U.S. regulators have approved updated versions of the COVID vaccine, though a much smaller group of people will be eligible to receive them this fall after Health and Human Services Secretary Robert F. Kennedy Jr. took aim at the shots earlier this year.

The Food and Drug Administration on Wednesday cleared COVID shots that target strains related to the prevailing JN.1 variant of the virus.

People 65 and older and those who have underlying conditions that put them at higher risk from COVID are eligible to receive one. People over 6 months who don’t fall into that category can still get the vaccines, with the approval of a doctor. Last year, everyone was eligible for the shot without having to see a physician.

Moderna Inc. and Pfizer Inc. were both up around 1%, while Novavax Inc. shares gained 2.1% at 3:38 p.m. in New York on Wednesday. The companies all make COVID shots approved by the FDA for use this fall.

Who can get which COVID vaccine?

The FDA approval for a seasonal shot is normally a formality that draws little attention, but immunizations have become a major flashpoint in recent years. They’ve drawn even more scrutiny since Kennedy, a vaccine critic, was appointed to lead HHS earlier this year.

Under his leadership, agencies that are a part of HHS have taken a tougher stance on vaccines. In one of its more dramatic shifts, in May, the FDA said it would only give the green light to shots for older people and those with underlying conditions. The decision meant those who don’t qualify for the shots can only get them if their doctor prescribes the vaccine off-label, which could complicate insurance coverage in the future.

Kennedy’s moves have alarmed physicians’ groups, including the American Academy of Pediatrics, which called the latest restrictions on COVID vaccines “deeply troubling” on Wednesday. The group still recommends most children get vaccinated for COVID, and the American College of Obstetricians and Gynecologists advises women to get the annual shot whether they’re planning to get pregnant, carrying a child or lactating.

Curtailing access to COVID vaccines “puts millions of lives at risk,” the Infectious Diseases Society of America said in response to Wednesday’s FDA label decision, urging insurers to continue covering the shots and calling on Congress to take action.

Last year, HHS approved and called for COVID shots for everyone older than 6 months. Regulators had also expanded the vaccines’ availability through an emergency authorization, which Kennedy revoked Wednesday.

Limiting the number of people who get the vaccines could mean more people get COVID, or have worse outcomes, over the coming months. However, the shots were already widely unpopular. Just 23% of U.S. adults and 13% of children got a COVID booster made available last fall, according to the Centers for Disease Control and Prevention.

The FDA’s Wednesday decision is related to a process of putting out shots for diseases that rapidly mutate, meaning manufacturers tweak the formulas each year to target the strain they expect to circulate over the fall and winter. Typically they base their decision on recommendations from the World Health Organization.

Advisers to the agency met earlier this year and decided to pinpoint the JN.1 variant. After the strain is selected, manufacturers produce large quantities of the shot.

The FDA then later approves the new formula, which allows companies to ship doses. That clearance was what went through Wednesday, meaning the latest COVID boosters will soon arrive at pharmacies, hospitals and clinics.

Pfizer also received FDA clearance Wednesday for its COVID shot in children as young as 5 who have at least one underlying condition that puts them at high risk for severe disease. Additionally, Novavax’s vaccine is approved for people 12 and older at elevated risk.

Moderna’s shot won approval for children as young as 6 months in July.

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