FDA clears Pfizer vaccine for adults over 50

[January 03, 2012]  WASHINGTON (AP) -- Federal regulators have approved a vaccine for adults age 50 and older to prevent pneumococcal disease, including the most common type of pneumonia.

Friday's announcement from the Food and Drug Administration that it has approved Pfizer Inc.'s best-selling Prevnar 13 vaccine for such use was widely anticipated. It comes a little more than a month after a panel of federal health experts voted overwhelmingly to recommend Prevnar 13 as a safe and effective vaccine to prevent the bacterial infections in adults.

Prevnar 13 protects against 13 strains of pneumococcal bacteria, which cause meningitis, pneumonia and ear infections.

It's already a standard vaccination for infants and young children, who are most vulnerable to infection.

But the FDA said 300,000 adults 50 or older are hospitalized every year for pneumococcal pneumonia.

"The FDA approval of Prevnar 13 for these adults offers the potential to contribute to the health of millions of aging Americans," Ian Read, Pfizer's chairman and chief executive, said in a statement.

Some 5,000 older adults succumb to the disease annually, according to figures from the Centers for Disease Control and Prevention.

Prevnar, which was first approved in 2000, is a conjugated vaccine, which means it contains pneumococcal bacteria bound to a protein. The addition of the protein helps the body's immune system recognize the bacteria, especially in babies.

The drug also has received approval for adults 50 and older in the European Union, Australia, Mexico and more than 10 other countries, Pfizer said.

Pfizer is based in New York. Its shares slipped 3 cents to $21.61 in aftermarket trading. The stock ended the regular session down 7 cents at $21.64.

[Associated Press]

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