Merck's pneumococcal vaccine wins US approval for high-risk children, teens

Merck & Co

18/06/2026 11:45

    June 18 (Reuters) - Drugmaker Merck MRK.N said on Thursday the U.S. health regulator has approved an expanded use of its pneumococcal vaccine for children and teenagers who face a higher risk of catching the bacterial disease due to chronic health conditions.

Here are the details:
The expanded approval covers patients aged 2 to 17 who have already completed a standard childhood pneumococcal vaccination schedule but have chronic conditions such as heart, lung, kidney, liver disease, or diabetes, which raise their risk of serious infections.

        The vaccine, branded as Capvaxive, is designed to protect against multiple strains of the Streptococcus pneumoniae bacteria.
      

        It was 
        first approved
         by the U.S. Food and Drug Administration for adults in June 2024.
      
Pneumococcal disease, caused by the bacteria, can lead to serious illnesses including pneumonia, meningitis, and blood infections.  
The disease spreads through contact with respiratory secretions such as saliva or mucus, and young children under five and adults 50 years and older are at higher risk of infection.

        Thursday's approval was based on results from a late-stage trial involving 874 participants, where the new vaccine matched or outperformed PPSV23, an older pneumococcal vaccine. Side effects were generally short-lived, Merck said.
The vaccine is given as a single dose and is intended to complement existing childhood pneumococcal vaccines.


 (Reporting by Kamal Choudhury in Bengaluru; Editing by Sahal Muhammed)
 ((Kamal.Choudhury@thomsonreuters.com;))