The postmarketing safety profile of varicella vaccine

The postmarketing safety profile of varicella vaccine was evaluated by analyzing selected adverse experience reports temporally associated with the administration of the vaccine. There were 7963 reports voluntarily submitted to Merck for an overall reporting rate of 5.0 per 10 000 doses of vaccine d...

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Bibliographic Details
Published in:Vaccine 2000-11, Vol.19 (7), p.916-923
Main Authors: Sharrar, Robert G., LaRussa, Philip, Galea, Susan A., Steinberg, Sharon P., Sweet, Ann R., Keatley, R.Michael, Wells, Matthew E., Stephenson, Wendy P., Gershon, Anne A.
Format: Article
Language:English
Subjects:
Adolescent
Adult
Adverse Drug Reaction Reporting Systems
Adverse experiences
Anaphylaxis - etiology
Ataxia - etiology
Biological and medical sciences
Chickenpox - etiology
Chickenpox - transmission
Chickenpox - virology
Chickenpox Vaccine - adverse effects
Child
Child, Preschool
Epidemiology. Vaccinations
Erythema Multiforme - etiology
Exanthema - etiology
Female
General aspects
Herpes Zoster - etiology
Herpesvirus 3, Human - genetics
Herpesvirus 3, Human - isolation & purification
Humans
Immunocompromised Host
Infant
Infectious diseases
Male
Medical sciences
Polymerase Chain Reaction
Product Surveillance, Postmarketing
Safety
Thrombocytopenia - etiology
vaccines
varicella
Varicella vaccine
varicella-zoster virus
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Summary:The postmarketing safety profile of varicella vaccine was evaluated by analyzing selected adverse experience reports temporally associated with the administration of the vaccine. There were 7963 reports voluntarily submitted to Merck for an overall reporting rate of 5.0 per 10 000 doses of vaccine distributed. A varicella zoster virus (VZV) identification program detected the presence of the Oka vaccine strain in three individuals with an immune deficiency — two with pneumonia and one with hepatitis — and in three instances of secondary transmission from vaccinees with vesicular lesions to susceptible household contacts. The Oka vaccine strain was present in 23 patients and wild-type VZV was present in 15 patients with herpes zoster. Vesicular rashes that occurred within 2 weeks of vaccination were more likely to contain the presence of wild-type VZV, while vesicular rashes that occurred more than 2 weeks post-vaccination were more likely to contain the Oka vaccine strain. Eleven patients were hospitalized with complications of breakthrough varicella infection.
ISSN:0264-410X
1873-2518
DOI:10.1016/S0264-410X(00)00297-8