ZOSTAVAX^* is a lyophilized preparation of the Oka/Merck strain of live, attenuated varicella-zoster virus (VZV). The virus was initially obtained from a child with naturally-occurring 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 was performed at Merck Research Laboratories (MRL) in human diploid cell cultures (MRC-5). The cells, virus seeds, virus bulks and bovine serum used in the manufacturing are all tested to provide assurance that the final product is free of adventitious agents. ZOSTAVAX, when reconstituted as directed, is a sterile preparation for subcutaneous administration. Each 0.65-mL dose contains a minimum of 19,400 PFU (plaque-forming units) of Oka/Merck strain of VZV when reconstituted and stored at room temperature for up to 30 minutes. Each dose also contains 31.16 mg of sucrose, 15.58 mg of hydrolyzed porcine gelatin, 3.99 mg of sodium chloride, 0.62 mg of monosodium L-glutamate, 0.57 mg of sodium phosphate dibasic, 0.10 mg of potassium phosphate monobasic, 0.10 mg of potassium chloride; residual components of MRC-5 cells including DNA and protein; and trace quantities of neomycin and bovine calf serum. The product contains no preservatives.

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