Moderna Inc (MRNA)

[DewDiligence]

GSK/(PFE)/(MRNA)—FDA_lowers_youngest_age_for Arexvy to 50—(rather than 60):

https://www.businesswire.com/news/home/20240606055012/en

The regulatory application was supported by positive results from a phase III trial (https://www.clinicaltrials.gov/study/NCT05590403 ) evaluating the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, including those at increased risk for RSV-LRTD due to certain underlying medical conditions.

ACIP will presumably endorse this change at its meeting on Jun 26-27, making GSK the first RSV-vaccine company with a recommendation for the 50-59 group.

The clinical trial referenced above was a “bridging study” rather than an efficacy study. I.e., the trial showed that adults age 50-59 given Arexvy had a non-inferior safety profile and immune response compared to adults age 60+ in a separate arm of same trial.