Global Advisory Committee on Vaccine Safety

Last updated
Global Advisory Committee on Vaccine Safety
World Health Organization Logo.svg
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
Dr Rita Helfand
Vice-Chair
Professor Dure Samin Akram
Parent organization
World Health Organization
Website Official website

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.

Contents

In order to maintain 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:

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 immunization 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 was published by the WHO in 2020, upon recommendation and guidance of GACVS members. [13]

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. 1 2 3 4 5 6 7 8 "WHO | The Global Advisory Committee on Vaccine Safety". WHO(). Retrieved 4 October 2020.{{cite web}}: |archive-format= requires |archive-url= (help); External link in |archive-format= (help)
  2. 1 2 3 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. 1 2 3 4 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. 1 2 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. "GACVS Members". World Health Organization. Archived from the original on October 20, 2014. 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. "Covid-19 vaccines: safety surveillance manual". www.who.int. Archived from the original on 15 March 2021. Retrieved 2 April 2021.
  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.

Related Research Articles

Vaccine Pathogen-derived preparation that provides acquired immunity to an infectious disease

A vaccine is a biological preparation that provides active acquired immunity to a particular infectious disease. A vaccine typically contains an agent that resembles a disease-causing microorganism and is often made from weakened or killed forms of the microbe, its toxins, or one of its surface proteins. The agent stimulates the body's immune system to recognize the agent as a threat, destroy it, and to further recognize and destroy any of the microorganisms associated with that agent that it may encounter in the future. Vaccines can be prophylactic, or therapeutic. Some vaccines offer full sterilizing immunity, in which infection is prevented completely.

Vaccine hesitancy is a delay in acceptance, or refusal of vaccines despite the availability of vaccine services. The term covers outright refusals to vaccinate, delaying vaccines, accepting vaccines but remaining uncertain about their use, or using certain vaccines but not others. The scientific consensus that vaccines are generally safe and effective is overwhelming. Vaccine hesitancy often results in disease outbreaks and deaths from vaccine-preventable diseases. Therefore, the World Health Organization characterizes vaccine hesitancy as one of the top ten global health threats.

The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a postmarketing surveillance program, collecting information about adverse events that occur after administration of vaccines to ascertain whether the risk–benefit ratio is high enough to justify continued use of any particular vaccine.

A vaccine adverse event (VAE), sometimes referred to as a vaccine injury, is an adverse event caused by vaccination. The World Health Organization (WHO) knows VAEs as Adverse Events Following Immunization (AEFI).

Paul Offit American pediatric immunologist

Paul Allan Offit is an American pediatrician specializing in infectious diseases, vaccines, immunology, and virology. He is the co-inventor of a rotavirus vaccine. Offit is the Maurice R. Hilleman Professor of Vaccinology, professor of pediatrics at the Perelman School of Medicine at the University of Pennsylvania, former chief of the Division of Infectious Diseases (1992–2014), and the director of the Vaccine Education Center at The Children's Hospital of Philadelphia. He has been a member of the Centers for Disease Control (CDC) Advisory Committee on Immunization Practices. Offit is a board member of Every Child By Two and a Founding Board Member of the Autism Science Foundation (ASF).

The Joint Committee on Vaccination and Immunisation (JCVI) is an independent expert advisory committee that advises United Kingdom health departments on immunisation, making recommendations concerning vaccination schedules and vaccine safety. It has a statutory role in England and Wales, and health departments in Scotland and Northern Ireland may choose to accept its advice.

Rotavirus vaccine is a vaccine used to protect against rotavirus infections, which are the leading cause of severe diarrhea among young children. The vaccines prevent 15–34% of severe diarrhea in the developing world and 37–96% of severe diarrhea in the developed world. The vaccines decrease the risk of death among young children due to diarrhea. Immunizing babies decreases rates of disease among older people and those who have not been immunized.

Gagandeep Kang FRS is an Indian Microbiologist and virologist who is the Professor in the Department of Gastrointestinal Sciences at the Christian Medical College, Vellore, India and from August 2016 to July 2020 was executive director of the Translational Health Science and Technology Institute, Faridabad, an autonomous institute of the Department of Biotechnology, Ministry of Science and Technology, Government of India. She is a leading researcher with a major research focus on viral infections in children, and the testing of rotaviral vaccines. She also works on other enteric infections and their consequences when children are infected in early life, sanitation and water safety. She was awarded the prestigious Infosys Prize in Life Sciences in 2016 for her contributions to understanding the natural history of rotavirus and other infectious diseases. In 2019, she became the first Indian woman to be elected as a Fellow of the Royal Society. She was on the Life Sciences jury for the Infosys Prize in 2020.

Riko Muranaka

Riko Muranaka is a medical doctor, journalist and recipient of the 2017 John Maddox Prize for fighting to reduce cervical cancer and countering misinformation about the human papilloma virus (HPV) vaccine dominating the Japanese media, despite facing safety threats. Despite the lack of evidence, the HPV vaccine is infamous in Japan due to misattributed adverse effects, with government suspending promotion and coverage. While the World Health Organization (WHO) safety and efficacy information about the vaccine is consistent with Muranaka's reporting, a court ruled against Muranaka in an unrelated slander lawsuit in 2016 for claims of alleged fabrication. Under threat of legal harassment by antivaccine activists, publishers declined some of her works including a book on the HPV vaccine.

