- Moderna Inc MRNA has announced interim data from the Phase 2/3 KidCOVE study of its COVID-19 vaccine (mRNA-1273) in children six months to under six years.
- The interim analysis showed that two 25 μg doses of mRNA-1273 in participants 6 months to under six years met the primary endpoint with robust neutralizing antibody response similar to adults mRNA-1273 and a favorable safety profile.
- The Company did say statistically significant vaccine efficacy was observed during the omicron wave, consistent with the lower two-dose effectiveness against omicron in adults.
- Last month, the FDA postponed the AdComm meeting scheduled for Pfizer Inc (NYSE: PFE) / BioNTech SE's BNTX COVID-19 vaccine in children six months through 4 years of age.
- Moderna is moving forward with global regulatory submissions for mRNA-1273 for primary vaccination of children six months to under six years of age in the coming weeks.
- Additionally, Moderna has initiated a submission to the FDA for emergency use authorization of mRNA-1273 in children 6 to under 12 years of age.
- mRNA-1273 is approved for use in this age group in Europe, Canada, and Australia.
- Moderna is preparing to evaluate the potential of a booster dose for all pediatric populations. The Company is assessing booster doses of mRNA-1273 and its bivalent booster candidate (mRNA-1273.214), including omicron variant booster and mRNA-1273.
- Price Action: MRNA shares are down 4.08% at $179.11 on the last check Wednesday.
- Photo by mufidpwt via Pixaby
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