SmartVax Related Journal Articles & PUBLISHED PRESENTATIONS
Applying causal inference and Bayesian statistics to understanding vaccine safety signals using a simulation study
Community perception of vaccine safety influences vaccine uptake. The objective of this study was to assess current vaccine safety monitoring by examining factors that may influence the availability of post-vaccination survey data, including that obtained through Australia’s active vaccine safety surveillance system AusVaxSafety, and thereby the specificity and sensitivity of existing signal detection methods.
7 September 2024 – npj Vaccines 2024, 9, 163; https://doi.org/10.1038/s41541-024-00955-4
Short-Term Active Safety Surveillance of the Spikevax and Nuvaxovid Priming Doses in Australia
Australia commenced administration of the Spikevax (Moderna mRNA-1273) COVID-19 vaccine in August 2021 and Nuvaxovid (Novavax NVX-CoV2373) in January 2022. This study describes the short-term safety profile of priming doses of the Spikevax and Nuvaxovid vaccines given between September 2021 and September 2023 through results of online surveys sent via AusVaxSafety, Australia’s active vaccine safety surveillance system.
27 August 2024 – Vaccines 2024, 12(9), 971; https://doi.org/10.3390/vaccines12090971
National pharmacovigilance of seasonal influenza vaccines in Australia
The early detection of adverse events following immunisation (AEFI) is essential to protect public health and to maintain confidence in vaccination. Vaccine pharmacovigilance — the monitoring, detection, investigation and actioning of vaccine safety signals — occurs across a collaborative landscape that includes the Therapeutic Goods Administration (TGA), the nationally funded surveillance initiative AusVaxSafety, and state and territory health departments.
29 July 2024 – Med J Aust || doi: 10.5694/mja2.52381
Attitudes, perceptions, and experiences of Western Australians towards vaccine safety surveillance systems following COVID-19 vaccines: A qualitative descriptive study
Concerns regarding adverse events following immunisation are a barrier to vaccine uptake.
Health professionals use vaccine safety surveillance systems (VSSSs) to monitor vaccines and inform the public of safety data.
With little known about public attitudes, perceptions, and experiences with VSSS, this study examined them in the context of COVID-19 vaccinations in Western Australia.
February 2024 – Australian and New Zealand Journal of Public Health, Issue 1, 2024, 48(1), [100108]. https://doi.org/10.1016/j.anzjph.2023.100108
Making a SmartStart for peanut introduction to support food allergy prevention guidelines for infants
Food allergy affects up to 10% of Australian infants. It was hypothesized that if parents follow the Australasian Society of Clinical Immunology and Allergy guidelines, Australian food allergy rates may stabilize or decline.
This project aimed to determine whether SmartStartAllergy influenced parental introduction of peanut by age 12 months, including in high-risk infants.
Results found that SmartStartAllergy appears to be an effective tool for encouraging parental introduction of peanut.
27 March 2023 – Journal of Allergy and Clinical Immunology. 2 (2), 100102, AUGUST 2023. https://www.jaci-global.org/article/S2772-8293(23)00027-9/fulltext
The AuTOMATIC trial: a study protocol for a multi-arm Bayesian adaptive randomised controlled trial of text messaging to improve childhood immunisation coverage.
While most Australian children are vaccinated, delays in vaccination can put them at risk from preventable infections. Widespread mobile phone ownership in Australia could allow automated short message service (SMS) reminders to be used as a low-cost strategy to effectively ‘nudge’ parents towards vaccinating their children on time.
This study will aim to optimise SMS reminders for childhood vaccination in primary care clinics, directly comparing alternative message framing and message timing. We anticipate that the trial will be an exemplar in using Bayesian adaptive methodology to assess a readily implementable strategy in a wide population, capable of delivery due to the levels of digital automation. Methods and findings from this study will help to inform strategies for implementing reminders and embedding analytics in primary health care settings.
7 February 2023 – Trials;24(1):97. doi: 10.1186/s13063-023-07097-3. PMID: 36750833; PMCID: PMC9904255.
Short term adverse event profile of COVID-19 mRNA vaccines in children aged 5-15 years in Australia.
