Approvals

Merck, known as MSD outside of the US and Canada, has announced that the US Food and Drug Administration (FDA) has approved Capvaxive (Pneumococcal 21-valent Conjugate Vaccine).

The vaccine has been approved for the active immunisation of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B, as well as for the prevention of pneumonia caused by S pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B, both in individuals.

Capvaxive is designed to protect against the serotypes that cause the majority of invasive pneumococcal disease (IPD) cases.

This approval follows the FDA’s Priority Review of the vaccine. The US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices is intended to meet later in June to make its recommendations for the vaccine’s use in adult patients.

Dr Walter Orenstein, professor emeritus of medicine, epidemiology, global health and pediatrics at Emory University, US, and member of Merck’s Scientific Advisory Committee, commented: “Complications from invasive pneumococcal disease can lead to hospitalisation, organ damage and even death. Many cases of adult disease are caused by serotypes not included in other approved pneumococcal conjugate vaccines. Capvaxive is designed to include the serotypes that cause the majority of invasive pneumococcal disease in adults, helping to protect adults against invasive pneumococcal disease and pneumococcal pneumonia.”

“Today’s approval is a testament to our population-specific strategy behind Capvaxive, which demonstrated robust immunogenicity in a range of adult populations and is driven by a deep understanding of pneumococcal disease,” added Dr Dean Y Li, president, Merck Research Laboratories.

“We are proud to provide Capvaxive as a new option specifically designed to help protect against the majority of invasive pneumococcal disease-causing serotypes in adults.”