‘A milestone’: FDA approves Pfizer-BioNTech COVID-19 vaccine
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The FDA on Monday issued its full approval of the Pfizer-BioNTech COVID-19 vaccine for people aged 16 years or older — a long-awaited decision that could have implications for vaccine mandates and uptake in the United States, experts said.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Acting FDA Commissioner Janet Woodcock, MD, said in making the announcement.
The messenger RNA vaccine, now branded as Comirnaty, has been available under an emergency use authorization (EUA) since Dec. 11, 2020, which was later expanded on May 10 to include adolescents aged 12 to 15 years. Children in that age group are still eligible to receive the vaccine under the EUA but were not included in the full approval issued Monday — the first for a COVID-19 vaccine in the U.S.
Pfizer has said it expects to be able to submit the vaccine for an EUA in children aged as young as 2 years sometime next month.
For now, the full approval is for two doses of the vaccine given 3 weeks apart in anyone aged 16 years or older.
“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.
The approval could impact vaccine mandates as a condition of employment, said Amesh A. Adalja, MD, senior scholar at Johns Hopkins Center for Health Security. Adalja said companies may feel more comfortable and supported now when issuing such mandates.
“I think that will be a good thing because this is something that we're kind of hitting the wall about,” Adalja told Healio. “We think that one way to get vaccines up is for organizations and businesses to realize how important having a vaccinated workforce is to their continuity of operations and to the safety of their workplace. This will hopefully pave the way for this to become a very common practice.”
In a statement, the Infectious Diseases Society of America said the approval also “gives people who have not yet taken the vaccine additional assurance that this vaccine is safe and effective.”
Paul A. Offit, MD, director of the Vaccine Education Center at The Children's Hospital of Philadelphia, said the approval could help alleviate some vaccine hesitancy from a psychological standpoint.
“I think some people are saying they don't want to get the vaccine until it's fully approved, or they don't trust that the vaccine has yet been proven to be safe, effective, or yet been proven to be manufactured in a consistent and reliable way,” Offit told Healio. “The approval really is more of a psychological thing than anything else, and that's not trivial.”
Two other vaccines remain available in the U.S. under EUAs, including the mRNA vaccine manufactured by Moderna, which has said it expects to complete the process of applying for FDA approval this month. Johnson & Johnson said in April that it would apply for full approval of its one-dose vaccine “later in 2021.”
As of Sunday evening, more than 170.8 million Americans — or 51.5% of the population — were fully vaccinated against COVID-19, according to CDC tracking. That includes just over 60% of the population aged 12 years or older.
Monday’s approval of the Pfizer-BioNTech vaccine comes in the wake of other regulatory decisions and federal recommendations meant to boost Americans’ protection against the delta variant of SARS-CoV-2, including the FDA’s decision to allow certain immunocompromised patients to receive a third dose of vaccine.
That was followed by the Biden administration’s announcement that the U.S. will begin offering COVID-19 booster doses to all fully vaccinated Americans beginning Sept. 20. Pending FDA authorization and CDC recommendations, booster doses would be available 8 months following the administration of a second dose of an mRNA COVID-19 vaccine.
The CDC’s Advisory Committee on Immunization Practices will meet early next week to discuss the booster program.
With all the focus on vaccines, Infectious Disease News Editorial Board Member Jeanne M. Marrazzo, MD, MPH, director of the division of infectious diseases at the University of Alabama at Birmingham, worries that the U.S. may be losing focus on other measures to protect against COVID-19, including masks.
“Which is worrisome because masks offer immediate protection— you don’t need to wait several weeks for protective antibodies to be made — don’t care what variant they encounter, and with the delta variant being so contagious, offer another layer of barrier protection even for those already vaccinated,” Marrazzo told Healio. “For vaccinated people whose antibody levels are waning — after around 8 months — masks can be particularly important right now as we try to get through the current wave.”
Perspective
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Leonard H. Calabrese, DO
I am heartened to finally see full FDA approval for one of our vaccines — though I truly believe (and have tweeted extensively) that this approval, in my opinion, has been long overdue. Never has a vaccine been used this extensively and generated such a robust integrated safety data base as the Pfizer-BioNTech COVID-19 vaccine.
As we now confront the reality that we are facing two epidemics — namely of the vaccinated and, unfortunately, the unvaccinated — the full stamp of approval from the FDA should remove one of the last issues of concern among many who are still vaccine hesitant.
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