Global Advisory Committee on Vaccine Safety

The Global Advisory Committee on Vaccine Safety (GACVS) is a group of experts that provides independent and authoritative guidance to the World Health Organization (WHO) on the topic of safe vaccine use.

Global Advisory Committee on Vaccine Safety
AbbreviationGACVS
Formation1999
Purpose"To respond promptly, efficiently, and with scientific rigour to vaccine safety issues of potential global importance."[1]
HeadquartersGeneva, Switzerland
Membership
15 experts
Chair
Helen Petousis-Harris
Vice-Chair
Neelam Adhikari
Parent organization
World Health Organization
WebsiteOfficial website

In order to clarify its independence, GACVS members may not represent WHO in any way. The Committee was established by the WHO in 1999, and as part of its responsibilities, oversees the Vaccine Safety Net. The group meets twice yearly and publishes its findings in the WHO Weekly Epidemiological Record.

Engagements and topics undertaken by the GACVS have included the safety of vaccines for measles, influenza, human papilloma virus, Japanese encephalitis, rotavirus and hepatitis B. In May 2020, as part the WHO's aim to coordinate global research on tests, treatments and vaccines against the SARS-CoV-2, the GACVS addressed the issue of rapidly developing COVID-19 vaccines during a global emergency and growing misinformation and vaccine hesitancy.

Purpose

The purpose of the GACVS is to provide a ready group of independent experts that can advise the WHO on issues relating to vaccine safety, enabling the WHO to respond quickly and authoritatively with potential global importance.[1][2][3] As part of its responsibilities, GACVS oversees the Vaccine Safety Net.[1]

History and function

WHO established the GACVS in 1999 on a background of advances and increasing knowledge of vaccines accompanied by concerns relating to their safety and subsequent influence on public confidence in vaccine programmes.[2][3][4] Its membership consists of a number of experts in several fields that touch on the topic of vaccine safety, including epidemiology, vaccinology, ethics, neurology, internal medicine, and autoimmunity.[1] It is an advisory body that provides the WHO with scientifically backed "advice on vaccine safety issues of potential global importance", makes recommendations for policy-making and bringing together ad hoc task forces, and prioritizes aspects of checking vaccine safety.[5]

An example of an issue, on which the Committee might be called to provide guidance, is the matter of short- and long-term national vaccination programmes.[1] According to its 2017 terms of reference, the Committee:

  • reviews up-to-date knowledge around vaccine safety,
  • identifies causal relationships
  • creates task forces as required and when needed
  • makes recommendations to the WHO
  • cascades its findings by various means.[1]

Members are nominated by the Director of WHO's Department of Essential Medicines and Health Products, and are appointed for an initial term of three years. Current members can only be renewed for one additional term.[1]

To maintain independence in advising, it reports that its members may not represent WHO "in any capacity or in any forum."[1] Current and former members of the GACVS can be found on the official website.[6] The group meets twice yearly and publishes its findings in the WHO Weekly Epidemiological Record.[3]

Engagements and topics undertaken by the GACVS include the safety of immunization during pregnancy.[7] The GACVS is also aware of its increasing responsibility towards low- and middle-income countries that make vaccines for export.[2]

Vaccine hesitancy

The GACVS aims to respond quickly and authoritatively in addressing vaccine-related adverse effects, thereby maintaining confidence in vaccines and immunisation coverage with the result that the incidence of disease falls.[3] The GACVS evaluates and interprets reports of adverse effects of vaccines that impact on international vaccination programmes, helping to develop better surveillance systems, particularly in low- and middle-income countries. It also monitors the clinical testing of new vaccines and their use in immunization programs.[8]

The GACVS has been involved in issues relating to vaccine hesitancy regarding several vaccines including vaccines for measles,[9] influenza, human papilloma virus, Japanese encephalitis, rotavirus[10] and hepatitis B.[11]

COVID-19

In May 2020, during the global emergency of COVID-19 and as part of the WHO's aim to coordinate global research on tests, treatments and vaccines against the coronavirus responsible for COVID-19 disease, the GACVS addressed the issue of monitoring fast-emerging COVID-19 vaccines amid a global emergency and growing misinformation and vaccine hesitancy.[5][12]

A COVID-19 vaccine safety surveillance manual[13] is being developed under the guidance and recommendation of GACVS members. In preparation for this upcoming manual, the WHO has published the draft document available for review by public consultation. The manual will have nine chapters, including the following modules:

