Biotech | April 29, 2022
Moderna files for authorization of its Covid-19 vaccine in young children six months to six years
Submission to regulators globally is based on phase 2/3 studies of mRNA-1273 in young children
Submission to regulators globally is based on phase 2/3 studies of mRNA-1273 in young children
Both mRNA-1020 and mRNA-1030 target hemagglutinin and neuraminidase antigens, two major influenza surface glycoproteins that are essential across the viral life cycle
The FDA decision is primarily informed by the positive results of a proof-of-concept, Phase 2a study evaluating the safety, immunogenicity, and efficacy of a single dose of 120µg RSVpreF in a human viral challenge model in healthy adults 18 to 50 years of age
High level of vaccine efficacy maintained over a 6-month period of surveillance
Monitoring results demonstrated a good safety profile of the combination. No serious adverse events related to vaccination were registered
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Primary endpoints and secondary endpoints for which data are available were met in trial dominated by Covid-19 variants
The submission is based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11
The Phase 3 study is designed to bridge data collected from the vaccine efficacy trial conducted in India to the U.S. population
First participants enrolled in Phase 1 clinical trial of combination NanoFlu/NVX-CoV2373 vaccine with Matrix-M adjuvant. The Phase 1/2 study will also evaluate immunogenicity and safety
The study is being carried out by the platform VISION (Vaccine Immunology Studies – Indian Outbreak-response Network) which includes top public and private research institutes.
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