Committee reports
12–14 November 2024 meeting - Full report
The 3-day hybrid meeting of ACSoMP and GACVS, held on 12–14 November 2024, included topics specific to vaccine safety, pharmacovigilance issues common to both vaccines and medicines and topics specific to medicines safety.
15–17 May 2024 meeting - Full report
The 47th GACVS meeting, held virtually on 15–17 May 2024, brought together global experts to address a range of issues in vaccine safety.
13–15 November 2023 meeting - Full report
The 3-day hybrid meeting of ACSoMP and GACVS, included topics specific to vaccines safety, pharmacovigilance issues common to both vaccines and medicines, and topics specific to medicines safety.
15-16 May 2023 meeting - Full report
GACVS held a virtual meeting to discuss innovative approaches in monitoring adverse events following immunization (AEFI). Safety of vaccines including novel oral polio vaccine (nOPV2), COVID-19 vaccines, TAK-003 dengue vaccine and malaria vaccines (RTS,S/AS01 and R21/MatrixM) were also discussed.
14-16 December 2022 meeting - Full report
WHO convened the second joint meeting of the Advisory Committee on Safety of Medicinal Products (ACSoMP) and the Global Advisory Committee on Vaccine Safety (GACVS) on 14–16 December 2022
14-16 June 2022 meeting - Full report
An integrated WHO Pharmacovigilance team was established in 2020, to combine work related to the safety of medicines and vaccines within the Department of Regulation and Prequalification (RPQ). Following this transformation WHO convened a joint meeting with both the Advisory Committee on Safety of Medicinal Products (ACSoMP) and the Global Advisory Committee on Vaccine Safety (GACVS) for the first time on 14–16 June 2022
15 December 2021 meeting - Full report
GACVS held a special virtual meeting, reviewed the work achieved on the safety of COVID-19 vaccines, and the latest evidence on case management for thrombosis with thrombocytopenia syndrome (TTS). They also reviewed the guidance on vaccine-associated enhanced disease (VAED) as an adverse event of special interest (AESI) and the evaluation criteria 2.0 for Vaccine Safety Net (VSN). A summary of the session, the recommendations and conclusions of the meeting are presented below.
10 August 2021 meeting - Full report
GACVS held a special virtual meeting, on the RTS,S/AS01 malaria vaccine, collected through the Malaria Vaccine Pilot Evaluation (MVPE), which is the evaluation component of the Malaria vaccine implementation programme (MVIP).
17 September 2021 meeting - Full report
Addressed GACVS nOPV2 Sub-committee, safety and genetic stability data of the novel type-2 monovalent oral poliovirus (nOPV2) vaccine implemented under WHO Emergency Use Listing (EUL) in 4 countries.
8-9 June 2021 meeting - Full report
Addressed GACVS COVID-19 Sub-committee, COVID-19 vaccine-related events early warning system and Safety profile of nOPV2 vaccine.
1-3 December 2020 meeting - Full report
Addressed pharmacovigilance of COVID-19 vaccines, safety in pregnancy: the Global Vaccine Safety Multi-country Collaboration Project, vaccine safety indicator for the immunization agenda 2030 and safety of RTS,S malaria vaccine.
27-28 May 2020 meeting - Full report
Addressed pharmacovigilance preparedness for the launch of the future COVID-19 vaccines.
4-5 December 2019 meeting - Full report
Safety of vaccines against rotavirus, Ebola virus and human papilloma viruses. It also reviewed 2 generic issues: updating of the global vaccine safety strategy and case reviews of communications on vaccine safety.
5-6 June 2019 meeting - Full report
Clinical development of Ebola virus vaccines, updating a global strategy on vaccine safety, use of a network of distributed data to monitor the safety of vaccines and case studies of communication about the safety of human papillomavirus (HPV) vaccines.
5-6 December 2018 meeting - Full report
Safety of typhoid conjugate vaccine, Vaccine injury compensation programmes, Immunization stress-related responses, Vaccine safety strategy post-2020, Report of the sub-committee on vaccine safety communication.
6-7 June 2018 meeting - Full report
Pharmacovigilance in pilot use of malaria vaccine, Safety of dengue vaccine in the Philippines, Progress in the Global Vaccine Safety Initiative, Vaccine safety communication, Vaccine safety net.
6-7 December 2017 meeting - Full report
Vaccine pharmacovigilance readiness for malaria vaccine implementation, Rotavirus vaccine safety update, Dengue vaccine safety update, Interrater reliability of causality assessment for serious adverse events following immunization, Guidance on prevention and management of immunization-triggered stress responses, Harmonized approaches for the vigilance of interventions during pregnancy.
7-8 June 2017 meeting - Full report
Safety monitoring of the RTS,S vaccine pilot implementation programme; Safety update of BCG vaccine; Safety update of HPV vaccines; Template for reviewing the safety profile of new vaccines.
