SAEFVIC - Surveillance of Adverse Events Following Vaccination In the Community
Vaccine research, safety and surveillance, and immunisation education.
Surveillance of Adverse Events Following Vaccination In the Community (SAEFVIC) is a public health partnership initiative of the Victorian Immunisation Program.
SAEFVIC is partly funded by the Department of Health Victoria and partners with with epidemiology and health informatics experts.
SAEFVIC consists of the following subgroups:
- Clinical and surveillance
- Vaccine-preventable disease (VPD) and conditions of public health importance research
- Immunisation education through the Melbourne Vaccine Education Centre (MVEC)
We are a vaccine safety service and clinical immunisation research team, focusing on vaccine safety and surveillance. This includes management of adverse events following immunisation (AEFI), vaccine-preventable disease research and immunisation education.
Clinical approach
Recognised as a national leader in vaccine safety, SAEFVIC offers expert immunisation safety advice to healthcare professionals and families. We can facilitate individualised clinical assistance and support for children and adults affected by an adverse event following immunisation (AEFI) through our outpatient clinic at The Royal Children's Hospital (RCH) and other partnering hospitals.
SAEFVIC also provides regional clinical support via TeleHealth. Reports collected are notified and investigated with Victorian and national health authorities including the Therapeutic Goods Administration (TGA).
Our research
The SAEFVIC research team brings over 15 years of experience in Vaccine-preventable disease (VPD) and conditions of public health importance research, with core responsibilities including patient recruitment, hospital-based surveillance and clinical case reporting. Our projects cover numerous national and international collaborative networks.
Education
MVEC is a notforprofit, independent source of immunisation education, advice and recommendations for healthcare professionals and members of the public.
Our resources are evidence-based, up-to-date and regularly reviewed by vaccine experts. MVEC is a proud member of the World Health Organization (WHO) Vaccine Safety Net (VSN) as a source of reliable and credible vaccine safety information.
Our impact
Integrating all aspects of our research areas, SAEFVIC provides support to immunisation providers and members of the public through reporting and managing an adverse event following immunisation (AEFI).
Surveillance data collected through our national and international studies helps SAEFVIC Research inform AEFI management, and enables MVEC to develop targeted and accessible immunisation education resources to promote vaccine coverage and confidence.
More information
- SAFEVAC: Vaccine safety reporting service in Victoria
- Melbourne Vaccine Education Centre (MVEC)
- MVEC Education Portal
Group Leaders
Group Members
Our projects
Infection X Research Platform
Transforming understanding of infectious diseases into actionable solutions that protect lives today and strengthen resilience for the future.
The Infection X Research Platform is a vital, innovative initiative born from lessons of the COVID-19 pandemic.
It addresses the urgent need for a coordinated, timely research response to emerging infectious diseases, with a special focus on children who may face greater risks in future pandemics.
Read more...
SNIFFLES - Southern Hemisphere Nasal Influenza Flu Vaccine Experience Study
Influenza, or the flu, is a contagious virus that can range from mild symptoms to severe illness and can sometimes be life-threatening. Children are often the most affected. In 2024, over 365,000 Australians were diagnosed with the flu, the highest number on record, with most cases in children under 10.
This study compares the standard flu shot with FluMist, a nasal spray vaccine, to see how well children’s immune systems respond to each. While flu vaccines are effective, we are still learning exactly how they work in the body.
Read more...Surveillance of Adverse Events Following Vaccination In the Community (SAEFVIC)
SAEFVIC is an enhanced passive central reporting service in Victoria for significant adverse events following immunisations (AEFI). It is a public health partnership initiative of the Victorian Immunisation Program funded by the Department of Health, Victoria.
Melbourne Vaccine Education Centre (MVEC)
MVEC went live in 2014 as an educational website. It now provides vaccine news and education via its website, newsletter, podcasts and social media platforms. MVEC also offers professional development opportunities on our Education Portal, through facetoface and online events, including the Clinical Vaccinology Update (CVU) and practical Immunisation Skills Workshops.
MVEC provides accessible education resources to promote vaccine safety and encourage health providers and members of the public alike to become better informed decision-makers when it comes to immunisation.
