The U.S. Food and Drug Administration has announced the official approval of the Pfizer-BioNTech COVID-19 vaccine months after granting it an emergency use authorization status.
In an announcement Monday, the FDA said that the Pfizer vaccine, first made available under EUA last December, was the first COVID-19 vaccine to get full approval for people 16 years and over and will be marketed as Comirnaty.
Acting FDA Commissioner Dr. Janet Woodcock stated the approval is “a milestone as we continue to battle the COVID-19 pandemic.”
“While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” Woodcock said in a statement.
“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
Last November, Pfizer Inc. and BioNTech announced that they developed a vaccine that was reportedly over 90% effective in preventing COVID-19 in those without evidence of prior infection. The following month, the FDA approved the Pfizer vaccine for emergency use to mitigate the spread of the coronavirus in the United States and abroad.
“Based on the longer-term follow-up data that we submitted, today’s decision by the FDA affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed," Pfizer Chief Executive Officer Albert Bourla said in a statement Monday.
"About 60 percent of eligible Americans are fully vaccinated, and infection, hospitalization and death rates continue to rise rapidly among unvaccinated populations across the country."
Bourla said that he is hopeful that the full approval will "increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity."
"Hundreds of millions of doses of our vaccine already have been administered in the U.S. since December 2020, and we look forward to continuing to work with the U.S. government to reach more Americans now that we have FDA approval," Bourla concluded.
The FDA's announcement comes not long after former President Donald Trump implored supporters at a rally in Alabama over the weekend to get vaccinated just as he and his family did before he left office in January.
“I recommend, take the vaccine!” declared Trump, who nevertheless expressed opposition to mandating vaccination. “I did it. It’s good. Take the vaccines … It is working.”
The weekend rally was not the first time that Trump urged his supporters to get vaccinated. In March, the former president said on Fox News that he would recommend people get vaccinated.
“It’s a great vaccine, and it’s a safe vaccine,” Trump said at the time.
Despite the push by many to get more Americans vaccinated, some, including immunologist and physician Dr. Hooman Norchashm, have expressed concern about the potential dangers of vaccinating people who either have or had COVID-19.
In a recent interview, Norchashm said that while he supports the COVID-10 vaccines, he said it is a mistake to apply this "therapy" in a "one-size-fits-all" fashion.
"We are deploying this vaccine in the midst of an outbreak where literally millions of people across the United States and the world have already had natural infections and are therefore immune," he said.
"The idea of vaccinating someone who is already immune is a violation of medical necessity as a principle of medical ethics. And it has the potential to do harm. The reason why I am critical is not so much about the vaccine itself. I think the vaccine is an amazing technological feat. I received the vaccine myself. I advocate for all non-immune Americans to get this vaccine as soon as possible. But the problem is its indiscriminate application to folks who do not stand to benefit from it."
In a letter to health officials in January, Norchashm wrote that the "goal of maximally and quickly vaccinating the population is the correct and laudable public health goal."
“But [we need to] robustly mitigate against known and rationally prognosticated dangers to the minority subset of persons at risk of harm," he wrote.
“I am recommending to you, as our lead FDA regulators, not to gloss over the real possibility that vaccinating persons with pre-existing SARS-CoV-2 viral antigens in their tissues could cause that subset of people grave immunological harm — and especially the frail with cardiovascular disease.”