WASHINGTON - As part of an effort to rebuild the country's limited supply of flu vaccine, federal drug regulators announced the fast-track approval of a new vaccine yesterday.
Stocks dipped below necessary levels last year after regulators found contamination at the British plant of a major manufacturer.
Food and Drug Administration officials, in approving Fluarix, an influenza vaccine for adults, said yesterday that the decision would be a significant boost toward ensuring an ample supply of vaccine. They stopped short of saying the estimated 80 million doses needed for the flu season would be available.
"FDA's approval of Fluarix is a big step toward providing an adequate supply of flu vaccine for the American public," Secretary of Health and Human Services Michael O. Leavitt said.
More than 200,000 Americans are hospitalized in an average year from flu complications, and 36,000 people die.
Fluarix is manufactured by GlaxoSmithKline. A spokesman said the company will immediately begin shipping 8 million doses from its plant in Dresden, Germany, to suppliers in the United States.
The vaccine was the first to be approved under the FDA's accelerated approval process for drugs treating serious or life-threatening illnesses.
Tests of 1,200 adults, combined with data from other countries where Fluarix is already approved, showed that the vaccine produced antibodies in the blood likely to prevent the flu. GlaxoSmithKline will continue studies to further confirm the immunizing effect.
The vaccine is for adults 18 and older and is to be used against influenza virus types A and B, the FDA said.
Last October, Chiron Corp.'s plant in England was shut down after British regulators found sanitary problems, limiting supplies of its Fluvirin vaccine in the United States.
Chiron said in a statement that it intends to manufacture vaccines for the coming flu season, after an FDA inspection of the plant in July found the company's improvements and plans for further corrections "generally acceptable."
Jesse Goodman, director of the FDA Center for Biologics Evaluation and Research, said in a statement that "additional work is needed to determine the amount of vaccine Chiron may be able to supply the U.S. market for the upcoming flu season."