FDA: Full approval for Moderna's Covid vaccine for children, limited eligibility

Moderna’s Covid-19 vaccine for children has been given full Food and Drug Administration approval, making it the first Covid vaccine for kids in the United States that will no longer be administered under an emergency use authorization. 

But the approval comes with a proviso: It is for use in children who have at least one medical condition that puts them at increased risk of severe illness from Covid, according to the FDA.

The company announced Thursday that the FDA has approved a supplemental Biologics License Application for its vaccine, Spikevax, to include children ages 6 months to 11 years. Spikevax was issued a BLA for use in people 12 years of age and older in early 2022.

“Covid-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions. Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization,” Moderna CEO Stéphane Bancel said in a statement.

The company said it expects to have its updated version of the vaccine available for the 2025-26 respiratory virus season.

Children ages 6 months to 23 months who have never been vaccinated against Covid need two shots, spaced one month apart. Children who have been previously vaccinated, or who are older than 2 years of age, should get a single shot.

The limitation on who is eligible to receive the vaccine follows from health secretary Robert F. Kennedy Jr.’s announcement in late May that he had unilaterally revised the recommendations on who should be vaccinated against Covid. In that unprecedented announcement, Kennedy said Covid vaccine would no longer be recommended for healthy children and healthy pregnant people.

That approach has been criticized by experts who say it ignores what is known about who is at risk from Covid infections. Very young children are considered one of the populations most likely to need hospitalization for Covid infection. 

“Young age by itself is a risk factor for severe Covid,” said Fiona Havers, a medical epidemiologist who quit the Centers for Disease Control and Prevention last month over Kennedy’s vaccination policies. 

“We know that more than half of the children who are being hospitalized for Covid are less than age 2, and among those, most of them do not have an underlying medical condition,” Havers told STAT in an interview. Havers had led the CDC’s Respiratory Virus Hospitalization Surveillance Network.

Data presented last month to the CDC’s expert vaccines panel, the Advisory Committee on Immunization Practices, showed that babies under 6 months old have the second-highest rate of hospitalization for Covid, after adults aged 75 and older.

Infants under 6 months are too young to be vaccinated. But babies ages 6 to 23 months also have an elevated risk of hospitalization — about the same rate as adults aged 50 to 64 years.

In a statement, a spokesman for the Department of Health and Human Services maintained that healthy children with Covid have “consistently shown strong resilience and face an extremely low risk of serious illness or harm. For these children, the risks of the COVID-19 vaccine may outweigh the potential benefits.”

“All families retain the option to consult with their child’s physician about whether to receive the COVID-19 vaccine,” the spokesman, Andrew Nixon, said.

Havers said the ACIP’s Covid work group was planning to revise the Covid vaccination recommendations when Kennedy fired the entire committee in early June. The group had already signaled it was likely to change its recommendation for older children — that they could get vaccinated, but wouldn’t be urged to do so — and it was considering recommending children under age 2 be vaccinated.

Kennedy’s recommendation — and the FDA license stipulation — will likely make it difficult for parents who want to get their babies vaccinated against Covid to do so, Havers said. Among other considerations, physicians may be concerned about liability if they recommend what is effectively off-label use of the vaccine, she said.

“They’re naive to the virus, and, generally speaking, it’s riskier for a very young infant to have any sort of respiratory infection than it is for an older child,” Havers said. “So this FDA decision is going to leave infants vulnerable to severe disease, and parents who want to protect their baby from severe Covid are going to be left with fewer choices.”