FDA Approves Influenza Vaccines To Be Manufactured For Upcoming Flu Season

Costa Mesa, CA - The US FDA announced that it has approved this year's seasonal influenza (flu) vaccines that include the new strains of virus judged likely to cause flu in the Northern Hemisphere in 2006-07.

Vaccine manufacturers have projected making a total of about 100 mln doses of influenza vaccine for the 2006–2007 season, but these projections could change as manufacturing continues.

Four vaccine manufacturers are approved to market their vaccines in the US: Chiron Vaccines Ltd; GlaxoSmithKline Biologicals; MedImmune Vaccines Inc.; and Sanofi Pasteur Inc.

According to the US Centers for Disease Control & Prevention, every year in the US, on average, 5-20% of the population contracts the flu. Over 200,000 people are hospitalized from its complications and approx 36,000 people die from it. Some individuals are at high risk for serious complications from influenza, such as the elderly, children and people with certain chronic medical conditions.

"These approvals signal our commitment to doing all we can to help ensure the timely availability of seasonal flu vaccine for the American public," said Jesse L. Goodman MD MPH, Director of FDA's Center for Biologics Evaluation & Research. "We will continue to work closely with the manufacturers so they can deliver vaccine in time for the start of vaccinations, which begin in the fall."

Each year influenza vaccine manufacturers submit information and samples to FDA of their virus strains being manufactured for the upcoming seasonal influenza season for review and testing in FDA laboratories. Because different influenza virus strains may appear each year, 1 or more of the strains in the vaccine may need to be changed to protect against what public health experts think are the strains most likely to infect people that year.

This season's approved formulation for the US vaccine is identical to that recommended by both the World Health Organization and FDA's Advisory Committee. The formulation includes 1 strain that was used in last year's vaccine and 2 new strains. Seasonal flu vaccines do not protect against avian flu, which is caused by different viral strains.

CDC officials explained that influenza is a contagious respiratory illness caused by influenza viruses. It can cause mild to severe illness, and at times can lead to death. The best way to prevent this illness is by being vaccinated. Although it is best to be immunized in the fall, being vaccinated in the winter months when flu season often peaks is also recommended.

SOURCE: FDA