Australia’s active safety surveillance system AusVaxSafety monitors the safety of COVID-19 vaccines. We report on the short-term adverse event profile of mRNA COVID-19 vaccines in >390,000 children aged 5–15 years by age, dose, brand and pre-existing comorbidity.
We examined the proportions of respondents reporting any AEFI 0–3 days post-vaccination, medical review for AEFI, and impact on daily activities. All analyses were conducted in R version 4.1.0.
The study was conducted with ethics approval from Sydney Children’s Hospitals Network
20 January 2023 – Lancet Reg Health West Pac. 2023 Feb;31:100684. doi: 10.1016/j.lanwpc.2023.100684. Epub 2023 Jan 20. PMID: 36694479; PMCID: PMC9854254.
Safety of Four COVID-19 Vaccines across Primary Doses 1, 2, 3 and Booster: A Prospective Cohort Study of Australian Community Pharmacy Vaccinations
We sought to examine adverse events following immunisation (AEFI) at days 3 and 42 after primary doses 1, 2, 3 and booster.
We conducted active vaccine safety surveillance from 130 community pharmacies in Australia integrated with AusVaxSafety, between August 2021–April 2022.
29 November 2022 – Vaccines. 10 (12), 2017. https://doi.org/10.3390/vaccines10122017
Promoting Introduction of Peanut in the First Year using an SMS and Smart-Based Application - SmartStartAllergy
ASCIA Guidelines for infant feeding and allergy prevention recommend introducing peanut and other food allergens before 12 months of age.
Parents who engaged with SmartStartAllergy and received health promotion messages when their child was 6 months and 9 months of age were more likely to introduce peanut by 12 months of age than parents receiving standard care.
Presented by Michael O’Sullivan at the ASCIA Conference 2022 – 30 August to 2 September 2022
Promoting the ASCIA guidelines for infant feeding and allergy prevention using a novel tool - have we made a SmartStart?
Promotion of the ASCIA Guidelines for infant feeding and allergy prevention has not previously been undertaken at a national level.
SmartStartAllergy appears to be an effective tool for encouraging parents to introduce peanut by 12 months of age.
Presented by Sandra Vale at the ASCIA Conference 2022 – 30 August to 2 September 2022
SmartStartAllergy - A Novel Tool For Monitoring Parent-Reported IgE Food Allergy in Infants
Infant food allergy is a major public health challenge. This study aimed to describe the proportion of infants with parent-reported allergic reactions and likely IgE-mediated allergy to common food allergens in the first year of life.
Presented by Samantha Thomas at the ASCIA Conference 2022 – 30 August to 2 September 2022
A scoping review of active, participant-centred, digital adverse events following immunization (AEFI) surveillance: A Canadian immunization research network study.
Post-licensure adverse events following immunization (AEFI) surveillance is conducted to monitor vaccine safety, such as identifying batch/brand issues and rare reactions, which consequently improves community confidence. The objectives of this scoping review were to map the research landscape on digital systems used for active, participant-centred, AEFI surveillance and describe their core components.
29 July 2022 – Vaccine. 40 (31):4065-4080. doe: 10.1016/j.vaccine.2022.04.103. Epub 2022 Jun6. PMID: 35680501
The short term safety of COVID‐19 vaccines in Australia: AusVaxSafety active surveillance, February – August 2021
An assessment of the short term safety of the COVID‐19 vaccines Comirnaty (Pfizer–BioNTech BNT162b2) and Vaxzevria (AstraZeneca ChAdOx1) in Australia using online surveys by AusVaxSafety, a national active vaccine safety surveillance system, three and eight days after vaccination.
11 July 2022 – Medical Journal of Australia; DOI: 10.5694/mja2.51619
Safety profile comparison of chimeric live attenuated and Vero cell-derived inactivated Japanese encephalitis vaccines through an active surveillance system in Australia
Limited information is available about post-marketing safety of Japanese encephalitis (JE) vaccines. Using data from SmartVax, an active surveillance system for monitoring vaccine safety, adverse events following immunizations (AEFIs) were compared between the two JE vaccines available in Australia.
