Merck MRK announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of 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 European Commission will now review the CHMP’s opinion and a final decision from the regulatory body is expected by the second quarter of 2025.

The FDA approved Capvaxive for 21 serotypes, which account for 84% of all IPDs in older adults, in June 2024.

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.

In the past year, shares of Merck have plunged 21.7% compared with the industry’s decrease of 2.6%.

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More on the CHMP Opinion for MRK's Capvaxive

The latest CHMP recommendation for Capvaxive was based on data from multiple phase III studies.

Among them 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.

A potential approval in the EU will mark the fourth authorization of Capvaxive for the prevention of IPD and pneumococcal pneumonia in adults.

Along with the United States, Capvaxive is also approved in Canada and in Australia. A regulatory filing seeking approval for Capvaxive is currently under review in Japan.

MRK markets another PCV vaccine, Vaxneuvance, which is approved for 15 serotypes in older adults.

Other Drugmakers in the PCV Space

Pfizer 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.

In the first nine months of 2024, Pfizer recorded $4.8 billion from combined sales of Prevnar 13 and Prevnar 20.

In December 2024, Sanofi SNY expanded its agreement with SK bioscience to develop, license and commercialize next-generation PCVs for treating IPD in pediatric and adult patient populations.

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 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.

In September 2024, PCVX announced positive top-line data from a phase I/II study that evaluated VAX-31 in adults aged 50 years and older.

Vaxcyte is also evaluating VAX-31 in a phase II study for the prevention of IPD in healthy infants. Top-line data from the same is expected in mid-2026.

MRK's Zacks Rank

Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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