Nudging towards COVID-19 and influenza vaccination uptake in medically at-risk children: EPIC study protocol of randomised controlled trials in Australian paediatric outpatient clinics.

INTRODUCTION: Children with chronic medical diseases are at an unacceptable risk of hospitalisation and death from influenza and SARS-CoV-2 infections. Over the past two decades, behavioural scientists have learnt how to design non-coercive 'nudge' interventions to encourage positive health behaviours. Our study aims to evaluate the impact of multicomponent nudge interventions on the uptake of COVID-19 and influenza vaccines in medically at-risk children. METHODS AND ANALYSES: Two separate randomised controlled trials (RCTs), each with 1038 children, will enrol a total of approximately 2076 children with chronic medical conditions who are attending tertiary hospitals in South Australia, Western Australia and Victoria. Participants will be randomly assigned (1:1) to the standard care or intervention group. The nudge intervention in each RCT will consist of three text message reminders with four behavioural nudges including (1) social norm messages, (2) different messengers through links to short educational videos from a paediatrician, medically at-risk child and parent and nurse, (3) a pledge to have their child or themselves vaccinated and (4) information salience through links to the current guidelines and vaccine safety information. The primary outcome is the proportion of medically at-risk children who receive at least one dose of vaccine within 3 months of randomisation. Logistic regression analysis will be performed to determine the effect of the intervention on the probability of vaccination uptake. ETHICS AND DISSEMINATION: The protocol and study documents have been reviewed and approved by the Women's and Children's Health Network Human Research Ethics Committee (HREC/22/WCHN/2022/00082). The results will be published via peer-reviewed journals and presented at scientific meetings and public forums. TRIAL REGISTRATION NUMBER: NCT05613751.

Parental awareness and attitudes towards prevention of respiratory syncytial virus in infants and young children in Australia.

AIM: To assess parental awareness of respiratory syncytial virus (RSV) and the level of acceptance of future RSV prevention strategies. METHODS: A cross-sectional online survey was implemented targeting "future" and "current" parents of children aged ≤5 years in Australia. RESULTS: From 1992 eligible participants, two non-mutually exclusive subgroups were formed: "current" parents (N = 1931) and "pregnant/planning" parents (N = 464: 403 also "current" parents and 61 "future" parents). Participants were predominantly (86.6%) aged 25-39 years and 68.5% with university education. The majority (89.6% current; 78.7% future) had heard of RSV. Of those, 64.2% (current) and 50.0% (future) were aware that pneumonia is associated with RSV; 71.8% (current) and 52.1% (future) were aware that bronchiolitis is associated with RSV. In multivariable logistic regression analyses, Australian-born parents (aOR = 2.47 [95% CI: 1.48-4.12]), living in the eastern states (e.g., New South Wales: aOR = 6.15 [95% CI:2.10-18.04]), with a university-level education (aOR = 2.61 [95% CI:1.38-4.94]) and being a current parent (aOR = 12.26 [95% CI:2.82-53.28]) were associated with higher RSV awareness. There was a high level of acceptance for maternal vaccines (future: 79.3%) and infant immunisation (all: 81.7%). CONCLUSION: While RSV awareness and immunisation acceptance were high, there was limited knowledge of severity of RSV, especially in future parents. Education campaigns need to be developed to increase RSV knowledge.

Attitudes, perceptions, and experiences of Western Australians towards vaccine safety surveillance systems following COVID-19 vaccines: A qualitative descriptive study.

OBJECTIVE: 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, we examined them in the context of COVID-19 vaccinations in Western Australia. METHODS: Researchers conducted 158 qualitative interviews between March 2021 and May 2022 within the broader [name redacted] project. Data regarding VSSS were coded in NVivo using the deductive and inductive methods. RESULTS: Despite some not knowing about VSSS, participants expected follow-up post COVID-19 vaccination. Vaccine hesitant or refusing participants knew about VSSS and regarded these systems positively. Additional considerations concerned the reliability of data collected by VSSS. CONCLUSION: Perceptions of VSSS signal a lack of understanding about how these systems work. Future studies should further explore the public's understanding of VSSS, whether VSSS improves vaccine confidence, and how governments can better communicate to the public about VSSS. IMPLICATIONS FOR PUBLIC HEALTH: Lack of understanding of how VSSS operate may be stymying attempts to build public vaccine confidence. Healthcare providers and governments could build public knowledge and understanding of VSSS to mitigate concerns of adverse events following immunisation.

