Congenital anomalies: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data

ongenital anomalies: Case definition and guidelines for data ollection, analysis, and presentation of immunization safety data alini DeSilvaa, Flor M. Munozb, Mark Mcmillanc,d, Alison Tse Kawaie, Helen Marshalld, ristine K. Macartneyf,g, Jyoti Joshih, Martina Onekoi, Annette Elliott Rose j, Helen Dolkk, rancesco Trotta l, Hans Spiegelm, Sylvie Tomczykn, Anju Shresthao, Sonali Kochharp, lyse O. Kharbandaa,∗, The Brighton Collaboration Congenital Anomalies Working Group1

[1]  Y. Zheteyeva,et al.  Safety of meningococcal polysaccharide-protein conjugate vaccine in pregnancy: a review of the Vaccine Adverse Event Reporting System. , 2013, American journal of obstetrics and gynecology.

[2]  Stéphanie Dagron,et al.  Die International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) , 2014 .

[3]  W. Roper,et al.  Prevention and control of influenza: Part I, Vaccines. Recommendations of the Advisory Committee on Immunization Practices (ACIP). , 1994, MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports.

[4]  T. Heikkinen,et al.  Safety of MF 59-adjuvanted A / H 1 N 1 influenza vaccine in pregnancy : a comparative cohort study , 2012 .

[5]  B. Källén,et al.  Vaccination against H1N1 influenza with Pandemrix® during pregnancy and delivery outcome: a Swedish register study , 2012, BJOG : an international journal of obstetrics and gynaecology.

[6]  T. Shimabukuro,et al.  Adverse Events Following Measles, Mumps, and Rubella Vaccine in Adults Reported to the Vaccine Adverse Event Reporting System (VAERS), 2003-2013. , 2015, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[7]  S. Reef,et al.  Fetal Risk Associated With Rubella Vaccination During Pregnancy , 2007, The Pediatric infectious disease journal.

[8]  Vaccines against influenza WHO position paper – November 2012. , 2012, Releve epidemiologique hebdomadaire.

[9]  S. Shapiro,et al.  Birth defects and drugs in pregnancy , 1977 .

[10]  F. Struyf,et al.  Pooled analysis of large and long-term safety data from the human papillomavirus-16/18-AS04-adjuvanted vaccine clinical trial programme , 2014, Pharmacoepidemiology and drug safety.

[11]  J. Chuang,et al.  Safety of inactivated monovalent pandemic (H1N1) 2009 vaccination during pregnancy: a population-based study in Taiwan. , 2014, Vaccine.

[12]  D. McIntire,et al.  Pregnancy Outcomes After Antepartum Tetanus, Diphtheria, and Acellular Pertussis Vaccination , 2015, Obstetrics and gynecology.

[13]  Population-based birth defects surveillance data from selected states, 2000-2004. , 2007, Birth defects research. Part A, Clinical and molecular teratology.

[14]  C. Byington,et al.  Tetanus, diphtheria, acellular pertussis vaccine during pregnancy: pregnancy and infant health outcomes. , 2013, The Journal of pediatrics.

[15]  L. Camacho,et al.  Pregnancy outcomes following rubella vaccination: a prospective study in the state of Rio de Janeiro, Brazil, 2001-2002. , 2011, Journal of Infectious Diseases.

[16]  Update on overall prevalence of major birth defects--Atlanta, Georgia, 1978-2005. , 2008, MMWR. Morbidity and mortality weekly report.

[17]  Vaccines against human papillomavirus in low and middle income countries: a review of safety, immunogenicity and efficacy , 2015, Infectious Agents and Cancer.

[18]  Z. Bankowski,et al.  Council for International Organizations of Medical Sciences , 1991 .

[19]  S. Cochi,et al.  The Vaccine Adverse Event Reporting System (VAERS). , 1994, Vaccine.

[20]  A. Czeizel,et al.  Tetanus toxoid and congenital abnormalities , 1999, International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics.

[21]  J. Boyd,et al.  Fetal damage after accidental polio vaccination of an immune mother. , 1984, The Journal of the Royal College of General Practitioners.

[22]  Tom Jefferson,et al.  Vaccines for preventing influenza in healthy adults. , 2014, The Cochrane database of systematic reviews.

[23]  G. Koren,et al.  Pregnancy outcome following rubella vaccination: A prospective controlled study , 2004, American journal of medical genetics. Part A.

