Varicella vaccine exposure during pregnancy: data from the first 5 years of the pregnancy registry.
OBJECTIVE
To assess the risks of congenital varicella syndrome and other birth defects in offspring of women who inadvertently received varicella vaccine during pregnancy or within 3 months of conception.


METHODS
Pregnant women inadvertently exposed to varicella vaccine, reported voluntarily, were enrolled in the Pregnancy Registry for VARIVAX (Merck & Co., Inc., West Point, PA). The pregnancies were monitored and the outcomes ascertained from questionnaires completed voluntarily by the health care providers. The rates of congenital varicella syndrome and congenital anomalies were calculated for seronegative women prospectively reported to the registry.


RESULTS
From March 17, 1995 through March 16, 2000, 362 pregnancy outcomes were identified from prospective reports. Ninety-two women were known to be seronegative to varicella, of whom 58 received their first dose of vaccine during the first or second trimester. No cases of congenital varicella syndrome were identified among 56 live births (rate 0%, 95% confidence interval [CI] 0, 15.6). Among all the prospective reports of live births, five congenital anomalies were reported. No specific pattern was identified in either the susceptible cohort or the sample population as a whole.


CONCLUSIONS
No abnormal features have been reported that suggested the occurrence of congenital varicella syndrome or other birth defects related to vaccine exposure during pregnancy. Because of the small numbers, this study has limited precision, so continued surveillance is warranted. However, these results should provide some assurance to health care providers and women with inadvertent exposure before or during pregnancy.
Shields
K E
KE
Worldwide Product Safety & Epidemiology, Merck Research Laboratories, Merck & Co., Inc., USA. kristine_shields@merck.com
Galil
K
K
Seward
J
J
Sharrar
R G
RG
Cordero
J F
JF
Slater
E
E
D000293:Adolescent; D000328:Adult; D019433:Chickenpox Vaccine / Q000009:adverse effects*; D000013:Congenital Abnormalities / Q000453:epidemiology / Q000209:etiology*; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D011247:Pregnancy; D011256:Pregnancy Outcome; D011446:Prospective Studies; D012042:Registries; D018570:Risk Assessment; D013997:Time Factors
D019433:Chickenpox Vaccine