Moderna Says COVID Vaccine Works For Young Children, Will Seek FDA Approval

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Moderna said on Wednesday that its coronavirus vaccine works in children ages 6 months to 6 years old, and that it plans to seek approval from global health regulators.

The pharmaceutical company said in a statement on Wednesday that a COVID-19 vaccine study on children ages 6 months to 6 years old was successful. The $75 billion vaccine-maker described the results in a press release but has not published the results in a medical journal.

No COVID-19 vaccine has been OK’d for use in children under the age of 5 years old in the US. Last month, Pfizer postponed its own authorization application for young children, saying it would wait for additional data on a three-dose course expected in early April.

Moderna tested a two-dose regimen with 25 microgram shots, still a fraction of the original 100 microgram dose given to adults, but still far higher than what Pfizer had been testing with a 3 microgram dose. Moderna said its study involved about 6,700 children in two groups: ages 6 months to under 2 years old and 2 years to under 6 years old.

Despite claims of success, the efficacy results were modest. Moderna said the vaccine was about 44% effective at preventing symptomatic infections in children between 6 months and 2 years old. For children between 2 and 5 years old, the two-dose regimen was 38% effective at preventing symptomatic infection.

No children in the vaccinated or placebo groups developed severe COVID-19, were hospitalized, or died.

“We believe these latest results from the KidCOVE study are good news for parents of children under 6 years of age,” said Stéphane Bancel, Moderna’s CEO, in the statement. “We now have clinical data on the performance of our vaccine from infants six months of age through older adults.”

The safety profile was in line with children ages 6 to 12 years old, Moderna said. Most side effects were mild or moderate and happened more frequently after the second dose, the company said. The study identified no new safety concerns, Moderna added.

The company said it would now seek approval from the US Food and Drug Administration, the European Medicines Agency, and other global regulators.

Moderna said it would also ask the FDA for permission to offer the shot to kids ages 6 to 12 in the US. Those older kids can already get the shot in Europe and Canada.