Chicken Pox Vaccine

VARIVAX – Merck – Product Insert
http://www.merck.com/product/usa/pi_circulars/v/varivax/varivax_pi.pdf

VARIVAX is a preparation of live, attenuated varicella virus.  The virus was initially obtained from a child with natural 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) from aborted fetal tissue. (See page 6)

“There are insufficient data to assess the rate of protection of VARIVAX against the serious complications of chickenpox in adults (e.g., encephalitis, hepatitis, pneumonitis) and during pregnancy (congenital varicella syndrome).”  (Page 3)

“Post-marketing experience suggests that transmission of vaccine virus may occur rarely between healthy vaccinees who develop a varicella-like rash and healthy susceptible contacts. Transmission of vaccine virus from vaccinees without a varicella-like rash has been reported but has not been confirmed.” (Top of page 5)

“The duration of protection of VARIVAX is unknown; however, long-term efficacy studies have demonstrated continued protection up to 10 years after vaccination.” (Page 7)

 “Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with VARIVAX as Reye's Syndrome has been reported following the use of salicylates during natural varicella infection.” (Page 5)

“Pregnancy should be avoided for three months following vaccination.” (Page 7)

“VARIVAX has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.” (Page 8)

Post-marketing adverse reactions: Anaphylaxis (including anaphylactic shock) and related phenomena such as angioneurotic edema, facial edema, and peripheral edema, thrombocytopenia (including ITP), Encephalitis; cerebrovascular accident; transverse myelitis; Guillain-Barré syndrome; Bell's palsy; ataxia; non-febrile seizures; aseptic meningitis; dizziness; paresthesia, 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. (Page 5)

VARIVAX Ingredients: sucrose, phosphate, glutamate, gelatin, monosodium L-glutamate, sodium phosphate dibasic, potassium phosphate monobasic, potassium chloride, sodium phosphate monobasic, potassium chloride, EDTA, residual components of MRC-5 cells including DNA and protein, neomycin, fetal bovine serum, human diploid cell cultures (WI-38), embryonic guinea pig cell cultures, human embryonic lung cultures
http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf
 

 
© 2011 - • VaccineDecision.info