Merck Gets EC Nod for 21-Valent Pneumococcal Jab Capvaxive

Merck MRK announced that the European Commission (“EC”) has approved its 21-valent pneumococcal conjugate vaccine (“PCV”), Capvaxive, for the prevention of invasive pneumococcal disease (“IPD”) and pneumococcal pneumonia in individuals aged 18 years and above.The FDA had approved Capvaxive for 21 serotypes, which account for 84% of all IPDs in older adults, in June 2024.The EC nod for Capvaxive marks the fourth authorization of the vaccine for the prevention of IPD and pneumococcal pneumonia in adults. Capvaxive is also approved in Canada and Australia.Capvaxive targets serotypes that account for approximately 84% of all IPD in older adults (50 years and older) in the United States, including eight serotypes not covered by currently licensed vaccines.Year to date, shares of Merck have plunged 11.5% against the industry’s rise of 4.4%.Image Source: Zacks Investment ResearchMore on the EC's Nod for MRK's CapvaxiveThe EC’s nod for Capvaxive was based on safety and immunogenicity data from the STRIDE clinical program.Among these are data from the phase III STRIDE-3 study, which evaluated Capvaxive compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in adults aged 18 years and above who had not previously received a pneumococcal vaccine.It also included data from the phase III STRIDE-4, STRIDE-5, STRIDE-6, STRIDE-7 and STRIDE-10 studies, which investigated Capvaxive in vaccine-naïve and vaccine-experienced adults.The EC’s approval for Capvaxive was expected, as, in January, the Committee for Medicinal Products for Human Use had recommended the approval of Capvaxive for the prevention of IPD and pneumococcal pneumonia in individuals aged 18 years and older.Other Players in the PCV SpacePfizer PFE is a key player in the PCV vaccine space.PFE markets Prevnar 20, which is approved for the prevention of IPD caused by 20 serotypes in individuals aged six weeks and older. PFE also markets Prevnar 13, which contains 13 serotypes and has the FDA’s approval for use in individuals aged six weeks and older.Pfizer recorded $6.4 billion from combined sales of Prevnar 13 and Prevnar 20 in 2024.Sanofi SNY has expanded its existing agreement with SK bioscience to develop, license and commercialize next-generation PCVs for treating IPD in pediatric and adult patient populations in December 2024.The latest deal builds on the existing collaboration between SNY and SK bioscience to develop and commercialize a 21-valent PCV (PCV21) for the pediatric patient population. Per the expanded collaboration agreement, Sanofi and SK bioscience will jointly fund all research and development costs to support the launch of PCV21 and next-generation vaccines.Once the vaccine is registered, SNY will commercialize the same across the world except for South Korea, where SK bioscience will hold commercial exclusivity.Small vaccine maker Vaxcyte PCVX is also developing its investigational 31-valent PCV, VAX-31, which is in mid-to-late-stage studies, for preventing IPD in both pediatric and adult patient populations.Vaxcyte is also evaluating VAX-31 in a phase II study for the prevention of IPD in healthy infants. PCVX expects to report top-line data from the same in mid-2026.MRK's Zacks RankMerck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.Only $1 to See All Zacks' Buys and SellsWe're not kidding.Several years ago, we shocked our members by offering them 30-day access to all our picks for the total sum of only $1. No obligation to spend another cent.Thousands have taken advantage of this opportunity. Thousands did not - they thought there must be a catch. Yes, we do have a reason. We want you to get acquainted with our portfolio services like Surprise Trader, Stocks Under $10, Technology Innovators,and more, that closed 256 positions with double- and triple-digit gains in 2024 alone.See Stocks Now >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sanofi (SNY): Free Stock Analysis Report Pfizer Inc. (PFE): Free Stock Analysis Report Merck & Co., Inc. (MRK): Free Stock Analysis Report Vaxcyte, Inc. (PCVX): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks