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FDA Panel Backs Pfizer Vaccine for Adults

From Associated Press (November 16, 2011)

WASHINGTON -- A panel of federal health experts voted overwhelmingly Wednesday to recommend that Pfizer's best-selling vaccine be approved for a new use in preventing pneumococcal disease in adults age 50 and older.

The Food and Drug Administration's vaccine panel voted 14-1 that data supports Pfizer's Prevnar 13 as a safe and effective vaccine for preventing the bacterial infection in adults. Pneumococcal disease causes meningitis, pneumonia and ear infection.

Prevnar 13 protects against 13 strains of the disease and is already a standard vaccination for infants and young children, who are most vulnerable to infection. But the disease also affects 36,000 older adults per year, killing 5,000 of them, according to the latest figures from the Centers for Disease Control and Prevention.

Pfizer, which is based in New York, has asked the FDA to expand Prevnar's approval for adults 50 and older. The agency will make a final ruling in January, taking into consideration the recommendation of its panel.

The CDC currently recommends vaccination for all adults 65 or older with Merck's Pneumovax, which protects against 23 strains of pneumococcal disease, including 12 that overlap with Prevnar. Only about two-thirds of eligible seniors get the injection.

But Merck's vaccine has not been shown to protect against pneumococcal pneumonia, one of the most dangerous infections associated with the disease. The FDA agreed to give Prevnar an accelerated review, based on currently available studies, because of its potential to defend against pneumonia. Pfizer is still conducting an 85,000-patient study in the Netherlands to assess Prevnar's strength against pneumonia in adults.

Pneumovax was first approved in 1977 and uses an older vaccine mechanism than Prevnar, which was first approved in 2000. Prevnar 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.

Shares of Pfizer fell 30 cents to close Wednesday at $19.57.


Posted: November 2011