FDA Approves New Flu Vaccine

Sept. 28, 2007 - A new flu vaccine called Afluria was approved for U.S. marketing by the Food and Drug Administration Friday.

The vaccine will be available in limited supplies to patients starting this fall, the agency said. It’s been approved for adults 18 years of age and older.

CSL Ltd., the Australian company that makes the vaccine, only plans to sell about 2 million doses in the U.S. this year. It comes atop what public health officials have said they expect to be a record year for flu vaccine production.

The FDA gave Afluria a fast-track approval as part of a move to rapidly increase both the number of manufacturers supplying the U.S. and boost the number of doses for sale.

Doctors, clinics, and patients were confronted with shortages in 2004 when a major vaccine production plant in England was shut down. Nearly half of America's flu vaccine supply came from that one plant.

Three manufacturers were servicing the U.S. market at the time.

CSL is now the sixth manufacturer set to sell vaccine in the U.S. “That puts us in a position where we’re better prepared for every year’s flu season,” says Jesse Goodman, MD, director of the FDA’s Center for Biologics Evaluation and Research.

Fast-Track Approval

The fast-track approval means that officials approved Afluria based on its ability to produce an immune response in the body that is "likely to be effective in preventing seasonal influenza," according to an FDA news release. It has not technically been proven to prevent flu disease. But additional studies will be done to confirm its effectiveness in flu prevention.

Officials said last week they expect manufacturers to produce a record 132 million vaccine doses this year. At the same time, they said they would extend the normal flu vaccination season past Christmas in an effort to get more Americans vaccinated.

“Everyone who shows up for a vaccination should be able to get one,” says Kerry Weems, the acting administrator of the Center for Medicare and Medicaid Services.

Afluria contains inactivated or "killed" influenza viruses and is given by injection. The FDA advises that people with allergy to eggs or any other component of the vaccine should not receive Afluria.

Adverse effects from Afluria include pain, redness, swelling at the injection site, headache, fatigue, and muscle aches.

Influenza causes about 200,000 hospitalizations and 36,000 deaths per year, primarily in elderly patients. Still, less than half of the 218 million Americans eligible for vaccinations got immunized in 2005-2006, according to the CDC.

CDC’s current recommendations urge annual vaccination for the following groups:

• All children between 6 months and 5 years of age
• Persons with certain chronic medical conditions
• Persons with suppressed immune systems caused by medications or HIV
• People who live in nursing homes or chronic care facilities
• All adults 50 years and older
• Household contacts and caregivers of persons with high risk of flu complications
• Health care workers
• Pregnant women
• Anyone else who wants to lower the risk of getting the flu or transmitting it to others

Getting vaccinated early in the flu season is best, but you can still get vaccinated anytime during the season.