Merck’s Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) has earned a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the prevention of invasive pneumococcal disease (IPD) and pneumonia in adults aged 18 and older. The recommendation is based on extensive data from Merck’s Phase 3 STRIDE trials, and a final decision by the European Commission (EC) is expected by Q2 2025. If approved, Capvaxive would provide significant protection against Streptococcus pneumoniae serotypes responsible for the majority of adult IPD cases.1
In an exclusive interview, Heather Platt, MD, section head for respiratory vaccines at Merck, provided insights into this moment. “We are delighted to speak with you about the latest achievement for V116, or Capvaxive, which is our trademark name for our adult-specific pneumococcal conjugate vaccine,” she said. “Our section includes pneumococcal vaccines, so I’m delighted to have worked on the clinical development of V116, and I couldn’t be happier to relay exciting news about our work in the European Union.”
Platt elaborated on the key benefits of Capvaxive, particularly its targeted approach based on serotype distribution data for adults. “What this really means is that the serotypes in Capvaxive are responsible for about 85% of invasive pneumococcal disease in adults in the US, and approximately the same amount globally. Specifically, in the European Union, we can look at some specific markets with strong epidemiological data,” she explained.
She pointed to the vaccine’s success in key European markets:
• In Germany, the serotypes in Capvaxive are responsible for about 84% of disease in adults aged 60 years and older.
• In France, about 85% in adults aged 65 years and older.
• In Italy, approximately 77% of disease.
• In Spain, about 82% of disease.
Phase 3 Trials Demonstrate Capvaxive’s Efficacy
The CHMP recommendation follows the results from multiple Phase 3 trials, including STRIDE-3, which compared Capvaxive to the 20-valent pneumococcal vaccine (PCV20) in vaccine-naïve adults. CAPVAXIVE demonstrated superior immune responses and broader serotype coverage compared to PCV20 in countries like Germany, France, Italy, and Spain, making it a promising option for preventing pneumococcal disease in high-risk populations.
When Merck's 21-valent pneumococcal conjugate vaccine, Capvaxive (V116), was approved by the US FDA, we interviewed Platt, and she discussed the importance of Capvaxive in addressing the significant burden of pneumococcal disease in adults, particularly those aged 50 and older. She detailed the Phase 3 trial results, which showed that Capvaxive outperformed the existing PPSV23 vaccine in immune response rates, especially for unique serotypes not covered by other vaccines. Platt also emphasized how Capvaxive's approval could help reduce hospitalizations, fatalities, and the overall healthcare burden, ultimately improving public health outcomes.2
“Capvaxive was approved in June 2024 in the US, followed by approval in Canada, and just recently, in January 2025, it was approved in Australia,” Platt noted. “This latest positive opinion by the CHMP in the EU represents a key approval. The EU serves as a reference for many world markets, and it represents a number of countries that have strong vaccine evaluation processes. Many countries look to the EU as a reference. Therefore, gaining a positive opinion from the CHMP, pending approval by the European Union's EMA, represents a significant advance in bringing this vaccine to those who need it most.”
Global Rollout and Next Steps for Capvaxive
Platt also outlined the next steps in the global rollout of Capvaxive. “It’s critical to get this vaccine into those key markets that serve as references,” she said. “We’re currently under review in Japan, which is an important market and serves as a key reference for the Asia-Pacific region. We’re also looking forward to other countries within the European Union, which will also serve as references. One of those countries is the UK, which looks to the European Union as a reference state.”
In discussing the broader impact of Capvaxive, Platt noted that the vaccine is already undergoing evaluation by National Immunization Technical Advisory Groups (NITAGs) in various countries. “Many of these markets will influence each other in many ways. They're observing how each country evaluates the vaccine—not just from a regulatory standpoint, but also from an advisory one,” she explained. “Of course, the regulatory agencies are critical, but we also consider NITAGs (National Immunization Technical Advisory Groups) and their assessments of our vaccine. These groups evaluate clinical data to assess potential impact, cost-effectiveness, and how they can incorporate CAP-FACTS into their adult pneumococcal vaccination guidelines.”
When asked about the patient perspective, Platt emphasized the vaccine’s relevance to high-risk populations, including those with chronic conditions and immunocompromised individuals. “We included patients with chronic kidney disease, chronic heart disease, chronic lung disease—those who are at a higher risk for pneumococcal disease. All of these patients were evaluated in our clinical program,” she said. “So, for patients considering, ‘Is this vaccine right for me? Did they really evaluate it in patients like me?’—for the vast majority of patients, the answer is yes. We understood that patients and clinicians would have those questions.”
Platt also highlighted the inclusion of HIV patients in the trials, a population often at higher risk for pneumococcal disease. “We also conducted a study evaluating patients living with HIV, who are relatively immunocompromised. They’re an important population, and clinicians will want to know, ‘Did they study it in patients with HIV?’ It was really well tolerated, with a safety profile comparable to other conjugate vaccines.”
What You Need To Know
Capvaxive shows superior immune responses and broader serotype coverage, protecting against 85% of invasive pneumococcal disease in adults in key European countries.
With positive CHMP feedback, Capvaxive is on track for potential EU approval, following approvals in the US, Canada, and Australia, and reviews in Japan.
Capvaxive's clinical trials focused on high-risk groups, including individuals with chronic conditions and HIV, ensuring targeted protection for these populations.
ACIP Recommendations and Benefits of Early Vaccination
Addressing concerns patients may have about vaccination, Platt reassured that Capvaxive's benefits extend beyond just the individual. “One last point I’d like to mention is the recent change in ACIP recommendations. In October, ACIP lowered the age for routine vaccination to 50 years and older, recognizing that risk doesn’t skyrocket when you turn 65, but it does increase over time as you age,” she explained. “There’s a benefit to getting vaccinated earlier to help prevent disease and keep you healthier longer. I wanted to mention that because it’s a significant part of vaccine development.”
The clinical trials supporting CAPVAXIVE are extensive, with a focus on diverse patient populations. “We made sure that men, women, and all races were represented, ensuring a diverse patient population that reflects all of those who might be eligible for vaccination,” Platt said, emphasizing the inclusivity of the study participants. “That’s an incredibly important component in building confidence in decision-making, helping patients and clinicians determine whether the vaccine is right for them.”
With CAPVAXIVE poised to become an essential tool in pneumococcal disease prevention, its potential to reduce the disease burden globally is clear. If approved by the European Commission and other markets, the vaccine will offer protection against the leading causes of adult pneumococcal disease, potentially saving lives, reducing healthcare costs, and improving quality of life for vulnerable populations.
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