HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Shields, K. E. Articles by Slater, E. Search for Related Content PubMed PubMed Citation Articles by Shields, K. E. Articles by Slater, E.

Varicella Vaccine Exposure During Pregnancy: Data from the First 5 Years of the Pregnancy Registry

From Worldwide Product Safety & Epidemiology, Merck Research Laboratories, Merck & Co., Inc.

Address reprint requests to: Kristine E. Shields, MSN, MPH, Worldwide Product Safety & Epidemiology, Merck & Co., Inc., PO Box 4, BLB - 30, West Point, PA 19486; E-mail: kristine_shields{at}merck.com

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.

CONCLUSION: 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.

This article has been cited by other articles:

				M. A. K. Ryan, T. C. Smith, C. J. Sevick, W. K. Honner, R. A. Loach, C. A. Moore, and J. D. Erickson Birth Defects among Infants Born to Women Who Received Anthrax Vaccine in Pregnancy Am. J. Epidemiol., August 15, 2008; 168(4): 434 - 442. [Abstract] [Full Text] [PDF]

				L. B. Holmes, E. J. Baldwin, C. R. Smith, E. Habecker, L. Glassman, S. L. Wong, and D. F. Wyszynski Increased frequency of isolated cleft palate in infants exposed to lamotrigine during pregnancy Neurology, May 27, 2008; 70(22_Part_2): 2152 - 2158. [Abstract] [Full Text] [PDF]

				Chickenpox, pregnancy and the newborn DTB, September 1, 2005; 43(9): 69 - 72. [Abstract] [Full Text] [PDF]

				L. B. Holmes, D. F. Wyszynski, and E. Lieberman The AED (Antiepileptic Drug) Pregnancy Registry: A 6-Year Experience Arch Neurol, May 1, 2004; 61(5): 673 - 678. [Abstract] [Full Text] [PDF]

				Inadvertent Varicella Vaccination During Pregnancy: No Link to Congenital Varicella Syndrome Journal Watch Women's Health, September 18, 2001; 2001(918): 3 - 3. [Full Text]