GlaxoSmithKline Announces FDA Approval of Fluarix
PHILADELPHIA, August 31, 2005 -- In a major step toward increasing flu vaccine supply in the United States, GlaxoSmithKline announced today that the U.S. Food and Drug Administration has approved its influenza vaccine, Fluarix [Influenza Virus Vaccine] for distribution in time for the 2005/2006 influenza season.
The introduction of Fluarix, indicated for adults 18 and older against influenza disease, is the next immediate step in that commitment. Fluarix, currently distributed in 79 countries, will be available exclusively in prefilled Tip-Lok(R) syringes.
"The introduction of Fluarix is a vital step in the effort to improve vaccination rates in the United States and protect against this highly communicable infection that threatens young and old alike," said Dr. John Treanor, associate professor of Medicine, Infectious Diseases Unit, University of Rochester Medical Center, Rochester, N.Y. "Influenza can be a serious health threat, so the increased availability of this vaccine is critical to help keep the virus at bay and to potentially avoid epidemics."
Influenza is a highly contagious and potentially fatal virus that affects five to 20 percent of the total U.S. population during each influenza season. Between 1990 and 1999, approximately 36,000 people died in the United States each year from complications of influenza infection; more than 90 percent of these deaths occurred in persons 65 years of age and older. Influenza can reach epidemic levels and poses a significant threat to public health, particularly among the nationâ€™s oldest and youngest citizens. Influenza vaccination is the primary method for preventing influenza and its severe complications.
Jean-Pierre Garnier, CEO of GlaxoSmithKline, said the company was pleased that it could bolster the countryâ€™s supply of flu vaccine in time for the 2005/2006 flu season. "The shortage of flu vaccine last year was a reminder of the importance of vaccines in health care," Garnier said. "GSK worked quickly with government officials to make Fluarix available and increase supply at a critical time. We appreciate the spirit of cooperation and commitment on the part of the FDA and U.S. Department of Health and Human Services. Now we look forward to working with health authorities to encourage vaccination among those who are most vulnerable."
Fluarix [Influenza Virus Vaccine] Clinical Trials
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.
Fluarix has been in use outside the United States since 1992. More than 150 million doses of Fluarix have been distributed worldwide since that time. Because the prevalent strains of influenza can change from season to season, the composition of the vaccine is adjusted yearly to match the recommendations of the FDA and the Centers for Disease Control and Prevention (CDC). As a result of these changes in the influenza virus, the CDC recommends annual vaccination, particularly for groups at high risk of complications.
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 the U.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.
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. (See adverse reactions section of the Prescribing Information for Fluarix for other potential adverse events.) As with any vaccine, vaccination with Fluarix may not protect 100% of susceptible individuals.
Posted: August 2005
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