By Michael Dabaie
Moderna Inc. said it had positive interim data from the Phase 2/3 study of its Covid-19 vaccine candidate in children 6 to under 12 years of age.
The interim analysis showed a robust neutralizing antibody response after two doses of mRNA-1273 at the 50 ug dose level with a favorable safety profile, the company said Monday.
Moderna said it plans to submit these data to the U.S. Food and Drug Administration, European Medicines Agency and other global regulators in the near term.
Its shares rose 0.8% to $329.01 premarket.
The cohort enrolled 4,753 participants who were 6 to less than 12 years of age. The company said the results demonstrate strong immune response in this cohort of children one month after the second dose and met the co-primary immunogenicity objective for 6 to less than 12 years olds in its KidCOVE study.
KidCOVE is a study to evaluate the safety, tolerability, reactogenicity and effectiveness of two 50 ug doses of mRNA-1273 given to healthy children 28 days apart. The study population is divided into 3 age groups--6 to less than 12 years, 2 to less than 6 years, and 6 months to less than 2 years. Moderna on Monday reported on the 6 to under 12 years of age cohort.
MRNA-1273 was generally well tolerated with a safety and tolerability profile generally consistent with the Phase 3 COVE study in adolescents and adults, Moderna said. The majority of adverse events were mild or moderate in severity. The most common solicited adverse events were fatigue, headache, fever, and injection site pain, it said.
Moderna said safety data continue to accrue and the study continues to be monitored by an independent safety monitoring committee. All participants will be monitored for 12 months after their second injection.
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(END) Dow Jones Newswires