- The FDA has approved a new version of a Pneumococcal vaccine developed by Merck (NYSE:MRK) for the prevention of invasive disease caused by 15 strains of Streptococcus pneumoniae, the company announced on Friday.
- VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) is indicated for adults 18 years of age and older.
- An expert panel of the U.S. Centers for Disease Control and Prevention (CDC) is expected to meet next week to issue recommendations on the use of the vaccine, Merck said in a statement.
- The clinical data have indicated that in terms of protection against 13 strains of the bacteria, the newly approved vaccine is comparable in efficacy to Prevnar 13 developed by Pfizer (NYSE:PFE).
- However, compared to Prevnar 13, its immune response is superior against a shared strain called serotype 3 and two additional strains uniquely targeted by the vaccine called 22F and 33F.
- “Serotypes 3, 22F, and 33F contribute significantly to the burden of IPD, and serotype 3 is the leading cause of IPD in adults in the U.S.,” Merck added.
- The approval comes just over a month after the FDA decision to greenlight PREVNAR 20, an updated version of the company’s existing Pneumococcal shot that generated $5.9B sales in 2020.
- Merck is partnered with Ligand Pharmaceuticals (LGND -2.3%) on the vaccine, which uses the latter's CRM197 carrier protein (PeliCRM).