FDA Approves New Vaccine in Time for Flu Season

Published October 1, 2005

In a major step toward increasing the supply of flu vaccine in the United States, GlaxoSmithKline (GSK) announced August 31 that the U.S. Food and Drug Administration (FDA) has approved the firm’s influenza vaccine, Fluarix, for distribution in time for the 2005-2006 influenza season.

“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 in the Infectious Diseases Unit at the University of Rochester Medical Center, in a statement when the approval was announced.

“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,” Treanor said.

Danger Includes Deaths, Epidemics

Influenza is a highly contagious, potentially fatal virus that affects 5 to 20 percent of the U.S. population each flu 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 those deaths occurred in persons 65 years of age or older.

Influenza can reach epidemic levels and poses a significant threat to public health, particularly among the nation’s oldest and youngest citizens. Influenza vaccination is the primary method for preventing influenza and its severe complications.

Move Alleviates Import Woes

Jean-Pierre Garnier, CEO of GlaxoSmithKline, said the company was pleased it could bolster the country’s supply of flu vaccine in time for the upcoming flu season. “The shortage of flu vaccine last year was a reminder of the importance of vaccines in health care,” Garnier said in a statement announcing the approval.

“GSK worked quickly with government officials to make Fluarix available and increase supply at a critical time,” Garnier continued. “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 has been in use outside the United States since 1992. More than 150 million doses of Fluarix have been distributed in 79 countries.

Last flu season, contamination issues at British vaccine suppliers to the United States caused severe shortages of flu vaccine in this country.

“The great thing about America is that the market works,” said Sally Pipes, president of the Pacific Research Institute, about the FDA approval. “We need to expand market opportunities so we all benefit from better health care options.”

Costly to Individuals, Economy

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.

Although October or November is the best time to get vaccinated, vaccinations in December or even later can be beneficial in most flu seasons.

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 health care workers.

In addition to the public health threat, influenza 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 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 infections to the U.S economy at $71 billion to $167 billion per year.

Susan Konig ([email protected]) is managing editor of Health Care News.