ZOSTAVAX is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older. ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia. ZOSTAVAX should not be used for prevention of primary varicella infection (Chickenpox).

Vaccination with ZOSTAVAX does not result in protection of all vaccine recipients.

ZOSTAVAX is contraindicated in: persons with a history of anaphylactic or anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine; persons with a history of primary or acquired immunodeficiencies; persons on immunosuppressive therapy; pregnant women or women of childbearing age.

A reduced immune response to ZOSTAVAX was observed in individuals who received concurrent administration of PNEUMOVAX^®23 (Pneumococcal Vaccine Polyvalent) and ZOSTAVAX compared with individuals who received these vaccines 4 weeks apart. Consider administration of the two vaccines separated by at least 4 weeks.

Serious vaccine-related adverse reactions that have occurred following vaccination with ZOSTAVAX include asthma exacerbation and polymyalgia rheumatica. Other serious adverse events reported following vaccination with ZOSTAVAX include cardiovascular events (congestive heart failure, pulmonary edema). The rate of serious adverse reactions from Days 0 to 42 postvaccination may be increased. Common adverse reactions occurring in >1% of vaccinated individuals during clinical trials include injection-site reactions (erythema, pain/tenderness, swelling, hematoma, pruritus, warmth) and headache.

Transmission of vaccine virus may occur between vaccinees and susceptible contacts. Deferral should be considered in acute illness (for example, in the presence of fever) or in patients with active untreated tuberculosis.