European Commission approves Merck's pneumococcal vaccine Vaxneuvance

KENILWORTH, N.J : European Commission has granted approval to pharmaceutical company Merck for its Pneumococcal 15-valent Conjugate Vaccine, Vaxneuvance™, for active immunization to prevent the disease. The approval allows the company to market and administer the vaccine in European Union (EU) Member States plus Iceland, Norway and Liechtenstein.

The administration of the vaccine in accordance with the official recommendations can effectively prevent invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals aged 18 years and older. While healthy adults can suffer from pneumococcal disease, patient populations particularly vulnerable to infection include older adults aged 65 years and older, people with HIV, and those with certain chronic health conditions.

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.The sample population included healthy adults aged 50 years and older, adults aged 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-naive adults aged 50 and older, immune responses elicited by the vaccine were non-inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 shared serotypes. This was 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, 22F and 33F. Randomized controlled trials assessing the clinical efficacy of Vaxneuvance compared to PCV13 are yet to be conducted.

Speaking on developing a vaccine potentially offering protection from IPD and pneumococcal pneumonia, Dr Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, Merck Research Laboratories said, “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. 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 percent of IPD cases in adults over 65 in the largest EU member countries.”

Merck's pneumococcal vaccine Vaxneuvance had received approval from the U.S. Food and Drug Administration (FDA) earlier this year for active immunization for the prevention of invasive disease caused by certain serotypes of Streptococcus pneumoniae in adults 18 years and older.