Pneumococcal 21-valent Conjugate Vaccine

On February 4, Merck & Co. announced its 2024 financial results, revealing total revenue of $64.168 billion, marking a 7% increase year-on-year. The pharmaceutical segment alone generated $57.400 billion, also reflecting a 7% growth. However, research and development (R&D) spending dropped significantly to $17.938 billion, a decline of 41%. In a concerning trend, revenue from the Chinese market fell by 20% to $5.394 billion, representing 9.4% of Merck's global pharmaceutical sales. Despite these challenges, Merck's flagship product, Keytruda (pembrolizumab), set new sales records, achieving $29.482 billion in revenue, an 18% increase that accounted for nearly 46% of the company’s total revenue. As Keytruda continues to thrive, Merck is actively working to maximize its clinical and commercial value. This includes expanding early indications, exploring combination therapies, and developing a subcutaneous formulation. In November 2024, the subcutaneous formulation's Phase III study was successfully completed, reducing administration time to just 2-3 minutes compared to intravenous infusion. Other oncology products also performed well, with the world’s first HIF-2α inhibitor, Welireg, generating $509 million in sales, up 133% year-on-year. This drug received approval in China in November 2024. Additionally, Lynparza (olaparib) contributed $1.311 billion to the revenue. Merck's HPV vaccine, Gardasil/Gardasil 9, reported sales of $8.583 billion, a 3% decrease from the previous year. The decline was largely attributed to reduced demand in China, exacerbated by intense competition from domestic nine-valent vaccines and price wars involving two-valent HPV vaccines. In response, Merck has begun targeting the male market for HPV vaccination. In January 2025, Gardasil was approved in China for use in males aged 9-26, marking it as the first HPV vaccine approved for this demographic. Merck has also been proactive in updating its vaccine portfolio. In June 2024, it launched the 21-valent pneumococcal conjugate vaccine, Capvaxive, enhancing its product lineup alongside Pneumovax 23 and Vaxneuvance. In the cardiovascular sector, the new pulmonary arterial hypertension (PAH) drug Winrevair has emerged as a star product. Approved in March 2024, it has quickly generated $419 million in sales within its first year. The drug has also been submitted for approval in China. Looking ahead, Merck is optimistic about its pipeline, which includes oral PCSK9 inhibitors and dual agonists for GLP-1R/GCGR expected to yield critical research data in 2025. The company is also ramping up efforts in infectious diseases and ophthalmology, with Clesrovimab submitted for U.S. approval as a single-dose RSV monoclonal antibody. Merck's business development activities have intensified, particularly in China, with several strategic acquisitions aimed at expanding its innovative capabilities. These include a $700 million acquisition of CD3/CD19 bispecific antibodies and a $588 million agreement for a PD-1/VEGF bispecific antibody project. Robert M. Davis, Merck’s Chairman and CEO, expressed confidence in the company’s long-term growth potential, stating, “Our strong growth in 2024 reflects the market demand for our innovative product portfolio, including Keytruda, Winrevair, and our robust animal health business.” Looking forward to 2025, Merck anticipates global sales between $64 billion and $65.6 billion.

Merck & Co’s – known as MSD outside the US and Canada – adult-specific 21-valent pneumococcal conjugate vaccine has been recommended for approval by the European Medicines Agency’s human medicines committee. The Committee for Medicinal Products for Human Use (CHMP) has recommended that Capvaxive be used to prevent invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals aged 18 years and older. Diseases caused by Streptococcus pneumoniae bacteria are currently considered a “major public health problem” by the World Health Organization (WHO). There are more than 100 different types of pneumococcal bacteria and Merck’s Capvaxive, which is administered in a single dose, is specifically designed to help protect against the ones that are responsible for the majority of adult invasive pneumococcal disease, including eight strains not covered by any other approved pneumococcal vaccine. The CHMP’s recommendation was based on results from the late-stage STRIDE-3 trial, which compared Capvaxive to Pfizer’s 20-valent vaccine (PCV20) in adults who had not previously received a pneumococcal vaccine. Capvaxive elicited non-inferior immune responses compared to PCV20 for all ten serotypes common to both vaccines in adults aged 50 years and older, and generated superior immune responses for ten of its 11 unique serotypes. Additionally, Merck’s vaccine elicited non-inferior immune responses in adults aged 18 to 49 years compared to those aged 50 to 64 years and had a safety profile comparable to PCV20. The recommendation was also supported by results from the phase 3 STRIDE-4, STRIDE-5, STRIDE-6, STRIDE-7 and STRIDE-10 trials. The European Commission (EC) will now review the positive opinion as it makes a final decision on Capvaxive, which is expected by the second quarter of 2025. Paula Annunziato, senior vice president, infectious diseases and vaccines, global clinical development, Merck Research Laboratories, said: “This positive opinion is yet another testament to the clinical profile of Capvaxive and brings us a step closer to helping protect adults in the EU against pneumococcal disease. “Invasive pneumococcal disease can lead to serious consequences, including hospitalisation, organ damage and even death. We are pleased with the CHMP recommendation and look forward to the EC’s decision.”