US drugmaker Pfizer has received expanded approval from the European Commission (EC) for its Prevenar 13 (pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed), to prevent pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults aged 18 years and older.
Prevnar 13 is a vaccine approved in the US for adults 50 years of age and older to prevent pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F).
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Pfizer Europe vaccines medical and scientific affairs 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.
The company has also updated the summary of product characteristics, including an efficacy data from its Community-Acquired Pneumonia Immunisation Trial in Adults (CAPiTA) study.
The 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).
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The CAPiTA study is a double-blind randomised, placebo-controlled vaccine efficacy trial carried out in older adults, which achieved its primary and secondary objectives.
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By GlobalDataThe trial involved around 85,000 subjects aged 65 years and older. It was carried out by Julius Clinical, an academic research organisation affiliated with the University Medical Centre Utrecht (UMCU) in the Netherlands.
In December 2009, Prevenar 13 was first introduced in Europe for use in infants and young children.
The vaccine is currently approved for use in adults 50 years of age and older in around 90 countries, as well as approved in the US, European Union (EU) and other countries for use in older children and adolescents aged six to 17 years.
Image: Streptococcus pneumoniae growing on Columbia agar supplemented with Horse Blood. Photo: courtesy of Nathan Reading, flickr.com/photos/nathanreading.
