FDA Approves Prevnar 13® of Pfizer in Adults Age 18 Through 49

Pfizer Igea Luca Dezzani

July 12, 2016

Pfizer Inc. has announced that Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) received approval from U.S. Food and Drug Administration (FDA) for an expanded age indication to include adults 18 through 49 years of age, in addition to the already approved indication for adults 50 years and older. This Prevnar 13 can be used for active immunization for the prevention of pneumonia and invasive disease caused by 13 Streptococcus pneumoniae (S. pneumoniae) serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Prevnar 13 is the only pneumococcal vaccine approved across the lifespan.

The expanded age indication now more closely aligns with the recommendations of 2012 U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunizations Practices (ACIP) for adults 19 years of age and older with immunocompromising conditions (e.g., HIV, cancer, chronic renal failure), cerebral spinal fluid leak, functional or anatomic asplenia (e.g., sickle cell disease), and Cochlear implants.

Dr. Luis Jodar, Chief Medical and Scientific Affairs Officer, Pfizer Vaccines, said: “This expanded age indication in adults 18 to 49 offers an important public health benefit as appropriate vaccination against S. pneumoniae is critical to reducing the risk of pneumococcal disease, including in those with immunocompromising conditions.”


FDA Approves Prevnar 13® of Pfizer in Adults Age 18 Through 49 last edit: 2016-07-18T17:48:17+00:00 da Luca

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