WASHINGTON, D.C. - U.S. Sen. Olympia J. Snowe, R-Maine, recently praised U.S. Secretary of Health and Human Services (HHS) Tommy Thompson for "leaving no stone unturned" in securing up to 4 million additional flu vaccine doses from GlaxoSmithKline to help fill the shortage that currently exists nationwide.

Thompson announced recently that the Food and Drug Administration authorized the use of GlaxoSmithKline’s vaccine, Fluarix, in the United States under an Investigational New Drug application.

"Secretary Thompson should be commended for leaving no stone unturned to meet our national demand for additional flu vaccine," said Snowe. "Today’s announcement is indeed good news for our most vulnerable, at-risk citizens in Maine and around the country. They will finally have access to additional vaccine supplies before the worst of the flu season begins."

The Fluarix vaccine will be sent to the United States for distribution by the Centers for Disease Control and Prevention (CDC), based on the agency’s determination of communities most in need. Fluarix has not been licensed for use in the United States and will be administered under an Investigational New Drug application (IND). The Fluarix vaccine being purchased by HHS has been approved by the European equivalents of the Food and Drug Administration (FDA), but is considered an IND because it is not currently licensed by FDA.

The IND allows the investigational use of Fluarix, and HHS is immediately purchasing 1.2 million doses that are available this month. GlaxoSmithKline (GSK) has agreed to make up to 4 million doses available under the IND.

Sponsors of INDs are required to monitor the use of the investigational product, maintain adequate records, control the supply of product, provide periodic reports to FDA regarding safety and other issues and make sure informed consent is obtained from individuals before receiving the vaccine. CDC will assist GSK with these activities.

Snowe has been working since the onset of the flu vaccine shortage to secure additional flu vaccine supplies. In October, she sent a letter to Thompson urging HHS to recognize the unique needs of individual states, particularly Maine, and to ensure that those available doses of flu vaccine are targeted to those at greatest risk.

Snowe has cosponsored legislation with Sen. Jack Reed, D-R.I.,to give the nation’s health agencies the tools they need to protect the public health from the danger of influenza, and to maximize the value of reduced vaccine stocks. The bill provides for the purchase of vaccine for use in high-risk populations from those who serve low-risk populations. It also provides the expedited approval and purchase of additional stocks of vaccine that have already been approved by regulatory authorities in Europe, Canada and Japan.

On Oct. 5, the Chiron Corporation announced that it would be unable to supply influenza vaccine for the 2004-05 flu season, resulting in the loss of approximately half of the U.S. supply of influenza vaccine. The Chiron Corporation and Aventis Pasteur are the only two flu vaccine manufacturers with licenses in the United States. Maine has been particularly impacted as 123,000 of the 150,000 doses the state government ordered came from Chiron.

Influenza results in approximately 36,000 American deaths per year. The United States has made great progress in improving vaccinations, approximately doubling the vaccination rates in high-risk groups in the 1990s.