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FDA expands use of Pfizer's Prevnar 13

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Pfizer ($PFE) harbors big expectations for its top-selling pneumococcal conjugate vaccine Prevnar 13. The company is increasing its manufacturing capacity for the shot and investing in a multidose vial. And the World Health Organization offered requalification for use of Prevnar 13 in adults over 50 late last year.

A recent expansion could help Pfizer reach its lofty goals: The FDA will now allow use of the vaccine in children and adolescents ages 6 to 17. Prevnar 13 protects against infection with 13 strains of Streptococcus pneumoniae bacterium, which can cause pneumonia, ear infections and other afflictions.

More than 110 countries approve Prevnar 13 (Prevenar 13 outside the U.S.) for use in infants and young children. Last year, sales hit $3.72 billion, up from $3.66 billion in 2011. Analysts expect sales to hit $6.75 billion by 2018.

"As a global leader in pneumococcal disease prevention, extending the impact of Prevnar 13 to older children and adolescents aged 6 through 17 years is a reflection of our dedication to improving public health worldwide," Susan Silbermann, president of Pfizer vaccines, said in a statement. "We continue to work tirelessly to make this vaccine available to people at risk for invasive pneumococcal disease."

Prevnar 13 first hit the market in Europe in December 2009. The U.S. followed suit, approving the shot two months later in February 2010. Pfizer has distributed more than 500 million doses worldwide, making the shot the most widely used pneumococcal conjugate vaccine.

- see the FDA approval letter
- get more from Pfizer
- read Reuters' take

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