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.