Capvaxive’s EU Approval and Impact on Pneumococcal Disease Prevention: A Focus on At-Risk Populations

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) for adults aged 18 and older to prevent invasive disease and pneumonia caused by Streptococcus pneumoniae. A final decision from the European Commission (EC) is expected by Q2 2025, which, if approved, will extend Capvaxive’s authorization to the EU, Iceland, Liechtenstein, and Norway.

Already approved in the US in June 2024, Canada in July 2024, and Australia in January 2025/ Capvaxive is currently under regulatory review in EU, Japan and additional countries. The vaccine targets serotypes responsible for most cases of invasive pneumococcal disease (IPD) in adults, demonstrating broader coverage than PCV20 in pivotal Phase 3 trials, including the STRIDE-3 study, with supporting clinical data from Germany, France, Italy, and Spain.

Future Pediatric Applications and Real-World Evidence

In the next part of our conversation with Heather Platt, MD, clinical director at Merck, she highlighted the ongoing evaluation of Capvaxive in at-risk pediatric populations—a significant expansion beyond the standard primary pediatric regimen.

"One of the populations that we are studying, and hopefully we'll be able to, is in the population of children at risk. And this is different than a primary pediatric regimen," Platt explained. "Those children have a higher risk of disease as well, just like I mentioned that the adults have a higher risk of disease. So we are evaluating giving those particular at-risk children a dose of Capvaxive, and I think this will be important to many clinicians who want to make sure that Capvaxive is being studied in the population they see."

Merck is also investing in real-world evidence studies to assess Capvaxive’s effectiveness beyond clinical trials. Platt emphasized the significance of real-world observational studies, particularly in monitoring pneumococcal pneumonia cases in hospital settings.

"We need to know how this vaccine is going to perform in a real-world setting with actual individuals coming in to get vaccinated, or if they're already presenting to a hospital," Platt noted. "One of the investments that we're making is a real-world observational study to evaluate Capvaxive and how it prevents pneumococcal pneumonia. So this study is being planned. We need to have the vaccine approved first, right, and then we'll be able to understand who is actually coming into the hospital because they are sick with pneumonia, and then we'll look to see, did they get vaccinated? Yes or no, and we will be able to assess the effectiveness of Capvaxive."

Platt also confirmed that Merck’s outcomes research group will be presenting key findings at the ECCMID 2025 conference.

"Our outcomes research group is going to be at the ESCMID 2025 conference. They will have quite a bit of information to share, so I think that is going to be meaningful to many of your viewers," she said. Additionally, clinical data on cross-reactivity of immune responses will be presented, furthering the understanding of the vaccine’s immunogenicity.

Part 1 of our conversation: Merck's Capvaxive Pneumococcal Vaccine: EU Approval Progress and Global Access

Reference

News Release. Merck Receives Positive EU CHMP Opinion for CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for Pneumococcal Vaccination in Adults. Merck. January 31, 2025. Accessed March 25, 2025. https://www.merck.com/news/merck-receives-positive-eu-chmp-opinion-for-capvaxive-pneumococcal-21-valent-conjugate-vaccine-for-pneumococcal-vaccination-in-adults/