FDA nod for Merck's Vaxneuvance

The US Food and Drug Administration (FDA) approved Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.

The approval, for US pharma giant Merck & Co (NYSE: MRK), follows the FDA’s Priority Review of Merck’s application. Vaxneuvance is contraindicated for individuals with a history of severe allergic reaction (eg, anaphylaxis) to any component of Vaxneuvance or to diphtheria toxoid.

The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to meet in October to discuss and make recommendations on the use of Vaxneuvance in adults.