| ■ Seniors' Flu Vaccine Approved by FDA | 2009.12.25 |
| 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. |