Merck & Co. (MSD) recently announced that the U.S. FDA has approved Vaxneuvance, a 15-valent pneumococcal vaccine, to prevent Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V in adults over 18 years of age. , 14, 18C, 19A, 19F, 22F, 23F and 33F caused by aggressive diseases. Vaxneuvance has obtained priority review qualification granted by the US FDA.

Pneumococcal disease is an infection caused by Streptococcus pneumoniae. Highly invasive strains or serotypes may expose more people to non-invasive pneumococcal disease and invasive pneumococcal disease (IPD). 80% of adult IPD burden occurs in adults over 50 years old. Serotype 3, 22F, and 33F have a significant impact on the burden of IPD, and serotype 3 is the leading cause of the burden of IPD in the United States.

This approval is based on data from 7 randomized double-blind clinical trials evaluating the safety, tolerability and immunogenicity of Vaxneuvance in adults. The data shows that for the serotype shared with the approved 13-valent pneumococcal conjugate vaccine (PCV13), the immune response induced by Vaxneuvance meets the standard of non-inferiority.

In addition, against the serotype 3 shared by the two vaccines and the two serotypes unique to Vaxneuvance (22F and 33F), Vaxneuvance elicited better immune responses than PCV13.

"At Merck, we are committed to protecting more people from invasive pneumococcal disease. This is why we set out to develop a conjugate vaccine containing the serotypes that pose the greatest threat. Type of strong immune response.” said Dr. Roy Baynes, chief medical officer and head of global clinical development at Merck Laboratories, “Vaxneuvance’s approval provides a new option for the prevention of pneumococcal disease. It includes serotypes that cause a large burden of disease in adults. It is associated with highly aggressive diseases and antibiotic resistance."