Indications and Usage

Afluria^® is indicated for active immunization of persons 18 years of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. This indication is based on immune response elicited by Afluria^®; there have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with Afluria^® (for more information see IMMUNOGENICITY).

Use in Specific Populations

Pregnant women
Safety and effectiveness have not been established in pregnant women. Afluria^® should be given to pregnant women only if clearly needed.

Nursing mothers
Afluria^® has not been evaluated in nursing mothers. It is not known whether Afluria^® is excreted in human milk. Caution should be exercised when Afluria^® is administered to nursing women.

Pediatrics
Safety and effectiveness in the pediatric population have not been established.

Elderly
In clinical studies, 343 subjects 65 years of age or older received Afluria^®. Serum hemagglutination-inhibiting (HI) antibody responses were lower after administration of Afluria^® in comparison to younger adults, which confirmed what has been observed with the other vaccines, i.e. that age has an effect on the immune response. Adverse events were generally similar in frequency to those reported in younger subjects (≥18 to <65 years), although some differences were observed.

Important Safety Information

Afluria^® is indicated for active immunization of persons 18 years of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. The indication is based on the immune response elicited by Afluria^®; no controlled clinical studies have demonstrated a decrease in influenza disease after vaccination with Afluria^®.

Afluria^® should not be administered to individuals with hypersensitivity to eggs or chicken protein or other components of Afluria^®, or to anyone who has had a life-threatening reaction to previous influenza vaccination. The most common injection-site adverse reactions were tenderness, pain, redness, and swelling. The most common systemic adverse reactions were headache, malaise, and muscle aches.

Vaccination with Afluria^® may not protect all individuals. Immunocompromised persons may have a diminished immune response. If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give Afluria^® should be based on careful consideration of the potential benefits and risks.

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