If the vaccine gets approved by the Food and Drug Administration (FDA), Moderna will be the first vaccine in the United States to have approval for children under the age of five.

“I think the FDA now has all of the core fundamental data they need to be able to begin an application review. So yes, we’re very confident,” said Dr. Paul Burton, the company’s chief medical officer.

Moderna’s vaccine has already been approved for children under five years old in Canada, Australia, and Europe.

“The safety profile we’ve seen in this vaccine in these very youngest kids is very reassuring – actual rates of safety events even lower than we’ve seen in the six-year-olds to 12-year-olds and that’s great,” Burton said.

Burton said that the company is testing another booster shot that could be superior and will target not only COVID-19 but also the beta variant. He said these new booster vaccines should be ready by fall 2022.

If the FDA approves the Moderna vaccine for children under five years old, then the Center for Disease Control and Prevention (CDC) will have to recommend which children will need the vaccine.

There is a whole process that needs to be followed for the vaccine to get approved. First, the FDA must evaluate the emergency use request, and then a public meeting of the vaccine advisory committee needs to be scheduled. The CDC’s Advisory Committee on Immunization Practices will need to evaluate the vaccine, as does the American Academy of Pediatrics and the American Academy of Family Physicians. 

This vaccine for children under five years old will consist of a two-dose primary series of shots, with 25 micrograms in each dose.

If this vaccine does get approved by the FDA, it may still be a while before the vaccine is given to children under five years old just for extra precaution.