[Pepper]

December 08, 2004

The US made a special exception on Tuesday to purchase as many as 4 million doses of flu vaccine not licensed for use in the US.

The Food and Drug Administration authorized the use of GlaxoSmithKline influenza vaccine, Fluarix, as an " Investigational New Drug."



This week, Glaxo will start shipping 1.2 million doses of the vaccine from its German manufacturing facility.

"With this latest purchase, we will be able to protect more high-risk Americans this flu season in communities across the country," said outgoing HHS Secretary Tommy G. Thompson in a statement.

Because Fluarix isn't licensed for use in the US, patients offered the vaccine must sign a consent form acknowledging they are aware of potential adverse side effects.

Although Fluarix hasn't been licensed for use in the US, it has been approved for use in Europe by various health agencies.

http://www.healthtalk.ca/flu_vaccine_purchase_12082004_8821.php

[CanadaSue]

By their own approval guidelines, this product has to be labelled as it is been. However, it's been used successfully in Europe for a long time - no worries there.

[booger]

http://www.clickondetroit.com/health/3988331/detail.html

Government Announces Plan To Test European Flu Vaccine

POSTED: 12:37 pm EST December 10, 2004
WASHINGTON -- Government health officials say they'll start testing a European flu vaccine this month.

The National Institute of Allergy and Infectious Disease is starting the trial as a way of boosting U.S. flu vaccine supplies. Officials say they hope to test the vaccine on 1,000 healthy adults in four locations. They aim to enroll the volunteers before Christmas.

Four out of every five volunteers in the new trial will receive Fluarix, while the fifth will receive a placebo. Those receiving placebo vaccine will be offered U.S.-licensed flu vaccine at the end of the month-long study.

The vaccine made by GlaxoSmithKline Biologicals of Belgium is used worldwide, with more than 126 million doses distributed in more than 70 countries, but it has never been licensed in the United States.

"Expanding the number of influenza vaccine sources is critical as we ready ourselves for next year's flu season," said NIAID Director Anthony Fauci.

Earlier this week, Health and Human Services Secretary Tommy Thompson announced a plan to import 4 million doses of Fluarix as an "investigational new drug." Under that category, people given the vaccine must first sign a consent form acknowledging that they are aware of the potential risks and benefits of the drug.

Healthy adults ages 18 to 64 who have not received a flu shot this year are eligible to volunteer for the study. Participants will visit the clinic twice in the course of the trial.

If you're interested in volunteering, contact one of these locations, where the study will be conducted: University of Rochester Medical Center, Cincinnati Children's Hospital, University of Maryland School of Medicine in Baltimore, and Baylor College of Medicine in Houston.