• Staff

Merck Looks For FDA Review for 15-strain Pneumonia Vaccine

Prevnar 13, Pfizer’s $5.8 billion-a-year vaccine is unarguably one of the firm’s top blockbusters and the undisputed leader in the pneumococcal vaccines’ market. But in terms of the next generation of pneumonia protection, Pfizer is facing a tough competitor in Merck.

Merck is pulling close to Pfizer in the race to launch a next-generation-pneumococcal vaccine on the market thanks to the FDA, which approved the company’s application for the experimental shot V114 – and granted it priority review. The agency is in line to decide on Merck’s product by July 18, 2021.

The FDA granted V114 a quick review just a month after doing the same for Pfizer’s next-generation vaccine candidate, 20vPnC. The agency aims to rule on that vaccine in June. Pfizer’s vaccine covers 20 strains of the pneumococcal bacterium, while Merck’s covers 15.

The FDA prioritized review of Merck’s vaccine based on phase 2 and 3 studies in which adults were given the shot in various settings, including co-administration with the flu vaccine, the company disclosed in a statement.

However, Merck has also placed V114 in head-to-head matchups against Prevnar 13 and showed impressive results. In a study of healthy adults age 50 and older, Merck’s experimental vaccine turned had similar efficacy as Prevnar 13 in protecting against the 13 strains that Pfizer’s vaccine covers.

Merck’s next-generation-shot beat Prevnar in shielding against two additional strains that the company estimates brings about 13% of invasive pneumonia cases in Americans over age 65.

At a presentation during the yearly J.P. Morgan healthcare conference on Jan. 11, Merck’s CEO Ken Frazier tagged V114 a vital driver in the company’s late-stage portfolio and part of a “suite of vaccines” to shield against pneumonia that are entering the market. He added that Merck anticipates advancement of clinical trials for two additional pneumococcal vaccines, V116 and V117, this year.

Merck’s V117 is already in the development stage for kids and could become a major player in the firm’s push to rival Pfizer in the pediatric market for pneumococcal vaccines. Merck’s Pneumovax is only cleared for adults, while Pfizer’s Prevnar 13 is approved for both adults and kids.

Merck developed V114 with an identical conjugate technology to the one used for Prevnar 13, and the firm is testing it in children. The company expects to complete the pediatric trials in November, which could actually place it ahead of Pfizer’s next-generation vaccine in that market. Pfizer confirmed that it will submit an application for pediatric approval of its 20-valent vaccine in late 2022.