FDA Grants Breakthrough Therapy Designation to Pneumococcal Vaccine

This morning, Merck (MSD) announced their investigational pneumococcal conjugate vaccine received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA). The 21-valent vaccine, V116, targets serotypes responsible for 85% of all pneumococcal disease.

The vaccine prevents invasive pneumococcal disease (IPD) and pneumococcal pneumonia caused by the Streptococcus pneumoniae serotypes 3, 6A/C, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B/C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B. Pneumococcal disease can range in severity from ear and sinus infections to pneumonia, meningitis, and bloodstream infections.

“V116 is specifically designed to address strains of disease-causing pneumococcal bacteria that are most prevalent in adults, reflecting our population-specific approach to developing pneumococcal conjugate vaccines,” said Eliav Barr, MD, senior vice president, head of global clinical development, and chief medical officer of Merck. “It includes 8 serotypes not covered by currently licensed vaccines.”

The FDA granted V116 the Breakthrough Therapy Designation in response to positive data from the 2-part, randomized, computer-controlled, double-blind phase 1/2 trial V116-001 (NCT04168190). The study assessed the immunogenicity, as well as safety and tolerability, of a single dose of V116. Phase 1 of the trial included adults 18-49 years who had bever received a pneumococcal vaccine, and phase 2 included participants 50 years and older. Merck will present the full results of these trials at the June 2022 International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD).

Later this year, Merck expects to begin phase 3 clinical trials for V116 in adults 18 years and older. “We look forward to discussing the ongoing development of this investigational vaccine, including the approach for Phase 3 studies, with the FDA and other regulatory agencies,” Barr said.

Those most at risk for pneumococcal disease are children under 2 and adults over 65 years of age. The US Centers for Disease Control and Prevention (CDC) lists risk factors as chronic heart, lung, or kidney disease, cerebrospinal fluid (CSF) leak, cochlear implant, diabetes, HIV infection, cancer, solid organ transplant, nephrotic syndrome, sickle cell disease, a damaged spleen or no spleen, and having a condition or taking medicine that weakens the immune system.