Sometimes, individuals should read the FDA comments on delayed timeline for approvals. Maybe doing so would help one credibility wise. The delays seen here with the Moderna RSV vaccine have nothing to do with myocarditis, especially that none was reported in the clinical trial program. It is a simple administrative delay, as clearly demonstrated in the attached reference. Sorry Nikolai Petrovsky, you are totally wrong on all on this RSV vaccine. As a proof of such: « While the previously communicated Prescription Drug User Fee Act date was May 12, 2024, the FDA is now working to conclude the review by the end of May 2024. The Company has not been informed of any issues related to vaccine safety, efficacy or quality. The vaccine candidate is also on track to be reviewed at the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) meeting on June 26 to 27, 2024. The investigational mRNA-1345 vaccine is intended for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease in adults aged 60 years or older. The BLA is supported by data from the double-blind, placebo-controlled ConquerRSV trial (ClinicalTrials.gov Identifier: NCT05127434), which included approximately 37,000 adults 60 years of age and older. Study findings showed vaccine efficacy of 83.7% (95.88% CI, 66.1-92.2; P <.0001) against RSV-LRTD, defined by 2 or more symptoms. Vaccine efficacy against RSV-LRTD with 3 or more symptoms was reported to be 82.4% (96.36% CI, 34.8-95.3; P =.0078). The most common adverse reactions included injection site pain, fatigue, headache, myalgia, and arthralgia. » https://lnkd.in/epSCKEik
The big question - will FDA approve Moderna's RSV vaccine on the expected timeline without concrete data on the probability of it causing myocarditis - or are they not worried about this in this older population, and just let the market decide? If offered an mRNA RSV vaccine as opposed to the two existing protein RSV vaccines what would make someone pick the mRNA version over the others? Definitely more reactogenic and no evidence of any greater efficacy - you would have to imagine that even if FDA approved, being a late entrant with no market advantage it will be a major market flop. But first lets see what happens with the FDA approval.
