FDA Approves 21-Valent Pneumococcal Vaccine

According to a report from MedPage Today, the Food and Drug Administration (FDA) has approved a 21-valent, single-dose pneumococcal conjugate vaccine (Capvaxive) for preventing invasive pneumococcal disease and pneumococcal pneumonia in adults. The vaccine is from drugmaker Merck, which says it is designed to immunize adults to prevent disease caused by several serotypes of the Streptococcus pneumoniae bacteria. Such infections are estimated to cause over 150,000 adult hospitalizations annually in the U.S. A medical spokesman from Emory University in Atlanta said complications from invasive pneumococcal disease can lead to hospitalization, organ damage, and even death, and the new vaccine is designed to include the serotypes that cause the majority of invasive pneumococcal disease in adults. The vaccine reportedly contains eight unique serotypes that are not covered by other available vaccines. Based on epidemiologic data from the Centers for Disease Control and Prevention (CDC), the serotypes included in the vaccine together cause roughly 84% of the cases of invasive pneumococcal disease in adults 50 and older. The FDA approval of the vaccine was granted under the accelerated pathway based on immune response data and may be contingent on demonstration of clinical benefit in a confirmatory trial. As with all vaccines, patients are urged to check with their professional healthcare provider about whether to receive this new vaccine.

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