"Fighting the pandemic!" Western Australian pharmacists' perspectives on COVID-19 vaccines: A qualitative study.

BACKGROUND: In Western Australia, community pharmacists are authorized to administer a range of vaccines without a prescription. Since mid-July 2021, pharmacists can also administer Coronavirus Disease 2019 (COVID-19) vaccines. Little is known about how pharmacists think and feel about giving and receiving COVID-19 vaccines and how they discuss it with patients. AIM: This study aimed to explore Western Australian pharmacists' perceptions on being vaccinated with, administering, and communicating about COVID-19 vaccines. METHODS: Semi structured interviews were conducted with 20 pharmacists from metropolitan and regional areas of Western Australia across a two-week period in July and early August 2021. Interview transcripts were coded using NVivo 20 and data was thematically analyzed using the framework method. RESULTS: Most pharmacists (n = 16, 80 %) had received at least one dose of a COVID-19 vaccine. Some expressed difficulty accessing the vaccine while two unvaccinated pharmacists were hesitant to receive it due to concerns about vaccine development. The majority of pharmacists spoke positively about administering the vaccines, discussing perceived facilitators such as designated vaccination days but also perceived barriers such as inadequate financial reimbursement compared to other healthcare providers. Many pharmacists obtained their information from Australian government sources and training modules. Pharmacists were only passively promoting COVID-19 vaccines, with conversations mostly initiated by patients. Most pharmacists specified they would highlight the common side effects when administering the vaccine and would provide patients with written information. CONCLUSION: The majority of pharmacists were willing to administer and be vaccinated with COVID-19 vaccines. Since pharmacists play an important role in increasing vaccine uptake, governments should provide equitable reimbursement to pharmacists in line with other vaccinators such as General Practitioners. We welcome the recent resources produced by governments and pharmacy professional organizations to help pharmacists actively promote the vaccines since this work was undertaken.

West Australian parents' views on vaccinating their children against COVID-19: a qualitative study.

BACKGROUND: Australian children and adolescents were among the last local cohorts offered COVID-19 vaccines. Despite promising initial uptake, coverage subsequently plateaued, requiring further efforts to improve access and build parents' recognition of the importance of COVID-19 vaccination. We sought to understand West Australian (WA) parents' willingness to vaccinate their children to inform strategies for improving uptake at the time in which they were becoming eligible. METHODS: We undertook in-depth qualitative interviews with 30 parents of children aged 5-17 years from June - December 2021. During this period, children aged 12-15 years became eligible for vaccination; children aged 5-11 years became eligible shortly thereafter. Data were thematically analysed in NVivo. RESULTS: Most parents intended on vaccinating their children once eligible. Parents sought to protect their children, to protect the community, to resume travel, and to get back to "normal". They reflected that vaccination against key infectious threats is a routine activity in childhood. Some were concerned about the vaccine, particularly mRNA vaccines, being new technology or impacting fertility. "Wait-awhiles" wanted to see what other parents would do or were delaying until they felt that there was a higher risk of COVID-19 in WA. Most parents of younger children wanted their child to be vaccinated at the general practice clinic due to familiarity and convenience. Parents were particularly eager for clear and consistent messaging about vaccination of children and adolescents, including safety, importance, scientific evidence, and personal stories. CONCLUSION: For future pandemic vaccinations pertaining to children, governments and health officials need to address parents' concerns and meet their preferences for the delivery of the vaccine program to children and adolescents.

Randomised controlled trials of behavioural nudges delivered through text messages to increase influenza and COVID-19 vaccines among pregnant women (the EPIC study): study protocol.

