FDA authorizes Pfizer and Moderna COVID vaccines for children under 5

The Food and Drug Administration clearance allows the use of Pfizer’s three-dose vaccine for youngsters ages six months through 4 years, made with German partner BioNTech SE, and Moderna’s two-dose vaccine for children six months through 5 years, according to a statement from the agency. The FDA also cleared the use of Moderna’s COVID shot for children and adolescents 6 to 17 years old. Until now, only Pfizer’s vaccine was available for this age group.

It’s been a year and a half since vaccines first became available, and an authorized vaccine will be welcome news for parents whose youngsters haven’t been able to get their shots. Pfizer’s vaccine had been delayed earlier when a two-dose regimen didn’t evoke an adequate response. 

The vaccines for the youngest of kids are expected to be rolled out as early as June 21, the Biden administration said earlier this month. The U.S. government has already secured a supply of 10 million doses from Pfizer and Moderna to vaccinate under-5s as soon as the FDA and the Centers for Disease Control and Prevention give the green light. 

Government programs and medical groups will provide education around vaccination’s risks and benefits. Once fully cleared by FDA and recommended by CDC, the shots will become available through a variety of locations, including pediatrician’s offices, and information will be available at the vaccines.gov website. 

While children are less likely than adults to experience the worst outcomes of COVID, the health officials have warned that the rate of hospitalization and death for children, particularly during the Omicron wave, has been concerning.

“Certainly our elder community has been among those that have been highest to cause risk of severe disease and death, but I will also say that COVID is one of the top leading killers of children right now,” CDC Director Rochelle Walensky said during a Senate Health, Education, Labor, and Pensions committee hearing on Thursday. Deaths from Covid among children, Walensky added, “have been higher than what we’ve seen for flu.”

Advisers to the CDC will hold are holding a meeting Friday and Saturday to discuss the shots for kids. The panel of outside experts, the Advisory Committee on Immunization Practices, advises the CDC on how best to administer new vaccines. Walensky will need to sign off on any recommendations before vaccines can begin to be administered.