Moderna Inc (NASDAQ: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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