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Re: DewDiligence post# 236061

Wednesday, 06/09/2021 11:42:03 AM

Wednesday, June 09, 2021 11:42:03 AM

Post# of 251541
FDA approves PFE’s Prevnar-20 pneumococcal_vaccine_for_adults:

https://finance.yahoo.com/news/u-fda-approves-prevnar-20-231200834.html

Prevnar-20 is PFE’s enhancement to Prevnar-13 — with protection for 7 additional serotypes that account for about 40% of serious pneumococcal infections. Prevnar-13 has been PFE’s biggest-selling product,* doing $5.9B in 2020 sales. The Prevnar-20 pediatric program has its own set of clinical trials, with an expected BLA submission in 2022.

Meanwhile, MRK is trying to compete in the adult and pediatric pneumococcal-vaccine markets with V114, a 15-serotype. V114 for adults is under FDA review with a PDUFA date in Jul 2021. MRK expects a BLA submission for the pediatric market in late 2021.

Prevnar-20 would seem to have an insurmountable edge versus V114 due to coverage of 5 additional serotypes; however, the commercial success of both vaccines will depend greatly on the recommendations of the CDC’s ACIP committee. ACIP is scheduled to convene in Oct 2021 to make recommendations vis-à-vis the adult market.

PFE recently started a trial to co-administer (but not co-formulate) Prevnar-20 and PFE’s COVID-19 vaccine (#msg-163985031). Although Prevnar has no efficacy against COVID per se, it protects against secondary bacterial pneumonia infections that are the proximal cause of many COVID-related deaths.

*Eliquis is a bigger-selling drug, but Eliquis revenues are split between PFE and BMY.

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