New Pneumococcal Vaccine CAPVAXIVE Approved by FDA

The U.S. Food and Drug Administration (FDA) has approved CAPVAXIVE (pneumococcal 21-valent conjugate vaccine) for active immunization for the prevention of invasive disease caused by 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 and active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older. CAPVAXIVE is specifically designed to help protect adults against the serotypes that cause the majority of invasive pneumococcal disease cases.

Among the clinical data supporting the approval are results from the pivotal Phase III STRIDE-3 trial, which evaluated CAPVAXIVE compared to PCV20 in adults 18 years of age and older who had not previously received a pneumococcal vaccine. Approval is also supported by results from the Phase III STRIDE-5 and STRIDE-6 trials evaluating CAPVAXIVE in vaccine-naive and vaccine-experienced adults.

“Today’s approval is a testament to our population-specific strategy behind CAPVAXIVE, which demonstrated robust immunogenicity in a range of adult populations and is driven by a deep understanding of pneumococcal disease,” said Dean Y. Li, MD, PhD, president of Merck Research Laboratories. “We are proud to provide CAPVAXIVE as a new option specifically designed to help protect against the majority of invasive pneumococcal disease-causing serotypes in adults.”

The accelerated approval was based on immune responses as measured by opsonophagocytic activity. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.