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 antibody titers and concluded that the immunogenicity and reactogenicity of the vaccine in young children appeared to be similar to that of adults in Moderna’s Phase 3 COVE study.
The data collected in the KidCOVE study largely coincided with the omicron wave.
Moderna is also testing booster doses of its vaccine in children.
Pfizer and BioNTech are also pursuing regulatory authorization for their COVID-19 vaccine in young children. However, the two companies agreed to gather more data earlier this year before seeking such authorization.
On April 25, a House committee submitted a letter to FDA Commissioner Dr. Robert Califf seeking clarification concerning FDA’s plans to authorize COVID-19 vaccines in young children.
The Biden administration had reportedly discussed delaying authorization of COVID-19 vaccines in young children until June, according to a Politico article.
Chief Medical Advisor to the President Dr. Anthony Fauci recently said that FDA was mulling authorizing the Moderna and Pfizer vaccines in young children simultaneously to simplify messaging to parents. The Pfizer vaccine will like consist of a three-dose primary series for young children in contrast to Moderna’s, which would likely require two.
Filed Under: clinical trials, Drug Discovery, Infectious Disease