Dive Brief:
- The Food and Drug Administration has granted a priority review to Merck & Co.’s experimental pneumococcal vaccine, agreeing to decide on approval of the shot for adults by June 17, 2024.
- Referred to as V116, Merck’s conjugate shot is designed to protect against 21 strains of pneumococcal bacteria to prevent pneumonia and disease in adults. The pathogen presents greater risk to older adults or those who are immunocompromised, and V116 is meant to offer broader coverage than available vaccines.
- If approved, V116 will add to Merck’s pneumococcal vaccine franchise and compete against Pfizer’s leading Prevnar 20 shot.
Dive Insight:
Merck and Pfizer have been major players in the lucrative market for pneumococcal disease vaccines, but Pfizer has had the upper hand with its blockbuster Prevnar franchise. Prevnar 20, which was approved by the FDA in 2021, succeeded the earlier Prevnar 13 shot and has helped boost the company’s vaccine sales.
Merck also won a U.S. approval for a new pneumococcal vaccine, Vaxneuvance, in 2021. That shot, which protects against 15 strains, supplements the pharmaceutical company’s older Pneumovax 23 product.
V116 would be its next competitor. In July, Merck said the candidate succeeded in two late-stage clinical trials, one of which compared the shot to Prevnar 20. The company has touted the vaccine’s coverage of 8 strains that are not included in other shots, but are responsible for about 30% of invasive pneumococcal disease cases in adults 65 years and older.
The FDA grants priority review to drugs and therapeutics that could provide “significant improvement” in treatment or prevention of serious conditions.
Elsewhere, GSK and biotechnology company Vaxcyte are developing 24-valent vaccines against pneumococcal disease.