Replies to post #244249 on Biotech Values

[DewDiligence]

PFE’s RSV vaccine_for adults—>May23 PDUFA—(with_FDA_priority_review):

https://www.businesswire.com/news/home/20221206006147/en

[DewDiligence]

MRNA is_a_serious_player_in RSV vaccines for_adults:

https://www.accesswire.com/735567/Moderna-Announces-mRNA-1345-an-Investigational-Respiratory-Syncytial-Virus-RSV-Vaccine-Has-Met-Primary-Efficacy-Endpoints-in-Phase-3-Trial-in-Older-Adults

Moderna…today announced positive topline data from its ConquerRSV Phase 3 pivotal efficacy trial of mRNA-1345, an investigational mRNA vaccine targeting respiratory syncytial virus (RSV) in older adults. Following review by an independent Data and Safety Monitoring Board (DSMB), the primary efficacy endpoints have been met, including vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p<0.0001) against RSV-associated lower respiratory tract disease (RSV-LRTD) as defined by two or more symptoms. Based on these results, Moderna intends to submit for regulatory approval in the first half of 2023.

…The ConquerRSV trial is a randomized, double-blind, placebo-controlled study of approximately 37,000 adults 60 years or older in 22 countries, including the US (https://clinicaltrials.gov/ct2/show/NCT05127434 ). The primary efficacy endpoints were based on two definitions of RSV-LRTD defined as either two or more symptoms, or three or more symptoms of disease… The other primary efficacy endpoint against RSV-LRTD defined by three or more symptoms was also met, with a VE of 82.4% (96.36% CI: 34.8%, 95.3%; p=0.0078). The trial is ongoing, and additional efficacy analyses are planned as cases accrue, including for severe RSV.

The interim analysis of the primary endpoint based on 2+ symptoms had 64 cases: the placebo-to-vaccine split was 55:9; the interim analysis of the primary endpoint based on 3+ symptoms had 20 cases: the placebo-to-vaccine split was 17:3.

The full dataset will be presented at an unspecified medical conference.