Merck's Capvaxive: A Step Closer to EU Approval, Boosting Global Market Share

Merck (NYSE: MRK), known as MSD outside the U.S. and Canada, has received a significant boost for its pneumococcal vaccine, Capvaxive, with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending its approval. This positive opinion brings Merck one step closer to gaining marketing authorization in the European Union, Iceland, Liechtenstein, and Norway, potentially expanding its reach to a larger customer base and increasing its global market share in the pneumococcal vaccine sector.

Capvaxive is specifically designed to protect adults against the serotypes that cause the majority of invasive pneumococcal disease (IPD) cases. Based on country-level data from select EU countries, the serotypes covered by Capvaxive are responsible for more cases of IPD in adults compared to PCV20, a pneumococcal 20-valent conjugate vaccine. This suggests that Capvaxive could have a competitive advantage in the market, offering broader protection against the most prevalent serotypes.

The CHMP's recommendation is supported by results from the pivotal Phase 3 STRIDE-3 trial, which evaluated Capvaxive compared to PCV20 in adults 18 years of age and older who had not previously received a pneumococcal vaccine. The study found that Capvaxive was noninferior to PCV20 for the 10 shared serotypes, demonstrating the vaccine's safety, tolerability, and immunogenicity. Additionally, the recommendation is supported by results from the Phase 3 STRIDE-4, STRIDE-5, STRIDE-6, STRIDE-7, and STRIDE-10 trials, which evaluated Capvaxive in both vaccine-naïve and vaccine-experienced adults.

If approved in the EU, it would mark the fourth authorization of Capvaxive for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. Merck has already received approval for Capvaxive in the U.S., Canada, and Australia. In addition, Capvaxive is currently under review in Japan, and other worldwide regulatory filings are underway. This expansion into key markets could drive potential revenue growth for Merck, contributing to its overall market share in the pneumococcal vaccine sector.

The global pneumococcal vaccines market size was valued at USD 6.5 billion in 2020 and is expected to grow at a compound annual growth rate (CAGR) of 7.5% from 2021 to 2028. The EU represents a significant portion of this market, with a well-established healthcare system and a high demand for vaccines. Assuming that Capvaxive captures a significant share of the EU pneumococcal vaccines market, the potential revenue implications for Merck could be substantial.



In conclusion, the CHMP's positive opinion for Capvaxive has the potential to significantly impact Merck's global market share in the pneumococcal vaccine sector by expanding its reach to key markets, offering a competitive product, and driving potential revenue growth. The EU market offers a larger population and a well-established healthcare system, which could lead to higher sales and revenue for Merck. However, the actual revenue generated will depend on various factors, such as pricing, market penetration, competition, and regulatory approval timelines.