7 March 2022 – Taylor & Francis Online; Human Vaccines & Immunotherapeutics, DOI: 10.1080/21645515.2021.2020573
Adverse events following Influenza immunization: understanding the role of age and sex interactions
Reduction of adverse events following immunization (AEFI) could improve vaccine uptake. Evidence suggests sex and age affect AEFI rates but, with limited understanding of their interaction, groups at higher risk for adverse reaction cannot be identified.
2 January 2022 – Expert Review of Vaccines, 21:3, 415-422, DOI: 10.1080/14760584.2022.2021075
Smartphone-based active vaccine safety surveillance (SmartVax) at a Swiss adult vaccination clinic – a pilot study
Post-licensure surveillance of adverse events following immunisation (AEFI) is critical for detecting rare but severe AEFI. We report on a pilot study to test the feasibility and acceptance of SmartVax in Switzerland.
14 December 2021 – Swiss Medical Weekly; 2021;151:w30090
Immunisation provider experiences with an automated short message service-based active surveillance system for monitoring adverse events following immunisation: A qualitative descriptive study.
This study explore pharmacists’ experiences with SmartVax: an active surveillance system that has recently been integrated for use in Australian community pharmacies. Specifically, it explores pharmacists’ perceived benefits of using SmartVax, areas for improvement in the system, and issues with future/ongoing access to the system.
September 2021 – Digital Health 29;7:20552076211038165. doi: 10.1177/20552076211038165. PMID: 34616563; PMCID: PMC8488908.
Active vaccine safety surveillance of seasonal influenza vaccination via a scalable, integrated system in Western Australian pharmacies: a prospective cohort study
We integrated an established participant-centred active vaccine safety surveillance system with a cloud-based pharmacy immunisation-recording program in order to measure adverse events following immunisation (AEFI) reported via the new surveillance system in pharmacies, compared with AEFI reported via an existing surveillance system in non-pharmacy sites (general practice and other clinics).
8 June 2021 – BMJ Open 2021; 11:e048109. doi:10.1136/bmjopen-2020-048109
Safety of live attenuated herpes zoster vaccine in Australian adults 70-79 years of age: an observational study using active surveillance
Herpes zoster (HZ) is a painful rash associated with significant morbidity in approximately 20% of those with HZ. Live attenuated herpes zoster vaccine live (ZVL; Zostavax) is recommended to prevent HZ infection in older adults and is funded under the National Immunisation Programme (NIP) for adults aged 70-79 years. This is the first time a live attenuated vaccine has been routinely used in older adults in Australia. AusVaxSafety aimed to assess the safety of live attenuated herpes zoster vaccine live (ZVL) through cumulative analysis of near real-time, participant-based active surveillance from Australia’s AusVaxSafety system in Australian adults 70-79 years of age.
25 March 2021 – BMJ Open 2021; 11:e043880. doi:10.1136/bmjopen-2020-043880
Active SMS-based surveillance of adverse events following immunisation with influenza and pertussis-containing vaccines in Australian pregnant women using AusVaxSafety
Maternal immunisation is important to protect both mother and baby, but safety concerns can lead to low uptake. AusVaxSafety participant-based surveillance actively monitors adverse events following immunisation (AEFI) in Australia. We aimed to analyse AEFI in the days following vaccination with seasonal inactivated influenza vaccine (IIV) and/or reduced antigen diphtheria-tetanus-acellular pertussis vaccine (dTpa) in pregnant women in Australia.
26 June 2020 – Vaccine. 38 (31): 4892-4900
Early impact of the Australian national shingles vaccination program with the herpes zoster live attenuated vaccine
The Australian National Shingles Vaccination Program (commenced November 2016) provides free herpes zoster vaccination for eligible adults aged 70 years, with a 5-year catch-up program (until October 2021) for adults aged 71–79 years.
Recent results indicate that the National Shingles Vaccination Program has been highly successful in vaccinating a considerable proportion of Australian adults aged 70–79 years against herpes zoster and suggest that vaccine uptake was associated with decreased incidence of herpes zoster.
