Moderna seeks emergency use authorization for Covid-19 vaccine for children ages
“We believe mRNA-1273 will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19, and will be especially welcomed by parents and caregivers,” Stéphane Bancel, chief executive officer of Moderna, said in a news release.
No Covid-19 vaccines have been authorized for children younger than 5 in the US — about 18 million people — and a timeline to potential authorization is not yet clear. Moderna officials have said the FDA is expected to move fast, and a Pfizer official suggested its vaccine for younger children could be available in June, if its authorized.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, this week called vaccines for younger children “one of our highest priorities,” but acknowledged the agency needed complete applications from vaccine manufacturers in order to finish its review.
The FDA will ask its independent vaccine advisers to weigh in on vaccines for younger children, too, and Marks said the agency would release a timeline for advisory committee meetings in the next week.
Moderna’s vaccine results
In late March, Moderna announced results of a clinical trial that included 2,500 children ages 6 months through 24 months and 4,200 children ages 2 through 5. The company said that two 25-microgram doses of its vaccine led to a similar immune response in young children as two 100-microgram doses for adults ages 18 to 25. And it said this should predict protection from Covid-19 and severe Covid-19 down to 6 months of age.
In Thursday’s news release, the company said the data showed “a robust neutralizing antibody response” and “a favorable safety profile.”
“We like to see anything above 1,000 units, and what we, in fact, saw here are levels somewhere between 1,400 and 1,800 units,” Dr. Paul Burton, chief medical officer of Moderna, said Wednesday. “So that’s extremely reassuring.”
Burton also said the vaccines were very safe for this age group. The most common reactions were pain at the injection site and fever. There were no cases of heart inflammation, or myocarditis, in the study. Heart inflammation has been an extremely rare side effect of the mRNA vaccines. Myocarditis is more common after Covid-19 infection than after vaccination.
The results announced in March were mostly collected during the Omicron wave, and included home testing for Covid-19. As a result, the company said the vaccines looked less effective for children than they did for older age groups.
The data presented by Moderna Thursday limited the analysis only to cases confirmed positive by sensitive PCR tests. In the revised analysis, the vaccines were 51% effective at preventing symptoms in children ages 6 months to under 2 years; they were 37% effective at preventing symptoms in kids ages 2 through 5. The company said these efficacy estimates are similar to those among adults against Omicron after two doses.
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