The Food and Drug Administration has granted full approval of the Pfizer/BioNTech COVID-19 vaccine, which will now be marketed as Comirnaty (koe-mir’-na-tee), the agency announced Monday.
The vaccine's full approval—or Biologics License Application (BLA)—applies for use of a two-dose regimen, given three weeks apart, in people ages 16 years and older. It is the first BLA to be issued for a vaccine against COVID-19. The vaccine will still be available under an Emergency Use Authorization (EUA) for adolescents ages 12 to 15 and for use as a third booster dose in certain people with compromised immune systems.
The name Comirnaty—already in use elsewhere, including Europe—is a mash-up of "COVID-19 immunity" and "mRNA" that is meant to evoke the word "community."
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic," acting FDA Commissioner Janet Woodcock said in a statement. "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. 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 US.”
In the US, over 200 million doses of Comirnaty have been administered since it initially earned an EUA on December 11, 2020. The BLA document submitted by Pfizer and BioNTech this May "builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made," the FDA said. The agency also noted that it conducts its own data analyses to determine safety and efficacy.
In a tweet, Pfizer CEO Albert Bourla said the company and BioNTech were celebrating the approval. "It is our hope that this news will instill even further public confidence in our vaccine and the science that made it possible," Bourla added.
Safety review
Amid another devastating and entirely preventable wave of the deadly pandemic, the full approval is expected to spur more vaccination mandates by universities, healthcare systems, and other employers. Though the federal Equal Employment Opportunity Commission determined in May that employers can indeed mandate COVID-19 vaccination under the EUA, given reasonable accommodations, some have suggested a full approval could give employers more confidence in issuing a mandate.
Still, mandates or not, the approval alone may sway some vaccine holdouts. Previous polling by the Kaiser Family Foundation found that 31 percent of unvaccinated people would be more likely to get their shots if a vaccine earned full approval.
In the announcement Monday, the FDA also took the time to try to ease concerns and dispel myths about the vaccine. The agency noted that the mRNA vaccine works by providing to human cells a genetic code for a snippet of the pandemic coronavirus SARS-CoV-2. From there, the cells translate the code into a protein that can essentially be used as target practice by the immune system. "The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19," the FDA noted. "The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into—nor does it alter—an individual’s genetic material."
Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, also emphasized how rigorously the agency looked over the plethora of safety data accumulated so far. “Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine," he said. "We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities. We have not lost sight that the COVID-19 public health crisis continues in the US and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the US."
Pfizer and BioNTech submitted the BLA document in May of this year, and the FDA granted it a priority review in July. The FDA is also reviewing a BLA submission for Moderna's similar mRNA-based COVID-19 vaccine, and full approval could come in coming weeks.
This post has been updated.
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