Pfizer gets approval expansion from FDA for pneumonia vaccine

pharmafile | July 13, 2016 | News story | Research and Development, Sales and Marketing FDA, Pfizer, Prevnar 13, adults, approval 

The US Food and Drug Administration (FDA) has issued an expanded approval for Pfizer’s pneumococcal pneumonia vaccine Prevnar 13 to include adults between the ages of 18 and 49, in addition to the already approved 50 years and over.

Prevnar 13 is now approved in the US for the prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumoniae strains in the vaccine and in children aged six weeks through to 17 years of age for the latter indication.

This expanded approval now more closely aligns with the recommendations from the US Centers for Disease Control and Prevention’s Advisory Committee on Immunisation practices recommendations, issued in 2012, for adults 19 years and older with immunocompromising conditions, functional or anatomic asplenia, cerebral spinal fluid leak, and Cochlear implants.

The FDA’s decision comes on the back of a Phase III trial which compared the immunogenicity, safety and tolerability of Prevnar 13 in adults aged 18 to 49 with adults aged 60 to 64, for whom it was already approved.

Dr Luis Jodar, chief medical and scientific affairs officer at Pfizer Vaccines, says: “This expanded 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.”

Sean Murray

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