Moderna Asks FDA To Authorize First COVID Vaccine For Young Children

By Bill Galluccio

April 28, 2022

Photo: Getty Images

Moderna has requested an emergency use authorization from the Food and Drug Administration for its COVID-19 vaccine for young children. If authorized, it would be the first vaccine for children between the ages of six months and five years old.

"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 press release.

Moderna said that clinical trials showed a robust immune response when young children were given two 25-microgram doses of the vaccine. The company said that the amount of neutralizing antibodies was similar to that of adults, who were given two 100-microgram doses of the vaccine.

"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. "So that's extremely reassuring."

The company said that the efficacy of the vaccines was 51% for children between two and five years old, while it was 37% for children between six months and two years old. That is similar to the efficacy against the Omicron variant for adults.

It is unclear when the FDA will review the data and authorize the vaccine. According to a report from Politicothe FDA may wait until late June so it can approve Moderna's vaccine at the same time it authorizes one made by Pfizer.

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