Safety profile of rubella vaccine administered to pregnant women: A systematic review of pregnancy related adverse events following immunisation,including congenital rubella syndrome and congenital rubella infection in the foetus or infant |
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| Institution: | 1. Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK;2. Paul Ehrlich-Institut, Paul-Ehrlich-Straße 51-59, 63225 Langen, Germany;3. Infectious Diseases, Department of Medicine II, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Germany;4. Department of Epidemiology, Helmholtz Centre for Infection Research (HZI), Braunschweig, Germany;1. Department of Medicine, New York University School of Medicine, NY, NY, United States;2. Division of Ethics, Department of Population Health, New York University School of Medicine, NY, NY, United States;1. Department of Infectious Diseases, Centre Hospitalier Universitaire Saint-Pierre, Université Libre de Bruxelles (ULB), Brussels, Belgium;2. Epidemiology of Infectious Diseases, Sciensano, Brussels, Belgium;3. Department of Paediatrics, Centre Hospitalier Universitaire Saint-Pierre, Université Libre de Bruxelles (ULB), Brussels, Belgium;4. Department of Obstetrics-Gynecology, Centre Hospitalier Universitaire Saint-Pierre, Université Libre de Bruxelles (ULB), Brussels, Belgium;5. Microbiology, Laboratoire Hospitalier Universitaire de Bruxelles-Universitair Laboratorium Brussel (LHUB-ULB), Brussels, Belgium;6. Centre for Environmental Health and Occupational Health, School of Public Health, Université libre de Bruxelles (ULB), Belgium;7. Institute for Medical Immunology, Université libre de Bruxelles (ULB), Belgium;1. Interuniversity Institute for Biostatistics and Statistical Bioinformatics, UHasselt (Hasselt University), Diepenbeek, Belgium;2. Center for Clinical Epidemiology and Outcomes Research (CLEO), Athens, Greece;3. Service of Epidemiology of Infectious Diseases, Department of Public Health and Surveillance, Scientific Institute for Public Health, Brussels, Belgium;4. Centre for Health Economics Research and Modeling Infectious Diseases and Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Wilrijk, Belgium;5. School of Public Health and Community Medicine, The University of New South Wales, Sydney, Australia;6. Department of Epidemiology and Social Medicine, University of Antwerp, Wilrijk, Belgium;1. Christian Medical College, Vellore, Tamil Nadu, India;2. All India Institute of Medical Sciences, Jodhpur, India;3. Bangalore Medical College and Research Institute, Vanivilas Women and Children’s Hospital, Bengaluru, Karnataka, India;4. KEM Hospital, Pune, India;5. Postgraduate Institute of Medical Education and Research, Chandigarh, India;6. Tata Main Hospital, Jamshedpur, Jharkhand, India;7. National Institute of Virology, Bengaluru Unit, Bengaluru, India;8. National Institute of Virology, Pune, India;9. Indira Gandhi Institute of Child Health, Bengaluru, India;10. Indian Council of Medical Research, New Delhi, India;11. National Institute of Epidemiology, Chennai, India;1. Department of Obstetrics and Gynecology, Hôpital Foch, 92120 Suresnes, France;2. Risk in Pregnancy University Department, IAME, INSERM, Université Paris-Diderot, 75013 Paris, France;3. Groupe de Recherche sur les Infections pendant la Grossesse (GRIG), France;4. AP-HP, Hôpital Paul Brousse, Department of Virology, WHO Rubella NRL, 94804 Villejuif, France;5. AP-HP, Hôpital Antoine Béclère, Department of Obstetrics, Gynecology and Reproductive Medicine, Univ Paris-Sud, 92140 Clamart, France;6. EA2493, Université Versailles Saint-Quentin-en-Yvelines, 78180 Montigny-le-Bretonneux, France;7. Hôpital Foch, DRCI-Clinical Research Unit, 92120 Suresnes, France;8. Univ Paris-Sud, INSERM U1193, Villejuif, 94804 France;1. Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China;2. Women’s Health and Perinatology Research Group, Department of Clinical Medicine, UiT – The Arctic University of Norway, Tromso, Norway;3. Department of Maternal and Child Health, National Health and Family Planning Commission of the People’s Republic of China, Beijing, China;4. Shanghai Key Laboratory of Female Reproductive Endocrine-Related Diseases, Shanghai, China;5. Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institute, Stockholm, Sweden |
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| Abstract: | BackgroundData on the safety of inadvertent rubella vaccination in pregnancy is important for rubella vaccination programs aimed at preventing congenital rubella syndrome.MethodsThe association between monovalent rubella or combination vaccinations in or shortly before pregnancy and potential harm to the foetus was examined by conducting a systematic review and meta-analysis using fixed effect methods and simulation.ResultsFour cohort studies of inadvertently vaccinated and unvaccinated women were found, 15 cohorts of pregnant women who were rubella susceptible at time of inadvertent vaccination and 9 cohort studies with no information on susceptibility and case series. No case of vaccine associated congenital rubella syndrome (CRS) was identified. Cohort studies with an unvaccinated comparison group were limited in number and size, and based on these only a theoretical additional risk of 6 or more cases of CRS per 1000 vaccinated women (0% observed, upper 95% CI 0.6%) could be excluded. Based on cohorts of vaccinated rubella susceptible pregnant women a maximum theoretical risk of 1 CRS case in 1008 vaccinated women (0% observed, upper 95% CI 0.099%) was estimated. Asymptomatic rubella vaccine virus infection of the neonate was also noted (fixed effects estimate of risk overall 1.74%, 95% CI 1.21, 2.28).ConclusionThere is no evidence that CRS is caused by rubella-containing vaccines but transplacental vaccine virus infection can occur. CRS is effectively prevented by vaccination, thus the risk/benefit balance is unequivocally in favour of vaccination. The data confirm previous recommendations that inadvertent vaccination during pregnancy is not an indication for termination of pregnancy. |
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| Keywords: | Rubella containing vaccine Adverse events following immunisation Vaccine safety Pregnancy Congenital rubella syndrome Congenital rubella infection |
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