Pfizer has announced that the European Commission approved an expanded indication for the use of Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) for 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 landmark 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.
“We welcome the approval of this new indication for Prevenar 13 in the EU, which will enable healthcare 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,” said Rene Reinert, Vice President, Pfizer Vaccines Medical and Scientific Affairs, Europe. “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.”