• Posted July 11, 2025

FDA Fully Approves Moderna’s COVID Vaccine for Some Young Kids

Moderna’s COVID-19 vaccine has received full approval from the U.S. Food and Drug Administration (FDA) for use in children with medical conditions that put them at higher risk of severe illness.

The move makes Moderna’s vaccine, called Spikevax, the first COVID shot for kids in the U.S. to be fully approved, rather than used under emergency authorization, STAT News reported.

The vaccine can now to be given to children ages 6 months through 11 years, but only if they have at least one health issue that increases their COVID risk.

“COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions," Moderna CEO Stéphane Bancel in a statement.

"Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization,” he added.

Spikevax was already fully approved for people 12 and older. Moderna expects to have an updated version of the vaccine ready for the 2025-26 virus season.

Children ages 6 months to 23 months who have never been vaccinated need two shots, a month apart. Kids older than 2, or those who have already been vaccinated, should get one shot.

The FDA action comes weeks after U.S. Health Secretary Robert F. Kennedy Jr. said the government would no longer recommend the COVID vaccine for healthy children or pregnant people.

Dr. Fiona Havers is a former U.S. Centers for Disease Control and Prevention (CDC) medical expert who recently left the agency due to Kennedy's new vaccine policies.

“Young age by itself is a risk factor for severe COVID,” she told STAT News.

"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," she added.

Babies under 6 months of age have the second-highest rate of hospitalization for COVID after adults 75 and older, according to recent data from the U.S. Centers for Disease Control and Prevention (CDC).

These infants are too young to be vaccinated, but even 6- to 23-month olds have a hospitalization rate similar to adults aged 50 to 64, STAT News reported.

Havers said a CDC group had planned to revise recommendations to encourage COVID vaccination for kids under 2. But that work stopped when Kennedy fired the CDC’s entire vaccine committee last month.

She said the FDA’s new limits along with Kennedy’s many changes may make it harder for parents who want to vaccinate their babies.

Some doctors may also hesitate to give the vaccine to healthy kids if it’s not officially approved for them, she added.

“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.”

More information

Moderna has more on Spikevax.

SOURCE: STATNews, July 10, 2025