Moderna applies to clear COVID shot for young kids
Moderna Inc. applied for emergency use authorization for its COVID-19 vaccine in children from six months to under 6 years old after a successful trial showed two doses generate high levels of antibodies to the virus.
The highly anticipated application comes just over a month after Moderna said a large trial showed two low doses of its vaccine produced powerful immune responses in young kids. Even though its effectiveness against omicron-related infections is modest, the application will put tremendous pressure on the Food and Drug Administration to quickly make a decision on whether to authorize it.
Similar submissions for clearance are underway with regulators outside the U.S., Moderna said Thursday in a statement. Meanwhile, Moderna has also initiated a submission for authorization of its vaccine for use in kids ages 6 to 11.
While the vaccine from partners Pfizer Inc. and Biontech SE is authorized for kids 5 and up in the U.S., there is no COVID vaccine those under 5, much to the consternation of many parents. More than 900 doctors sent a letter Wednesday to FDA Commissioner Robert Califf asking for quick review of a vaccine for young children.
Pfizer’s effort to bring forward a vaccine for the youngest children was delayed after immune responses from two doses appeared insufficient in some, and the company decided to wait for results from a third. But in an interview, Moderna Chief Medical Officer Paul Burton said the immune response generated by two doses of its vaccine should be enough to provide significant protection against severe disease in very young kids.
“There is an important unmet need here,” Burton said. The two-dose regimen “should be sufficient for primary vaccination” in the young kids, as it produced antibody levels similar to the levels that showed protection against serious disease in younger adults, he said.
Moderna received no indication of whether the FDA would wait for Pfizer’s upcoming three-dose data in young kids before deciding what to do with the company’s two-dose regimen, Burton said.