US regulators give full approval to Pfizer COVID-19 vaccine

WASHINGTON — The U.S. gave full approval to Pfizer’s COVID-19 vaccine Monday. This milestone could boost public confidence in the shots and spur more companies, universities, and local governments to make vaccinations mandatory. The Pentagon immediately announced it will press ahead with plans to require military members to get the vaccine as the U.S., and the world, battle the extra-contagious delta variant.

The formula made by Pfizer and its German partner BioNTech now carries the strongest endorsement from the Food and Drug Administration, which has never before had so much evidence to judge a shot’s safety. Since December, more than 200 million Pfizer doses have been administered in the U.S. — and hundreds of millions more worldwide — under special emergency provisions.

“Vaccines are one of our greatest weapons against the virus,” acting FDA Commissioner Janet Woodcock said. “We hope this approval will bolster confidence in those who’ve been wavering.”

Pfizer said the U.S. is the first country to grant the company’s vaccine full approval. The shot will be marketed in the U.S. under the brand name Comirnaty.

Moderna has also applied to the FDA for full approval of its vaccine. Johnson & Johnson, maker of the third option in the U.S., said it hopes to do so later this year.

Just over half of the U.S. population is fully vaccinated. Vaccinations in this country bottomed out in July at an average of about a half-million shots per day, down from a peak of 3.4 million a day in mid-April. As the delta variant fills hospital beds, pictures rise again, with a million a day given Thursday, Friday, and Saturday.

Full approval of Pfizer’s COVID-19 vaccine means it meets the same “very high standards required of all the approved vaccines we rely on every day,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. That should help “anyone who still has concerns gain confidence” in the shots. Earlier this month, Defense Secretary Lloyd Austin said he would seek the president’s OK to make the vaccine mandatory by mid-September or once the FDA grants final approval, whichever comes first. On Monday, after the FDA acted, the Pentagon said guidance on vaccinations will be worked out, and a timeline will be provided in the coming days.

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