On July 16, 2021, Merck Sharp & Dohme announced that the US FDA approved its new Vaxneuvance (V114) for the prevention of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B in adults over 18 years of age. Invasive diseases caused by, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F, such as bacteremic pneumonia, meningitis, sepsis and bacteremia. 

During the approval process of Vaxneuvance (V114), it obtained the priority review qualification granted by the US FDA. The American Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practice (ACIP) is expected to meet in October 2021 to discuss the use of Vaxneuvance in the adult population and make recommendations.

Currently, this vaccine is also being reviewed by EMA. The key clinical trial PNEU-AGE showed that compared with the marketed Pfizer 13-valent pneumococcal conjugate vaccine (PCV13, Prevnar 13), for the 13 serotypes jointly targeted by the two vaccines, Merck’s 15-valent pneumococcal conjugate vaccine V114 Meet the non-inferiority standard; for the two serotypes 22F and 33F for V114 (not Prevnar 13), V114 meets the superiority standard.

The Phase III clinical research and development project of Merck's 15-valent pneumococcal conjugate vaccine product V114 covers 16 trials to study its safety, tolerability and immunogenicity in different populations with increased risk of pneumococcal disease. These groups include healthy but older adults, healthy children, and people with immunodeficiency diseases or chronic diseases.

Previously, in May 2021, Merck announced that the 15-valent pneumococcal conjugate vaccine product V114 has reached the main immunogenicity and safety endpoints in two phase 3 trials of the phase 3 pediatric clinical program. These data support the potential application of V114 in healthy infants, including: (1) infants who may have previously been vaccinated with the currently available 13-valent pneumococcal conjugate vaccine (PCV13) (PNEU-DIRECTION trial); (2) not yet vaccinated Pneumococcal vaccine (vaccine-naive) or infants who have previously received a complete or partial immunization regimen of low-priced pediatric pneumococcal conjugate vaccine (PCV) (PNEU-PLAN trial).

However, in June 2021, Prevnar 20 (20-valent pneumococcal conjugate vaccine) from Pfizer has been approved in the United States, and this market will intensify competition.