U.S. regulators on Tuesday authorized another COVID-19 booster for people age 50 and older, a step to offer extra protection for the most vulnerable in case the coronavirus rebounds.
The Food and Drug Administration's decision opens a fourth dose of the Pfizer or Moderna vaccines to that age group at least four months after their previous booster.
Until now, the FDA had cleared fourth doses only for people 12 and older who have severely weakened immune systems. The agency said this especially fragile group also can get an additional booster, a fifth shot.
The latest expansion, regardless of people's health, allows an extra shot to millions more Americans — and the question is whether everyone who's eligible should rush out and get it. The Centers for Disease Control and Prevention is expected to weigh in.
Everyone eligible for a first booster who hasn't gotten one yet needs to, FDA vaccine chief Dr. Peter Marks said. But the second booster is only for these higher-risk groups because “current evidence suggests some waning of protection” for them.
The move comes at a time of great uncertainty. COVID-19 cases have dropped to low levels after the winter surge of the super-contagious Omicron variant. Two vaccine doses plus a booster still provide strong protection against severe disease and death, CDC data show.
There's limited evidence to tell how much benefit another booster could offer right now. The FDA made the decision without input from its independent panel of experts that has wrestled with how much data is required to expand shots.
About two-thirds of Americans are fully vaccinated, and half of those eligible for a first booster haven’t gotten one.
None of the COVID-19 vaccines are as strong against the Omicron mutant as they were against earlier versions of the virus. Also, protection against milder infections naturally wanes over time. But the immune system builds multiple layers of defense and the type that prevents severe illness and death is holding up.
The newest booster expansion may not be the last: Next week, the government will hold a public meeting to debate if everyone eventually needs a fourth dose, possibly in the fall, of the original vaccine or an updated shot.
Additional reporting by The Associated Press.