01 December 2017 - NEWS
AEFI-CAN launches new national clinical database
The Adverse Event Following Immunisation-Clinical Assessment Network (AEFI-CAN) is excited to announce the launch of its national clinical database: www.aefican.org.au.
AEFI-CAN is a formal collaboration between state- and territory-based specialist immunisation clinics, and includes representatives from the Therapeutic Goods Administration (TGA), with funding provided by the Department Health via AusVaxSafety, coordinated by the National Centre for Immunisation Research and Surveillance (NCIRS).
This database is part of national vaccine safety collaboration, led by SAEFVIC (at the Murdoch Children’s Research Institute), with development and IT support from ChordWizard Systems (Stephen Clarke).
The database has both an AEFI reporting and a clinical follow-up arm, and is designed to help capture uniform data throughout Australia.
As a national network, AEFI-CAN works collaboratively to clinically assess and manage individual patients following serious or unexpected AEFI. AEFI-CAN provides the important link between surveillance and clinical assessment and management. As such, AEFI-CAN can assist in determining patient outcomes and support investigation of possible safety signals in a real-time integrated way.
The database is currently being used in Victoria, with work underway to provide opportunities for all state and territory specialist vaccine safety clinics to adopt the database.
09 November 2017 – PUBLICATION
Active SMS-based influenza vaccine safety surveillance in Australian Children
Alexis Pillsbury, Helen Quinn, Patrick Cashman, Alan Leeb, Kristine Maccartney, on behalf of the AuxVaxSafety consortium
Australia’s novel, active surveillance system, AusVaxSafety, monitors the post-market safety of vaccines in near real time. This paper analysed cumulative surveillance data for children aged 6 months to 4 years who received seasonal influenza vaccine in 2015 and/or 2016 to determine: adverse event following immunisation (AEFI) rates by vaccine brand, age and concomitant vaccine administration.
7402 children were included in the analysis and no safety signals or excess of adverse events were detected.
03 October 2017 - MEDIA RELEASE
New AusVaxSafety data reinforces vaccination safety
Innovative new AusVaxSafety data confirms the 2017 influenza vaccines to be safe. No vaccine safety concerns were identified in approximately 74,000 adults and children vaccinated since April this year.
In the past five months over 102,000 people who have received the influenza vaccine across Australia have been sent a follow-up survey 3 days after vaccination to monitor vaccine reaction rates in real-time. With over 70% response rates, consumers have consistently replied that any effects after vaccination were generally mild and within expected ranges. This data, largely provided by SmartVax SMS surveys, reinforces the safety of the currently approved influenza vaccines. Only 6.6% had any potential reaction and an even smaller 0.4% sought attention from a healthcare provider in the days after vaccination.
Deputy Director of the National Centre for Immunisation Research and Surveillance (NCIRS) and paediatric infectious disease consultant Associate Professor, Kristine Macartney says, “We know the importance of vaccination and since implementing this program as an Australian first, we’ve received ongoing positive results that confirm and assure the safety of vaccines.”
“The AusVaxSafety results showcase how Australia takes a lead in feeding back information to the rest of the world in regard to influenza vaccination safety. Countries now entering winter in the Northern Hemisphere will be particularly interested in these results as they are starting to use 2017/18 vaccines containing the same strains shown to be safe in Australia,” she said.
AusVaxSafety is a national active vaccine safety surveillance system that monitors vaccine safety across more than 200 ‘sentinel’ sites. These include general practices (GPs), Aboriginal medical services, immunisation clinics and hospital clinics. Led by the NCIRS, this world-leading system actively monitors the safety of a number of vaccines and aims to increase public confidence in immunisation.
28 June 2017 - AusVaxSafety at the Communicable Diseases Control (CDC) Conference 2017
The Communicable Diseases Control (CDC) Conference 2017 was held in Melbourne from 26 to 28 June 2017, and brought together researchers, experts, policy makers and students in the field of public health to discuss the Conference theme, ‘Infectious Diseases: a global challenge’. It was an exciting opportunity to showcase some of the work being undertaken by AusVaxSafety collaborators in the field of vaccine safety.
