptics to get inoculated, especially as the U.S. battles a surge in cases driven by the more contagious delta variant.
In a statement released following the formal approval, Pfizer CEO Albert Bourla said he hopes the decision “will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives.”
The shot will now be marketed in the U.S. by the brand name Comirnaty.
Following the FDA’s announcement Monday, global health nonprofit Doctors Without Borders (MSF) called on the pharmaceutical giant to share its vaccine technology to increase the global supply. According to MSF, only 1% of Pfizer’s vaccine supply has been delivered to countries on the African continent.
“The only reason these vaccines aren’t being produced more widely is because Pfizer-BioNTech and Moderna are refusing to share mRNA vaccine technology and information with manufacturers, including those in Egypt, Morocco, South Africa and Tunisia that could have the capacity to produce up to 100 million doses annually within a 10-month timeframe,” Lara Dovifat, campaign manager for MSF’s Access Campaign, said in a statement.
More than 200 million Pfizer doses have been administered in the U.S. and hundreds of millions more worldwide.
Information in this report came from The Associated Press and Reuters.
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