FDA Grants Priority Review to Merck BLA for Investigational 21-Valent Pneumococcal Vaccine

The US Food and Drug Administration today granted priority review to the biologic license application submitted by Merck for the company’s investigational, 21-valent pneumococcal conjugate vaccine V116, the first vaccine of its kind designed specifically for adults, according to a statement from Merck. V116 covers 21 serotypes that lead to approximately 83% of invasive pneumococcal disease among individuals aged 65 years and older, the company said. The FDA has set a PDUFA date of June 17, 2024.

“Invasive pneumococcal disease poses a greater risk to older adults or those with weakened immune systems, in part due to disease-causing serotypes not covered by currently licensed pneumococcal conjugate vaccines,” said Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “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 working with urgency to bring this potential new preventative measure to adult patients.”

Data from the pivotal phase 3 STRIDE-3 clinical trial, which compared the immunogenicity, tolerability, and safety of V116 to the pneumococcal 20-valent conjugate vaccine in pneumococcal vaccine-naïve adults, were foundational components of the BLA. Those findings, presented in November at the World Vaccine Congress West Coast, were combined with results from multiple other phase 3 trials evaluating V116 in vaccine-experienced as well as vaccine-naïve adults, including STRIDE-4, STRIDE-5, and STRIDE-6, to complete the BLA, the company said.

V116 includes 8 Streptococcus pneumoniae serotypes associated with approximately 30% of cases of invasive pneumococcal disease (IPD) in people aged ≥65 years that are not currently covered by approved pneumococcal vaccines, according to the Centers for Disease Control and Prevention (CDC). Healthy adults are susceptible to pneumococcal disease, but older adults are more vulnerable to the infection as are adults with certain chronic or immunocompromising health conditions, et, heart, lung, and hepatic disease. Mortality from invasive pneumococcal disease is highest among adults 50 years of age and older.

“Despite the availability of current pneumococcal conjugate vaccines, many adults remain vulnerable to pneumococcal disease, especially those who are older,” Barr said. The totality of the current data “support the potential for V116 to become an important new preventative option for adults, regardless of prior pneumococcal vaccination status."

Merck indicated that data from additional trials will be presented to the scientific community at future congresses.

Source: FDA grants priority review to Merck’s new biologics license application for V1116, an investigational, 21-valent pneumococcal conjugate vaccine specifically designed to protect adults. News release. Merck. December 19, 2023. Accessed December 19, 2023. https://www.merck.com/news/fda-grants-priority-review-to-mercks-new-biologics-license-application-for-v116-an-investigational-21-valent-pneumococcal-conjugate-vaccine-specifically-designed-to-protect-adults/