PHILADELPHIA (KYW Newsradio) — Moderna is preparing to ask the FDA to approve a COVID-19 vaccine for children 6 months to 6 years old. Experts are finding that evaluating the data for children this young can be a bit tricky, so they could have an uphill battle in getting emergency use authorization.
Moderna said there was a good antibody response in the study of about 6,700 children. According to Moderna, the vaccine decreased symptomatic disease by 43.7% for kids 6 months to 2 years old. For kids between 2 and 6 years old, the reduction was 37.5%.
While that may sound lower than previous vaccine studies, the company noted that the data came during the time of the omicron variant, and those percentages for children in the study were similar to numbers seen in adult populations.
Experts have said the true benefit of vaccines is preventing severe disease and death.
No children in the study died or were hospitalized, either in the placebo group or in the group that got the vaccine.
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Dr. Darren Mareiniss with Einstein Medical Center said there is some protection with the vaccine and only very minor side effects, with no cases of myocarditis.
“It may be protective, as we see with adults for severe disease, hospitalization and death, but there just wasn't any of that in the study, so it’s hard to say,” Dr. Mareiniss said.
“We would need a bigger study, I think, to discern that, and we just cannot in absolute terms say that based on this study data.”
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He said he feels some protection is worthwhile, so if it were up to him, he would approve it for now and continue studies on a larger group.
“Then going full forward, we could do more surveillance and study on a larger group to prove what we suspect, which is that it prevents serious disease, hospitalization and death,” he added.
Dr. Mareiniss said if the FDA doesn’t want to go that far, they could approve it for children at higher risk of severe disease.
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In the United States, Moderna is currently only offered to adults. Pfizer’s vaccine is available for everyone 5 years old and older, the only vaccine currently available for children in the U.S.
But currently, there is no vaccine offered for children under age 5. Pfizer was about to request approval for the younger age group last month, but pulled back.
Moderna also said that it would update its request to the FDA for a two-dose primary vaccine for children 6 to 12 years old, and a more powerful dose for kids 12 to 17 years old.
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