Korean MSD announced on Tuesday the official launch of Capvaxive, a 21-valent pneumococcal conjugate vaccine specifically designed to prevent pneumococcal diseases in adults.
Approved by the FDA on August 27 last year, Capvaxive is a newly developed pneumococcal vaccine intended to prevent invasive pneumococcal disease (IPD) and pneumonia in adults.
The vaccine is administered as a single dose to adults 18 and older and will be available at healthcare facilities nationwide starting Tuesday.
IPD occurs when pneumococci infiltrate the bloodstream or cerebrospinal fluid, potentially causing pneumonia, meningitis, and bacteremia.
The risk of IPD is particularly high for seniors over 65 and individuals with chronic conditions such as diabetes, with mortality rates increasing with age.
Pneumonia, notably, was ranked as the third leading cause of death in South Korea as of 2024 and the primary cause of death from respiratory diseases, underscoring its severity.
While existing pneumococcal vaccines have been used for both children and adults, the rise in childhood vaccination rates has led to an increase in adult IPD cases caused by non-vaccine serotypes.
To address this gap in adult pneumococcal disease prevention, Capvaxive targets 21 serotypes responsible for 80% of adult IPD cases (based on U.S. data from 2018-2022) and includes 8 unique serotypes not found in existing vaccines.
Recognized for its novel composition, Capvaxive was designated as a new drug by the FDA last August.
The vaccine’s efficacy has been demonstrated through multiple global Phase 3 clinical trials (the STRIDE study).
The STRIDE-3 trial, focusing on adults over 50 with no prior pneumococcal vaccination, showed superior immunogenicity for 10 out of 11 serotypes not included in the control vaccine and non-inferiority for the 10 common serotypes.
Immunobridging analysis confirmed immune responses to all 21 serotypes in adults aged 18 to 49, with safety profiles comparable to existing vaccines.
The STRIDE-6 study further validated the immunogenicity and safety of Capvaxive in adults aged 50 and older who had received another pneumococcal vaccine at least 1 year prior.
Results indicated that Capvaxive induces immune responses regardless of prior vaccination history with PCV13, PCV15, PPSV23, or with sequential PCV and PPSV23 vaccinations.
Jo Jae Yong, Executive Director of the Vaccine Business Division at Korean MSD, expressed enthusiasm about the launch of Capvaxive, saying the company is pleased to introduce a tailored pneumococcal prevention option for adults in South Korea. He added that the goal is to significantly reduce the nationwide burden of pneumococcal disease.