US Approves Latest Covid Shots With New Limits on Who Gets Them

The Food and Drug Administration on Wednesday cleared Covid shots that target strains related to the prevailing JN.1 variant for people 65 and older or who have underlying conditions. Last year, everyone was eligible for a Covid booster.

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 Robert F. Kennedy Jr., a vaccine critic, was appointed to lead the US Department of Health and Human Services 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, and insurance may not cover it.

Each year, FDA advisers meet to formally decide which strains to include, typically aligning with recommendations from the World Health Organization. Once selected, manufacturers, like Moderna Inc. and Pfizer Inc., produce large quantities of the shot. 

The FDA then later approves the new formula, which allows companies to ship doses to pharmacies, hospitals and clinics. 

Pfizer also received approval 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, Kennedy said Wednesday. Additionally, Novavax Inc.’s vaccine is approved for people 12 and older at elevated risk.

Moderna’s shot was already approved in July.

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

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