Merck's Capvaxive Pneumococcal Vaccine: EU Approval Progress and Global Access
Following up with Heather Platt, MD, to revisit CAPVAXIVE’s progress and global accessibility as the European Commission prepares its decision.
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 18 and older to prevent invasive disease and pneumonia caused by Streptococcus pneumoniae. The European Commission (EC) is expected to review the recommendation, with a final decision anticipated by Q2 2025. If approved, the vaccine will be approved in the EU, Iceland, Liechtenstein, and Norway.
Capvaxive targets serotypes responsible for most invasive pneumococcal disease (IPD) cases in adults. Clinical data from Germany, France, Italy, and Spain indicate broader coverage than PCV20, supported by pivotal Phase 3 trials, including the STRIDE-3 study. Already approved in the U.S. (June 2024), Canada (July 2024), and Australia (January 2025), the vaccine is under review in Japan and additional countries.
Heather Platt, MD, clinical director at Merck, emphasized the significance of this milestone. “We are really excited to have received a positive opinion from CHMP in the EU, and that was in January of 2025, which means that we are on the precipice of a decision from the European Commission. And we couldn’t be more excited to bring this vaccine to more people.”
Merck is working to ensure global access to Capvaxive, particularly in lower-resource settings. “One thing that we always consider, that we do, is that for any of the countries that participate in our clinical studies, we make sure that we have a plan to bring that vaccine to those patients in that country,” Platt said. “For the Phase 3 program, we were quite broad. We conducted the Phase 3 clinical program in 26 countries. So that means we have a lot of work to do, and we’re ready to do it.”
Platt also highlighted the vaccine’s importance for adult populations at higher risk of pneumococcal disease. “Adults have an increased risk of pneumococcal disease, and that can mean pneumococcal pneumonia, that can mean invasive disease, where patients have a chance of getting sicker, right? Once that bacteria is in the bloodstream, or, you know, crosses the barrier, meningitis. These are severe disease manifestations, and the risk increases with age. So Capvaxive was developed for adults.”
Beyond regulatory approval, Merck is focused on understanding the vaccination landscape across different regions. “We have work to do to identify what are the countries that are going to benefit, who has this burden of disease, which countries also have a really strong implementation process and can support vaccination of adults,” Platt explained. “We also need to understand the barriers to vaccination so we can work with those countries as well.”
This conversation serves as a follow-up to our earlier discussion with Platt when this recommendation first occurred, reinforcing its relevance and importance. Stay tuned for the next part of our conversation as we continue exploring Capvaxive’s global impact and accessibility.