30 November-1 December 2016 meeting - Full report
Vaccine Safety Net; Update on GACVS operations; New data on narcolepsy following the 2009 pandemic influenza vaccine; Safety of typhoid vaccines; Yellow fever mass vaccination campaigns using fractional dose.
15-16 June 2016 meeting - Full report
New initiative on health product vigilance; Serious AEFI during primary infant vaccination series in South India; Global Alignment of Immunization safety Assessment in pregnancy (GAIA) project; Dengue vaccine update; Proof-of-concept study through multi-country collaboration.
2-3 December 2015 meeting - Full report
Clusters of anxiety-related reactions following immunization; Vaccine safety signals from the Uppsala Monitoring Centre database; RTS,S malaria vaccine; Safety of HPV vaccines; Influenza A (H1N1) 2009 pandemic vaccine and narcolepsy; Safety of smallpox vaccines.
10-11 June 2015 meeting - Full report & Addendum
The WHO Vaccine Safety Net – improving global communication on vaccine safety; Observed rates of adverse vaccine reactions; Safety of two candidate Ebola virus vaccines; Preparing for RTS,S malaria vaccine introduction.
3-4 December 2014 meeting - Full report
Preparing for dengue vaccine introduction; Preparing for malaria vaccine introduction; Safety of Ebola virus vaccines; Performance indicators for vaccine safety monitoring systems; Criteria for assessing websites with vaccine safety content; Use of vaccines during pregnancy.
11-12 June 2014 meeting - Full report
Safety profile of a novel live attenuated rotavirus vaccine; Safety profile of a recombinant hepatitis E vaccine; Meningococcal A conjugate vaccine during pregnancy; Preparing for malaria vaccine introduction; Fifteen years of GACVS: challenges and opportunities.
11-12 December 2013 - Full report
Safety profile of Japanese encephalitis (JE) chimeric vaccine; Safety of inactivated poliovirus vaccines (IPV); Increased occurrence of febrile seizures with a seasonal influenza vaccine; Update on intussusception following rotavirus vaccine administration; Human papillomavirus vaccines safety (HPV); Vaccine safety monitoring manual.
12-13 June 2013 meeting - Full report
Pentavalent vaccine in Asian countries; Zoster vaccine safety and varicella vaccine safety in immunocompromised populations; Immunization during pregnancy; Yellow Fever vaccine safety during mass immunization campaigns in sub-Saharan Africa; Safety profile of Japanese encephalitis vaccines; Update on human papillomavirus vaccines;Update on pandemic influenza vaccine (Pandemrix®) and narcolepsy.
5-6 December 2012 meeting - Full report
Varicella vaccines; Pandemic Influenza vaccines; Live attenuated dengue vaccines; Global Vaccine Safety Initiative.
6-7 June 2012 meeting - Full report
Thiomersal in vaccines; Aluminium adjuvants; Vaccine safety in pregnancy and lactation; Use of influenza vaccines during pregnancy; Causality assessment of Adverse Events following Immunization; Core variables for AEFI monitoring.
7-8 December 2011 meeting - Full report
Safety of influenza A(H1N1) pdm09 vaccines; Rotavirus vaccines and intussusception; Vaccine safety in pregnancy and lactation; Global network for postmarketing surveillance and AEFI monitoring; Implementing the Global Vaccine Safety Blueprint.
15-16 June 2011 meeting - Full report
Safety profile of meningococcal A conjugate vaccine; Causes of adverse events following immunization; Information about rates of reactions to vaccines; Developing a global strategy for enhancing vaccine safety;
8-9 December 2010 - Full report
Rotavirus vaccine and intussusception; Safety of pandemic influenza A(H1N1) 2009 vaccines; Yellow fever vaccine and HIV infection; Meningitis A conjugate vaccine.
16-17 June 2010 meeting - Full report
Safety of pandemic A (H1N1) influenza vaccines; Febrile seizures after seasonal influenza vaccine in Australia; Porcine circoviruses and rotavirus vaccines; Live attenuated hepatitis A vaccine; Updated safety of meningococcal A conjugate vaccine; Yellow fever vaccine and breastfeeding.
3-4 December 2009 meeting - Full report
Safety of pandemic A (H1N1) influenza vaccines; Review of safety profile on meningococcal A conjugate vaccine from clinical trials; Use of BCG vaccine in HIV-infected infants; Strengthening global monitoring of adverse events following immunization.
17-18 June 2009 meeting - Full report
Safety of experimental malaria vaccine RTS,S/AS01; Age of administration of rotavirus vaccines; Safety of human papillomavirus vaccines; Assessing the safety of novel influenza vaccines; Safety of measles vaccine in children infected with HIV.
