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FDA authorizes 2nd COVID booster shots for adults 50 and up

FDA authorizes 2nd COVID booster shots for adults 50 and


The Food and Drug Administration on Tuesday signed off on a second booster shot for older Americans and people who are immunocompromised.

The second dose of the Pfizer-BioNTech or Moderna booster shots was authorized by the federal agency for people ages 50 and up and those with severely weakened immune systems at least four months following their first booster.

The FDA had previously only cleared the fourth doses of the Pfizer or Moderna vaccines for people ages 12 and older who were immunocompromised. That group can now get a fifth shot — three doses and two boosters — with Tuesday’s FDA authorization.

“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals,” the FDA’s vaccine chief, Dr. Peter Marks, said in a statement.

Data shows an initial booster dose is critical to protect all adults from “potentially severe outcomes” of COVID-19, Marks said.

“So, those who have not received their initial booster dose are strongly encouraged to do so,” Marks’ statement continued.

Tuesday’s authorization applies solely to the Pfizer-BioNTech and Moderna coronavirus vaccines, the FDA said.

The FDA approved a second COVID booster for people who are immunocompromised or over age 50.
AP Photo/Charles Krupa, File
According to the FDA, the booster shot's protection against COVID-19 was found to wane over time.
According to the FDA, the booster shot’s protection against COVID-19 was found to wane over time.
REUTERS/Andrew Kelly/File Photo

“The agency will continue to evaluate data and information as it becomes available when considering the potential use of a second booster dose in other age groups,” the agency said in a news release announcing the approval.

Pfizer previously asked the FDA to approve a fourth shot for people age 65 and up, while drugmaker Moderna wanted another booster dose for all adults.

The FDA said it considered Israel’s approach in offering a fourth dose — a second booster — to people 60 and older at least four months after receiving a third dose. No “new safety concerns” were found in a review of the 700,000 fourth doses doled out, according to the FDA.

The Centers for Disease Control and Prevention is expected to give what’s called a permissive recommendation, CNN reported, but it not expected to officially recommend the additional boosters.

Just 46 percent of Americans ages 12 and older who have been eligible for a third vaccine dose have received one since January, according to data cited by CNN.



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