Moderna to File for EUA of COVID-19 Shot for Very Young Kids by April 30

By Reuters Staff

April 22, 2022

(Reuters) - Moderna plans to submit an application to the U.S. health regulator for emergency use authorization (EUA) of its COVID-19 vaccine among kids between the ages of six months to five years by end of the month, a company spokesperson said on Wednesday.

Omicron was the predominant ciruculating variant during Moderna's pediatric trial, and the drugmaker said two doses were around 38% effective at preventing infections in 2 to 5-year-olds and 44% effective for children aged 6 months to under 2 years.

Last week, Pfizer Inc and BioNTech said a third dose of the COVID-19 vaccine produced significant protection against the Omicron variant in healthy children from ages 5 to 11.

Earlier this year, the U.S. Food & Drug Administration authorized a third dose of the Pfizer/BioNTech vaccine for children ages 12 to 15 and those aged 5 through 11 who are immunocompromised.