THURSDAY, Dec. 24, 2009 (HealthDay News) -- Fluzone High-Dose, a seasonal flu vaccine for people 65 and older, has been approved by the U.S. Food and Drug Administration, the agency said in a news release.
Seniors are at highest risk for complications of seasonal flu, including hospitalization and death. The Fluzone High-Dose vaccine, designed to prevent infection with influenza subtypes A and B, was given accelerated approval as a product designed to prevent serious or life-threatening disease. As part of the approval, manufacturer Sanofi Pasteur is required to "conduct further studies to verify that [the vaccine] will decrease seasonal influenza after vaccination," the FDA said.
Because of the vaccine's higher potency, mild side effects were reported more frequently compared with Sanofi's standard-strength Fluzone vaccine, the agency said. These included pain, injection-site redness and swelling, headache, muscle ache and fever.
People who are sensitive to egg products or who have had life-threatening reactions to prior flu shots shouldn't be vaccinated with Fluzone High-Dose, the FDA said.
The U.S. Centers for Disease Control and Prevention has more about flu vaccination.