21-valent Pneumococcal Conjugate Vaccine Candidate Granted Priority Review

Merck today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a new Biologics License Application (BLA) for V116, a 21-valent pneumococcal conjugate vaccine candidate specifically designed to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults.

The FDA grants priority review to medicines and vaccines that, if approved, would significantly improve the safety or effectiveness of the treatment or prevention of a serious condition. The FDA has set a Prescription Drug User Fee Act of June 17, 2024.

The serotypes covered by V116 are responsible for approximately 83% of invasive pneumococcal disease in individuals 65 and older.

Dr. Eliav Barr, senior vice president, head of global clinical development, and chief medical officer, Merck Research Laboratories, commented in a press release on December 19, 2023, "If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed to address the serotypes that cause most adult invasive pneumococcal disease."

"We look forward to discussing the data that support our filing with the FDA and are urgently working to bring this potential new preventative measure to adult patients."

Merck says V116 includes eight unique serotypes not covered by currently licensed pneumococcal vaccines, responsible for approximately 30% of invasive pneumococcal disease in individuals 65 and older.