FDA approves Merck’s Capvaxive for prevention of pneumococcal disease
Betsy Goodfellow | June 18, 2024 | News story | Medical Communications | Capvaxive, FDA, Infections and infestations, Merck, pneumonia
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 18 years of age and older.
Capvaxive is designed to protect against the serotypes which 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.”
Betsy Goodfellow
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