Merck's 21-Valent Pneumococcal Conjugate Vaccine V116 Receives FDA Breakthrough Therapy Designation for Adults

On April 14, MSD announced that the FDA had granted its investigational 21-valent pneumococcal vaccine V116 Breakthrough Therapy designation for the prevention of pneumococcal infections and bacterial pneumonia in adults aged 18 years and older.

V116 Demonstrates Immune Protection Against 21 Serotypes of Streptococcus pneumoniae Strains, Including 3, 6A/C, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B/C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B. A Two-Phase, Randomized, Double-Blind, Positive-Controlled Phase I/II Study, V116-001 (NCT04168190), Evaluated the Safety, Tolerability, and Immunogenicity of a Single Dose of V116 in Adults Who Had Not Previously Received a Pneumococcal Vaccine. Phase 1 Enrolled Participants Aged 18–49 Years, While Phase 2 Enrolled Those Aged 50 Years and Above.

FDA made the decision to grant BTD after obtaining the data from the study, and detailed results will be announced at the International Symposium on Pneumococcus and Pneumococcal Diseases in June. The Phase III study of V116 is planned to commence within this year.

Pneumococcal infection can lead to pneumococcal diseases, including non-invasive conditions such as bacterial pneumonia, sinusitis, and otitis media, as well as invasive diseases like meningitis. The susceptible populations are children under 2 years old, adults over 65, and individuals with weakened immune systems or chronic illnesses.

Pfizer and MSD Are the Two Major Players in the Pneumococcal Vaccine Market, Closely Competing in Product Development. Pfizer's 13-valent pneumococcal vaccine, Prevnar 13 (PCV13, Prevenar 13), is a long-standing bestseller with widespread vaccination among children under 2 years old. Although MSD’s 23-valent pneumococcal vaccine, Pneumovax 23, covers more serotypes than PCV13, it shows poor protection in children under 2 years old. The U.S. Centers for Disease Control and Prevention (CDC) recommends: All children under 2 years old and children at higher risk of pneumococcal infection should be vaccinated with Prevnar 13; adults aged 19-64 with chronic diseases and adults aged 65 or older should receive the Pneumovax 23 vaccine. Sales of Prevnar 13 have consistently remained above $5 billion, while sales of Pneumovax 23 are around $1 billion.

PF-06482077 (20vPnC), a 20-valent pneumococcal vaccine developed by Pfizer, was approved by the FDA on June 8, 2021, for use in adults aged 18 years and older. The 20vPnC vaccine includes all 13 serotypes of pneumococcal strains contained in PCV13, as well as an additional 7 common serotypes responsible for invasive pneumococcal disease and pneumonia globally. Thus, 20vPnC covers nearly all 20 major serotypes of pneumococcal strains causing pneumonia outbreaks in the United States and worldwide.

On July 16, 2021, MSD's 15-valent pneumococcal vaccine V114 (PCV15) was approved by the FDA for market release to prevent pneumococcal infections and bacterial pneumonia in adults aged 18 years and above. V114 includes all 13 serotypes of Prevenar 13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and adds two serotypes, 22F and 33F, which are common in invasive pneumococcal disease among the elderly. Although this approval does not directly threaten the pediatric market of PCV13, in January 2019, V114 was granted Breakthrough Therapy Designation by the FDA for the prevention of invasive pneumococcal disease in both the pediatric population aged 6 weeks to 18 years and adults aged 18 years and above. MSD’s ambition for the under-2-year-old market is evident.

This time, MSD's V116, which received the FDA Breakthrough Therapy Designation, aims to further strengthen its competitiveness in the adult population. Since V116 contains 21 serotypes, it can cover 85% of the strains causing invasive pneumococcal disease in adults aged 65 and above in the U.S., and V116 includes eight serotypes that are not covered by any currently marketed vaccine products.