AusVaxSafety presentations included:
- AusVaxSafety: a new active vaccine safety surveillance system in AustraliaSpeaker: Anastasia Phillips (NCIRS)
- Flexible active, real-time vaccine safety surveillance: customising AusVaxSafety to monitor new vaccines. Speaker: Alexis Pillsbury (NCIRS)
- Searching for swollen little limbs: AusVaxSafety expands to monitor pertussis booster Vaccines. Speaker: Helen Quinn (NCIRS)
- AusVaxSafety: Active, real-time surveillance to monitor seasonal influenza vaccine safety in children. Speaker: Alexis Pillsbury (NCIRS)
In addition to AusVaxSafety specific presentations, members of the AusVaxSafety Consortium presented the following:
- Text messaging to monitor for adverse events following Bexsero® vaccination Speaker: Alan Leeb (GP and SmartVax developer)
- Real-time vaccine safety surveillance for delayed AEFIs with serial SMS: STARSS RCT. Speaker: Gabriella Lincoln (University of Adelaide).
Thank you to the Communicable Diseases Network Australia, the Public Health Laboratory Network and the Public Health Association of Australia for convening such an engaging and diverse conference.
03 June 2017 - PUBLICATION
Participant-centred active surveillance of adverse events following immunisation: a narrative review
International Health 2017;9:164-76
Cashman P, Macartney K, Khandaker G, King C, Gold M, Durrheim DN.
This paper reviews Australian and overseas studies of adverse events following immunisation (AEFI) surveillance systems that involve active contact with individuals following vaccination, and describe how these approaches improve our understanding of vaccine safety. The authors conclude that "Public health authorities require near real-time sensitive post-marketing AEFI surveillance systems to ensure public safety and public confidence in vaccines. Passive surveillance is the cornerstone of vaccine safety but has limitations of under reporting and imprecise risk estimates. Active surveillance can offer more sensitive surveillance, timely signal detection and provides phase IV (i.e., post-marketing safety) data for regulators and public health authorities. By having active surveillance, which directly surveys the consumers in near real time and makes the results publically available, active surveillance systems address transparency concerns and contributes to public confidence in the whole immunisation programme. A number of exploratory systems utilising e-technology have been developed and their potential for scaling up and application in developing settings deserves further investigation." Access the full text publication here.
19 May 2017- MEDIA RELEASE
2017 Influenza vaccine safety confirmed by Australian-first vaccine safety surveillance system
AusVaxSafety introduces active safety surveillance of vaccines across the country to provide real-time monitoring and boost confidence in immunisation
New data released by the AusVaxSafety program have shown the 2017 influenza vaccines to be safe, with no significant, unexpected or unusual reactions experienced by the close to 40,000 adults and children who have been vaccinated and participated in the program to date. It is now flu season and this system tells us the vaccines available this year are safe.
The results of a recent poll of Australian parents found that almost 9 in 10 parents (88 per cent) are unsure about the safety of the flu vaccine. Our data, straight from parents whose children have been vaccinated, tells us the 2017 influenza vaccines are safe.
For the first time in Australia, AusVaxSafety, a ground-breaking national vaccine surveillance system, is now monitoring, in real-time, the effects of vaccines on Australians of all ages in over 150 ‘sentinel’ sites across the country. These include general practices (GPs), Aboriginal Medical Services, immunisation clinics and hospital clinics. Led by the National Centre for Immunisation Research and Surveillance (NCIRS), this cutting-edge system actively monitors vaccine safety and aims to increase public confidence in immunisation.
The AusVaxSafety system utilises de-identified information provided directly by the people who receive the vaccines (or their parent or carer). The majority of responses are sought via an SMS sent from the patient’s immunisation clinic or GP using the automated SmartVax or Vaxtracker software at around 3 days after a vaccination. This form of active vaccine safety surveillance has not been implemented on this scale in Australia or internationally before.
The Deputy Director of NCIRS and paediatric infectious disease consultant, Associate Professor Kristine Macartney, has said, “Influenza is a serious disease in people of all ages and is the leading cause of hospitalisation due to a vaccine-preventable disease in Australian children under 5 years. The Australian government recommends everyone from 6 months old be vaccinated against influenza.”
“This robust vaccine safety surveillance mechanism is an active way of making sure vaccines perform as safely as we expect them to, and also serves as an early warning system for any unexpected outcomes. We are delighted to see such positive and encouraging feedback about AusVaxSafety. On average, we have a 70% response rate within 3 to 4 days of sending an SMS which is fantastic to see”, she added.
