US Food and Drug Administration Approves New Pneumococcal Vaccine

Merck & Co.’s new vaccine, CAPVAXIVE (V116), has been approved by the FDA for preventing invasive diseases and pneumonia in adults 18 and older caused by specific strains of the bacteria Streptococcus pneumoniae. This vaccine is particularly aimed at protecting adults over 50 from around 84% of invasive pneumococcal diseases. In several studies, CAPVAXIVE showed strong immune responses in both people new to vaccines and those who had previous vaccinations. 

JoinAStudy.ca would like to congratulate Dr Peter Dzongowski and his team at Milestone Research, whose efforts were crucial in gathering the data necessary to arrive at these conclusions and eventual approval. The study participants also deserve acknowledgment and thanks for providing their valuable time and effort.   

The vaccine was developed to cover more strains of pneumococcal diseases than other vaccines already available, including eight unique serotypes that are responsible for a significant percentage of cases in older adults. Clinical trials demonstrated that CAPVAXIVE effectively triggers immune responses and has a safety profile similar to other vaccines. The CDC’s Advisory Committee on Immunization Practices will soon provide recommendations on using CAPVAXIVE in adults. 

Key safety information includes not administering the vaccine to individuals with severe allergies to its components and acknowledging that immunocompromised individuals may have a reduced response. Common side effects include pain at the injection site, fatigue, and headaches. 

To read the full press release from Merck & Co., please click here.