TUESDAY, SEPTEMBER 27, 2016

Pfizer gains EU approval for pneumococcal vaccine

Courtesy of underconsideration.com

The European Commission recently granted an expanded indication for Pfizer, Inc.'s Prevenar 13 to vaccinate adults for pneumonia caused by the 13 pneumococcal serotypes contained in the vaccine.

The approval means that the vaccine can now be administered to adults 18 years and older in Europe.

The commission also updated the Summary of Product Characteristics to include data from Pfizer's Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), which showed a decline in the number of first episodes of vaccine-type pneumococcal community-acquired pneumonia.

A similar request is awaiting approval by the U.S. Food and Drug Administration, as well as regulatory agencies in Canada and Australia.

“We welcome the approval of this new indication for Prevenar 13 in the EU, which will enable health care professionals to help adults reduce their risk of pneumococcal pneumonia caused by the 13 serotypes in the vaccine,” Rene Reinert, vice president of Pfizer Vaccines Medical and Scientific Affairs in Europe, said. “This is particularly important for older adults and those with medical conditions that may make them more vulnerable to this serious, debilitating and potentially deadly disease. Pfizer looks forward to working with vaccine technical committees in Europe to discuss this new indication and the CAPiTA data, as well as potential updates to recommendations for the use of Prevenar 13 in adults.”

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