Visit Melbourne Vaccine Education Centre (MVEC)
SAEFVIC research
PAEDS Study
The Paediatric Active Enhanced Disease Surveillance (PAEDS) Network is a national hospital-based active surveillance system based at eight tertiary paediatric hospitals across Australia. There are two sites in Melbourne, RCH and Monash Children’s.
PAEDS employs prospective case ascertainment for selected serious childhood conditions, particularly vaccine-preventable diseases and potential adverse events following immunisation (AEFI).
PAEDS data is used to better understand the conditions, inform policy and practice under the National Immunisation Program (NIP), and enable rapid public health responses for certain conditions of public health importance.
The current conditions under surveillance by the PAEDS network are:
- Acute flaccid paralysis (condition causing paralysis and loss of tone in one or more limbs, which can be caused by the polio virus)
- Acute childhood encephalitis (inflammation and/or infection of the brain)
- Invasive group A streptococcus (severe bacterial infection)
- Kawasaki disease (rare disease in which blood vessels throughout the body become inflamed)
- PIMS-TS (Paediatric Inflammatory Multisystem Syndrome temporally associated with SARS-CoV-2)
FluCAN
The PAEDS network, in collaboration with the National FluCAN Network, provides real-time sentinel hospital surveillance for acute respiratory disease requiring hospitalisation.
This research has demonstrated the previously unrecognised burden of influenza in paediatric hospitals, explored risk factors for severe disease, evaluated antiviral and vaccine use and estimates vaccine effectiveness on an annual basis.
The current respiratory conditions under surveillance are:
WHO Respiratory syncytial virus (RSV) Surveillance
Respiratory syncytial virus (RSV) is a common cause of respiratory tract infection in children. It is associated with potentially severe acute lower respiratory infections including bronchiolitis and pneumonia.
Very young children and those with comorbidities including prematurity, congenital heart disease and chronic lung disease are at increased risk of developing severe RSV disease with prolonged hospitalisation. Despite this there has been very little coordinated, global collection of epidemiological data on RSV in children aged under 2 years old.
In 2017 the World Health Organization (WHO) establish a global RSV Network to address this information gap. This project aims to enhance recognition of RSV among children aged under 2 years, increasing virus monitoring to differentiate virus types, and generating a better understanding of the seasonality, age groups at risk and disease burden.
We have been the only Australian site to take part in this ongoing project since 2017.
RSV GOLD
The RSV Global Online Mortality Database (RSV GOLD) is the first global registry for young children (less than 5 years old) dying with Respiratory Syncytial Virus (RSV) infection. RSV is a common cause of respiratory tract infections including bronchiolitis and pneumonia.
The aim of RSV GOLD is to identify clinical and socioeconomic characteristics of these children to ultimately strive to combat RSV-associated childhood deaths.
Understanding Severe Influenza in Paediatrics (USIP)
The Understanding Severe Influenza in Paediatrics (USIP) Study aims to advance understanding of influenza disease severity in children and adolescents by collecting detailed clinical data and characterising the immune profiles of hospitalised patients with influenza-related complications.
The study’s objectives are to understand the natural history and outcomes of severe influenza, to improve diagnosis and treatment, to guide vaccination strategies, to establish a biologic sample repository, and to build a national network for rapid research during novel influenza outbreaks.
The USIP Study is conducted at multiple clinical sites across the United States, with Boston Children’s Hospital leading the overall study, and our team serving as the only leading Australian collaborator.
Understanding AESI (adverse events of special interest)
This global project aims to better understanding the cause, risk factors and genetics of adverse events of special interest (AESI) following newly developed vaccines and novel vaccine platforms.
This information is necessary to inform immunisation policy, vaccine development and to ensure the safety of, and maintain confidence in, immunisation programs. It is run in conjunction with the International Network of Special Immunization Services (INSIS) and Global Vaccine Data Network (GVDN).
Understanding AESI was established at MCRI in 2023 in response to the introduction of the various COVID-19 vaccines. It involves collecting data and samples from individuals who had an AESI post a COVID-19 vaccine and those who didn’t to act as controls.
