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EU Approves New Pneumococcal Vaccine for Adults
ROME (AP) — The European Commission has granted approval for MSD’s pneumococcal vaccine (V116), a 21-valent vaccine, for active immunization against invasive disease and pneumonia in adults 18 and older. The vaccine targets Streptococcus pneumoniae serotypes 3, 6a, 7f, 8, 9n, 10a, 11a, 12f, 15b, 15c, 16f, 17f, 19a, 20a, 22f, 23a, 23b, 24f, 31, 33f, and 35b.
According to MSD, the pharmaceutical company that developed the vaccine, V116 is specifically designed to protect adults from the serotypes responsible for the majority of invasive pneumococcal disease (IPD) cases. The approval is based on data from Phase 3 clinical trials demonstrating the vaccine’s safety and immunogenicity.
Expert Commentary
Enrico Di Rosa, Director of Hygiene and Public Health Service (SISP) ASL Rome 1 and President of the Italian Society of Hygiene, Preventive Medicine and Public Health (SItI), hailed the approval as a significant advancement. “With this new vaccine, for the first time, we will have a new option specifically designed and developed for the adult population,” Di Rosa said. He added that the 21-valent vaccine is tailored to the specific epidemiology affecting adults and the elderly,extending serotype coverage while maintaining vaccine effectiveness.
Availability and Global approvals
The European Commission’s decision authorizes the marketing of MSD’s 21-valent pneumococcal vaccine in all 27 EU member states, and also Iceland, Liechtenstein, and Norway. The timeline for V116’s availability in individual countries will depend on various factors, including the completion of reimbursement procedures. The vaccine received approval in the United States in June 2024, Canada in July 2024, and Australia in January 2025.
Tommasa Maio, national manager of the Italian Vaccine area of General Medicine Medici (Fimmg), emphasized the impact of invasive diseases and pneumococcal pneumonia on adult health, particularly among the elderly. ”This new vaccine represents a crucial progress in the prevention of these pathologies, since it is specifically designed for adults and the elderly,” Maio stated.
Vaccination Rates and Public Health Impact
Maio noted that current vaccination coverage for this immunization remains below the 75% target.She stressed the importance of intensifying efforts to prevent these significant pathologies, highlighting the potential impact of this innovation on the health and well-being of the elderly population.
Giancarlo Icardi, a professor of hygiene, preventive medicine and public health at the University of Genoa, emphasized the vaccine’s immunogenicity profile in the adult and elderly populations, including those with diabetes, cardiovascular pathologies, and chronic respiratory diseases. He noted that V116 was designed based on the epidemiology of serotypes most involved in invasive diseases and pneumococcal pneumonia.
Michele Conversano, director of the Department of Prevention of the ASL of Taranto and President of Happy Ageing, underscored the public health significance of pneumococcal pathologies, particularly for adults and the elderly. He advocated for targeted prevention tools to protect the growing elderly population and ensure the sustainability of healthcare systems.
Clinical Trial Data
The European Commission’s decision followed a positive proposal from the European Medicines agency (EMA) and was based on results from the Phase 3 Scree-3, Scree-10, Scree-4, Scree-5-6, and Scree-7 studies. These studies evaluated V116 compared to PCV20 (20-valent pneumococcal vaccine) and PPSV23 (23-valent pneumococcal polysaccharide vaccine) in adults with and without prior pneumococcal vaccination.
Economic Impact
Giovanna Elisa Calabrò,associate professor at the University of Cassino and Southern Lazio,stated that the new 21-valent pneumococcal vaccine could prevent over 11,000 cases of invasive and non-invasive pneumococcal disease,generating total savings of approximately 56 million euros. Adapting Italian epidemiology with French surveillance data, the benefit of V116 could reach about 21,000 cases avoided, with total savings exceeding 110 million euros.
EU Approves new Pneumococcal Vaccine for adults: Your Top Questions Answered
What is the new pneumococcal vaccine approved for adults in the EU?
The European Commission has approved MSD’s 21-valent pneumococcal vaccine, known as V116.This vaccine is for active immunization against invasive disease and pneumonia in adults aged 18 and older. It targets specific Streptococcus pneumoniae serotypes.