18 May 2020 – Human Vaccines & Immunotherapeutics Journal
Comparative Postmarket Safety Profile of Adjuvanted and High-Dose Influenza Vaccines in Individuals 65 Years or Older
In this cohort study of active safety surveillance system data including 50 134 adults 65 years or older who responded to a short messaging service–based survey of self-reported adverse events following immunization, 94.4% of participants received an adjuvanted TIIV or high-dose TIIV. Individuals who received a high-dose TIIV reported higher rates of select adverse events, including fever and injection site reactions, but rates of seeking care were low and did not differ between enhanced vaccine groups.
5 May 2020 – JAMA Network Open
Adverse Events Following Immunization With Combined vs Concurrent Monovalent Hepatitis A and Typhoid Vaccines in Children
Combined hepatitis A and typhoid vaccine is available in Australia, but licensed for use from age 16 years; however it is used “off-label” in children. The combined vaccine is well tolerated in children aged 2–16 years and the risk of adverse events is similar to those receiving concurrent monovalent vaccines.
25 April 2020 – Journal of Paediatric Infectious Diseases Society
Timeliness of Signal Detection For Adverse Events Following Influenza Vaccination in Young Children: A Simulation Case Study
A new case study has found that active vaccine safety surveillance leading to rapid detection of a safety signal would likely have resulted in earlier suspension of Fluvax from the vaccination programme, prevention of many febrile convulsions and maintenance of public confidence in influenza vaccination for young children.
1 March 2020 – BMJ Open, Volume 10, Issue 2
MJA Podcasts 2020 Episode 2: SmartStartAllergy, with Sandra Vale, Dr Michael O'Sullivan and Dr Alan Leeb
Dr Alan Leeb, GP and developer of SmartStartAllergy and SmartVax, Sandra Vale, National Allergy Strategy Manager, and Dr Michael O’Sullivan, consultant immunologist at Perth Children’s Hospital discuss the strong uptake of new infant feeding for allergy prevention guidelines.
12 February 2020 – Medical Journal of Australia (MJA)
SmartStartAllergy: A novel tool for monitoring food allergen introduction in infants
SmartStartAllergy is an active surveillance tool, that incorporates the experience and infrastructure of SmartVax, for promoting the ASCIA guidelines and monitoring parent‐reported allergic reactions to food during the first year of life.
In this article we describe a novel approach to assessing the introduction of peanut and other common food allergens and the rates of parent‐reported food‐related allergic reactions in 12‐month‐old infants.
10 February 2020 – Medical Journal of Australia (MJA)
Symptom profile of patients receiving antibiotics for upper respiratory tract infections in general practice: an observational study using smartphone technology
Upper respiratory tract infections (URTIs) are a common presentation in general practice and are linked to high rates of inappropriate antibiotic prescription. There is limited information about the trajectory of patients with this condition who have been prescribed antibiotics.
The objective of this study was to document the symptom profile of patients receiving antibiotics for URTIs in Australian general practice using smartphone technology and online surveys.
8 October 2019 – Family Practice. 36 (5):560-567
2019 AMA National Congress - Day 1, Session 3
To view the presentation of the 2019 AMA Excellence in Healthcare Award to Dr Alan Leeb for his work with SmartVax, click on the link below.
The presentation can be seen at 1:46:50 to 1:54:30.
24 May 2019 – YouTube – Australian Medical Association (AMA)
SmartVax – Australian active adverse event surveillance following immunisation (AEFI) in primary care using SMS and smartphone technology
Dr Alan Leeb’s presentation at the European Academy of Paediatric Societies in Paris, France. Session 42, Vaccines
2 November 2018 – European Academy of Paediatric Societies
Active surveillance of 2017 seasonal influenza vaccine safety: an observational cohort study of individuals aged 6 months and older in Australia
Influenza vaccines are given to hundreds of millions of people within short, fixed periods of time worldwide each year. This widespread use, coupled with the high degree of influenza vaccine variability, including multiple vaccine types (live, inactivated, subunit or adjuvanted), manufacturing processes (in eggs, cell lines or with recombinant techniques) and strain compositions (trivalent or quadrivalent, with the potential for vaccine viruses to change twice yearly across the Southern and Northern Hemisphere seasons), underscores the need for timely postmarketing vaccine safety surveillance.
