Moderna said Thursday that it asked the Food and Drug Administration for emergency use authorization of its COVID-19 vaccine in kids under age 6, making it the first drug company to do so.
The long-awaited announcement has been monitored closely by lawmakers, public health advocates and parents hoping to protect toddlers and babies against the virus. Pfizer is expected to soon follow Moderna and submit an emergency use application for its vaccine.
The request is based on a 25-microgram two-dose primary series and the application will be complete next week, the company said.
Initial data showed that Moderna’s COVID-19 vaccine was very safe for young kids, but not hugely effective at preventing infection. In March, Moderna announced its vaccine was roughly 44 percent effective at preventing mild illness in babies up to age 2, and 38 percent effective for kids ages 2 to 6.
The vaccine maker ran clinical trials before the omicron wave, and it’s unclear how the vaccine responds to the latest variant. Omicron and its subvariants now make up nearly 99 percent of sequenced COVID-19 cases in the U.S., according to the latest data from the Centers for Disease Control and Prevention.
Despite the data, Moderna CEO Stéphane Bancel said the vaccine application will make a big difference.
“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, Bancel said in a statement.
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