Health Law and Regulation

The FDA has approved this year's seasonal influenza vaccines that include new strains of the virus likely to cause flu in the United States during the 2008-2009 season.

The six manufacturers and their vaccines are: CSL Limited, Afluria; GlaxoSmithKline Biologicals, Fluarix; ID Biomedical Corporation of Quebec, FluLaval; MedImmune Vaccines Inc., FluMist; Novartis Vaccines and Diagnostics Limited, Fluvirin; and Sanofi Pasteur Inc., Fluzone.

This season's vaccines contain three strains of the influenza virus that disease experts expect to be the most likely cause of the flu in the United States. Each season's vaccines are modified to reflect the virus strains most likely to be circulating. The closer the match between the circulating strains and the strains in the vaccines, the better the protection. There is always a possibility of a less than optimal match between the virus strains predicted to circulate and what virus strains end up causing the most illness. Even if the vaccines and the circulating strains are not an exact match, they will provide some protection and may reduce the severity of the illness or prevent flu-related complications.

The FDA changed all three strains for this year's influenza vaccine — an unusual occurrence, as usually only one or two strains are updated from year to year. Of note, two of the three strains recommended for the U.S. this year are now in use for the Southern Hemisphere's 2008 influenza season, which is currently underway.

Vaccination remains the cornerstone of preventing influenza, a contagious respiratory illness caused by influenza viruses. According to the CDC, every year an average of 5 to 20 percent of the U.S. population gets the flu, more than 200,000 are hospitalized from flu complications and there are about 36,000 flu-related deaths. Some individuals — the elderly, young children and people with chronic medical conditions — are at higher risk for flu-related complications. Vaccination of these groups and of healthcare personnel is critical.

"Currently, only 40 percent of healthcare workers in the United States are vaccinated against influenza," said HHS' assistant secretary of health Joxel Garcia, M.D., M.B.A. "Increasing the number of vaccinated healthcare personnel can be a strong front in the annual battle against the flu. Healthcare workers can set an example for the patients they serve as well as decrease the likelihood of contracting and transmitting the virus."

Source: U.S. Food and Drug Administration, August 5, 2008

Pandemic Influenza: Preparedness in the Healthcare Facility

This program focuses on preparedness in the event of an influenza pandemic. It gives an overview of the definition of a pandemic as well as how the influenza virus mutates to become a pandemic virus.

Pandemic Influenza: Preparedness in the Healthcare Facility is available from the Healthcare Intelligence Network for $63 by visiting our Online Bookstore or by calling toll-free (888) 446-3530.