Global Advisory Committee on Vaccine Safety  |
| Abbreviation | GACVS |
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| Formation | 1999 |
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| Purpose | "To respond promptly, efficiently, and with scientific rigour to vaccine safety issues of potential global importance." [1] |
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| Headquarters | Geneva, Switzerland |
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Membership | 15 experts |
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Chair | Dr Rita Helfand |
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Vice-Chair | Professor Dure Samin Akram |
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Parent organization | World Health Organization |
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| Website | Official website |
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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.
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.
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:
- cascades its findings by various means. [1]
- creates task forces as required and when needed
- identifies causal relationships
- makes recommendations to the WHO
- reviews up-to-date knowledge around vaccine safety,
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]
A vaccine is a biological preparation that provides active acquired immunity to a particular infectious or malignant disease. The safety and effectiveness of vaccines has been widely studied and verified. 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 recognize further and destroy any of the microorganisms associated with that agent that it may encounter in the future.
Vaccine hesitancy is a delay in acceptance, or refusal, of vaccines despite the availability of vaccine services and supporting evidence. The term covers 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 believed to have been caused by vaccination. The World Health Organization (WHO) knows VAEs as Adverse Events Following Immunization (AEFI).
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.
The Canadian Paediatric Society (CPS) is a national association of paediatricians.
The 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 the risk of death among young children due to severe 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 has been leading the work on enteric diseases, diarrheal infections and disease surveillance at the Bill & Melinda Gates Foundation since 2023.
Professor Helen Rees OBE GCOB D.Sc. Medicine LLD is a medical doctor, and the founder and executive director of Wits RHI, the largest research Institute at the University of the Witwatersrand in Johannesburg, South Africa. She is a Personal Professor in the University of Witwatersrand's Department of Obstetrics and Gynaecology, co-director and co-founder of the Wits African Leadership in Vaccinology Expertise (ALIVE), Honorary Professor in the Department of Clinical Research at the London School of Hygiene and Tropical Medicine and an Honorary Fellow at Cambridge University's Murray Edwards College, UK.
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.
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.
The HPV Prevention and Control Board, founded in 2015, is an independent group of international experts supported by unrestricted grants from the pharmaceutical industry 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.
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.
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 Witwatersrand.
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.
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 the suspension of its use until its safety had been reassessed. On 5 May 2022 the FDA posted a bulletin limiting the use of the Janssen Vaccine to very specific cases due to further reassessment of the risks of TTS, although the FDA also stated in the same bulletin that the benefits of the vaccine outweigh the risks.
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.