BACKGROUND: Influenza and COVID-19 infections during pregnancy may have serious adverse consequences for women as well as their infants. However, uptake of influenza and COVID-19 vaccines during pregnancy remains suboptimal. This study aims to assess the effectiveness of a multi-component nudge intervention to improve influenza and COVID-19 vaccine uptake among pregnant women. METHODS: Pregnant women who receive antenatal care at five tertiary hospitals in South Australia, Western Australia and Victoria will be recruited to two separate randomised controlled trials (RCTs). Women will be eligible for the COVID-19 RCT is they have received two or less doses of a COVID-19 vaccine. Women will be eligible for the influenza RCT if they have not received the 2023 seasonal influenza vaccine. Vaccination status at all stages of the trial will be confirmed by the Australian Immunisation Register (AIR). Participants will be randomised (1:1) to standard care or intervention group (n = 1038 for each RCT). The nudge intervention in each RCT will comprise three SMS text message reminders with links to short educational videos from obstetricians, pregnant women and midwives and vaccine safety information. The primary outcome is at least one dose of a COVID-19 or influenza vaccine during pregnancy, as applicable. Logistic regression will compare the proportion vaccinated between groups. The effect of treatment will be described using odds ratio with a 95% CI. DISCUSSION: Behavioural nudges that facilitate individual choices within a complex context have been successfully used in other disciplines to stir preferred behaviour towards better health choices. If our text-based nudges prove to be successful in improving influenza and COVID-19 vaccine uptake among pregnant women, they can easily be implemented at a national level. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT05613751. Registered on November 14, 2022.

Parents' COVID-19 vaccine intentions for children under 5 years: Brief reflections from a qualitative study.

AIM: Australian authorities made COVID-19 vaccines available for children aged under 5 years old with serious comorbidities in August 2022. There is presently no universal programme for young children, but crucial to any rollout's success is whether parents are motivated and able to vaccinate. By examining parents' vaccine intentions, this study aims to inform current and future COVID-19 vaccine roll-outs for children aged under 5 years. METHODS: As part of the mixed methods project 'Coronavax: Preparing Community and Government' we interviewed 18 Western Australian parents of young children about their intentions in late 2021. RESULTS: Two thirds intended to vaccinate if and when they could, with one third intending to delay for reasons including risk and safety perceptions, fears about side effects and influence from their social networks. However, even those choosing to delay were waiting rather than refusing. CONCLUSIONS: To improve uptake, targeted messaging should emphasise that COVID-19 can be a serious disease in young children, with such messaging drawing on the reputability and esteem of scientific and technical authorities. Such messaging should be oriented towards parents of children with serious comorbidities at the present time. It will be important to emphasise that government vaccine recommendations are based on supporting families to protect their children and keep them healthy.

Team-based care: an expanded medical assistant role - enhanced rooming and visit assistance.

Primary care practices face significant challenges as they pursue the Quadruple Aim. Redistributing care across the interprofessional primary care team by expanding the role of the medical assistant (MA) is a potential strategy to address these challenges. Two sequential, linked processes to expand the role of the MA, called Enhanced Rooming and Visit Assistance, were implemented in four family medicine residency clinics in Minnesota. In Enhanced Rooming, MAs addressed preventive services, obtained a preliminary visit agenda, and completed a warm hand-off to the provider. In Visit Assistance, MAs stayed in the room the entire visit to assist with the visit workflow. Enhanced Rooming and Visit Assistance processes were successfully implemented and sustained for over one year. MAs and providers were satisfied with both processes, and patients accepted the expanded MA roles. Mammogram ordering rates increased from 10% to 25% (p < 0.0001). After Visit Summary (AVS) print rates increased by 12% (p < 0.0001). Visit Turn-Around-Time (TAT) decreased 3.1 minutes per visit (p = 0.0001). Expanding the MA role in a primary care interprofessional team is feasible and a potentially useful tool to address the Quadruple Aim.

