EC approval of pneumococcal vaccine for adults (V116)

The European Commission (EC) has granted marketing authorization for MSD’s 21-valent pneumococcal conjugate vaccine (V116). This vaccine is indicated for preventing invasive pneumococcal disease (IPD) and pneumonia caused by Streptococcus pneumoniae in adults aged 18 years and above. The EC’s decision was informed by safety and immunogenicity data derived from the Phase 3 STRIDE clinical program. The authorization of V116 follows the approval of the 15-valent conjugate vaccine three years prior, which is indicated for pediatric use, thereby providing comprehensive vaccination coverage across all age demographics. Clinical trials have substantiated the efficacy and safety profile of V116, suggesting the potential for lifetime immunization with a single dose. Tommaso Maio, national head of the Vaccine Area of the Italian Federation of General Practitioners (FIMMG), has noted that current vaccination rates for this immunization remain below the target of 75%. Italian experts expect this advance to be made available to regional health systems, starting with the upcoming pneumococcal vaccination initiative, which will be launched in conjunction with the anti-influenza campaign. This authorization permits the commercial distribution of MSD’s 21-valent pneumococcal conjugate vaccine (V116) throughout the 27 member states of the European Union (EU), as well as Iceland, Liechtenstein, and Norway. The specific timeline for availability within individual countries is subject to various considerations. This vaccine was approved in the United States in June 2024, in Canada in July 2024, and in Australia in January 2025.