No. of Recommendations: 2
Moderna's RSV vaccine, which was recently shown to be highly effective at preventing symptoms of RSV in a Stage 3 trial, received a boost from the US federal government yesterday.
Press release from Moderna:
https://finance.yahoo.com/news/moderna-granted-fda..."
Moderna ... today announced [their] investigational mRNA vaccine candidate for respiratory syncytial virus (RSV), has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) in adults aged 60 years or older. The designation was based on positive topline data from the ConquerRSV Phase 3 pivotal efficacy trial...
The FDA's Breakthrough Therapy Designation is granted to expedite the development and review of drugs that are intended to treat a serious condition, and when preliminary clinical evidence indicates the drug or vaccine may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)...
Moderna intends to submit a license application for regulatory approval in the first half of 2023.
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Pfizer is ahead of Moderna in this race, having previously received the same designation and already having completed their submission for approval, which is receiving priority review and should have a decision in May. Preliminary results indicate an edge for Moderna's vaccine at preventing 2 or more symptoms, so it should be highly competitive when it gets to market. If things go smoothly, it could have approval in time for the fall/early winter vaccinations.