  • COVID-19 vaccines: description and general safety considerations for implementation
  • Stakeholders for safety surveillance of COVID-19 vaccines
  • Establishing COVID-19 vaccine safety surveillance systems
  • Responding to adverse events following immunization
  • Responding to adverse events of special interest
  • Data management systems for COVID-19 vaccine safety surveillance
  • Engaging with the pharmaceutical industry on COVID-19 vaccine safety
  • Regulatory reliance and work-sharing
  • COVID-19 vaccine safety communication

Evaluation

Upon the 15-year anniversary of the GACVS, a number of members reviewed the Committee's contributions and ongoing challenges.[14]

Reference section
  1. "WHO | The Global Advisory Committee on Vaccine Safety". WHO. Archived () from the original on 5 October 2020. Retrieved 4 October 2020.
  2. Das Gupta, Rajib; Arora, Narendra K. (2013). "23. An international perspective on vaccine safety". In Archana Chatterjee (ed.). Vaccinophobia and Vaccine Controversies of the 21st Century. New York: Springer. pp. 419–435. ISBN 978-1-4614-7437-1.
  3. Barrett, Alan D. T. (2011). "10. Vaccines in the tropics". In Guerrant, Richard L.; Walker, David H.; Weller, Peter F. (eds.). Tropical Infectious Diseases: Principles, Pathogens and Practice (Third ed.). Saunders Elsevier. p. 67. ISBN 9780702039355.
  4. Milligan, Gregg N; Barrett, A. D. T (2015). Vaccinology: an essential guide. p. 331. ISBN 978-1-118-63652-7. OCLC 881386962.
  5. Santé, World Health Organization = Organisation mondiale de la (10 July 2020). "Global Advisory Committee on Vaccine Safety, 27–28 May 2020 – Comité consultatif mondial pour la sécurité des vaccins, 27-28 mai 2020" (PDF). Weekly Epidemiological Record. 95 (28): 325–336.
  6. "WHO | GACVS Members". WHO. Retrieved 3 September 2020.
  7. Kochhar, Sonali; Bauwens, Jorgen; Bonhoeffer, Jan (December 2017). "Safety assessment of immunization in pregnancy". Vaccine. 35 (48): 6469–6471. doi:10.1016/j.vaccine.2017.09.033. PMC 5714434. PMID 29031696.
  8. Autran, Brigitte; Asturias, Edwin J.; Evans, Stephen; Hartigan-Go, Kenneth; Hussey, Gregory; John, T. Jacob; Lambert, Paul-Henri; Law, Barbara; Midthun, Karen; Nohynek, Hanna; Salmaso, Stefania (1 June 2009). "Global safety of vaccines: strengthening systems for monitoring, management and the role of GACVS". Expert Review of Vaccines. 8 (6): 705–716. doi:10.1586/erv.09.40. ISSN 1476-0584. S2CID 15740291.
  9. Aronson, Jeffrey K. (2015). Meyler's Side Effects of Drugs: The International Encyclopedia of Adverse Drug Reactions and Interactions (16th ed.). Elsevier. p. 760. ISBN 978-0-444-53717-1.
  10. Dittman, S. (2008). "32. Vaccines". In Jeffrey K. Aronson (ed.). Side Effects of Drugs Annual: A Worldwide Yearly Survey of New Data and Trends in Adverse Drug Reactions. Elsevier. pp. 374–377. ISBN 978-0-444-52767-7. ISSN 0378-6080.
  11. Dittman, S. (25 November 2009). "Vaccines". In Jeffrey K. Aronson (ed.). Side Effects of Drugs Annual: A Worldwide Yearly Survey of New Data and Trends in Adverse Drug Reactions. Elsevier. p. 521. ISBN 978-0-444-53294-7.
  12. Petousis-Harris, Helen (30 September 2020). "Assessing the Safety of COVID-19 Vaccines: A Primer". Drug Safety. doi:10.1007/s40264-020-01002-6. ISSN 1179-1942. PMC 7526515. PMID 32997318.
  13. "WHO | Public consultation for review of draft COVID-19 vaccines: Safety Surveillance manual". WHO. Retrieved 2020-11-05.
  14. Asturias, Edwin J.; Wharton, Melinda; Pless, Robert; MacDonald, Noni E.; Chen, Robert T.; Andrews, Nicholas; Salisbury, David; Dodoo, Alexander N.; Hartigan-Go, Kenneth; Zuber, Patrick L. F. (2016-06-17). "Contributions and challenges for worldwide vaccine safety: The Global Advisory Committee on Vaccine Safety at 15 years". Vaccine. 34 (29): 3342–3349. doi:10.1016/j.vaccine.2016.05.018. ISSN 0264-410X. PMC 5085263. PMID 27195758.
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