Merck’s adult-specific pneumococcal vaccine Capvaxive granted FDA approval

19 Jun 2024
pmlive.com
Drug ApprovalPhase 3Clinical ResultVaccineAccelerated Approval
Merck’s adult-specific pneumococcal vaccine Capvaxive granted FDA approval
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Source: PMLiVE
Merck & Co – known as MSD outside the US and Canada – has received approval from the US Food and Drug Administration (FDA) for its adult-specific 21-valent pneumococcal conjugate vaccine.
Capvaxive is now authorised to prevent invasive pneumococcal disease and pneumococcal pneumonia in individuals aged 18 years and older.
Diseases caused by Streptococcus pneumoniae bacteria are currently considered a “major public health problem” by the World Health Organization.
There are more than 100 types of pneumococcal bacteria and Merck’s Capvaxive is specifically designed to help protect against the ones that are responsible for the majority of adult invasive pneumococcal disease, including eight strains not covered by any other approved pneumococcal vaccine.
The clinical data supporting the FDA’s decision included results from the late-stage STRIDE-3 trial, which compared Merck’s vaccine to Pfizer’s PCV20 in individuals aged 18 years of age and older who had not previously received a pneumococcal vaccine.
The approval was also supported by results from the phase 3 STRIDE-5 study, which evaluated Capvaxive co-administered with a quadrivalent influenza vaccine in adults aged 50 years and older, and the phase 3 STRIDE-6 study of Capvaxive in adults aged 50 years and older who had received a pneumococcal vaccine at least one year before enrolment.
Dr Dean Li, president, Merck Research Laboratories, said: “[The] approval is a testament to our population-specific strategy behind Capvaxive, which demonstrated robust immunogenicity in a range of adult populations… 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 authorisation for Capvaxive for the prevention of pneumococcal pneumonia was granted under the FDA’s accelerated approval pathway and continued approval for this indication may be contingent on results from a confirmatory trial.
The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices is expected to meet later this month to discuss and make recommendations for the use of Capvaxive in adults.
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