Initial U.S. Approval: 2016
FLUCELVAX QUADRIVALENT is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and types B… approved for use in persons 6 months of age and older.
[U]nsolicited adverse events (for children 6 months to 3 years of age) were collected for 28 days after last vaccination… unsolicited adverse events were reported in 26.2% of subjects…
[S]erious adverse events… were collected throughout the study duration (until 6 months after last vaccination) and were reported by 0.9%…
Unsolicited adverse events were collected for 21 days after vaccination. In adults 18 years of age and older, unsolicited adverse events were reported in 16.1%…
[S]erious adverse events… were collected… until 6 months after vaccination… and were reported by 3.9%…
Postmarketing Experience
– Allergic or immediate hypersensitivity reactions, including anaphylactic shock.
– Syncope, presyncope, paresthesia.
– Generalized skin reactions including pruritus, urticaria or non-specific rash.
– Extensive swelling of injected limb.
[V]accine viruses… are propagated in Madin Darby Canine Kidney (MDCK*) cells…
Each dose… may contain residual amounts of MDCK cell protein… MDCK cell DNA… polysorbate 80…
5 mL multi-dose vials contain thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury.
FLUCELVAX QUADRIVALENT has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals.