US Regulators Give Full Approval to Pfizer COVID-19 Vaccine

Eight months after first authorizing the Pfizer-BioNTech COVID-19 vaccine for emergency use in the United States, the Food and Drug Administration on Monday issued full approval.

via: AP

The Pentagon immediately announced it will press ahead with plans to require members of the military 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. More than 200 million Pfizer doses have been administered in the U.S. — and hundreds of millions more worldwide — under special emergency provisions since December.

“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, shots are on the 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.

The FDA’s action may also lead to more vaccine mandates covering students, employees and customers.

“Mandating becomes much easier when you have full approval,” said Dr. Carlos del Rio of Emory University. “I think a lot of businesses have been waiting for it.”

Time will tell, if the FDA approval influences more people to get vaccinated.

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