US FDA narrows under-65 COVID vaccine eligibility; maintains full access for older Americans

By Patrick Wingrove and Sriparna Roy

Aug 27 (Reuters) - The U.S. Food and Drug Administration cleared updated COVID-19 vaccines for everyone over age 65 but narrowed its approval for younger people to those with health risks, the companies said on Wednesday, in a shift from prior years when most people were eligible for the inoculations.

The three approved shots are made by Pfizer PFE.N with German partner BioNTech 22UAy.DE, Moderna MRNA.O, and Novavax NVAX.O with Sanofi SASY.PA.

"Today’s decision does not affect access to these vaccines. These vaccines remain available to those who choose them in consultation with their healthcare provider," a spokesperson for the U.S. Department of Health and Human Services said, without elaboration.

Pfizer, the biggest maker of the shots, said the 2022 emergency use authorization for its COVID vaccine for children under age 5 had been rescinded.

Moderna's updated Spikevax shot was approved for people aged 6 months and up with at least one underlying condition that puts them at high risk from COVID, according to the company. The company said it would be available in the coming days.

Pfizer and BioNTech's updated version of Comirnaty was approved for individuals ages 5 through 64 years with at least one high-risk condition, while Novavax's was approved under the same criteria for ages 12 to 64, the companies said.

All three shots were approved for people aged 65 and over. High-risk conditions covered by the approvals include cancer and chronic kidney disease.

Former FDA Chief Scientist Jesse Goodman said he was concerned by the changes for people under 65.

"Will insurance cover it? Will access be complicated and difficult? If people have to pay for it or are worried they have to pay for it, that will certainly decrease use," Goodman said.

Insurers usually follow recommendations from the expert panel at the Centers for Disease Control and Prevention that advises on who should take FDA-approved vaccines, but the panel has yet to weigh in on updated COVID shots.

Aetna said it covers approved vaccines, including for COVID-19, with no cost sharing for members in fully insured plans, in line with state and federal rules. For self-funded plans that Aetna administers, coverage is set by the employers.

The narrowed approvals in the United States come as Health Secretary Robert F. Kennedy Jr., a longtime anti-vaccine campaigner, has moved quickly to reshape U.S. health policy.

Kennedy, who announced Wednesday's approvals in an X post, in June fired all 17 members of the CDC's expert vaccine advisory panel, before replacing eight.

Earlier this month, he pulled $500 million in messenger RNA vaccine funding, saying HHS will back "safer, broader vaccine platforms." Pfizer’s and Moderna’s COVID shots are based on mRNA.

He said in May the United States no longer recommends routine COVID-19 shots for healthy kids and pregnant women, prompting medical organizations and several states to formulate their own vaccine recommendations

The American Academy of Pediatrics last week recommended that all young children get vaccinated against COVID-19, in defiance of federal policy. The Infectious Diseases Society of America said on Wednesday it is working with other medical societies to finalize updated guidelines for COVID vaccination.

The IDSA said it expected to release its recommendations in September.