FDA Approves Pneumococcal 15-Valent Conjugate Vaccine for Adults 18 Years and Older

Officials with the FDA have approved Merck’s pneumococcal 15-valent conjugate vaccine (Vaxneuvance) for the prevention of invasive pneumococcal disease caused by 15 serotypes in adults 18 years of age and older, according to a press release.

Pneumococcal disease is caused by Streptococcus pnuemoniae bacteria and becomes invasive when the bacteria infect parts of the body that are typically free from germs. Approximately 80% of invasive pneumococcal disease occurs among adults 50 years of age and older.

“Some adults, including older adults or those with certain chronic medical conditions or immunocompromising conditions, are at increased risk for pneumococcal disease and its serious, sometimes life-threatening complications,” said Jose Cardona, MD, coordinating investigator of the PNEU-AGE trial, in the press release. “The FDA’s approval of Vaxneuvance is based on robust phase 2 and 3 studies assessing immune responses in a broad range of adult populations and provides an important new option in protection from invasive pneumococcal disease.”

Serotype 3 is the leading cause of invasive pneumococcal disease in adults and serotypes 22F and 33F also contribute significantly to the burden. Both 22F and 33F are unique to the newly approved vaccine and are associated with high antibiotic resistance, according to the press release.

The vaccine prevents disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F. It was approved based on data from 7 randomized, double-blind clinical trials assessing the vaccine’s safety, tolerability, and immunogenicity in adults, which found that immune responses elicited by the vaccine were non-inferior to the currently available 13-valent pneumococcal conjugate vaccine, according to the study.

In addition, immune responses in the clinical trials were superior to the PCV13 vaccine for serotype 3 and for the 2 serotypes unique to the new 15-valent vaccine: 22F and 33F. In the phase 3 PNEU-AGE study, the vaccine’s superiority over PCV13 was based on statistically significantly greater opsonophagocytic activity (OPA) geometric mean titers (GMT) ratios for both 22F and 33F serotypes, as well as for the key secondary objective assessing serotype 3.

REFERENCE

Merck Announnces US FDA Approval of Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Adults 18 Years and Older Caused by 15 Serotypes. News release. Merck. July 16, 2021. Accessed July 19, 2021. https://www.merck.com/news/merck-announces-u-s-fda-approval-of-vaxneuvance-pneumococcal-15-valent-conjugate-vaccine-for-the-prevention-of-invasive-pneumococcal-disease-in-adults-18-years-and-older-caused-by-15-serot/