Moderna Reports Interim Results of COVID-19 Vaccine (mRNA-1273) in P-II/III (KidCOVE) Study for Children Aged 6 Months to Under 6 Years
Shots:
- The P-II/III (KidCOVE) study evaluates mRNA-1273 in 11,700 pediatric patients including ~4,200 children aged 2 to ≤6yrs. & ~2,500 aged 6mos. to ≤2yrs. with COVID-19
- The study met its 1EPs i.e., the vaccine showed a robust neutralizing Ab response in both age groups after a 25µg two-dose primary series of mRNA-1273 along with a favorable safety profile, immunogenicity was similar to 100µg two-dose primary series in adults aged 18 to 25yrs. with no new safety concerns, no deaths, no myocarditis or pericarditis & no MIS-C were reported
- The company plans to submit a request to the US FDA, EMA & other global regulators for the EUA of mRNA-1273 for children aged 6mos. to ≤6yrs. in the coming wks.
Ref: Moderna | Image: Moderna
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