[24]  H. Marshall,et al.  Influenza vaccination during pregnancy: a systematic review of fetal death, spontaneous abortion, and congenital malformation safety outcomes. , 2015, Vaccine.

[25]  Y. Zheteyeva,et al.  Safety of quadrivalent human papillomavirus vaccine (Gardasil) in pregnancy: adverse events among non-manufacturer reports in the Vaccine Adverse Event Reporting System, 2006-2013. , 2015, Vaccine.

[26]  V. Demicheli,et al.  A/H1N1 pandemic influenza vaccination: A retrospective evaluation of adverse maternal, fetal and neonatal outcomes in a cohort of pregnant women in Italy. , 2015, Vaccine.

[27]  Influenza A/H1N1 MF59 adjuvanted vaccine in pregnant women and adverse perinatal outcomes: multicentre study , 2013, BMJ : British Medical Journal.

[28]  M. Gramegna,et al.  Evaluation of safety of A/H1N1 pandemic vaccination during pregnancy: cohort study , 2014, BMJ : British Medical Journal.

[29]  W. P. Glezen,et al.  Maternal immunization with pneumococcal polysaccharide vaccine in the third trimester of gestation. , 2001, Vaccine.

[30]  T. Heikkinen,et al.  Safety of MF59-adjuvanted A/H1N1 influenza vaccine in pregnancy: a comparative cohort study. , 2012, American journal of obstetrics and gynecology.

[31]  J. López-Camelo,et al.  Early exposure to yellow fever vaccine during pregnancy , 2007, Tropical medicine & international health : TM & IH.

[32]  J. Cuzick,et al.  A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. , 2015, The New England journal of medicine.

[33]  A. Distéfano,et al.  Rubella vaccination of unknowingly pregnant women during 2006 mass campaign in Argentina. , 2011, The Journal of infectious diseases.

[34]  Y. Ville,et al.  Low Rate of Pandemic A/H1N1 2009 Influenza Infection and Lack of Severe Complication of Vaccination in Pregnant Women: A Prospective Cohort Study , 2012, PloS one.

[35]  M. Cunningham,et al.  Final report on exposure during pregnancy from a pregnancy registry for quadrivalent human papillomavirus vaccine. , 2015, Vaccine.

[36]  S. Shakir,et al.  Influenza H1N1 (swine flu) vaccination: a safety surveillance feasibility study using self-reporting of serious adverse events and pregnancy outcomes , 2011, British journal of clinical pharmacology.

[37]  Alan D. Lopez,et al.  The Global Burden of Disease Study , 2003 .

[38]  Bernadette A. Thomas,et al.  Global, regional, and national age–sex specific all-cause and cause-specific mortality for 240 causes of death, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013 , 2015, The Lancet.

[39]  A. Scialli,et al.  Teratogenic exposures , 2011, American journal of medical genetics. Part C, Seminars in medical genetics.

[40]  Pertussis vaccines--WHO position paper. , 2005, Releve epidemiologique hebdomadaire.

[41]  B. Flannery,et al.  Follow-up study of unknowingly pregnant women vaccinated against rubella in Brazil, 2001-2002. , 2011, The Journal of infectious diseases.

[42]  L. Schuler‐Faccini,et al.  Prospective evaluation of pregnant women vaccinated against rubella in southern Brazil. , 2008, Reproductive toxicology.

[43]  R. Glaser,et al.  Inflammatory responses to trivalent influenza virus vaccine among pregnant women. , 2011, Vaccine.

[44]  A. Allignol,et al.  A(H1N1)v2009: a controlled observational prospective cohort study on vaccine safety in pregnancy. , 2012, Vaccine.

[45]  G. Kang,et al.  Safety of immunization during pregnancy: a review of the evidence of selected inactivated and live attenuated vaccines. , 2014, Vaccine.

[46]  V. Cáceres,et al.  Safety of tetanus toxoid in pregnant women: a hospital-based case-control study of congenital anomalies. , 1995, Bulletin of the World Health Organization.

[47]  S. Jalilvand,et al.  Inadvertent rubella vaccination of pregnant women: evaluation of possible transplacental infection with rubella vaccine. , 2006, Vaccine.

[48]  A. Mitchell,et al.  Risks and safety of pandemic H1N1 influenza vaccine in pregnancy: birth defects, spontaneous abortion, preterm delivery, and small for gestational age infants. , 2013, Vaccine.

[49]  P. Boyd,et al.  An aetiological classification of birth defects for epidemiological research , 2005, Journal of Medical Genetics.

