Pneumococcal 15-valent Conjugate Vaccine for Adults Approved in Europe
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New Jersey-based Merck announced today that the European Commission (EC) had approved VAXNEUVANCE™ for active immunization to prevent invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.
Today's EC approval allows the marketing of VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) in all 27 European Union (EU) Member States plus Iceland, Norway, and Lichtenstein.
The EC's decision follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products on Human Use which reviewed data from seven randomized, double-blind clinical studies evaluating VAXNEUVANCE. These studies included adults with risk factors for pneumococcal disease, and immunocompromised adults living with HIV.
In the pivotal, double-blind, active-comparator controlled study in 1,205 immunocompetent pneumococcal vaccine-naïve adults ages 50 and older, immune responses elicited by VAXNEUVANCE were non-inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 shared serotypes, as assessed by opsonophagocytic activity Geometric Mean Titers at 30 days post-vaccination.
Additionally, immune responses for VAXNEUVANCE were superior to PCV13 for shared serotype three and the two serotypes unique to VAXNEUVANCE, 22F and 33F.
Dr. Roy Baynes, SVP and head of global clinical development, chief medical officer, Merck Research Laboratories, commented in a press release issued on December 15, 2021, "With VAXNEUVANCE, we developed a conjugate vaccine that elicits a strong immune response to pneumococcal serotypes that contribute substantially to the burden of disease, including serotype 3, a leading cause of IPD in the EU."
"This approval provides physicians and patients in the EU with a new option that can help protect against pneumococcal serotypes responsible for around 40% of IPD cases in older adults in the largest member countries."
In July 2021, VAXNEUVANCE received approval from the U.S. FDA for active immunization for the prevention of invasive disease caused by “Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years and older.
The global prevalence of pneumococcal disease, an infection caused by bacteria called Streptococcus pneumoniae, is evolving.
Highly aggressive strains, or serotypes, threaten to put more people at risk for invasive pneumococcal illnesses such as bacteremia; pneumonia with bacteremia; and meningitis, as well as when the pneumococcal disease is confined to the lungs.
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