Wednesday, July 10, 2013

Reuters: Regulatory News: Pfizer gets EU approval for wider use of Prevenar vaccine

Reuters: Regulatory News
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Pfizer gets EU approval for wider use of Prevenar vaccine
Jul 10th 2013, 10:53

July 10 | Wed Jul 10, 2013 6:53am EDT

July 10 (Reuters) - Pfizer Inc said it received approval from the European health regulator to expand use of its anti-bacterial vaccine to a wider population of adults aged 18 to 49 years.

The vaccine, Prevenar 13, was previously approved in Europe for use in infants, young children and adolescents between the ages of 6 weeks and 17 years and adults of 50 years and over.

It is used to prevent infections from 13 strains of the Streptococcus pneumoniae bacterium, which can cause pneumonia, ear infections and even fatal diseases such as pneumococcal meningitis.

The vaccine is approved for use in infants and young children in more than 120 countries, and for use in adults aged 50 and over in over 80 countries in more than 80 countries.

In January, the U.S. Food and Drug Administration approved the use of the vaccine, known as Prevnar 13, in the United States, for children and adolescents aged 6 years to 17 years.

Sales of Prevnar, which is Pfizer's third-biggest brand, were hit in the first quarter, because wholesalers, with adequate supplies already on hand, held off on purchases of the vaccine. The company recorded $846 million in Prevnar sales during that period.

Pfizer had then said it expected Prevnar sales to strengthen during the year as wholesalers use up their existing supplies.

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