Guillain-Barré Syndrome: Recurrence of Guillain-Barré syndrome (GBS) has been temporally associated with administration of influenza vaccine. If GBS has occurred within 6 weeks of previous influenza vaccination, the decision to give FluQuadri should be based on careful consideration of the potential benefits and risks.
Preventing and Managing Allergic Reactions: Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
Altered Immunocompetence: If FluQuadri is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be obtained.
Limitations of Vaccine Effectiveness: Vaccination with FluQuadri may not protect all recipients.
Use in Children: Safety and effectiveness of FluQuadri in children below the age of 6 months have not been established. Safety and immunogenicity of FluQuadri was evaluated in children 6 months through 8 years of age. [See ADVERSE REACTIONS and Pharmacology: CLINICAL STUDIES under Actions.]
Use in the Elderly: Safety and immunogenicity of FluQuadri was evaluated in adults 65 years of age and older. [See ADVERSE REACTIONS and Pharmacology: CLINICAL STUDIES under Actions.] Antibody responses to FluQuadri are lower in persons ≥65 years of age than in younger adults.