Moderna Seeks FDA Emergency Use Nod For COVID-19 Shot In Kids 2-6 Years

Moderna Inc MRNA submitted a request for FDA emergency use authorization (EUA) for its COVID-19 vaccine (mRNA-1273) in children six months to under six years of age. 

The requests are based on a 25 μg two-dose primary series of mRNA-1273.

Positive interim results from the Phase 2/3 KidCOVE study showed a robust neutralizing antibody response in the six months to under six years of age group after a two-dose primary series of mRNA-1273 and a favorable safety profile. 

Related: Poland, Moderna Working Towards Increased Flexibility Of COVID-19 Vaccine Contracts: Reuters.

The antibody titers in the pre-specified 6-month to 23 months and two years to under six years age sub-groups met the statistical criteria for similarity to the adults in the COVE study.

Also See: Pfizer, BioNTech Seeks Emergency Use Nod For COVID-19 Vaccine For Kids 5-11 Years.

The EUA submission for children ages six months to under six years will be complete next week. Moderna is also currently studying booster doses for all pediatric cohorts.

Price Action: MRNA shares are up 0.15% at $142.64 during the market session on the last check Thursday.

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