Defining the interval for monitoring potential adverse events following immunization (AEFIs) after receipt of live viral vectored vaccines |
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| Affiliation: | 1. Global Healthcare Consulting, New Delhi, India;2. Erasmus MC, University Medical Center, Rotterdam, the Netherlands;3. University of Washington, Seattle, USA;4. International Vaccine Institute, Seoul, Republic of Korea;5. National Vaccine Program Office, Office of the Assistant Secretary for Health, US Department of Health and Human Services, Washington DC, USA;6. PaxVax Inc., San Diego, CA, USA;7. Immunization Safety Office, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA;8. Department of Microbiology and Immunology, New York Medical College, NY, USA;9. St. Giles Laboratory of Human Genetics of Infectious Diseases, Rockefeller University, New York, NY, USA;10. Division of Infectious Disease, Jordan University Hospital, Amman, Jordan;11. Division Immunology, Paul-Ehrlich-Institut, Langen, Germany;12. Immune System Management Clinic & Lab, Ottawa, Ontario, Canada;13. Independent Adviser (formerly of National Institute for Biological Standards and Control), Potters Bar, UK;14. Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), USA;15. Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA |
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| Abstract: | Live viral vectors that express heterologous antigens of the target pathogen are being investigated in the development of novel vaccines against serious infectious agents like HIV and Ebola. As some live recombinant vectored vaccines may be replication-competent, a key challenge is defining the length of time for monitoring potential adverse events following immunization (AEFI) in clinical trials and epidemiologic studies. This time period must be chosen with care and based on considerations of pre-clinical and clinical trials data, biological plausibility and practical feasibility. The available options include: (1) adapting from the current relevant regulatory guidelines; (2) convening a panel of experts to review the evidence from a systematic literature search to narrow down a list of likely potential or known AEFI and establish the optimal risk window(s); and (3) conducting “near real-time“ prospective monitoring for unknown clustering’s of AEFI in validated large linked vaccine safety databases using Rapid Cycle Analysis for pre-specified adverse events of special interest (AESI) and Treescan to identify previously unsuspected outcomes. The risk window established by any of these options could be used along with (4) establishing a registry of clinically validated pre-specified AESI to include in case-control studies. Depending on the infrastructure, human resources and databases available in different countries, the appropriate option or combination of options can be determined by regulatory agencies and investigators. |
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| Keywords: | Viral vector Vaccines Safety Surveillance Duration Adverse events following immunization (AEFI) Adverse event of special interest (AESI) Treescan |
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