EU approves Merck’s CAPVAXIVE for adult pneumococcal vaccination

RAHWAY, N.J. - Merck (NYSE: MRK), a prominent player in the pharmaceutical industry with a market capitalization of $222 billion and an impressive gross profit margin of 77%, has received approval from the European Commission (EC) for its pneumococcal 21-valent conjugate vaccine, CAPVAXIVE, for use in individuals aged 18 and older. According to InvestingPro analysis, Merck maintains excellent financial health with strong cash flows and consistent dividend payments for 55 consecutive years. This vaccine is designed to prevent invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes. The EC’s decision enables the marketing of CAPVAXIVE across the 27 European Union member states, as well as in Iceland, Liechtenstein, and Norway.

The approval, which follows a positive recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use in January 2025, is based on data from the Phase 3 STRIDE clinical program. CAPVAXIVE has been previously approved in the U.S. in June 2024, Canada in July 2024, and Australia in January 2025. With annual revenue of $64.2 billion and a robust research pipeline, Merck continues to strengthen its market position. For detailed analysis of Merck’s growth potential and comprehensive financial metrics, visit InvestingPro, where you’ll find exclusive insights and the complete Pro Research Report.

According to country-level data, CAPVAXIVE covers more cases of invasive pneumococcal disease (IPD) in adults than the pneumococcal 20-valent conjugate vaccine (PCV20) in selected European countries. The data, however, do not reflect the comparative efficacy of the vaccines.

The STRIDE clinical program included several Phase 3 trials which demonstrated that CAPVAXIVE was non-inferior or superior to PCV20 and PPSV23 (pneumococcal vaccine, polyvalent [23-valent]) in terms of immune response, as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers. Additionally, CAPVAXIVE was found to have a comparable safety profile to these vaccines.

CAPVAXIVE is specifically tailored to address the serotypes predominantly responsible for adult IPD, including eight unique serotypes not covered by other pneumococcal vaccines. It is administered as a single dose and has been indicated for use in the U.S. for active immunization against invasive disease and pneumonia caused by specific S. pneumoniae serotypes in adults.

Pneumococcal disease represents a significant health risk, particularly for older adults and those with chronic medical conditions or compromised immune systems. The approval of CAPVAXIVE in the EU marks a critical step in broadening the protection against this disease for the adult population.

The information in this article is based on a press release statement from Merck & Co., Inc.

In other recent news, Merck & Co. has announced an exclusive licensing agreement with Jiangsu Hengrui Pharmaceuticals, allowing Merck to develop and commercialize HRS-5346, an investigational Lipoprotein(a) inhibitor. This agreement includes an upfront payment of $200 million to Hengrui Pharma, with potential milestone payments up to $1.77 billion. The licensing deal is part of Merck’s broader strategy to expand its cardio-metabolic pipeline, as the drug aims to address cardiovascular conditions affecting a significant portion of the global population. Meanwhile, Moody’s Ratings has upgraded Merck’s ratings to Aa3 from A1, reflecting confidence in the company’s ability to manage long-term pressures, particularly with its Keytruda franchise and other pipeline opportunities.

Additionally, Merck has been involved in legal proceedings regarding its Gardasil vaccine, resulting in a favorable ruling as a judge dismissed over 200 cases related to alleged side effects. The decision was based on the lack of substantial evidence to support the claims. In another development, Merck has opened a $1 billion vaccine manufacturing facility in Durham, North Carolina, to strengthen its U.S. manufacturing capabilities. The facility incorporates advanced technologies and aligns with Merck’s mission to enhance domestic production. Citi analysts have maintained a Buy rating on Merck, emphasizing the strategic importance of the new licensing agreement in diversifying the company’s portfolio.

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