In a landmark decision that could have big ramifications for the state of the pandemic, the U.S. Food and Drugs Administration has granted full approval to the Pfizer-BioNTech coronavirus vaccine. The approval could go a long ways towards reassuring people who’ve been hesitant to get vaccinated and boosting a fresh round of vaccine mandates. The news is a boon to healthcare professionals fighting to stem the tide of a fresh wave of COVID-19 cases, fueled by the delta variant.
The FDA’s “scientific and medical experts conducted an incredibly thorough & thoughtful evaluation of this vaccine,” said FDA Biologies Director Dr. Peter Marks. “Although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”
Pfizer’s vaccine is the first to be granted full FDA approval following the emergency approval granted by the federal government late last year. Critics had pressured the FDA to speed up its approval process, but the agency insisted on six months of follow-up data from the candidates who went through clinical trial rounds. Even so, it was a record time for the FDA.
“It’s been remarkably fast,” Holly Fernandez Lynch, a bioethics expert and lawyer at the University of Pennsylvania told The Washington Post. “You can’t have it both ways. You can’t have people saying they won’t get vaccinated until there’s full approval and then say the FDA has to hurry up.”
It remains unclear just how much of a boost this will provide to current vaccination rates, which have lagged amidst skepticism fueled by online misinformation. However, the approval may be used by private companies like concert venues, restaurants and hospitals to support new vaccine requirements among staff and guests.
“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 chief executive Albert Bourla said in a statement. “I am hopeful this approval will help increase confidence in our vaccine.”