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FDA Approves Next Season’s Flu Vaccines

Posted on: Wednesday, 6 August 2008, 14:00 CDT

Six versions of the influenza vaccine were approved on Tuesday for the 2008-2009 flu season, U.S. health regulators said.

The U.S. Food and Drug Administration announced the approval of various vaccines by GlaxoSmithKline Plc's Fluarix and FluLaval; Novartis AG's Fluvirin; Sanofi Aventis SA's Fluzone and CSL Ltd's Afluria.

The FluMist nasal spray flu vaccine made by AstraZeneca Plc unit MedImmune was also given approval, according to the FDA.

The same three strains of the influenza virus are contained in each vaccine, which experts choose every year after weighing which ones are most likely to break out. Experts include two strains from Type A, an H1N1 and an H3N2 version, and one for Type B.

The Centers for Disease Control and Prevention said outbreaks of the influenza virus can start as early as October and last through May.

The FDA decided earlier this year to update the vaccine with three new strains rather than only one or two as it usually does.

Experts said vaccines for this past 2007-2008 flu season appeared largely ineffective in part because different strains than expected began circulating. Still, the CDC said a record 140 million doses were provided.

Both Sanofi Aventis and MedImmune have already begun shipping their products.

Earlier this week MedImmune said it plans to make 12 million doses of its nasal mist vaccine, which is approved for those ages 2 to 49.

Sanofi, which made 40 percent of last year's U.S. supply, last week said it had begun shipping an initial 1.3 million doses of its vaccine, which is approved for those at least 6 months old. It plans to double its U.S. capacity for the 2009- 2010 season.

The United States has experienced flu vaccine shortages over the last few years—when just three companies made the shots.

In 2004, a contamination at then-flu vaccine maker Chiron Corp prevented roughly one-half of the U.S. flu vaccine supply from hitting the market. Novartis now owns Chiron.

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On the Net:

• FDA
• CDC

Source: redOrbit Staff & Wire Reports

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