PHILADELPHIA, PA (December 7, 2004) – GlaxoSmithKline has announced that it will ship up to 4 million doses of its flu vaccine, Fluarix, to the United States beginning immediately and continuing through mid-January 2005.
This follows the United States Food & Drug Administration’s (FDA) review of the company’s flu vaccine manufacturing facilities, as well as a review of the manufacturing and clinical data provided for Fluarix.
Fluarix will be brought to the U.S. in accordance with the investigational new drug (IND) regulations, which allows for the use of unlicensed medicines or vaccines as part of a clinical trial. Those who receive the vaccine will be required to provide informed consent indicating their agreement to be vaccinated with Fluarix under these IND regulations.
The IND protocol allows for the use of Fluarix in individuals three years of age and older who are at increased risk of associated complications from influenza or are in close direct contact with other people at increased risk of complications from influenza as recommended by the Advisory Committee on Immunization Practices and Centers for Disease Control and Prevention (CDC).
“The U.S. government has taken extraordinary steps to address this year’s flu vaccine shortage in the U.S.,” said Christopher Viehbacher, president, U.S. Pharmaceuticals, GlaxoSmithKline. “We fully support FDA’s role in assuring safety of medicines and vaccines in the U.S., and are pleased to provide our Fluarix vaccine following their review of our manufacturing facilities and clinical data.”
Viehbacher said GlaxoSmithKline is committed to pursuing a long-term strategy to gain FDA approval for Fluarix in the U.S. through the biological license application process.
Details about the distribution of the Fluarix doses will be determined by the Department of Health and Human Services and CDC, GlaxoSmithKline said.
GlaxoSmithKline is a research-based pharmaceutical and healthcare company.