Replies to post #244373 on Biotech Values

[dewophile]

Although the statistical success criterion was not met for the second primary endpoint [prevention of hospitalization] clinically meaningful efficacy was observed for MA-LRTI of 57.1% (CI: 14.7%, 79.8%) in infants from birth through the first 90 days of life.

It looks like prevention of hospitalization was a secondary endpoint:

Secondary Outcome Measures :
The percentage reduction in the incidence of hospitalizations due to RSV in infants through 360 days of life

https://www.clinicaltrials.gov/ct2/show/NCT04424316

I think the other primary efficacy endpoint that was not met was "The percentage reduction in the incidence of medically attended LRTI (MA-LRTI) due to RSV in infants through 180 days of life" , which showed numerical benefit but probably had a CI whose lower bound was below the prespecified statistical threshold

[DewDiligence]

PFE’s maternal RSV vaccine has Aug 2023 PDUFA—(with_FDA_priority_review):

https://finance.yahoo.com/news/u-fda-accepts-biologics-license-114500315.html

In data reported in Nov 2022, one of two primary endpoints was met, but PFE said this was sufficient for FDA approval (#msg-170339033).

GSK terminated its own program for a maternal RSV vaccine, so PFE will have the only maternal RSV vaccine on the market if this BLA is approved.