Guide to active vaccine safety surveillance: Report of CIOMS working group on vaccine safety – executive summary

U. Heininger, K. Holm, I. Caplanusi, S. R. Bailey, Siti Asfijah Abdoellah, Felix Arellano, Peter Arlett, Ayman Ayoub, Novilia Sjafri Bachtiar, Priya Bahri, Steven R. Bailey, Raja Benkirane, Joan Benson, Ulf Bergman, Michael Blum, Jan Bonhoeffer, Irina Caplanusi, Marc Ceuppens, Rebecca Chandler, Peter Glen ChuaAdrian Dana, Mimi Darko, Frank DeStefano, Alex Dodoo, Dong Duo, William Gregory, Bhagwat Gunale, Ken Hartigan-Go, Katharina Hartmann, Ulrich Heininger, Suresh Jadhav, Corrine Jouquelet-Royer, Brigitte Keller-Stanislawski, Terhi Kilpi, Xavier Kurz, Fabio Leviano, Marie Lindquist, Dawei Liu, Patricia Mandali, Somnath Mangrule, Robert Maroko, David Martin, Eliane Matos dos Santos, Christine Maure, Reinaldo Menezes, Sergio Nishioka, Doris Oberle, Sten Olsson, Mayur Patel, Ajmeer Ramkishan, Martina Rauscher, Paulo Santos, Harry Seifert, Tom Shimabukuro, Françoise Sillan, Gunilla Sjölin-Forsberg, Swati Srivastava, Walter Straus, Amina Tebaa, Scott Winiecki, Claudia Vellozzi, Ashley Wivel, Wei Xia, Mona Hassan Abu Youssef, Patrick Zuber

Research output: Contribution to journalArticlepeer-review

10 Scopus citations


In 2013, the Council for International Organizations of Medical Sciences (CIOMS) created a Working Group on Vaccine Safety (WG) to address unmet needs in the area of vaccine pharmacovigilance. Generating reliable data about specific vaccine safety concerns is becoming a priority due to recent progress in the development and deployment of new vaccines of global importance, as well as novel vaccines targeting diseases specifically endemic to many resource-limited countries (RLCs), e.g. malaria, dengue. The WG created a Guide to Active Vaccine Safety Surveillance (AVSS) to assist national regulatory authorities and national immunization program officers in RLCs in determining the best course of action with regards to non-routine pharmacovigilance activities, when confronted with a launch of a new vaccine or a vaccine that is new to their country. Here we summarize the results of the WG, further detailed in the Guide, which for the first time provides a structured approach to identifying and analyzing specific vaccines safety knowledge gaps, while considering all available sources of information, in order to determine whether AVSS is an appropriate solution. If AVSS is confirmed as being the appropriate tool, the Guide provides additional essential information on AVSS, a detailed overview of common types of AVSS and practical implementation considerations. It also provides a framework for a well-constructed and informative AVSS when needed, thus aiming to ensure the best possible safety of immunization in this new landscape.

Original languageEnglish (US)
Pages (from-to)3917-3921
Number of pages5
Issue number32
StatePublished - Jul 13 2017


  • Active surveillance
  • Adverse event of specific interest
  • Resource-limited countries
  • Vaccine safety

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases


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