Merck and Co Inc (MRK)

[DewDiligence]

MRK’s Vaxneuvance—(f/k/a V114)—meets_immunogenicity_NI_endpoint_in all_but_one_serotype in_infants_<3mo:

https://www.businesswire.com/news/home/20210825005054/en

The comparator was PFE’s Prevnar-13, which is effectively an obsolete product now that PFE has Prevnar-20, which has protection for seven additional serotypes.

Vaxneuvance narrowly missed non-inferiority to Prevnar-13 on serotype 6A; it’s unlikely, IMO, that this one miss will prevent regulatory approval. (Non-inferiority in this trial was predefined as the lower bound of the 2-sided 95% CI on effect size being >0.50.)

The real issue for MRK’s Vaxneuvance is that PFE’s new Prevnar-20 looks set to capture the lion’s share of the market for next-generation pneumococcal vaccines.