Lifting the curtains of silence: Patient perceptions towards needs and responsibilities in contributing to the prevention of healthcare-associated infections and antimicrobial resistance.

BACKGROUND: Beyond the use of policy and system-focused approaches, it has been established globally that patients can play a role in enhancing the health care landscape. However, efforts to meaningfully translate patient engagement strategies that promote participation by hospitalized patients in relevant infection prevention and antimicrobial stewardship activities have not yet been realized. This study mapped the key factors acting as barriers and facilitators of patient engagement using a theoretical framework to identify potential new approaches to promote engagement. METHODS: Semistructured interviews were conducted with 36 patients from 3 major hospitals in Sydney, Australia, in 2019. Transcripts were inductively analyzed, with the resulting themes categorized into the components of the Capability-Opportunity-Motivation-Behavior model. RESULTS: The themes regarding barriers to patient engagement with relevant infection prevention and antimicrobial stewardship activities were: (1) Capability: misunderstanding and knowledge gaps about antimicrobial resistance; (2) Opportunity: strong family/patient support networks and good relationships with nursing staff provide an opportunity to support engagement; (3) Motivation: those who have some level of understanding or experience see the benefit and are most likely to engage actively. CONCLUSIONS: Assuming patients are inclined to participate in efforts, a logical starting point would be to build awareness amongst patients and providers; however, education will not suffice. There needs to be a system and policy shift to ensure that patient engagement is recognized as a worthy endeavor.

COVID-19 vaccine knowledge, attitudes, and experiences of health care workers in Perth, Western Australia: A qualitative study.

INTRODUCTION: Health care workers (HCWs) faced an increased risk of Coronavirus Disease 2019 (COVID-19). Australia's COVID-19 vaccine rollout commenced in February 2021 to priority groups, including HCWs. Given their increased risk, as well as influence on patients' vaccine uptake, it was important that HCWs had a positive COVID-19 vaccination experience, as well as trusting the vaccine safety and efficacy data. METHODS: Semi-structured interviews were undertaken with 19 public- and privately-practicing HCWs in Western Australia between February-July 2021. Data were deductively analysed using NVivo 12 and guided by the Capability-Opportunity-Motivation-Behaviour model. RESULTS: 15/19 participants had received at least one COVID-19 vaccine. Participants were highly motivated, mostly to protect themselves and to get back to "normal", but also to protect patients. Many had a heightened awareness of COVID-19 severity due hearing from colleagues working in settings more impacted than Western Australia. Participants trusted the COVID-19 vaccine development and approval process; their histories of having to accept vaccines for work helped them to see COVID-19 vaccination as no different. Many recalled initially being unsure of how and when they'd be able to access the vaccine. Once they had this knowledge, half had difficulties with the booking process, and some were unable to access a clinic at a convenient location or time. Participants learnt about COVID-19 vaccination through government resources, health organisations, and their workplace, but few had seen any government campaigns for the wider public. Finally, most had discussed COVID-19 vaccination with their social network. CONCLUSION: HCWs in Western Australia demonstrated good knowledge about COVID-19 vaccination, with many reasons to vaccinate themselves and support the vaccination of others. Addressing the barriers identified in this study will be important for planning to vaccinate health workforces during future pandemics.

'Corona is coming': COVID-19 vaccination perspectives and experiences amongst Culturally and Linguistically Diverse West Australians.

