The US Food and Drug Administration (FDA) has accepted Merck’s new biologics license application (BLA) for V116 and granted priority review to the 21-valent pneumococcal conjugate vaccine candidate.
The regulatory body has established a Prescription Drug User Fee Act (PDUFA) target action date of 17 June 2024.
V116 is designed to specifically mitigate the risk of invasive pneumococcal disease and pneumococcal pneumonia in adults. It is intended to be administered as a single dose.
Merck Research Laboratories senior vice president, global clinical development head, and chief medical officer Eliav Barr said: “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.
“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.”
The BLA for V116 draws, in part, from data obtained in the STRIDE-3 Phase 3 trial that assessed the immunogenicity, tolerability, and safety of the vaccine candidate in comparison to PCV20 (pneumococcal 20-valent conjugate vaccine). This was among adults who had not previously received a pneumococcal vaccine.
In the late-stage trial, V116 demonstrated superior immune responses for 10 out of 11 unique serotypes compared to PCV20 in adults aged 50 years and above.
Findings from the STRIDE-3 trial were presented at the World Vaccine Congress West Coast last month.
Additionally, the BLA for V116 is substantiated by results from several Phase 3 clinical studies that investigated the candidate in both vaccine-naïve and vaccine-experienced adult patient populations, covering trials such as STRIDE-4, STRIDE-5, and STRIDE-6.
Merc said that V116 has been formulated to target the Streptococcus pneumoniae serotypes primarily associated with adult pneumococcal disease. These include eight distinct serotypes, which are 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.
The eight serotypes account for around 30% of adult disease, as per US Centers for Disease Control and Prevention (CDC) data spanning 2018-2021. According to the same CDC data, the serotypes encompassed by V116 contribute to approximately 83% of invasive pneumococcal disease in individuals aged 65 and older.
