Moderna said Oct. 31 that the FDA needs more time to complete its review of its COVID-19 vaccine in children ages 12 to 17 as the agency analyzes the risk of myocarditis following inoculation.
The drugmaker was informed by the FDA on Oct. 29 that the review might not be completed before January, Moderna said in a news release.
The FDA is analyzing a potential increased risk of myocarditis — or inflammation of the heart muscle — following vaccination with Moderna's COVID-19 vaccine in children as young as 12. An increased risk of the condition has been seen in vaccine recipients, particularly in young men and after the second dose, though the CDC and World Health Organization have reported that cases of myocarditis generally have been mild.
Moderna said that more than 1.5 million kids have received its COVID-19 vaccine and that to date the observed risk of myocarditis reports in adolescents doesn't suggest an increased risk of the condition in the age group.
"The company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence," Moderna said in the release.
The drugmaker said it will delay filing emergency use authorization for its COVID-19 vaccine for children as young as 6 until the FDA completes its analysis of the shot in children as young as 12.
Moderna requested its vaccine be authorized for children as young as 12 in June, submitting data saying the shot was 100 percent effective against COVID-19 in the age group.