BACKGROUND: Culturally and Linguistically Diverse (CALD) groups within high-income countries are at risk of being left behind by the COVID-19 vaccination rollout. They face both access and attitudinal barriers, including low trust in government and health authorities. OBJECTIVE: To explore perceptions and attitudes towards COVID-19 vaccination, as well as facilitators, barriers and strategies to promote uptake among CALD residents of Western Australia (WA), where there were almost no COVID-19 cases for 2 years. DESIGN AND PARTICIPANTS: Perth, WA's capital, was chosen as the state's study site because most of the state's CALD population lives there. Eleven semistructured in-depth interviews and three focus groups (with 37 participants) were conducted with CALD residents between August and October 2021. Thematic analysis was conducted, informed by the 'Capability', 'Opportunity', 'Motivation', 'Behaviour' model. RESULTS: CALD participants faced barriers including a lack of knowledge about COVID-19 and the vaccines, low self-rated English proficiency and education levels, misinformation, passive government communication strategies and limited access to vaccine clinics/providers. They were, however, motivated to vaccinate by the imminent opening of state and international borders, trust in government and healthcare authorities, travel intentions and the desire to protect themselves and others. CONCLUSIONS: Despite high levels of trust and significant desire for vaccines among CALD communities in Perth, current strategies were not meeting their needs and the community remains at risk from COVID-19. Tailored intervention strategies are required to provide knowledge, address misinformation and facilitate access to ensure uptake of COVID-19 vaccines-including for additional doses-amongst CALD communities. Governments should work with trusted CALD community members to disseminate tailored COVID-19 vaccine information and adequately translated resources. PATIENT OR PUBLIC CONTRIBUTION: The Wesfarmers Centre of Vaccines and Infectious Diseases Community Reference Group at Telethon Kids Institute consulted on this project in September 2020; Ishar Multicultural Women's Health Services consulted on and facilitated the focus groups.

Western Australian health care workers' views on mandatory COVID-19 vaccination for the workplace.

Background: Health care workers (HCWs) are at an increased risk of catching and spreading Coronavirus Disease 2019 (COVID-19) compared with the general community, putting health systems at risk. Several jurisdictions globally have mandated or are looking to mandate COVID-19 vaccines for this cohort, but little is known about the acceptability of this measure, especially in different contexts, and there is little qualitative data to explore nuance, depth, and the reasons behind HCWs' opinions. Methods: In-depth semi-structured qualitative interviews were undertaken with 39 HCWs in Western Australia (WA) between February-August 2021, ascertaining their views on the prospective introduction and implementation of mandates for COVID-19 vaccines. Data were thematically analysed using NVivo 20. Results: There was broad support for COVID-19 vaccine mandates for HCWs amongst our participants, but also different views about what such a mandate would mean (redeployment versus termination) and how it would impact the rest of the workforce. One vaccine hesitant participant said that mandates would be their prompt to get vaccinated. Other participants invoked an informal code whereby HCWs have an obligation to be seen to support vaccination and to protect public health more broadly. However, they also raised concerns about implementation and procedural and policy fairness. Conclusion: Policymakers should consider how to mobilise the informal code of health promotion and public health support if introducing mandates. They should also consider whether HCWs will bring the same attitudes and approaches to mandates for additional vaccine doses.

Influenza vaccination among pregnant women in two hospitals in Sydney, NSW: what we can learn from women who decline vaccination.

OBJECTIVE: Pregnant women are recognised as being at risk of serious illness from influenza. Despite this, and longstanding national recommendations for vaccination in pregnancy, vaccine uptake remains suboptimal. This study aims to determine factors associated with women declining influenza vaccination in pregnancy. METHOD: We surveyed pregnant women from antenatal clinics at two Sydney hospitals as part of an evaluation of the New South Wales (NSW) Health 2017 influenza vaccination in pregnancy campaign. Factors associated with a woman's decision to decline influenza vaccination were assessed using Pearson's chi-square test and multivariable logistic regression. RESULTS: Among 642 women surveyed, 58% self-reported influenza vaccination during pregnancy and 19% reported they had declined vaccination. Factors associated with a decision to decline vaccination included lack of a recommendation from a maternity care provider (adjusted odds ratio [aOR] 6.06; 95% confidence interval [CI] 3.50, 10.50), recommendation against vaccination (aOR 4.17; 95% CI 2.07, 8.38), having never previously been vaccinated for influenza (aOR 2.75; 95% CI 1.64, 4.59) and, among third-trimester women, not having been vaccinated for pertussis (aOR 2.55; 95% CI 1.32, 4.89). On univariate analyses, women who declined vaccination were more likely to disagree or feel uncertain about vaccine safety or effectiveness compared with women who chose to be vaccinated. CONCLUSION: Recommendations from maternity care providers remain key to a woman's decision to be vaccinated for influenza during pregnancy. Time should be allocated for vaccine discussions early in pregnancy as part of routine care. Continued efforts are needed to improve messaging to pregnant women on the benefits, safety and efficacy of influenza vaccination.

