Jun 11, 2022 - Health

FDA says Moderna's COVID vaccine is safe and effective for children

A health worker fills a syringe with Moderna COVID-19 vaccine in London in April 2022.

A health worker fills a syringe with Moderna COVID-19 vaccine. Photo: Dinendra Haria/SOPA Images/LightRocket via Getty Images

Scientists with the Food and Drug Administration said in new analysis of data released on Friday that Moderna's coronavirus vaccine is safe and effective for young children and infants.

Why it matters: The FDA's outside advisers will review this data at a meeting next week and will also decide whether to authorize the company's vaccine for babies and children younger than 5 years old.

  • They remain the only people in the U.S. ineligible to receive a coronavirus vaccine.

The big picture: Moderna sent a request to the FDA in April for an emergency use authorization for vaccine in children 6 months to under 6 years of age.

  • Pfizer and BioNTech is also seeking an emergency use authorization to vaccinate children with their coronavirus vaccine. The FDA's outside advisers will also consider Pfizer and BioNTech's vaccine next week.
  • The CDC's advisory committee will then meet on June 17 and 18 to discuss approving the companies' vaccines.

Anticipating approval of the authorizations, the Biden administration said this week that it has made 10 million COVID-19 vaccine doses available for young children and infants.

  • It expects that the first doses could be available by June 21.

Go deeper: Biden administration outlines plan for vaccinating children under 5

Go deeper