Additional Vaccine for Upcoming Influenza Season

According to the CDC, about 5-20% of the population gets the season flu. Approximately 200,000 people are hospitalized from flu complications and 36000 people die each year. The best way to prevent influenza is to get vaccinated each year. In the past, influenza vaccine shortages have been a problem in the United States. To facilitate this problem, the FDA has approved a new vaccine by utilizing an accelerated approval pathway. This allows products for serious diseases to be approved based on early evidence of efficacy.

On October 5, 2006, the FDA approved FluLaval to immunize patients 18 years of age or older against strains most likely to cause influenza in the Northern Hemisphere, types A and B. The manufacturer proved early that immunization would cause antibodies in the blood to be effective in preventing influenza but more studies will be conducted to ensure efficacy. Safety was demonstrated in two clinical studies and in data from FluLaval use in Canada. Side effects are mild and similar to those experienced with other influenza vaccines. The most common side effects associated with FluLaval are pain, redness, swelling at the injection site, headache, fatigue, fever, myalgia, and malaise. It contains inactivated virus so it cannot cause influenza in patients receiving the vaccine. It should not be administered to patients with an allergy to eggs, chicken proteins, or any other component to the vaccine. The preservative thimerosal is used in the formulation. It is a mercury derivative; therefore, the manufacturer is working to develop a thimerosal-reduced or thimerosal- free product to study in pediatric patients.

References:

1. www.fda.gov
2. GlaxoSmithKline: GSL’s new flu vaccine, FluLaval, provides Americans with a new option for fighting the flu- Issued Thursday 5 October 2006
   http://www.gsk.com/ControllerServlet?appId=4&pageId=402&newsid=909

Ashley L. Drvar, Pharm.D. Candidate