FDA Grants Full Approval to Pfizer-BioNTech COVID-19 Vaccine

On Monday, the Food and Drug Administration (FDA) granted full approval to Pfizer and BioNTech Covid-19 vaccine, becoming the first in the U.S. to win the coveted designation.

This move gave businesses, schools and universities greater confidence to adopt vaccine mandates.

Pfizer’s vaccine met the agency’s “high standards for safety, effectiveness, and manufacturing quality,” acting FDA Commissioner Janet 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,” Woodcock added.

Federal health officials had been under growing pressure from the scientific community and advocacy groups to fully approve Pfizer and BioNTech’s vaccine ever since the drugmakers submitted their application to the agency in early May.

The companies submitted a Biologics License Application, which secures full approval, to the FDA on May 7 for patients age 16 and up.

FDA scientists evaluated “hundreds of thousands of pages” of vaccine data from 40,000 trial participants, according to the U.S. agency.

The vaccine was found to be 91% effective in preventing Covid, slightly lower than the 95% efficacy rate trial data showed when the shot was authorized late last year before the delta variant took hold in the U.S.

However, a new study showed the ability of vaccines against the recently emerged Delta variant, according to Daily Mail.

It highlighted that the Pfizer vaccine is only effective by 42% against the variant, on the other hand, the Moderna vaccine is effective by 76% against the Indian variant.