The European Commission (EC) has approved the Merck VaxNeuvance (Pneumococcal 15-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.
The approval allows marketing of Merck VaxNeuvance in all 27 European Union (EU) Member States plus Iceland, Norway and Lichtenstein. The use of Merck VaxNeuvance in the EU should be in accordance with official recommendations.
The EC’s decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products on Human Use (CHMP), which reviewed data from seven randomized, double-blind clinical studies evaluating VaxNeuvance in 7,438 individuals from a variety of adult populations and clinical circumstances. These included healthy adults ages 50 years and older, adults ages 18 to 49 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 (OPA) Geometric Mean Titers (GMTs) at 30 days post-vaccination. Additionally, immune responses for VaxNeuvance were superior to PCV13 for shared serotype 3 and for the two serotypes unique to VaxNeuvance, 22F and 33F. Randomized controlled trials assessing the clinical efficacy of VaxNeuvance compared to PCV13 have not been conducted.
“At Merck, we are committed to helping protect more people from invasive pneumococcal disease (IPD), as well as from pneumococcal pneumonia, the most common form of pneumococcal disease in adults,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “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 European Union with a new option that can help protect against pneumococcal serotypes responsible for around 40 percent of IPD cases in adults over 65 in the largest EU member countries.”
In July 2021, VaxNeuvance received approval from the US 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.