Moderna’s coronavirus vaccine for kids under 5 is safe and effective, reviewers with the US Food and Drug Administration said in a briefing document released late Friday ahead of an upcoming meeting about granting an emergency use authorization.
“Available data support the effectiveness of the Moderna COVID-19 vaccine in preventing symptomatic COVID-19 in pediatric age groups from 6 months through 17 years of age,” the document says.
The FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to meet next week to decide whether the agency should OK Moderna’s request for an emergency use authorization of its vaccine for kids from 6 months through 5 years old, as well as a request for kids from 6 through 17 years old. An application from Pfizer and partner BioNTech to authorize their pediatric vaccine for children under 5 will also be up for consideration.
Kids under 5 in the US still can’t receive a coronavirus vaccine. Older children can get Pfizer-BioNTech shots.
Read more: When Can Kids Get the COVID Vaccine or Booster?
Moderna’s low-dose pediatric vaccine was found to be 51 percent effective in preventing symptomatic infection in kids from 6 months to 2 years old and 37 percent effective in kids 2 to 5, The New York Times said in a report about the briefing document. The FDA cautioned that estimates on the vaccine’s effectiveness were based on only a few cases of COVID-19. The agency also said kids would probably need to get a booster shot, as adults already do.
The FDA reviewers said the Moderna vaccine for kids didn’t produce cases of inflammation of the heart muscle and surrounding tissue — myocarditis or pericarditis — a rare side effect that’s a risk for young men who get the Moderna or Pfizer shots, the Times reported.
This week, the White House said that if they’re approved, vaccines for kids under 5 could start being administered as soon as June 21 and that 10 million doses would initially be available, The Washington Post reported.
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