FDA approves Merck's adult pneumococcal vaccine Capvaxive

Merck & Co, known as MSD outside the United States and Canada, has recently received approval from the US Food and Drug Administration (FDA) for its new 21-valent pneumococcal conjugate vaccine specifically designed for adults. This vaccine, named Capvaxive, is now authorized to prevent both invasive pneumococcal disease and pneumococcal pneumonia in individuals aged 18 and older.

Diseases caused by the Streptococcus pneumoniae bacteria are identified by the World Health Organization as a significant public health issue. There are over 100 different types of pneumococcal bacteria, and Merck's Capvaxive aims to protect against those strains responsible for the majority of adult invasive pneumococcal diseases. Notably, Capvaxive covers eight strains not included in any other approved pneumococcal vaccines currently available.

The FDA's decision to approve Capvaxive was based on comprehensive clinical data, including the results from the STRIDE-3 trial. This late-stage study compared Merck’s vaccine to Pfizer's PCV20 in adults who had not previously received a pneumococcal vaccine. Additional support for the approval came from the phase 3 STRIDE-5 study, which evaluated the effects of Capvaxive when co-administered with a quadrivalent influenza vaccine in adults aged 50 and older. Furthermore, the phase 3 STRIDE-6 study assessed Capvaxive in individuals aged 50 and older who had received a pneumococcal vaccine at least one year prior to the study's commencement.

Dr. Dean Li, President of Merck Research Laboratories, remarked that the approval highlights the company's targeted strategy for Capvaxive, noting its strong immunogenicity across various adult populations. He expressed pride in offering Capvaxive as a new preventive measure against the majority of pneumococcal disease-causing serotypes in adults.

The FDA granted authorization for Capvaxive under its accelerated approval pathway for the prevention of pneumococcal pneumonia. Continued approval for this specific indication will depend on the results of a confirmatory trial.

Later this month, the Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) is scheduled to convene to discuss and provide recommendations on the use of Capvaxive in adults. Presently, the CDC advises pneumococcal vaccination for all adults aged 65 and older, as well as for those aged 19 to 64 who have certain risk conditions.