RAHWAY (UNITED STATES) (ITALPRESS) – MSD has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of V116 (21-valent pneumococcal 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 CHMP recommendation will now be considered by the European Commission (EC) for marketing authorization in the European Union (EU), Iceland, Liechtenstein, and Norway, with a final decision expected in the second quarter of 2025.”I express great satisfaction with the CHMP’s positive opinion on this new vaccine, which arouses considerable interest: for the first time we will have a product that is specifically designed and developed for the adult population,” said Enrico Di Rosa, Director of the Hygiene and Public Health Service of ASL Roma 1 and President of the Italian Society of Hygiene (SItI), who added: “In fact, V116 takes into account the specific epidemiology of this age group in a targeted manner, extending serological coverage to those strains that specifically affect adults and the elderly with the effect of expanding serotype coverage while maintaining, at the same time, the vaccine’s efficacy. We therefore await the end of the regulatory process to include this important new tool in the prevention toolbox.” V116 is specifically designed to protect adults against the serotypes that cause most cases of invasive pneumococcal disease (IPD). The vaccine has been studied nationally in four European Union countries (Italy, Germany, France, and Spain), and the serotypes covered by V116 are responsible for more cases of IPD in adults than PCV20 (20-valent pneumococcal conjugate vaccine). Data were compiled for some countries based on European Union membership, population size, and the most recent surveillance report. These values are based on epidemiological data at the national level and regional variations may exist; furthermore, these data do not reflect the efficacy of the respective vaccines. There are currently no studies comparing the efficacy of V116 and PCV20. “The positive CHMP opinion confirms the value of V116, a value demonstrated in all study phases with an optimal immunogenicity profile even in adult patients with higher risk of pneumococcal disease,” says Professor Francesco Blasi, Full Professor of Diseases of the Respiratory Tract University of Milan, Italy. “This vaccine proposes to optimize protection; in fact, V116 was designed based on epidemiological data of the serotypes most commonly implicated in invasive disease and pneumococcal pneumonia.Clinical data supporting the recommendation include results from the pivotal Phase 3 STRIDE-3 study (NCT05425732), which evaluated V166 versus PCV20 in adults aged 18 years and older who had not previously received a pneumococcal vaccine. The recommendation is also supported by the results of Phase 3 STRIDE-4 (NCT05464420), STRIDE-5 (NCT05526716), STRIDE-6 (NCT05420961), STRIDE-7 (NCT05393037), and STRIDE-10 (NCT05569954) trials, which evaluated V116 in adults naïve to pneumococcal vaccines and with previous experience with pneumococcal vaccines.If approved in the European Union, we would be looking at the fourth authorization of V116 for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. V116 was, in fact, first approved in the United States in June 2024, in Canada in July 2024, and in Australia in January 2025. In addition, V116 is currently under review in Japan and other evaluations are underway with regulatory bodies worldwide.In the United States, V116 is MSD’s 21-valent pneumococcal conjugate vaccine indicated for active immunization of adults aged 18 years and older for the prevention of invasive pneumococcal disease and pneumonia. V116 is specifically designed to counter Streptococcus pneumoniae and the serotypes predominantly responsible for invasive pneumococcal disease (IPD) in adults, including eight serotypes unique from other pneumococcal vaccines, 15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B. V116 is administered as a single dose.
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