Merck announced this week that the US Food and Drug Administration (FDA) has granted the company priority review of its application for approval of an investigational pneumococcal conjugate vaccine for adults.
Merck's 21-valent (21-strain) pneumococcal conjugate vaccine, V116, is designed to help prevent pneumococcal disease and pneumococcal pneumonia in adults, covering serotypes that are responsible for 83% of invasive pneumococcal disease in people 65 years of age and older. It includes eight unique Streptococcus pneumoniae serotypes not covered by currently licensed pneumococcal vaccines.
Targeting strains that target adults
"If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed to address the serotypes that cause most adult invasive pneumococcal disease," said Eliav Barr, MD, senior vice president, chief medical officer, and head of global clinical development at Merck Research Laboratories, in a company press release. "We look forward to discussing the data that support our filing with the FDA and are working with urgency to bring this potential new preventative measure to adult patients.”
The Biologics License Application is based on the results of multiple phase 3 trials that evaluated V116 in both vaccine-naïve and vaccine-experienced adults. In the STRIDE-3 trial, V116 elicited non-inferior immune responses to PCV20 (pneumococcal 20-valent conjugate vaccine) for all 10 serotypes covered by both vaccines, and superior immune responses for 10 of 11 serotypes included in V116 but not covered by PCV20.
The FDA has set a target action date of June 17, 2024.
If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed to address the serotypes that cause most adult invasive pneumococcal disease.