National Immunization Technical Advisory Group (NITAG) is an advisory committee consisting of multidisciplinary groups of experts responsible for providing information to national governments that is used to make evidence-based decisions regarding vaccine and immunization policy. The majority of industrialized and some developing countries have formally established advisory committees to guide immunization policies; other countries are working towards establishment of such committees. NITAG in each country may have different names, for example: Advisory Committee on Immunization Practices (ACIP) in the United States, Australian Technical Advisory Group on Immunisation (ATAGI) in Australia, Joint Committee on Vaccination and Immunisation (JCVI) in the United Kingdom, National Advisory Committee on Immunization (NACI) in Canada, National Immunisation Advisory Committee (NIAC) in Ireland, National Technical Advisory Group on Immunisation (NTAGI) in India, Standing Committee on Vaccination in Germany, and Technical Committee of Vaccination in France.

Vaccine Safety Net Network of medical information websites

Vaccine Safety Net (VSN) is a global network of websites aimed at helping people judge the quality of online information on vaccine safety. It was established in 2003 by the World Health Organization (WHO), which had previously set up the independent Global Advisory Committee on Vaccine Safety (GACVS), prompted by concern from public health officials regarding the dissemination of potentially harmful health information via the web. By appraising websites, using credibility and content criteria defined by GACVS, the VSN has been developed to deliver information that is easy to access and up-to-date. As of 2020, the initiative has 89 member sites in 40 countries and 35 languages.

The Strategic Advisory Group of Experts (SAGE) is the principal advisory group to World Health Organization (WHO) for vaccines and immunization. Established in 1999 through the merging of two previous committees, notably the Scientific Advisory Group of Experts and the Global Advisory Group by Director-General of the WHO Gro Harlem Brundtland. It is charged with advising WHO on overall global policies and strategies, ranging from vaccines and biotechnology, research and development, to delivery of immunization and its linkages with other health interventions. SAGE is concerned not just with childhood vaccines and immunization, but all vaccine-preventable diseases. SAGE provide global recommendations on immunization policy and such recommendations will be further translated by advisory committee at the country level.

HPV Prevention and Control Board

The HPV Prevention and Control Board, founded in 2015, is an independent group of international experts that bring together key professionals, groups and government officials to deal with issues related to screening and prevention programmes for human papillomavirus (HPV) infection, the persistence of which may lead to cervical cancer, the second most common cancer in women living in low-resource settings. The Board focusses on preventing cervical cancer in these countries by promoting the sharing of information on cervical screening and HPV vaccination, which by 2014 had reached only around 3% of eligible girls in low income countries.

<i>Weekly Epidemiological Record</i> Academic journal

The Weekly Epidemiological Record (WER) is a publication of the World Health Organization (WHO) that as of 2020 is in its 95th volume. It is published in English and French with the alternative title of the Relevé épidémiologique hebdomadaire. It aims to rapidly disseminate epidemiological information about outbreaks of diseases under the International Health Regulations and about communicable diseases of public health importance. This includes emerging or re-emerging diseases.

Helen Petousis-Harris is a New Zealand vaccinologist and associate professor in the Department of General Practice and Primary Health Care at the University of Auckland. She has been involved in research related to vaccination in New Zealand since 1998, with her main areas of focus being vaccine safety and effectiveness. Petousis-Harris has had a variety of lead roles in New Zealand and international organisations that focus on vaccination and is a regular media spokesperson in this field, especially during the COVID-19 pandemic.

Shabir Madhi South African physician and professor

Shabir Ahmed Madhi is a South African physician who is professor of vaccinology and director of the South African Medical Research Council Respiratory and Meningeal Pathogens Research Unit at the University of the Witwatersrand, and National Research Foundation/Department of Science and Technology Research Chair in Vaccine Preventable Diseases. In January 2021, he was appointed Dean of the Faculty of Health Sciences at the University of the Witwateratand.

The National Advisory Committee on Immunization is an advisory body that provides the Government of Canada with medical and scientific advice relating to human immunization.

Dr. Shelley Deeks, MD, MHSc, FRCPC, FFAFPM, is a Canadian public health expert who is the Chair of the National Advisory Committee on Immunization. Her advertised "specialities include communicable disease control, outbreak investigations, vaccine safety, epidemiology and program evaluation." She is a fellow of the Royal College of Physicians of Canada and the Australian Faculty of Public Health Medicine. Deeks was the executive lead in Ontario's COVID-19 pandemic response in 2020 in her role at Public Health Ontario.

Embolic and thrombotic events after COVID-19 vaccination Post vaccination adverse effects

Post-vaccination embolic and thrombotic events, termed vaccine-induced immune thrombotic thrombocytopenia (VITT), vaccine-induced prothrombotic immune thrombocytopenia (VIPIT), thrombosis with thrombocytopenia syndrome (TTS), vaccine-induced immune thrombocytopenia and thrombosis (VITT), or vaccine-associated thrombotic thrombocytopenia (VATT), are rare types of blood clotting syndromes that were initially observed in a number of people who had previously received the Oxford–AstraZeneca COVID‑19 vaccine (AZD1222) during the COVID‑19 pandemic. It was subsequently also described in the Janssen COVID‑19 vaccine leading to suspension of its use until its safety had been reassessed.

The Australian Technical Advisory Group on Immunisation (ATAGI) is a technical advisory group of the Australian Government. As part of the Department of Health, ATAGI provides advice to the Minister of Health on the immunisation program of Australia and related matters, including the strength of evidence pertaining to existing, new, and emerging vaccines.