Initial U.S. Approval: 2020
FLUAD QUADRIVALENT is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and types B… FLUAD QUADRIVALENT is approved for use in persons 65 years of age and older.
CONTRAINDICATIONS
Severe allergic reaction to any component of the vaccine, including egg protein…
The safety of FLUAD QUADRIVALENT was evaluated in two clinical studies…
Study 1… was a… non-influenza comparator-controlled efficacy and safety study… Solicited local and systemic adverse reactions were collected for 7 days after vaccination in a subset of 665 subjects who received FLUAD QUADRIVALENT and 667 subjects who received the comparator vaccine.
Unsolicited adverse events (AEs) were collected for all subjects for 21 days after vaccination. Related unsolicited AEs [adverse events] were reported by 303 (9.0%)… of the subjects for FLUAD QUADRIVALENT…
Serious adverse events (SAEs) and potentially immune-mediated adverse events of special interest (AESIs) were collected up to 366 days after vaccination. SAEs were reported by 238 (7.0%) FLUAD QUADRIVALENT recipients…
Study 2… was a… comparator-controlled study… 888 subjects received FLUAD QUADRIVALENT, 444 subjects received the licensed adjuvanted trivalent vaccine… and 444 subjects received an adjuvanted trivalent influenza vaccine with an alternate B strain…
Unsolicited AEs were collected for 21 days after vaccination. Related unsolicited AEs were reported by 39 (4.4%)… of subjects administered FLUAD QUADRIVALENT…
Serious AEs and AESIs were collected up to 181 days after vaccination. Within 6 months after vaccination, 37 (4.2%) FLUAD QUADRIVALENT recipients… experienced an SAE.
Postmarketing Experience
– Thrombocytopenia (some cases were severe with platelet counts less than 5,000 per mm3), lymphadenopathy
– Extensive swelling of injected limb lasting more than one week, injection site cellulitis-like reactions (some cases of swelling, pain, and redness extending more than 10 cm and lasting more than 1 week)
– Allergic reactions including anaphylactic shock, anaphylaxis, and angioedema
– Muscular weakness
– Encephalomyelitis, Guillain-Barré Syndrome, convulsions, neuritis, neuralgia, parasthesia, syncope, presyncope
– Generalized skin reactions including erythema multiforme, urticaria, pruritis or non-specific rash
– Vasculitis, renal vasculitis
…prepared from virus propagated in… embryonated hens’ eggs…
…contains MF59C.1 adjuvant (MF59®), a squalene based oil-in-water emulsion.
Each 0.5 mL dose contains… 9.75 mg squalene, 1.175 mg of polysorbate 80…
…may contain trace amounts of neomycin… kanamycin… hydrocortisone… egg protein…
FLUAD QUADRIVALENT has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals.