Merck's 21-Valent Pneumococcal Conjugate Vaccine Capvaxive Approved by FDA, Poised to Challenge Pfizer's Prevnar Dominance

MSD's (MRK.US) 21-valent pneumococcal conjugate vaccine Capvaxive (V116) has been approved by the U.S. Food and Drug Administration (FDA) for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults aged 18 years and older.

Studies show that Capvaxive can prevent bacterial strains responsible for approximately 80% of pneumococcal diseases, while the proportion for Pfizer's (PFE.US) 20-valent pneumococcal vaccine Prevnar is 50%. This implies that Capvaxive could become the preferred vaccine for preventing pneumococcal diseases and pose a challenge to Pfizer’s leading position in this vaccine market.

The commercial prospects of Capvaxive depend on the U.S. Centers for Disease Control and Prevention (CDC), which will decide later this month whether to recommend Merck Sharp & Dohme AG's vaccine for adults aged 50 and over.

Cantor Fitzgerald analyst Louise Chen said that if the CDC gives preferential treatment to Capvaxive, MSD may gain an advantageous position in its competition with Pfizer's Prevnar. Data shows that Prevnar holds nearly 95% of the market share, generating over $6 billion in annual revenue for Pfizer. Typically, people only receive this type of vaccine once in their lifetime.

Keytruda, the blockbuster cancer drug that contributes nearly half of MSD's revenue, will face pricing pressure by the end of this decade. As MSD strives to expand its new product portfolio, Capvaxive complements the company’s traditionally robust vaccine business. Data shows that MSD's HPV vaccine Gardasil generated nearly $9 billion in revenue for the company last year, while its pediatric pneumococcal conjugate vaccine Vaxneuvance, approved in 2022, added $665 million in revenue last year and is expected to become a multi-billion-dollar product.

Ann Philbrick, an associate professor in the Department of Family Medicine at the University of Minnesota, said that the prospect of a more effective pneumococcal vaccine is "really exciting" for healthcare providers. She stated, "Pneumonia causes a lot of morbidity and mortality in the elderly, and we need to take any measures to prevent this situation."