The US Food and Drug Administration (FDA) has granted Merck Research Laboratories, a 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, including serotypes that are responsible for 83% of invasive pneumococcal disease in people 65 years of age and older. 

• It has eight unique Streptococcus pneumoniae serotypes not covered in currently licensed pneumococcal vaccines.

• The 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.