The U.S. drug regulator on Monday granted full approval to the Pfizer Inc BioNTech SE COVID-19 vaccine, making it the first to secure such Food and Drug Administration validation as health authorities struggle to win over vaccine skeptics during a relentless pandemic.
The FDA, which gave the two-dose vaccine emergency-use authorization in December, gave its full approval for use in people age 16 and older based on updated data from the companies’ clinical trial and manufacturing review. Public health officials hope the action will convince unvaccinated Americans that Pfizer’s shot is safe and effective.
There is entrenched vaccine skepticism among some Americans, particularly conservatives. COVID-19 cases, driven by the highly infectious Delta variant, have surged in parts of the United States with lower vaccination levels.
“This FDA approval should give added confidence that this vaccine is safe and effective,” President Joe Biden, who has sought to increase vaccination levels, wrote on Twitter.
Shortly after the FDA’s announcement, the Pentagon said it is preparing to make the vaccine mandatory for U.S. military personnel. U.S. health officials expect that the FDA’s full approval also will prompt more state and local governments, as well as private employers, to impose vaccine mandates.
“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,” said Janet Woodcock, the FDA’s acting commissioner.
More than 204 million people in the United States have received the Pfizer vaccine. The FDA’s approval extends the shelf life of Pfizer shots from six months to nine months. It also confirms that the vaccine increases risk of heart inflammation, particularly among young men in the week following their second shot.
The approval makes it easier for physicians to prescribe a third dose of Pfizer’s vaccine off-label for people who may benefit from additional protection against COVID-19.
Pfizer shares were up around 2.5% and BioNTech shares were up more than 10%.