Varicella vaccine exposure during pregnancy: data from 10 Years of the pregnancy registry.
BACKGROUND
The Pregnancy Registry for Varivax (Merck) was established to monitor for congenital varicella syndrome or other birth defects in the offspring of women who were exposed to varicella vaccine while pregnant.


METHODS
The registry receives voluntary reports from health care providers or consumers about women given the vaccine 3 months before or during pregnancy. Follow-up is conducted to obtain and classify pregnancy outcomes. All reports are evaluated for the presence of birth defects. Outcomes from prospectively reported pregnancy exposures are used to calculate rates and 95% confidence intervals.


RESULTS
From 17 March 1995 through 16 March 2005, 981 women were enrolled. Pregnancy outcomes were available for 629 prospectively enrolled women. Among the 131 live births to varicella-zoster virus-seronegative women, there was no evidence of congenital varicella syndrome (rate, 0% [95% confidence interval [CI], 0%-6.7%]), and major birth defects were observed in 3 infants (rate, 3.7% [95% CI, 0.8%-10.7%]).


CONCLUSIONS
Although the numbers of exposures are not sufficient to rule out a very low risk, data collected in the pregnancy registry to date do not support a relationship between the occurrence of congenital varicella syndrome or other birth defects and varicella vaccine exposure during pregnancy.
Wilson
Eileen
E
Clinical Risk Management and Safety Surveillance, Merck & Co., Inc., West Point, Pennsylvania, USA. eileen_wilson2@merck.com
Goss
Mary Ann
MA
Marin
Mona
M
Shields
Kristine E
KE
Seward
Jane F
JF
Rasmussen
Sonja A
SA
Sharrar
Robert G
RG
D000293:Adolescent; D000328:Adult; D002644:Chickenpox / Q000517:prevention & control; D019433:Chickenpox Vaccine / Q000008:administration & dosage / Q000009:adverse effects*; D000013:Congenital Abnormalities / Q000453:epidemiology* / Q000209:etiology*; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D011247:Pregnancy; D011256:Pregnancy Outcome; D012042:Registries; D018570:Risk Assessment; D013997:Time Factors
D019433:Chickenpox Vaccine