(TNS) The U.S. Food and Drug Administration granted full approval Monday to the COVID-19 vaccine developed by Pfizer and BioNTech, whose shots are now the first to move beyond emergency status since the pandemic began.
The highly anticipated announcement was expected to boost confidence in the vaccine, potentially encouraging some of the 85 million unvaccinated Americans to get the shots. It may also spark a wave of vaccine mandates by employers and schools as the country faces a surge of infections and hospitalizations largely driven by the deadly delta variant.
For now, the full approval is effective only for people 16 and older getting their first or second shot. The vaccine will remain available under emergency-use status for children 12 through 15 years old and for a third dose in individuals with certain underlying medical conditions, according to the FDA. Pfizer and BioNTech said they will seek full approval for young teens and the third dose once they have enough safety and efficacy data.
Monday’s decision comes eight months after Pfizer was granted emergency use authorization to distribute the shots in the U.S. Since then, more than 200 million Pfizer shots have been administered nationwide, with many more around the world — a major undertaking that provided overwhelming evidence to federal health officials about the safety and efficacy of the vaccine.
An FDA review of about 22,000 people who received the vaccine and 22,000 who received a placebo found that Pfizer’s shots were 91% effective at preventing COVID-19, according to the agency.
“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,” acting FDA Commissioner Janet Woodcock said in a statement.
The Biden administration hopes Monday’s announcement will nullify one of the main arguments among anti-vaxxers, who claimed that a vaccine with temporary approval could not be trusted. The two other COVID-19 vaccines available in the U.S. — Moderna’s and Johnson & Johnson’s — remain under emergency use authorization.
“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 said. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
About 40% of people 12 and older still have not been vaccinated, according to the U.S. Centers for Disease Control and Prevention’s latest vaccination data.
The full approval also means Pfizer and BioNTech will be allowed to market their vaccine, which is not permitted under emergency status. The two companies plan to market the shots as Comirnaty, the FDA said.
Pfizer Chairman and CEO Albert Bourla celebrated the accomplishment on social media.
“Every day, I wake up proud of our team at @Pfizer. Proud of the work we do. Proud of the difference we are making. And I am especially proud today,” Bourla tweeted.
“It is our hope that this news will instill even further public confidence in our vaccine and the science that made it possible,” he said.
(By Nelson Oliveira, New York Daily News via Tribune News Service)