While a portion of the public is now eligible to receive a second booster dose of COVID-19 vaccine, the FDA has not yet authorized a vaccine for children aged 6 months to 5 years old.
Moderna (Nasdaq:MRNA) is vying to be the first. The company announced today that it is filing a request for emergency use authorization (EUA) for its mRNA-1273 vaccine in young children. The company anticipates that it will complete the filing next week.
The request breaks young children into two groups, with the first covering the ages of 6 months to under 2 years and the second covering kids between 2 and 5 years old. The authorization request refers to a primary series consisting of two 25-μg doses of mRNA-1273.
Moderna also seeks similar authorizations for young children from other international regulatory bodies.
The company is basing the requests on positive interim data from the Phase 2/3 KidCOVE study, which met its primary endpoint.
The study analyzed…