First COVID-19 Vaccine Gets Full Approval; HHS Plans to Distribute Boosters Starting Sept. 20

The FDA has granted full approval to Pfizer’s/BioNTech’s mRNA COVID-19 vaccine in people age 16 years and older. The move is expected to ease worries among some as-yet-unvaccinated people, as well as inspiring more vaccine mandates from businesses and institutions.

The much-anticipated approval was based on six-month efficacy and safety data after a second dose of the vaccine, which was the first COVID-19 vaccine to get Emergency Use Authorization (EUA) when FDA gave it the nod on Dec. 11, 2020. Moderna’s EUA followed on Dec. 18. Johnson & Johnson’s COVID-19 didn’t get its EUA until Feb. 27.

The approval “holds the promise of altering the course of the pandemic in the U.S.,” said Acting FDA Commissioner Janet Woodcock in a press briefing.

Next in line for a possible approval is Moderna, which filed its application for its BLA on June 1, three weeks after Pfizer and BioNTech (DID, June 2).

The FDA took about three months to analyze Pfizer’s/BioNTech’s data and come to a decision. The companies had filed their rolling Biologics License Application (BLA) in May (DID, May 10). In July, FDA granted the companies Priority Review for the vaccine (DID, July 20).

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

There were about 22,000 vaccine recipients and another 22,000 who received placebo in the trial. The vaccine was found to be 91 percent effective in preventing COVID-19. About 12,000 recipients were followed for at least six months after the second dose.

In excess of 1.2 billion Pfizer-BioNTech doses have been delivered to more than 120 countries or territories since it got its EUA. According to the Centers for Disease Control and Prevention (CDC), about 204 million doses of the vaccine have been administered across the U.S. under the vaccine’s EUA.

Given its new status, Pfizer and BioNTech are now free to market the vaccine, branded as Comirnaty. Also, patients are free to get the shots once the COVID-19 public health emergency is declared over.

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, Pfizer and BioNTech noted.

Also on Monday, the HHS announced its plan to offer booster shots to all Americans beginning the week of Sept. 20, starting eight months after an individual’s second dose.

HHS said it anticipates the first to get the booster will be healthcare providers, nursing home residents and other seniors. HHS will also deliver booster shots directly to residents of long-term care facilities at that time, given the distribution of vaccines to this population early in the vaccine rollout and the continued increased risk that COVID-19 poses to them, HHS said.

Earlier this month, the FDA green-lighted a booster dose of the vaccine for people 12 and over who have undergone solid organ transplantation or who are diagnosed with conditions that have rendered them equally immunocompromised.

Another boon for Pfizer on the booster front: A study by the Israeli Health Ministry showed that a third dose of the Pfizer-BioNTech vaccine offered four times as much protection against COVID-19 infection as two doses in people 60 and older. The level of protection was five to six times higher against serious illness and hospitalization. The study looked at protection provided 10 days after a third dose.

Pfizer and BioNTech announced Aug. 16 that they plan to seek licensure of a third, or booster dose of the vaccine in individuals 16 years of age and older via a supplemental BLA. They also intend to submit a supplemental BLA to support full FDA approval of the vaccine in people 12 through 15 years of age once the required data out to six months after the second vaccine dose are available. The FDA granted an EUA to the companies for that age group in May. — Suz Redfearn