Pfizer-BioNTech COVID-19 vaccine gains full US regulatory approval

The U.S. drug regulator on Aug. 23 granted full approval to the Pfizer Inc/BioNTech SE COVID-19 vaccine - the first to secure such Food and Drug Administration validation - prompting President Joe Biden to make a fresh pitch to vaccine skeptics to get the shot to fight the relentless pandemic.

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The FDA, which gave the two-dose vaccine emergency-use authorization in December, provided 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.

Speaking at the White House, Biden called the FDA approval "an important moment in our fight against the pandemic" and urged more private businesses to require employees to be vaccinated.

"If you're one of the millions of Americans who said that they will not get the shot until it has full and final approval of the FDA, it has now happened," Biden said.

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"It's time for you to go get your vaccination. Get it today," Biden added. "... There is no time to waste."

The Pentagon said it is preparing to make the vaccine mandatory for military personnel.

U.S. health officials expect that the FDA's action also will prompt more state and local governments, as well as private employers, to impose vaccine mandates. New York City said it will require vaccines for public-school teachers, while New Jersey announced that all state workers must get vaccinated by...