EU agency backs wider use of Pfizer's Prevenar 13

European regulators recommended approval of Pfizer Inc's Prevenar 13 vaccine for immunization of adults aged 50 years and older against pneumococcal disease.

Recommendations for marketing approval by the London-based Committee for Medicinal Products for Human Use are normally endorsed by the European Commission within a couple of months. The agency posted the letter, dated September 22, on its website.

In July, the U.S. Food and Drug Administration extended its review of the vaccine, which is sold as Prevnar 13 in the United States, for the same age group.

Prevnar 13 prevents infection by pneumococcal bacteria, which can cause pneumonia, meningitis and sepsis. The bacterium is one of the world's biggest killers of children, claiming up to 1.6 million lives a year.

It was approved for infants and young children in Europe in December 2009 and in the United States in February 2010. Pfizer is hoping that its approval for adults 50 and over will appreciably boost sales of the product, which is already among the world's biggest selling vaccines.

"This definitely expands the patient population for the vaccine, but I think a majority of sales is still going to come from the infant population," said Morningstar Inc analyst Damien Conover.

The Prevnar franchise generated global second-quarter sales of $821 million, making it Pfizer's fourth-biggest product. It is poised to become the company's biggest brand after cholesterol fighter Lipitor begins facing U.S. generic competition in November.

Sales of the Prevnar franchise could reach $5.83 billion in 2015, according to forecasts compiled by Thomson Reuters Pharma.

Pfizer acquired rights to the vaccine from its purchase of rival U.S. drugmaker Wyeth in late 2009.

Pfizer shares were down 0.6 percent to $17.38 in Friday afternoon trading on the New York Stock Exchange.

(Reporting by Anand Basu in New York; Editing by Michele Gershberg, Lisa Von Ahn, Tim Dobbyn)