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Pfizer wins new European approval for Prevenar 13

Expands use of pneumococcal disease vaccine to cover people aged 18 to 49

Pfizer headquartersPfizer's Prevenar 13 yesterday became the first vaccine available in Europe to protect against pneumococcal disease for people in at any stage of life after the European Commission (EC) approved its use in adults aged 18 to 49.

Previously, Prevenar 13, which protects against the 13 strains of the pneumoniae bacterium, was only available for use in children aged six weeks to 17 years and in adults aged 50 and over.

Both these groups are at heightened risk of developing pneumococcal disease, although it can affect people of all ages, especially those with conditions such as HIV infection, cancer, advanced kidney disease or other immunocompromising conditions.

The new approval expands use of the vaccine to the general population, and should help further boost sales of a product that made $3.72bn for Pfizer during 2012.

The EC's decision is based on phase III trial data showing Prevenar 13 is at least as able to provoke an immune response in healthy adults aged 18 to 49 years as it is in adults 60 to 64 years of age, as measured one month after vaccination.

“Prevenar 13 has been administered to millions of individuals around the world, and today's European approval for the expanded use of Prevenar 13 is a testament to Pfizer's continued commitment to developing innovative vaccines that can help prevent serious – and sometimes fatal – disease through every stage of life,” said Dr Emilio Emini, chief scientific officer, vaccine research, Pfizer.

The decision by the EC follows a similar move made by the US in June 2012, when the Centers for Disease Control and Prevention (CDC) recommended the vaccine in immunocompromised adults aged 19 or over. This approval expanded the potential reach of Prevnar 13, as it is known in the US, by as much as 10 million people.

11th July 2013

From: Sales



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