[50]  N. Cox,et al.  Prevention and Control of Influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP). , 2006, MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports.

[51]  T. Jefferson,et al.  Vaccines for preventing influenza in healthy adults. , 2014, The Cochrane database of systematic reviews.

[52]  A. Mitchell,et al.  Risks and safety of pandemic H1N1 influenza vaccine in pregnancy: exposure prevalence, preterm delivery, and specific birth defects. , 2013, Vaccine.

[53]  M. Sawyer,et al.  Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine (Tdap) in Pregnant Women — Advisory Committee on Immunization Practices (ACIP), 2012 , 2013, MMWR. Morbidity and mortality weekly report.

[54]  S. Rasmussen,et al.  Adverse event reports after tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines in pregnant women. , 2012, American journal of obstetrics and gynecology.

[55]  S. Garland,et al.  Pregnancy and Infant Outcomes in the Clinical Trials of a Human Papillomavirus Type 6/11/16/18 Vaccine: A Combined Analysis of Five Randomized Controlled Trials , 2009, Obstetrics and gynecology.

[56]  L. Saxén,et al.  Oral polio vaccination during pregnancy: lack of impact on fetal development and perinatal outcome. , 1994, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[57]  E. Amaral,et al.  The effects of yellow fever immunization (17DD) inadvertently used in early pregnancy during a mass campaign in Brazil. , 2006, Vaccine.

[58]  S. Rasmussen Human teratogens update 2011: can we ensure safety during pregnancy? , 2012, Birth defects research. Part A, Clinical and molecular teratology.

[59]  M. Cunningham,et al.  Pregnancy Outcomes From the Pregnancy Registry of a Human Papillomavirus Type6/11/16/18 Vaccine , 2009, Obstetrics and gynecology.

[60]  S. Rasmussen,et al.  Guidelines for case classification for the National Birth Defects Prevention Study. , 2003, Birth defects research. Part A, Clinical and molecular teratology.

[61]  S. Rasmussen,et al.  Varicella vaccine exposure during pregnancy: data from 10 Years of the pregnancy registry. , 2008, The Journal of infectious diseases.

[62]  D. McIntire,et al.  Effect of Influenza Vaccination in the First Trimester of Pregnancy , 2012, Obstetrics and gynecology.

[63]  J. Tourville Birth Defects and Drugs in Pregnancy , 1977 .

[64]  A. Deinard,et al.  A/NJ/8/76 influenza vaccination program: effects on maternal health and pregnancy outcome. , 1981, American journal of obstetrics and gynecology.

[65]  K. Shiota Variability in human embryonic development and its implications for the susceptibility to environmental teratogenesis. , 2009, Birth defects research. Part A, Clinical and molecular teratology.

[66]  Ich Harmonised,et al.  INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE , 2006 .

[67]  J. Dungan Pregnancy Outcomes Following Rubella Vaccination: A Prospective Study in the State of Rio de Janeiro, Brazil, 2001–2002 , 2012 .

[68]  M. Falagas,et al.  Safety of Hepatitis B, Pneumococcal Polysaccharide and Meningococcal Polysaccharide Vaccines in Pregnancy , 2012, Drug Safety.

[69]  M. Khoury Epidemiology of birth defects. , 1989, Epidemiologic reviews.

[70]  S. Schultz-Cherry,et al.  Serum Proinflammatory Cytokine Responses to Influenza Virus Vaccine among Women during Pregnancy versus Non‐Pregnancy , 2013, American journal of reproductive immunology.

[71]  S. Reef,et al.  Rubella vaccination of unknowingly pregnant women during mass campaigns for rubella and congenital rubella syndrome elimination, the Americas 2001-2008. , 2011, The Journal of infectious diseases.

[72]  F. Diomandé,et al.  Adverse events following immunization during mass vaccination campaigns at first introduction of a meningococcal A conjugate vaccine in Burkina Faso, 2010. , 2012, Vaccine.

[73]  Johannes B. Goll,et al.  Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial. , 2014, JAMA.

[74]  Robert T. Chen,et al.  The development of standardized case definitions and guidelines for adverse events following immunization. , 2007, Vaccine.

[75]  TORCH syndrome and TORCH screening , 1990, The Lancet.

[76]  N. Patel,et al.  Surveillance for violent deaths--National Violent Death Reporting System, 16 states, 2005. , 2008, Morbidity and mortality weekly report. Surveillance summaries.

[77]  L. Baril,et al.  Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience , 2014, Pharmacoepidemiology and drug safety.