Efficacy of Digital Health Tools for a Pediatric Patient Registry: Semistructured Interviews and Interface Usability Testing With Parents and Clinicians.

BACKGROUND: Acute respiratory infection (ARI) in childhood is common, but more knowledge on the burden and natural history of ARI in the community is required. A better understanding of ARI risk factors, treatment, and outcomes will help support parents to manage their sick child at home. Digital health tools are becoming more widely adopted in clinical care and research and may assist in understanding and managing common pediatric diseases, including ARI, in hospitals and in the community. We integrated 2 digital tools-a web-based discharge communication system and the REDCap (Research Electronic Data Capture) platform-into the Pragmatic Adaptive Trial for Acute Respiratory Infection in Children to enhance parent and physician engagement around ARI discharge communication and our patient registry. OBJECTIVE: The objective of this study is to determine the efficacy and usability of digital tools integrated into a pediatric patient registry for ARI. METHODS: Semistructured interviews and software interface usability testing were conducted with 11 parents and 8 emergency department physicians working at a tertiary pediatric hospital and research center in Perth, Western Australia, in 2019. Questions focused on experiences of discharge communication and clinical trial engagement. Responses were analyzed using the qualitative Framework Method. Participants were directly observed using digital interfaces as they attempted predetermined tasks that were then classified as success, failure, software failure, or not observed. Participants rated the interfaces using the System Usability Scale (SUS). RESULTS: Most parents (9/11, 82%) indicated that they usually received verbal discharge advice, with some (5/11, 45%) recalling receiving preprinted resources from their physician. Most (8/11, 73%) would also like to receive discharge advice electronically. Most of the physicians (7/8, 88%) described their usual practice as verbal discharge instructions, with some (3/8, 38%) reporting time pressures associated with providing discharge instructions. The digital technology option was preferred for engaging in research by most parents (8/11, 73%). For the discharge communication digital tool, parents gave a mean SUS score of 94/100 (SD 4.3; A grade) for the mobile interface and physicians gave a mean usability score of 93/100 (SD 4.7; A grade) for the desktop interface. For the research data management tool (REDCap), parents gave a mean usability score of 78/100 (SD 11.0; C grade) for the mobile interface. CONCLUSIONS: Semistructured interviews allowed us to better understand parent and physician experiences of discharge communication and clinical research engagement. Software interface usability testing methods and use of the SUS helped us gauge the efficacy of our digital tools with both parent and physician users. This study demonstrates the feasibility of combining qualitative research methods with software industry interface usability testing methods to help determine the efficacy of digital tools in a pediatric clinical research setting.

COVID-19 vaccine Mandates: An Australian attitudinal study.

BACKGROUND: The rollout of vaccines against COVID-19 is prompting governments and the private sector to adopt mandates. However, there has been little conceptual analysis of the types of mandates available, nor empirical analysis of how the public thinks about different mandates and why. Our conceptual study examines available instruments, how they have been implemented pre-COVID, and their use for COVID-19 globally. Then, our qualitative study reports the acceptability of such measures in Western Australia, which has experienced very limited community transmission, posing an interesting scenario for vaccine acceptance and acceptability of measures to enforce it. METHOD: Our conceptual study developed categories of mandates from extant work, news reports, and legislative interventions globally. Then, our empirical study asked 44 West Australians about their attitudes towards potential mandatory policies, with data analysed using NVivo 12. RESULTS: Our novel studies contribute richness and depth to emerging literature on the types and varying acceptability of vaccine requirements. Participants demonstrated tensions and confusion about whether instruments were incentives or punishments, and many supported strong consequences for non-vaccination even if they ostensibly opposed mandates. Those attached to restrictions for disease prevention were most popular. There were similar degrees of support for mandates imposed by employers or businesses, with participants showing little concern for potential issues of accountability linked to public health decisions delegated to the private sector. Participants mostly supported tightly regulated medical exemptions granted by specialists, with little interest in religious or personal belief exemptions. CONCLUSION: Our participants are used to being governed by vaccine mandates, and now by rigorous lockdown and travel restrictions that have ensured limited local COVID-19 disease and transmission. These factors appear influential in their general openness to COVID-19 vaccine mandates, especially when linked explicitly to the prevention of disease in high-risk settings.

