Initial U.S. Approval: 1995
VARIVAX is a vaccine indicated for active immunization for the prevention of varicella [chickenpox]…
[T]ransmission of varicella vaccine virus… resulting in varicella infection including disseminated disease may occur between vaccine recipients (who develop or do not develop a varicella-like rash) and contacts susceptible to varicella including healthy as well as high-risk individuals.
[V]accine recipients should attempt to avoid whenever possible close association with susceptible high-risk individuals for up to six weeks following vaccination with VARIVAX.
Post-Marketing Experience
– Anaphylaxis (including anaphylactic shock) and related phenomena such as angioneurotic edema, facial edema, and peripheral edema.
– Necrotizing retinitis (in immunocompromised individuals).
– Aplastic anemia; thrombocytopenia (including idiopathic thrombocytopenic purpura (ITP)).
– Varicella (vaccine strain).
– Encephalitis; cerebrovascular accident; transverse myelitis; Guillain-Barré syndrome; Bell’s palsy; ataxia; non-febrile seizures; aseptic meningitis; meningitis; dizziness; paresthesia. Cases of encephalitis or meningitis caused by vaccine strain varicella virus have been reported in immunocompetent individuals previously vaccinated with VARIVAX months to years after vaccination. Reported cases were commonly associated with preceding or concurrent herpes zoster [shingles] rash.
– Pharyngitis; pneumonia/pneumonitis.
– Stevens-Johnson syndrome; erythema multiforme; Henoch-Schönlein purpura; secondary bacterial infections of skin and soft tissue, including impetigo and cellulitis; herpes zoster.
VARIVAX [Varicella Virus Vaccine Live] is a… strain of live, attenuated varicella virus. The virus was initially obtained from a child with wild-type varicella, then introduced into human embryonic lung cell cultures, adapted to and propagated in embryonic guinea pig cell cultures and finally propagated in human diploid cell cultures (WI-38). Further passage of the virus for varicella vaccine was performed at Merck Research Laboratories (MRL) in human diploid cell cultures (MRC-5)…
This live, attenuated varicella vaccine is a lyophilized preparation containing sucrose, phosphate, glutamate, and processed gelatin as stabilizers.
Each 0.5-mL dose also contains approximately 24 mg of sucrose, 12.0 mg hydrolyzed gelatin, 3.1 mg of sodium chloride, 0.5 mg of monosodium L–glutamate [MSG], 0.44 mg of sodium phosphate dibasic, 0.08 mg of potassium phosphate monobasic, and 0.08 mg of potassium chloride. The product also contains residual components of MRC-5 cells including DNA and protein and trace quantities of sodium phosphate monobasic, EDTA, neomycin and fetal bovine serum.