“Vaccine-preventable diseases can impact us all, resulting in numerous doctor's visits, hospitalisations and premature deaths. With AusVaxSafety now established, the community can feel confident that an active system is in place to monitor vaccines”, said Karen Orr, Clinical Nurse Consultant specialising in immunisation and paediatrics at The Children’s Hospital at Westmead in Sydney.
15 May 2017 - NSW Doctor article - Advances in vaccination safety
Australia’s landmark system to monitor adverse reactions is increasing patients’ confidence in the safety of vaccines
Click here to read the article
AusVaxSafety, which actively monitors the safety of vaccines using SMS-feedback and email from recently vaccinated children and adults, is helping to ensure public confidence in taking up vaccination.
AusVaxSafety is a collaborative initiative led by the National Centre for Immunisation Research and Surveillance (NCIRS) and funded by the Australian Government Department of Health.
Currently established in 130 sentinel immunisation providers across all states and territories, AusVaxSafety will expand to more than 200 sites in 2017. General practices, hospital and community-based clinics, and Aboriginal Medical Services are participant partners.
The idea for the monitoring system was sparked in 2010, after a number of children suffered fever and febrile convulsions after receiving one brand of the flu vaccine (Fluvax and Fluvax Junior). There have been no safety concerns with the use of other brands of flu vaccine in children.
Despite withdrawing that brand of vaccine, many parents lost confidence in the flu vaccination. Research conducted by Professor Christopher Blyth of the Telethon Kids Institute revealed that in Western Australia, vaccine uptake was substantially reduced in the following 2 years.
These reactions prompted different groups across the country to develop a way to monitor adverse reactions to vaccinations, particularly in children.
Traditionally, it’s been left up to parents (or patients themselves) to report adverse reactions to a vaccination to their GP. This passive reporting system then relied on GPs to make a report to the Therapeutic Goods Administration (TGA).
In light of the events of 2010, several medical professionals identified the need for a more proactive reporting system that recorded how vaccination was performing across the population in real-time.
Dr Alan Leeb, a GP in Western Australia, set up a system called SmartVax that uses text messaging and clinical data extracted from existing medical practice management software to actively contact patients who have received a vaccination, to enquire whether they had experienced any adverse reactions.
Meanwhile Professor Mike Gold set up another active monitoring system in South Australia, and a similar system called Vaxtracker was established in NSW by Professor David Durrheim.
Recognising the value in monitoring vaccine safety, the Australian Government called for tenders to conduct surveillance of influenza vaccination in children aged under 5 for the next 3 years.
NCIRS won the tender. Now, using SmartVax as the main data collection tool in general practice, AusVaxSafety receives and analyses de-identified data from all states and territories and reports this to the Department of Health and TGA. AusVaxSafety currently monitors the safety of influenza vaccine in all ages (during the influenza season), pertussis vaccines in toddlers and young children, and zoster vaccine in adults.
SmartVax is a software program, designed to actively monitor the safety of all vaccines given in general practice and vaccination clinics via SMS and smartphone technology. When a practice uses SmartVax, an automated text message is sent to patients 3 days after their vaccination asking whether they experienced a reaction. Patients who respond ‘yes’ are sent a question about the severity of the reaction, and a survey. Many states and territories offer specialist vaccine adverse events clinics for patients who experience a reaction. Patients who experience a significant reaction can be referred by their GP to specialist vaccine adverse events clinics. For more information, contact the NSW Immunisation Specialist Service (NSWISS) on 1800 679 477.
SmartVax is completely free for practices. It is fully automated, and integrates with existing patient management systems. To get your practice involved, contact SmartVax via the website or by emailing email@example.com.
According to the NCIRS, “Patients respond extremely well to SmartVax and participation rates are high. As well as informing national vaccine safety monitoring, the use of SmartVax in practices helps GPs with their duty of care following vaccination.”
NCIRS provides reports regularly to the Department of Health, TGA and vaccine safety experts and clinicians throughout Australia. Any safety concerns are reviewed by the NCIRS Expert Leadership Group, and there are mechanisms in place to follow-up safety concerns through more detailed data analysis and clinical follow-up of patients.