Pfizer's COVID-19 vaccine is safe, effective in kids ages 5 to 11, setting up possible FDA nod

COVID-19 vaccine
Data released ahead of an FDA advisory committee meeting show the Pfizer vaccine is 90% effective in kids ages 5 to 11. (Getty/Meyer & Meyer)

Amid the nationwide COVID-19 vaccination campaign, youngsters 11 and under have been ineligible for shots—even though millions are back in school. With new Pfizer data, that could soon change.

On Friday, the FDA released (PDF) data showing the Pfizer vaccine is safe and effective in children ages 5 to 11 as a two-dose regimen. In testing in more than 2,200 kids, the shot was 90% effective in preventing symptomatic COVID-19.

The FDA released the data ahead of Tuesday’s advisory committee meeting to decide whether to recommend the age group for approval. Pfizer requested the nod earlier this month. A green light would clear 28 million kids in the United States to receive the shot.

RELATED: Pfizer's COVID-19 vaccine scores FDA nod in adolescents, enabling a wider rollout

Kids in the age group would receive doses a third of the size of what adults get, with the shots scheduled three weeks apart. In the study, the vaccine induced antibody levels in kids comparable to those seen in the control group, recipients ages 16 to 25.

No cases of the rare heart inflammation condition myocarditis were seen in the more than 1,500 children who received the shot, though researchers said the study size wasn’t large enough to assess a potential risk.

Myocarditis concerns have presented a potential stumbling block for the Moderna vaccine. After four Nordic countries suspended use of the shot for those under age 30, the FDA delayed a decision on whether to allow kids aged 12 to 17 to receive the jab, according to The Wall Street Journal.

RELATED: FDA delays decision on Moderna's COVID-19 vaccine in 12-17 age group because of myocarditis concerns: WSJ

In a study of 3,700 adolescents who received the Moderna vaccine, there were no reports of myocarditis. The company then followed up in June with a request to the FDA to expand use of its vaccine in teenagers.