Pfizer receives European approval for Prevenar 13 expanded indication

The European Commission has approved an expanded indication for the world’s most widely used pneumococcal conjugate vaccine (PCV) Prevenar 13 (13-valent, adsorbed) from US pharma giant Pfizer (NYSE: PFE).

The expanded indication includes the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults aged 18 years and older. The Summary of Product Characteristics has also been updated to include efficacy data from Pfizer’s Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), which demonstrated statistically-significant reductions in first episodes of vaccine-type pneumococcal community-acquired pneumonia (CAP), including non-invasive/non-bacteremic CAP, and invasive pneumococcal disease (IPD) in adults aged 65 and older. Pfizer conducted the CAPiTA study as part of its regulatory commitments to global regulatory authorities. The results have been submitted to the US Food and Drug Administration and regulatory agencies in other major markets, including Australia and Canada, for inclusion in the product’s labeling.

Rene Reinert, vice president, Pfizer Vaccines Medical and Scientific Affairs, Europe, said: “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. 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.”