Canadian company cleared to test flu vaccine in the United States
NEWS IN BRIEF — Posted Jan. 31, 2005
The Food and Drug Administration has given the go ahead to the Vancouver-based vaccine manufacturer ID Biomedical Corp. to begin testing its influenza vaccine under an investigational new drug application, according to a statement issued by the company this month.
ID Biomedical intends to enter the U.S. market by 2007, although it may do so earlier dependent on regulatory approval. This clearance is part of that process.
"We are very excited to initiate clinical testing of Fluviral in the United States," said Louis F. Fries, MD, vice president of clinical affairs at ID Biomedical. "We believe this trial data ... will be necessary to support licensure of Fluviral for the U.S. market."
ID Biomedical currently has the capacity to manufacture 22 million doses, with much of that being purchased by the Canadian government. The company intends to expand its capacity to 50 million by 2007.
The company is also developing an intranasal version of the vaccine. According to data, also released in January, use by healthy adults ages 18 to 64 was effective at preventing the flu without significant adverse events.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2005/01/31/hlbf0131.htm.