Moderna announces promising efficacy results from mRNA flu vaccine trial
mRNA-1010 demonstrated superior relative vaccine efficacy
mRNA-1010 demonstrated superior relative vaccine efficacy
In a Phase 3 trial, Pfizer and BioNTech’s combination vaccine candidate against influenza and COVID-19 met one of its two primary immunogenicity objectives
Higher efficacy was observed in mRNA-1283 compared to Spikevax in adults 18 years of age and older
Final stage in licensing OVM-200 from Oxford Vacmedix in the UK
mRNA-1345 demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease, defined by 2 or more symptoms in older adults
The approval follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October 2022
This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan
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
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