Pfizer COVID vaccine gets full FDA approval

On Monday, the Food and Drug Administration granted full approval to COVID-19 vaccines made by Pfizer BioNTech, a move that may encourage more people to get the vaccine and may also lead to more vaccine mandates. 

The approval came after a three-month review of the Pfizer BioNTech vaccine and applies only to people 16 and up. Emergency use authorization will still be in place for those aged 12 to 15.

The vaccine will now go by the name Comirnaty. Acting FDA Commissioner Janet Woodcock said the development “holds the promise of altering the course of the pandemic in the United States.”

“Unprecedented timeline”

“This is an unprecedented timeline given the volume of review and the meticulous manner in which it was done,” she said. “But we want to underscore that our efforts to move as quickly as possible have in no way sacrifice scientific standards for the integrity of our process.”

Some had pushed the FDA to give full approval sooner, but Woodcock said that the timeline was already “around 40%” of what it usually is for full approval.

More than 204 million doses of the Pfizer-BioNTech vaccine have been given in the U.S. while it was under emergency use authorization, Centers for Disease Control and Prevention data showed.

The full and permanent authorization may encourage around 30% of those who aren’t yet vaccinated to get the vaccine, according to surveys, which will help keep hospitalizations from overwhelming hospitals in certain areas.

At least two new vaccine mandates were triggered immediately by news of the full approval: the Pentagon will move forward to require all military to be vaccinated, and New York City will require teachers and staff in its schools to get the vaccine. Experts think more vaccine mandates will be coming now that full FDA approval has been accomplished.

Decreasing effectiveness

The Pfizer BioNTech vaccine has been shown in recent studies to have waning protection against infection with the virus, but is still highly protective against hospitalization and death. Axios reported that according to a not-yet-published study, the Pfizer vaccine was only 42% effective in the U.S. in July against the infefction from the delta variant.

Other studies have shown that Pfizer’s effectiveness against COVID-19 wanes with time. After 90 days, the vaccine was only 78% effective against infection by all strains of the virus.

The head of the Oxford Vaccine Group, Andrew Pollard, who helped develop the Astra Zeneca vaccine used predominantly in the U.K., said that herd immunity through vaccines would be a “myth” if vaccine efficacy drops as quickly as studies are suggesting, according to CNBC.

The Moderna vaccine seems to be providing more protection for a longer period of time, but has had approval for ages 12 to 15 delayed because of higher rates of heart-related side effects in younger males.

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