HHS: 1.2 million flu shots on the way
WASHINGTON (CNN) -- Health and Human Services Secretary Tommy Thompson announced Tuesday that the Food and Drug Administration has authorized 1.2 million doses of flu vaccine for use in the United States.
He said he expects them to be available this month.
The drugs are expected to ease the shortage of vaccine that occurred in October when contamination problems beset the Chiron Corp. plant in England, one of two major suppliers to the U.S. market.
The new product will be made available under an investigational new drug (IND) application, and were manufactured by GlaxoSmithKline in the company's Germany plant, which the FDA has inspected, Thompson said.
The company has agreed to make up to 4 million doses of the vaccine available, he said.
The Centers for Disease Control and Prevention will oversee the distribution, ensuring the doses are given only to high-risk individuals, such as the elderly and people with chronic illnesses, he said.
The product is not approved in the United States, so under the IND, the public will be required to sign a consent form that will explain "what we know of the risk," said the acting FDA commissioner, Dr. Lester Crawford.
"It's investigational not because we have real questions about it, but because the company elected not to enter the U.S. market, and so did not apply for approval," he said.
The product is available in 30 other countries, he said.
"The expectation of any real increased risk from this vaccine is very low indeed," he said.
The new product will add to the existing supply of 61 million doses of influenza vaccine -- 58 million of the injectable form and 3 million of FluMist spray.
Anyone having difficulties obtaining vaccine can call the CDC hotline at 800-CDCINFO, Thompson said.
Crawford said the FDA was in discussion with two other vaccine makers, one in Canada and the other in Switzerland. "We may have further announcements before the month is out," he said.
He added that U.S. public health officials were attempting to get more suppliers to enter the U.S. market to boost this year's single supplier.
Two companies announced this week that they want to enter the U.S. market. "One could be in as early as next flu season. The other one will be a bit later," maybe as late as 2007, Crawford said.