FDA Approves Capvaxive 21-Valent Pneumococcal Vaccine

On FRIDAY, June 21, 2024, the U.S. Food and Drug Administration (FDA) approved the Capvaxive pneumococcal 21-valent conjugate vaccine for adults, aimed at preventing invasive pneumococcal disease and pneumococcal pneumonia. This newly approved vaccine targets serotypes causing a significant portion of invasive pneumococcal disease cases. Specifically, Capvaxive covers Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals aged 18 and older, for both invasive disease and pneumonia.

The FDA's approval followed a priority review based on results from several pivotal clinical trials. The STRIDE-3 phase 3 trial compared Capvaxive to the pneumococcal 20-valent conjugate vaccine in adults 18 and older who had not previously received a pneumococcal vaccine. Further evaluations occurred in the STRIDE-5 and STRIDE-6 phase 3 trials, examining both vaccine-naive and vaccine-experienced adults. Capvaxive contains eight unique serotypes not included in other approved pneumococcal vaccines, which collectively are responsible for approximately 27 percent of invasive pneumococcal disease cases in adults 50 and older, and about 30 percent in adults 65 and older. Epidemiological data indicate that the vaccine covers serotypes responsible for roughly 84 percent of invasive pneumococcal disease cases in adults over 50.

Dr. Dean Y. Li from Merck Research Laboratories highlighted the importance of this development, stating, "Today's approval reflects our strategic approach with Capvaxive, which has shown strong immunogenic response across different adult populations. This achievement underscores our comprehensive understanding of pneumococcal disease." He emphasized that Capvaxive represents a new option specifically tailored to protect adults against the majority of serotypes causing invasive pneumococcal diseases.

Merck, the company behind Capvaxive, received the approval, marking a significant milestone in the ongoing fight against pneumococcal diseases in the adult population.