WASHINGTON (AP) — U.S. regulators approved Pfizer’s updated COVID-19 shot Wednesday but with limits that could complicate access for millions of American adults and children.
Pfizer said in a release its vaccine is now approved for all seniors to protect against the virus this fall. But the Food and Drug Administration narrowed its use for younger adults and children to those with at least one high-risk health condition, such as asthma or obesity. That presents new barriers to access for millions of Americans who’d have to prove their risk -- and millions more who may want to get vaccinated and suddenly no longer qualify.
U.S. health officials did not immediately confirm the news but they generally approve updated shots from the nation’s two leading COVID-19 vaccine makers at the same time.
Moderna did not immediately respond to requests for comment.
This year's updated vaccines target a newer version of the continuously evolving virus and are set to begin shipping immediately. But it could be days or weeks before many Americans know if they’ll be able to get one, with access dependent on various decisions by federal health advisers, private health insurers, pharmacies and state authorities.
The new restrictions — previewed by FDA officials in May — are a break from the previous U.S. policy, which recommended an annual COVID-19 shot for all Americans 6 months and up.
The approach reflects heightened skepticism about the ongoing risks of COVID-19 and the need for yearly booster shots from Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, who were both outspoken critics of wide-scale vaccinations.
Some medical groups, including the American Academy of Pediatrics, have objected to the new limits, saying they may block vaccine access for families who want to protect their children. Last week, the group offered its own recommendations for kids, saying annual COVID shots are strongly recommended for children ages 6 months to 2 years and advised for older children.
That differs from the latest guidance under Kennedy, which doesn’t recommend the shots for healthy children of any age, but says kids may get the shots in consultation with physicians.
Many countries have scaled back COVID-19 vaccinations in recent years, and some U.S. experts say the change makes sense here, given that nearly all Americans have some protection from previous vaccination or infection.
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AP Medical Writer Lauran Neergaard contributed to this story.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
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