18 October 2018 – BMJ Journals; BMJ Open
Presentations at the 16th National Immunisation Conference 2018
Including:
Dr Alan Leeb: The reactogenicity of MenB and 4vMenCV when administered concomitantly.
Lauren Bloomfield: Safety of HPV and Meningococcal ACWY vaccines in adolescents using active surveillance.
Alexis Pillsbury: Active surveillance verifies the safety of 2017 influenza vaccines in Australia.
Catherine Glover: AusVaxSafety goes to school: monitoring 9-valent HPV vaccine safety via school-based immunisation.
Chloe Damon: Building AusVaxSafety – Australia’s active vaccine safety surveillance system.
Catherine Glover: AusVaxSafety profiles of adverse events across the infant National Immunisation Program schedule.
5-7 June 2018 – 16th National Immunisation Conference, Adelaide
Active SMS-based influenza vaccine safety surveillance in Australian children
Australia’s novel, active surveillance system 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.
8 November 2017 – Vaccine. 35(51):7101-7106
21st WONCA World Conference of Family Doctors
Dr Alan Leeb presents SmartVax at the 21st WONCA World Conference of Family Doctors, held in Rio de Janeiro, Brazil.
See Abstract below.
2-6 November 2016
Dr Alan Leeb presents at GP16
Dr Alan Leeb presents “SmartVax – Building a national active vaccine safety surveillance system using SMS technology” at the RACGP GP16 Conference.
29 September to 1 October 2016
Continuous active surveillance of adverse events following immunisation using SMS technology
On-going post-licensure surveillance of adverse events following immunisation (AEFI) is critical to detecting and responding to potentially serious adverse events in a timely manner. SmartVax is a vaccine safety monitoring tool that uses automated data extraction from existing practice management software and short message service (SMS) technology to follow-up vaccinees in real-time. We report on childhood vaccine safety surveillance using SmartVax at a medical practice in Perth, Western Australia.
17 June 2016 – Vaccine. 34(29): 3350-3355
Real-time safety surveillance of seasonal influenza vaccines in children, Australia, 2015
In 2014, a multi-jurisdictional national system, AusVaxSafety, was established to undertake enhanced influenza vaccine safety surveillance and report real-time adverse events in children aged six months to four years. Here we report the results of our surveillance conducted during the 2015 Australian influenza season.
29 October 2015 – Eurosurveillance, Volume 20, Issue 43
Dr Alan Leeb presents at GP15
Dr Alan Leeb presents “Towards a national adverse event surveillance system following immunisation using data from a network of general practices” at the RACGP GP15 Conference.
21 to 23 September 2015
SmartVax presented at 9th NZ Immunisation Conference
Dr Alan Leeb presents “SmartVax – towards a nationwide active vaccine safety surveillance system using SMS technology” at the 9th New Zealand Immunisation Conference.
3 to 5 September 2015
SmartVax presented to Central Queensland, Wide Bay, Sunshine Coast PHN
Dr Alan Leeb presents “SmartVax – keeping vaccines safe” to the Central Queensland, Wide Bay, Sunshine Coast PHN.
4 September 2015
Dr Leeb presents on SmartVax at the NCIRS Vaccine Safety Seminar
Alan Leeb, a GP in WA, presented on SmartVax, a GP-based vaccine safety surveillance system which utilises a fully automated application to extract all vaccination data from practice software.
November 2014 – NCIRS, November Newsletter
Using automated text messages to monitor adverse events following immunisation in general practice
In this study, we aimed to assess SmartVax’s performance in terms of response rates and timeliness.
More than 70% of patients responded by SMS to an SMS query about whether they had any vaccine reactions, with the data received in near real-time.
21 April 2014 – MJA 2014; 200 (7): 416-418
Reactogenicity of two 2010 trivalent inactivated influenza vaccine formulations in adults
In 2010 CSL influenza vaccine was linked to increased febrile adverse events in children. In this study, the reactogenicity of the 2010 CSL influenza vaccine was compared to another brand among adults.
Swelling and muscle pain were significantly more common among adults who received CSL vaccine.
Increased reactions in both children and adults suggests the potential for a common causal pathway.
19 October 2011 – Vaccine, Volume 29, Issue 45