FDA approves Merck’s pneumococcal vaccine Capvaxive

The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Capvaxive (pneumococcal 21-valent conjugate vaccine), submitted by US pharma giant Merck & Co (NYSE: MRK).

The approval is for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in the adult population. It covers 21 different serotypes of Strep pneumoniae, including eight that are not targeted by any of the other available vaccines.

The indication for pneumococcal pneumonia is under accelerated approval. The FDA approval of Capvaxive, previously known as V116, triggers a $2 million milestone payment to Ligand Pharmaceuticals (Nasdaq: LGND) and the company is entitled to a royalty on worldwide net sales.