17-18 December 2008 meeting - Full report
Safety of rotavirus vaccines; Safety of human papillomavirus vaccines; Vaccine safety alerts; GACVS subgroups.
18-19 June 2008 meeting - Full report
Safety of yellow fever vaccine; Diphtheria-tetanus-pertussis vaccine and asthma; Non-specific effects of DTP vaccine on child mortality; Pregnancy outcomes after inadvertent immunization with rubella vaccine; Mitochondrial diseases and vaccination;Thiomersal; Report from subgroups.
12-13 December 2007 meeting - Full report
Guillain-Barré syndrome and vaccination; Safety of immunization in immunocompromised individuals; Safety of yellow fever vaccines; Hepatitis B vaccination and rheumatoid arthritis; Safety of live 14-14-2 Japanese encephalitis vaccine; Safety of meningococcal B vaccines; Rotavirus vaccines and Kawasaki disease; Modus operandi of the committee and additional information.
12-13 June 2007 meeting - Full report
Monitoring vaccine safety; Safety of vaccine formulations; Mumps vaccine virus strain repository; Safety of BCG vaccines; Safety of human papillomavirus vaccine; Update on Menactra® and Guillain-Barré syndrome; Safety of rotavirus vaccines; Influenza vaccines: update; Modus operandi of the Committee and additional information.
29-30 November 2006 meeting - Full report
Monitoring vaccine safety; Report of the WHO Expert Committee on Biological Standardization; Safety of vaccine formulations; Vaccinating adolescents and young adults: problems with coincidental pathologies and safety assessments; Safety of mumps vaccine strains; Safety of BCG vaccine in HIV-infected children; Update on Menactra® and Guillain-Barré syndrome; Pandemic influenza vaccines; Safety of Japanese encephalitis vaccination in India; Safety of pneumococcal conjugate vaccine.
6-7 June 2006 meeting - Full report
Vaccine safety monitoring and the WHO Programme for International Drug Monitoring; Post-marketing surveillance of rotavirus vaccines; Safety of squalene; Immunogenic overload; Safety of pandemic influenza vaccines; Safety issues of varicella vaccines; Modus operandi of the Committee and additional information
1-2 December 2005 meeting - Full report
Vaccine Safety Net; Safety issues associated with pandemic influenza vaccines; Safety of adjuvants; Rotavirus vaccine safety; Subacute sclerosing panencephalitis and measles vaccination; Chronic fatigue syndrome and hepatitis B vaccination; Conjugate meningococcal vaccine and Guillain-Barré Syndrome; Modus operandi of the Committee.
9-10 June 2005 meeting - Full report
Mouse brain-derived Japanese encephalitis vaccine; Safety of SA 14-14-2 Japanese encephalitis vaccine; Isoniazid resistance of bacille Calmette-Guérin strains; International drug monitoring; Thiomersal; Safety of hexavalent vaccines; Subacute sclerosing panencephalitis and measles vaccination; National regulatory authorities planning workshops.
2-3 December 2004 meeting - Full report
Safety of adjuvants; Thiomersal: neurobehavioural studies on animal models; Safety of residual cellular DNA in vaccines; Transmissible spongiform encephalopathy; Potential risk of vaccines produced on yeast; Safety of hexavalent vaccines; Yellow fever; Vaccine Safety Net.
10-11 June 2004 meeting - Full report
Safety of adjuvants; Dengue vaccine safety; Effect of diphtheria-tetanus-pertussis (DTP) vaccination on child survival
3–4 December 2003 meeting - Full report
Intranasal influenza virus vaccine; Influenzae vaccines and neurological complications; Influenza vaccination of women during pregnancy; Nonspecific effects of childhood immunization; Safety issues in the poliomyelitis eradication campaign; International reference laboratory for mumps virus isolates; Yellow fever vaccine safety; BCG immunization in HIV-positive subjects; Safety of smallpox vaccination; Switch from rubella vaccine to mumps, measles and rubella vaccine; Aluminium-containing vaccines and macrophagic myofasciitis.
11-12 June 2003 meeting - Full report
Adverse events following mumps vaccination; Safety of smallpox vaccines; Safety of BCG vaccination in immunocompromised individuals; Thiomersal
16-17 December 2002 meeting - Full report
MMR and autism; Oculorespiratory syndrome; Hepatitis B vaccination and leukaemia
20-21 June 2002 meeting - Full report
Safety of thiomersal-containing vaccines; Hepatitis B vaccine and leukaemia; Hepatitis B vaccine and multiple sclerosis; Aluminium-containing vaccines and macrophagic myofasciitis; Bell palsy following intranasal vaccination; Potential adverse impact of routine vaccination on child survival
23 March 2001 - Full report
Causality assessment of adverse events following immunization
15 October 1999 - Full report & Corrigendum
About GAVCS; Macrophagic myofasciitis and aluminium-containing vaccines.