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July 16, 2021Vaxneuvance Approved to Prevent Pneumococcal Disease
July 16, 2021 – The U.S. FDA has approved VaxneuvanceTM (pneumococcal 15-valent conjugate vaccine – Merck) for active immunization to prevent invasive disease caused by 15 serotypes of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) in adults.
Invasive pneumococcal disease (IPD) is caused by an S. pneumoniae bacterial infection that has invaded parts of the body where infectious organism normally aren’t found, such as the blood and cerebral spinal fluid. IPD is typically severe and may require hospitalization. It can also be life-threatening, leading to conditions such as pneumonia (inflammation of air sacs in the lungs), meningitis (swelling in the protective membranes of the brain and spinal cord), and bacteremia (infection of the blood).
Currently FDA-approved pneumococcal vaccines are designed to protect against as many as 23 different S. pneumoniae serotypes (strains). In clinical studies, Vaxneuvance was found to be non-inferior in eliciting an immune response compared to an already FDA-approved pneumococcal vaccine intended to protect against 13 serotypes of S. pneumoniae. Recommended dosing is a single 0.5mL intramuscular injection.
Launch and pricing information are not yet available.