2022-2023 Formula
Initial US Approval (Fluzone Quadrivalent): 2013
[I]ndicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses… approved for use in persons 6 months of age and older.
CONTRAINDICATIONS
Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including egg protein…
Among children 6 months through 8 years of age, unsolicited non-serious adverse events were reported in… 47.0%
Throughout the study period [6 months], a total of… 1.4%… experienced at least one SAE [serious adverse event]…
Post-Marketing Experience
– Thrombocytopenia, lymphadenopathy
– Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema)
– Ocular hyperemia
– Guillain-Barré syndrome (GBS), convulsions, febrile convulsions, myelitis (including encephalomyelitis and transverse myelitis), facial palsy (Bell’s palsy), optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination), dizziness, paresthesia
– Vasculitis, vasodilatation/flushing
– Dyspnea, cough, wheezing, throat tightness, oropharyngeal pain, rhinorrhea
– Rash, pruritus, and Stevens-Johnson syndrome
– Asthenia/fatigue, pain in extremities, chest pain
– Vomiting
[P]repared from influenza viruses propagated in embryonated chicken eggs.
The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100)*…
The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury.
Fluzone Quadrivalent has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals.