SAEFVIC
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 funded by the Department of Health, Victoria. It was established in 2007 and now comprises two units at two sites:
- Clinical and surveillance
- Epidemiology and signal investigation
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.
Most recently, we established the COVID-19 Platform of Research capturing clinical, biological, demographic and administrative data, as well as patient and healthcare worker experiences of COVID-19. In 2021, SAEFVIC supported the Victorian Specialist Immunisation Services (VicSIS) network established by the Victorian DH to support the COVID-19 vaccine roll-out.
SAEFVIC is a national leader in vaccine safety. The growing team includes immunisation nurses, administrative and research staff, epidemiologists, statisticians, data managers and clinicians. It is a specialist vaccine safety service that helps immunisation providers report and manage both children and adults who have had an AEFI.
Our Outpatient clinics are based at The Royal Children's Hospital (Parkville). SAEFVIC also provides regional clinical support via TeleHealth. Any trends in reports are notified and investigated quickly in close liaison with Victorian and national health authorities, such as the Therapeutic Goods Administration (TGA).
Our clinical research includes surveillance and clinical studies. Surveillance projects incorporate active and passive studies, including involvement in national collaborative networks, such as the AusVaxSafety and PAEDS (Paediatric Active Enhanced Disease Surveillance) networks. These networks focus on conditions of public health importance and support the NIP.
We also have National Health and Medical Research Centre (NHMRC)-funded projects, such as vaccine safety research into febrile seizures. SAEFVIC’s education activities include the Melbourne Vaccine Education Centre (MVEC).
MVEC is based at Murdoch Children’s Research Institute and is a digital information hub providing expert, independent and up-to-date immunisation resources across multiple platforms for both healthcare professionals and members of the public. Our aim is to strengthen and improve the quality and accessibility of vaccine information as well as provide targeted education for providers on vaccine recommendations, safety and vaccination procedures.
MVEC is a proud member of the World Health Organization (WHO)’s Vaccine Safety Net (VSN) as a source of reliable and credible vaccine safety information. MVEC undertakes a concerted effort to further develop immunisation content through various channels including providing expert reviews of up-to-date resources, eLearning videos and packages, social media channels, educational webinars and seminars, and collaboration with appropriate partners in developing effective communication of vaccine information to the public.
More information
Our projects
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 affiliated with SAEFVIC is an educational website developed with the aim of providing up-to-date immunisation information for both healthcare professionals and members of the public. The content of MVEC reflects a collaboration of information prepared by immunisation paediatricians and adult physicians, immunisation nurses, infectious disease specialists, allergy specialists and infection control teams.
All information is reviewed and updated on a regular basis. MVEC is a proud member of the World Health Organisation’s (WHO) Vaccine Safety Net and is recognised by the WHO as a source of reliable and credible vaccine safety information.
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, and
- address questions that are of keen interest for national and international public health policy.
COVID-Kids Inpatient
A prospective study to examine clinical, demographic, laboratory and outcome data on hospital paediatric patients with COVID-19. It incorporates the Sentinel Travellers and Research Preparedness for Emerging Infectious Diseases (SETREP-ID) study in adults coordinated by the Doherty Institute.
FFX+
A prospective observational study of COVID-19 transmission and disease course. The study involves a number of different components including the contribution of data to the Australian FFX project coordinated through the Peter Doherty Institute as a national study of household transmission.
Natural history of SARS-CoV-2 in comparison to influenza A virus: a multi-site study focused in the Southern Hemisphere and equatorial regions
Surveillance for SARS-CoV-2 and influenza virus at eight sites across the Southern Hemisphere and equatorial regions including Australia. Data was collected via the COVID-Kids Inpatient and FFX+ studies. They will compare this to patients with influenza infection with the aim to give context to the results obtained and better understand the implications for human health for those affected by COVID-19.
COVID-19 (PAEDS Study Arm 11.1)
Part of the National PAEDS network, this is a prospective surveillance study of COVID-19 in children presenting to contributing hospitals nationally. This study aims to:
- describe the demographic and clinical features of COVID-19 in children in Australia
- estimate the hospitalisation rate of COVId-19 in children using sentinel site data in Australia, and
- collect internationally comparable data for potential future data sharing to enable higher-powered analyses of COVID-19 in children.
- PIMS-TS (PAEDS Study Arm 12)
As part of the National PAEDS network, this is a prospective surveillance study of PIMS-TS in children admitted to PAEDS network hospitals. The main aims of this study are to:
- describe the demographic and clinical features of PIMS-TS in children and adolescents admitted to PAEDS network hospitals
- estimate the incidence and further characterise the aetiology of PIMS-TS in Australia
- determine the overlapping features of PIMS-TS with Kawasaki disease and COVID-19 in Australian children
- collect internationally comparable data for potential future data sharing to enable a higher-powered analysis of PIMS-TS in children and adolescents.
Serosurvey (PAEDS Study Arm 11.3)
Part of the National PAEDS network, this is a direct and targeted sampling study of well paediatric patients admitted to The Royal Children’s Hospital for an anaesthetic procedure. The aim is to gain an understanding of what proportion of the Australian population has or may have been exposed to COVID-19.
Saliva for diagnosis of COVID-19 in primary care, paediatric and out-of-hospital settings (The SPIT-C19 study)
This study aims to find out whether using saliva to diagnose COVID-19 is as reliable as a nose and throat swab by comparing these two tests.
Best Available Treatment for Paediatric Inflammatory Syndromes Temporally Associated with SARS-CoV-2
International registry with the aim to:
- understand the complete clinical spectrum of presenting signs and symptoms of children with PIMS-TS
- describe the clinical course and the risk of disease progression in children with PIMS-TS
- evaluate which treatments are being used worldwide to treat patients with PIMS-TS, and monitor the response to any immunomodulatory drugs given, and
- provide best care recommendations on treatment options in children with PIMS-TS with varying severity and multiorgan involvement.
PAEDS Study Arm 6: The Influenza Complications Alert Network (FluCAN) Surveillance system
The primary aim is to estimate vaccine effectiveness again hospitalisation with confirmed influenza. This study contributes to the National FluCAN network coordinated by the Alfred Hospital, Melbourne.
A platform trial approach to assess the immunogenicity and safety/reactogenicity of fractional COVID-19 vaccine(s) as an additional dose in primed populations
The objective of this programme is to generate data on fractional doses of COVID-19 vaccines when given as an additional single dose in previously primed populations (either via full or partial vaccination or natural infection).
A national, multi-centre study evaluating Thrombotic Thrombocytopenia Syndrome (TTS) associated with ChAdOx1 (AZD1222) and other SARS-CoV-2 vaccines (viral vector and m-RNA)
A harmonised national approach to:
- investigate TTS to identify clinical and genetic predictors that contribute to abnormal immune responses to vaccination, characterise the immunologic mechanisms underpinning these events, and
- determine the safest approach to treatment to ensure the best outcomes and guide future vaccination for individual patients and the population is vital in building, maintaining confidence and ensuring safety in SARS-CoV-2 vaccines.
Clinical And Molecular Epidemiology and Immune Characteristics Of Respiratory Syncytial Virus Infections in Children < 2 years of age (CAMEO-RSV) admitted to RCH for RSV respiratory tract infection
Study to compare clinical, immune and virological characteristics and outcomes of children <2 years old with severe versus non-severe RSV respiratory tract infections. The main objectives include evaluating the clinical characteristics and outcomes of hospitalised children with RSV infection are:
- describing the molecular epidemiology of RSV infections in children, using whole genome sequencing
- examining the association between genetic characteristics of RSV and disease severity, examining viral co-infection in children with severe lower respiratory tract infection due to RSV and other respiratory viral infections and relate these to disease severity, and
- comparing immune profiles in hospitalised pre-term or term children during acute RSV infection and recovery and evaluating chest x-ray findings associated with severe versus non-severe RSV disease.
A platform trial approach to assess the immunogenicity and safety/ reactogenicity of fractional COVID-19 vaccine(s) as an additional dose in primed populations
The study aims to assess the immune responses of two different booster vaccines (Pfizer and Moderna), given either as a standard or fractional (reduced) dose, among people who have previously received two doses of either Pfizer or AstraZeneca vaccines in Mongolia, Indonesia and Melbourne.
Understanding COVID-19 in Victorian Children
The aim of this project is to mitigate the impact of COVID-19 in the community in the future. This study integrates observational research in children to inform evidence-based future public health policies and communication.
COVID-19 Testing Methods in Children Under 5
Comparison of a nasal swab, saliva and nasal/oropharyngeal swab collection methods to determine the accuracy and feasibility of respiratory virus detection to detect SARS-CoV2 collected by parents in children under 5 years of age. This study also aims to understand the feasibility of testing in younger children, and which method children and parents prefer, to optimise the testing approach in this younger age group.
Funding
- Royal Children’s Hospital Foundation (RCHF)
- Coalition for Epidemic Preparedness Innovations (CEPI)
- Medical Research future Fund (MRFF)
- National Institutes of Health, USA
- WHO Collaborating Centre
- The University of Melbourne
- Shepherd Foundation
- National Health and Medical Research Council (NHMRC)
- Shepherd & Brockhoff Foundation
- Commonwealth Serum Laboratories (CSL)
- Department of Health, Victoria
- Department of Health, Canberra
- University of Sydney
Collaborations
- The University of Melbourne
- Monash Health
- PAEDS Network
- AusVaxSafety
- Peter Doherty Institute
- National Institutes of Health, USA
- WHO Collaborating Centre
- Department of Health, Victoria
- University of Sydney
- Healthed Pty Ltd
- Jean Hailes
Featured publications
- Immune responses to SARS-CoV-2 in three children of parents with symptomatic COVID-19
- Children and Adults in a Household Cohort Study Have Robust Longitudinal Immune Responses Following SARS-CoV-2 Infection or Exposure
- The cost of care for children hospitalised with Invasive Group A Streptococcal Disease in Australia
- Splenic cyst and its management in a 21-month-old boy: a rare complication of invasive meningococcal disease
- Active surveillance for adverse events following immunization