FDA Expands Prevnar 13 Use for Ages 18-49

The expanded approval of Prevnar 13 is based on data from a Phase 3 open-label trial
The expanded approval of Prevnar 13 is based on data from a Phase 3 open-label trial

Pfizer announced that the Food and Drug Administration (FDA) has approved Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) for use in adults aged 18–49 for the active immunization for the prevention of pneumonia and invasive disease caused by 13 Streptococcus pneumoniae serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). 

Prevnar 13 is already approved for use in adults aged ≥50 years and children aged 6 weeks–17 years for the prevention of invasive disease caused by 13 S. pneumoniae strains in the vaccine. The new age range now more closely follows the 2012 U.S. Centers for Disease Control and Prevention (CDC)'s Advisory Committee on Immunizations Practices (ACIP) recommendations for adults aged ≥19 years with immunocompromising conditions (eg, HIV, chronic renal failure, cancer), functional or anatomic asplenia, cerebral spinal fluid leak, and Cochlear implants, as well as the 2014 recommendations for adults aged ≥65 years. 

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The FDA's expanded approval was based on data from a Phase 3 open-label trial of Prevnar 13 in adults who were previously not vaccinated with the 23-valent pneumococcal polysaccharide vaccine (PPSV23). The study evaluated the immunogenicity, safety, and tolerability of Prevnar 13 in adults aged 18–49 years vs. adults aged 60–64 years. 

Prevnar 13, comprised of pneumococcal polysaccharides conjugated to a carrier protein (CRM197), elicits a T-cell dependent immune response. Protein carrier-specific T-cells provide the signals needed for maturation of the B-cell response. The vaccine delivers 30.8mcg of saccharides per 0.5mL dose.

For more information call (800) 438-1985 or visit Prevnar13.com.

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