Vote expands existing recommendation, which was for all adults aged 75 and older and high-risk adults aged 60 to 74
Decision on EU marketing authorisation for this population expected by September 2024
Over 13 million US adults aged 50-59 years have a medical condition that increases their risk of severe RSV outcomes
mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes
U.S. FDA has informed Moderna that due to administrative constraints, the agency will not complete its review of mRNA-1345 by the PDUFA date of May 12, 2024
The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia
Exothera will manufacture Meissa’s MV-012-968 vaccine candidate under CGMP regulations to supply Phase 2 clinical trials
Pfizer is likely to show GSK significant competition
The companies are now preparing to initiate a Phase 1 trial to assess the safety and immunogenicity of BLB-201 in healthy volunteers
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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