The initial AESI being investigated are myocarditis/ pericarditis, Guillain-Barré syndrome (GBS) and Thrombosis and Thrombocytopenia Syndrome (TTS).
Recruitment has ended and the project has moved to the analysis phase. If new AESI emerge following the introduction of new vaccines for any disease the project will be reactivated subject to funding.
Infection X Research Platform
The Infection X Research Platform is a multiyear longitudinal observational platform designed to support both prospective and retrospective research.
It serves as a pandemic preparedness platform, ready for activation to detect and characterise current and emerging diseases of interest as they arise in the community.
“Infection X” is a placeholder term referring to the next potential pandemic pathogen, or to current and recurrent diseases caused by either known or unknown pathogens.
Through surveillance of routine clinical data and the collection of biospecimens, this research platform aims to better understand the spectrum and natural history of illness, associated risk factors, diagnostic features, and clinical or laboratory markers of severe disease, ultimately to inform the most effective interventions for children.
COVID-19 at the Melbourne Children’s Campus: Program of Research
A prospective observational study capturing clinical, biological, demographic and administrative data, as well as patient and HCW experiences COVID-19. The primary objectives are to:
- Establish a platform of research to examine COVID-19 cases identified at RCH including epidemiologic, virologic, immunologic, economic and social science perspectives in a global pandemic.
- Reduce the burden on participants approached to become involved in COVID-19 studies by prioritising research objectives and collating baseline data using multiple methodologies to address key unknowns identified by our Melbourne Children’s Campus COVID-19 Research Expert Working Group.
- Address questions that are of keen interest for national and international public health policy.
FFX+
A prospective observational study of COVID-19 transmission and disease course, this study investigates the first paediatric COVID-19 cases in Victoria, Australia, to inform public health responses.
It examines disease presentation, household transmission, and impacts on children, while also assessing viral characteristics, immune responses, and the role of vaccination.
FFX+ includes multiple components, notably contributing data to the Australian FFX project coordinated by the Peter Doherty Institute as part of a national household transmission study.
VC2 /Prophecy Study
A prospective longitudinal cohort study at The Royal Children’s Hospital (RCH) involving paediatric special risk groups and healthy controls receiving a COVID-19 vaccine during the pandemic.
The Prophecy Study aims to collect samples at optimal timepoints from these participants and store them in the MCRI COVID-19 biobank.
These samples will be used by researchers at MCRI, as well as externally through the Victorian COVID-19 Vaccinees Collection (VC2) study, to improve understanding of the immune response to COVID-19 vaccination in paediatric special risk groups.
Funding
Thanks to our supporters.
- Astra Zeneca (Principle Investigator - Shidan Tosif)
- Coalition for Epidemic Preparedness Innovations (CEPI)
- Department of Health, Commonwealth
- Department of Health, Victoria (SAEFVIC Clinical and surveillance)
- National Health and Medical Research Council (NHMRC)
- National Institutes of Health (NIH), USA
- Pfizer (Principle Investigator - Shidan Tosif)
Collaborations
We partner with leading institutions and organisations worldwide, including:
- AusVaxSafety
- Department of Health, Victoria
- Healthed Pty Ltd
- Immunisation Foundation of Australia
- International Network of Special Immunization Services (INSIS)
- Monash Health/ Monash University
- PAEDS Network
- Peter Doherty Institute
- Raising Children’s Network
- Spleen Australia
- Sunshine Hospital - (SAEFVIC)
- The Children’s Hospital Corporation d/b/a Boston Children’s Hospital
- The Kids Research Institute
- The Royal Children’s Hospital (RCH)
- University of Melbourne
- WHO Collaborating Centre
Featured publications
Michelle Ylade, Richard B. Kennedy, Nigel W. Crawford, Regional progress and persistent gaps: toward measles elimination in Asia and the Pacific, Vaccine: X,Volume 28, 2026, 100772, ISSN 2590-1362
Mazarakis N, Toh ZQ, Nguyen J, Higgins RA, Rudge J, Whittle B, Woudberg NJ, Devine J, Gooley A, Lapierre F, Crawford NW, Tosif S, Licciardi PV. Evaluation of SARS-CoV-2 Antibody Response Between Paired Fingerprick (HemaPEN®) and Venepuncture Collected Samples in Children and Adults. Antibodies (Basel). 2025 Feb 5;14(1):13. doi: 10.3390/antib14010013. PMID: 39982228; PMCID: PMC11843976.
