BY OUR PHARMA CORRESPONDENT
2 September, 2005: In a major step toward increasing flu vaccine supply in the United States, the U.S. Food and Drug Administration has approved GlaxoSmithKline’s influenza vaccine, Fluarix for distribution in time for the 2005/2006 influenza season.
Fluarix, indicated for adults 18 and older against influenza disease, is currently distributed in 79 countries, will be available exclusively in prefilled Tip-Lok syringes.
The FDA reviewed safety and immunogenicity data from a phase III clinical trial which studied Fluarix in approximately 1,000 adults in the United States aged 18 to 64. This randomized, double-blind, placebo-controlled study showed Fluarix to be safe and immunogenic.
Many respiratory diseases occur every winter, but influenza is one of the most severe. The illness is easily passed from one person to another through the air by tiny droplets released when an infected individual coughs or sneezes. Most people recover fully within a week or two, but the risk of complications is elevated in very young, very old and chronically ill persons.
Although epidemics of flu happen in most years, the beginning, severity and length of the epidemic can vary widely from year to year. Before a season begins, it is not possible to accurately predict the features of any season. While October or November is the best time to get vaccinated, getting influenza vaccine in December, or even later, can be beneficial in most years. Flu season can begin as early as October and last as late as May. People who should receive the influenza vaccine include the very young, people 50 years of age or older, the chronically ill, women who will be pregnant during influenza season and all healthcare workers.
In addition to the public health threat influenza poses, the disease has economic repercussions. An average of approximately 226,000 influenza-related excess hospitalizations occurred per year in the United States between 1979 and 2001. Influenza epidemics can have a significant impact on theU.S.economy, as influenza infection results in an average of 2.8 lost workdays per episode, or $398 in lost wages for the average worker. Recent estimates put the cost of influenza epidemics to the economy at $71 —$167 billion per year.
A GSK release alerted that Fluarix should not be administered to anyone with known systemic hypersensitivity reactions to eggs, egg products, egg or chicken proteins, or any component of Fluarix, or to anyone who has had a life-threatening reaction to previous administration of any influenza vaccine. The most common adverse event in a clinical trial was pain at the injection site. Less common adverse events were muscle aches, fatigue, and headache. Most adverse events in clinical trials were mild and self-limiting.
Shipments that would begin going out immediately for its Fluarix vaccine and that it would be priced in line with other shots currently marketed in the United States, a GSK spokesperson said in the release.
Federal health officials want to prevent a recurrence of the 2004-5 season when the expected supply of 100 million shots was cut almost in half after British health regulators closed Chiron's plant.
Lawmakers held hearings earlier this year to call for a steady supply of vaccine against the flu, which is estimated to kill 36,000 Americans and hospitalize 200,000 annually.
Sanofi-Aventis, the biggest supplier to the United States, delivered about 58 million of the 61 million doses that were available in the 2004-5 season. Sanofi and Glaxo have both begun increasing production in plants in the United States and Europe.
Glaxo plans to double its annual flu shot production to 80 million shots by 2008. Sanofi is doubling an American plant's annual capacity to 100 million shots for the 2009 season, and may raise production capacity at a French plant.
The ID Biomedical Corporation, which makes flu shots for Canada, said in July that the F.D.A. granted the company an accelerated approval process for its Fluviral shot. The company expects to make as many as 25 million doses for the United States next year and as many as 40 million in
BY OUR PHARMA CORRESPONDENT