Replies to post #244239 on Biotech Values

[dewophile]

And to be clear GSKs maternal RSV program was not using adjuvant so very similar to what PFE has in the clinic.
Will be a nice win though if they cross the finish line. Gsk incidentally just got approval for their DPT vaccine to be used for vertical immunity in pregnancy for whooping cough. I can see pregnant women wanting to minimize any and all exposures so not sure the commercial opportunity

[DewDiligence]

PFE’s maternal RSV vaccine meets one of two primary endpoints, which PFE says is sufficient for FDA approval:

https://finance.yahoo.com/news/pfizer-announces-positive-top-line-103000293.html

The pre-planned, interim efficacy analysis conducted by an external and independent Data Monitoring Committee (DMC) met the success criterion for one of two primary endpoints. The observed efficacy for severe medically attended lower respiratory tract illness (severe MA-LRTI) was 81.8% (CI: 40.6%, 96.3%) through the first 90 days of life.

… 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.