Moderna Inc. gained U.S. approval for a new COVID vaccine for a narrower group of people, in the latest sign that regulators are restricting access to immunizations under the leadership of Health and Human Services Secretary Robert F. Kennedy Jr.

The company’s second-generation vaccine is cleared for all adults over 65 and anyone over 12 who has at least one risk factor for severe disease, Moderna said in a statement Saturday. Moderna’s COVID shot had previously been approved for people 12 years of age and older regardless of their underlying health.

Vaccine makers have been on high alert to challenges under Kennedy, a longtime critic of immunizations who leads the health agency that oversees the Food and Drug Administration.

The FDA’s decision on Moderna’s COVID vaccine was seen as a litmus test of whether Kennedy’s doubts about the shots would hinder future approvals.

Under Kennedy, U.S. health agencies have taken steps to limit who can get COVID vaccines, arguing there’s a lack of evidence for repeat doses.

In May, the FDA said it will no longer approve COVID booster shots for healthy adults and children without new studies confirming their safety and effectiveness. Kennedy also removed the COVID shot from a list of recommended vaccines for healthy children and pregnant women, which could limit insurance coverage.

The FDA recently gave full approval to a COVID vaccine made by Novavax Inc., but for a narrower group of people than before — adults 65 and older and those ages 12 to 64 who have an underlying condition that puts them at high risk if they get the virus.

Moderna’s approval faced even greater uncertainty because, unlike Novavax, its COVID vaccine uses mRNA technology, which has faced opposition from anti-vaccine groups that support Kennedy.

On Wednesday, U.S. health officials terminated a contract with Moderna worth up to $766 million to develop vaccines for bird flu. In a statement, an HHS spokesman said that “mRNA technology remains under-tested.”

Improved performance

Moderna’s next-generation COVID shot proved more effective in older adults in a key study than the version now available, called Spikevax.

Instead of targeting the entire spike protein on the surface of the virus, the new shot hones in on just two segments. The change helps it last longer when refrigerated, making it easier to distribute in certain parts of the world. It’s also more effective at lower doses, allowing the company to make combination shots that protect against both COVID and flu.

Packaging the two immunizations together will boost protection from COVID because more people get flu shots each year, according to the company.

More than five years after the start of the pandemic, the virus poses less of a threat, although the elderly and infants face higher risks than the general public. Many people no longer feel the urgency to get another COVID booster, having been infected multiple times and experienced mild symptoms. As a result, COVID vaccination rates have been in decline, with just 23% of U.S. adults getting the latest booster, according to the Centers for Disease Control and Prevention.

Kennedy has long criticized COVID shots, once claiming, without evidence, that they are “the deadliest vaccine ever made.” In a recent video announcing that COVID vaccines have been removed from the CDC’s recommended immunizations schedule, Kennedy said, “I couldn’t be more pleased.”

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(With assistance from Bill Haubert.)

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