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FDA approves COVID shots with new restrictions

Covid vaccine doses at a vaccination site at a shopping mall in Bayam, Puerto Rico (PHOTO: Erika P. Rodriguez/The New York Times)
28 Aug 2025 00:45

(The New York Times)

The US Food and Drug Administration on Wednesday approved updated COVID vaccines for the fall season and limited who can get the shots, the federal government’s most restrictive policy since the vaccines became available.

The agency authorised the vaccines for people who are age 65 and older, who are known to be more vulnerable to severe illness from COVID. Younger people would only be eligible if they had at least one existing medical condition that would put them at risk for severe disease. Healthy children younger than 18 could still receive the shots if a medical provider is consulted.

People seeking the shots will soon face another hurdle. An influential advisory committee to the Centres for Disease Control and Prevention must vote to recommend them. But that panel’s makeup shifted when Health Secretary Robert F. Kennedy Jr. unseated existing members, reduced the panel’s size and added some COVID vaccine opponents.

This would mark the first fall/winter season that COVID shots were not widely recommended to most people and children, pitting federal health officials in the Trump administration against several national medical groups that oppose the restrictions.

In a social media post, Kennedy said the approvals accomplished the goals of keeping vaccines available to people who want them and of demanding that companies conduct placebo-controlled trials. One new, required study would examine "post-COVID-19 vaccination syndrome” in patients, a condition that has been noted in at least one small preliminary medical report, but is still a matter of pitched debate.

"The American people demanded science, safety and common sense,” Kennedy’s post on X said. "This framework delivers all three.”

Many public health experts view the changes as part of Kennedy’s broader campaign against certain vaccines, especially his targeting of mRNA technology, which has been used in the vast majority of shots administered to Americans. They criticised his recent cancellation of $500 million in grants to study flu and COVID vaccines as a move that would significantly set back the nation’s efforts to develop better therapies and leave the nation reliant on older, slower approaches.

Those efforts have been tempered, to some degree, by the White House, where President Donald Trump remains proud of Operation Warp Speed, which was widely recognised as an impressive feat of science, organisation and execution to develop and deliver vaccines that helped bring the pandemic to an end.

"Operation Warp Speed, people say, is one of the greatest achievements ever in politics or in the military - because it was almost a military procedure,” Trump said during a Cabinet meeting Tuesday.

The FDA’s new limited approval covers two vaccines designed with mRNA that were updated to target the LP.8.1 variant, which represents nearly one-third of recent cases. The Moderna vaccine authorisation covers those who are 6 months old and older, have medical conditions and all people older than 65. The Pfizer shot was approved for the same group, ages 5 and older.

Source: NEW YORK TIMES
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