Crawford NW, Alafaci A, Clark JE, Francis JR, Blyth CC, Pienaar C, Minney-Smith C, Dougherty S, Panditha A, Francis L, Barr IG. Study of Children Aged Under 2 Years Admitted With RSV at Four Australian Hospitals [2021-2022]. J Paediatr Child Health. 2025 Mar;61(3):482-490. doi: 10.1111/jpc.16769. Epub 2025 Jan 18. PMID: 39825756; PMCID: PMC11883050.
Laemmle-Ruff I, Morgan HJ, Harris A, Abruzzo V, Clothier HJ, Osowicki J, Buttery JP, Kiers L, Crawford NW. Guillain-Barré syndrome temporally associated with COVID-19 vaccines - Progress over timeGuillain-Barré syndrome temporally associated with COVID-19 vaccines - Progress over timeGuillain-Barré syndrome temporally associated with COVID-19 vaccines - Progress over time. Vaccine. 2025 Jan 12;44:126072. doi: 10.1016/j.vaccine.2024.06.039. Epub 2024 Jun 17. PMID: 38890104
Imai C, Jayasinghe S, McRae J, Li-Kim-Moy J, Chiu C, Macartney K, Burns P, Cooper K, Cheng AC, Gibney K, Giles M, Jones C, Korman T, Liu B, Crawford NW; Australian Technical Advisory Group on Immunisation (ATAGI). ATAGI targeted review 2023: Vaccination for preventing influenza in Australia. Commun Dis Intell (2018). 2024 Jul 17;48. doi: 10.33321/cdi.2024.48.25. PMID: 39021121.
Osowicki J, Morgan HJ, Harris A, Clothier HJ, Buttery JP, Kiers L, Crawford NW; SAEFVIC and VicSIS investigators. Guillain-Barré syndrome temporally associated with COVID-19 vaccines in Victoria, Australia. Vaccine. 2022 Dec 12;40(52):7579-7585. doi: 10.1016/j.vaccine.2022.10.084. Epub 2022 Nov 7. PMID: 36357291; PMCID: PMC9637534.
Brusco NK, Alafaci A, Tuckerman J, Frawley H, Pratt J, Daley AJ, Todd AK, Deng YM, Subbarao K, Barr I, Crawford NW. The 2018 annual cost burden for children under five years of age hospitalised with respiratory syncytial virus in Australia. Commun Dis Intell (2018). 2022 Feb 16;46. doi: 10.33321/cdi.2022.46.5. PMID: 35168504.
Gordon SF, Clothier HJ, Morgan H, Buttery JP, Phuong LK, Monagle P, Chunilal S, Wood EM, Tran H, Szer J, Crawford NW; SAEFVIC and VicSIS investigators. Immune thrombocytopenia following immunisation with Vaxzevria ChadOx1-S (AstraZeneca) vaccine, Victoria, Australia. Vaccine. 2021 Nov 26;39(48):7052-7057. doi: 10.1016/j.vaccine.2021.10.030. Epub 2021 Oct 30. PMID: 34756770; PMCID: PMC8556135.
Wurzel D, McMinn A, Hoq M, Blyth CC, Burgner D, Tosif S, Buttery J, Carr J, Clark JE, Cheng AC, Dinsmore N, Francis JR, Kynaston A, Lucas R, Marshall H, McMullan B, Singh-Grewal D, Wood N, Macartney K, Britton PN, Crawford NW. Prospective characterisation of SARS-CoV-2 infections among children presenting to tertiary paediatric hospitals across Australia in 2020: a national cohort study. BMJ Open. 2021 Nov 8;11(11):e054510. doi: 10.1136/bmjopen-2021-054510. PMID: 34750151; PMCID: PMC8576200.