Congenital microcephaly: Case definition & guidelines for data collection, analysis, and presentation of safety data after maternal immunisation

Malini DeSilva; Flor M Munoz; Erick Sell; Helen Marshall; Alison Tse Kawai; Alisa Kachikis; Paul Heath; Nicola P Klein; James M Oleske; Fyezah Jehan; Hans Spiegel; Mirjana Nesin; Beckie N Tagbo; Anju Shrestha; Clare L Cutland; Linda O Eckert; Sonali Kochhar; Azucena Bardají; Brighton Collaboration Congenital Microcephaly Working Group

doi:10.1016/j.vaccine.2017.01.044

Congenital microcephaly: Case definition & guidelines for data collection, analysis, and presentation of safety data after maternal immunisation

Vaccine. 2017 Dec 4;35(48 Pt A):6472-6482. doi: 10.1016/j.vaccine.2017.01.044.

Authors

Malini DeSilva¹, Flor M Munoz², Erick Sell³, Helen Marshall⁴, Alison Tse Kawai⁵, Alisa Kachikis⁶, Paul Heath⁷, Nicola P Klein⁸, James M Oleske⁹, Fyezah Jehan¹⁰, Hans Spiegel¹¹, Mirjana Nesin¹², Beckie N Tagbo¹³, Anju Shrestha¹⁴, Clare L Cutland¹⁵, Linda O Eckert⁷, Sonali Kochhar¹⁶, Azucena Bardají¹⁷; Brighton Collaboration Congenital Microcephaly Working Group

Affiliations

¹ Health Partners Institute for Education and Research, United States.
² Baylor College of Medicine, United States.
³ Children's Hospital of Eastern Ontario, Canada.
⁴ Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network and Robinson Research Institute and School of Medicine, University of Adelaide, South Adelaide, Australia.
⁵ Department of Population Medicine, Harvard Medical School & Harvard Pilgrim Health, United States.
⁶ Department of Obstetrics and Gynecology, University of Washington, School of Medicine, Seattle, WA, United States.
⁷ St. Georges Vaccine Institute, Institute of Infection & Immunity, St. Georges University of London, London, UK.
⁸ Kaiser Permanente Vaccine Study Centre, Oakland, CA, United States.
⁹ Rutgers New Jersey Medical School, Newark, NJ, United States.
¹⁰ Department of Paediatrics and Child Health, Aga Khan University, Pakistan.
¹¹ Kelly Government Solutions (KGS), Contractor to DAIDS/NIAID/NIH, Rockville, United States.
¹² National Institutes of Health/National Institute of Allergy and Infectious Disease, United States.
¹³ Institute of Child Health & Department of Paediatrics, University of Nigeria Teaching Hospital, Enugu, Nigeria.
¹⁴ Sanofi Pasteur, Global Pharmacovigilance, Sanofi Pasteur, United States.
¹⁵ Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Johannesburg, Department of Science and Technology National Research Foundation, Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
¹⁶ Global Healthcare Consulting, Delhi, India; Erasmus University Medical Center, Rotterdam, The Netherlands.
¹⁷ ISGlobal, Barcelona Ctr. Int. Health Res. (CRESIB), Hospital Clínic - University of Barcelona, Barcelona, Spain. Electronic address: contact@brightoncollaboration.org.

No abstract available

Keywords: Adverse event; Brighton Collaboration; Case definition; Congenital microcephaly; GAIA; Guidelines; Immunisation.

Publication types

Guideline

MeSH terms

Adverse Drug Reaction Reporting Systems / standards*
Data Collection / standards*
Epidemiologic Methods*
Female
Humans
Microcephaly / epidemiology*
Pregnancy
Vaccination / adverse effects*