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news.The European Commission has approved an expanded indication for the use Pfizer's Prevenar 13 (pneumococcal polysaccharide conjugate vaccine) to prevent pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults aged 18 years and older.
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The company said that the label has also been updated to include efficacy data from Pfizer’s Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA).
The CAPiTA trial showed 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 Vaccines Medical and Scientific Affairs, Europe vice-president Rene Reinert said: "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.
"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."
The company has conducted the CAPiTA trial as part of its regulatory commitments to global regulatory authorities.
Results from the trial have been submitted to the US Food and Drug Administration (FDA) and regulatory agencies in other major markets, including Australia and Canada, for inclusion in the product’s labeling.
More than 85,000 subjects aged 65 years and older were included in the trial, which was conducted by Julius Clinical, an academic research organization affiliated with the University Medical Center Utrecht (UMCU) in the Netherlands.
Prevenar 13 is now indicated in the EU for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults =18 years of age and the elderly.