FDA Approves Merck's Vaccine for Pneumococcal Disease

Vaxneuvance is approved for 15 serotypes, including those that are major causes of disease.

Merck announced the FDA has approved Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine), a vaccine to prevent pneumococcal disease in adults 18 years of age and older. The vaccine provides immunization for the prevention of invasive disease caused by several serotypes of Streptococcus pneumoniae.

The approval was based on data from seven randomized, double-blind clinical studies assessing safety, tolerability, and immunogenicity in adults. Clinical data showed that immune responses elicited by Vaxneuvance were non-inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 shared serotypes.

Vaxneuvance is administered as a single dose via intramuscular injection. Common adverse reactions include pain at the injection site, fatigue, muscle pain, headache, redness and swelling at the injection site, and arthralgia.

“The FDA approval of Vaxneuvance builds on Merck’s more than 40 years of experience in pneumococcal disease prevention with a new option that includes serotypes responsible for substantial disease burden in adults, like serotype 3, as well as serotypes 22F and 33F, which are associated with a high degree of invasiveness and antibiotic resistance,” Roy Baynes, MB BCH, Ph.D., senior vice president and head of global clinical development, chief medical officer, at Merck Research Laboratories, said in a statement.

In January 2021, Vaxneuvance received Priority Review designation.