FDA Authorizes Pfizer And Moderna Booster Shots For All Adults

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FDA Authorizes Pfizer And Moderna Booster Shots For All Adults
Scientists previously advised the FDA to reject the Biden administration's plan to start distributing booster shots, citing a lack of supporting data.

U.S. regulators on Friday opened up COVID-19 booster shots to all adults, expanding the government’s campaign to shore up protection and get ahead of rising coronavirus cases that may worsen with the holidays.

Pfizer and Moderna announced the Food and Drug Administration’s decision after at least 10 states already had started offering boosters to all adults. The latest action simplifies what until now has been a confusing list of who’s eligible by allowing anyone 18 or older to choose either company’s booster six months after their last dose — regardless of which vaccine they had first.

But there’s one more step: The Centers for Disease Control and Prevention must agree to expand Pfizer and Moderna boosters to even healthy young adults. Its scientific advisers were set to debate later Friday.

If the CDC agrees, tens of millions more Americans could have three doses of protection ahead of the new year. Anyone who got the one-dose Johnson & Johnson vaccine can already get a booster.

All three COVID-19 vaccines used in the U.S. still offer strong protection against severe illness including hospitalization and death, but protection against infection can wane with time. Previously, the government had cleared boosters of Pfizer and BioNTech’s vaccine, as well as the similar Moderna vaccine, only for vulnerable groups including older Americans and people with chronic health problems.

Boosters for everyone was the Biden administration’s original goal. But in September, a panel of FDA advisers voted overwhelmingly against that idea based on the vaccines’ continued effectiveness in most age groups. Instead they endorsed an extra Pfizer dose only for the most vulnerable.

Since then, administration officials, including Dr. Anthony Fauci, have continued making the case for using boosters more widely, noting that even milder infections in younger people can cause “long COVID” and other complications.

Last week, Pfizer and its German partner BioNTech filed new data to make the case that broader boosters could help tamp down infections at a critical period.

“We have absolutely no chance in the current situation to control the pandemic without providing boosters to everyone,” BioNTech CEO Ugur Sahin told reporters during a visit to Washington last week.

The companies studied 10,000 adults of all ages and found that a booster restored protection against symptomatic infections to about 95% even while the extra-contagious Delta variant was surging. It’s too soon to know if that high level of protection will last longer after a third shot than after the second, something Sahin said the companies will carefully track.

More than 195 million Americans are fully vaccinated, defined as having received two doses of the Pfizer or Moderna vaccines or the single-dose Johnson & Johnson vaccine. More than 30 million already have received a booster.

Additional reporting by The Associated Press.