Does a major change to a COVID-19 vaccine program alter vaccine intention? A qualitative investigation.

BACKGROUND: On 8th April 2021, the Australian Technical Advisory Group on Immunisation (ATAGI) made the Pfizer-BioNtech (Comirnaty) vaccine the "preferred" vaccine for adults in Australia aged < 50 years due to a risk of thrombosis with thrombocytopenia syndrome (TTS) following AstraZeneca vaccination. We sought to understand whether this impacted COVID-19 vaccine intentions. METHOD: We undertook qualitative interviews from February - April 2021 before and after the program change with 28 adults in Perth, Western Australia. Using our COVID-19 vaccine intentions model, we assessed changes in participants' COVID-19 vaccine intention before and after the program change. Participants were classified as 1) 'acceptors': no concerns about COVID-19 vaccine safety, efficacy, access and would accept whatever vaccine is offered, 2) 'cautious acceptors': some concerns and would prefer a particular vaccine brand but would accept whatever is offered, 3) 'Wait awhile': for more data, easier access, for another vaccine brand, a greater perceived COVID-19 threat or until mandatory, or 4) 'refuser': no intention to vaccinate due to concerns about safety and/or efficacy. RESULTS: Before the change, 7/18 of those aged < 50 years were 'acceptors,' 10/18 were 'cautious acceptors' and 1/18 was 'wait awhile.' Overall, 14/18 participants had the same COVID-19 vaccine intention after the change; 4/18 became more concerned. For those aged ≥ 50 years and before the change, 5/10 were 'acceptors' and 5/10 were 'cautious acceptors.' After the change, 8/10 still had the same COVID-19 vaccine intention; 2/10 became more cautious. The major concern before the program change was COVID-19 vaccines having different vaccine efficacy; the concern pivoted to safety. CONCLUSION: The majority of participants were 'cautious acceptors' who intended on being vaccinated; many had this intention before and after the program change. The Australian government, health care providers and media need to better address COVID-19 vaccine concerns to assist those with COVID-19 vaccine intentions receive a vaccine.

Paediatric Active Enhanced Disease Surveillance (PAEDS) 2019: Prospective hospital-based surveillance for serious paediatric conditions.

INTRODUCTION: The Paediatric Active Enhanced Disease Surveillance (PAEDS) network is an Australian hospital-based active surveillance system employing prospective case ascertainment for selected serious childhood conditions, particularly vaccine preventable diseases and potential adverse events following immunisation (AEFI). This report presents surveillance data for 2019. METHODS: Specialist nurses screened hospital admissions, emergency department records, laboratory and other data on a daily basis in seven paediatric tertiary referral hospitals across Australia, to identify children with the conditions under surveillance. Standardised protocols and case definitions were used across all sites. In 2019, the conditions under surveillance comprised: acute flaccid paralysis (AFP; a syndrome associated with poliovirus infection), acute childhood encephalitis (ACE), influenza, intussusception (IS; a potential AEFI with rotavirus vaccines), pertussis, varicella-zoster virus infection (varicella and herpes zoster), invasive meningococcal and invasive Group A streptococcus diseases and two new conditions, Kawasaki disease and gram-negative bloodstream infections. An additional social research component continued to evaluate parental attitudes to influenza vaccination. RESULTS: PAEDS captured 2,701 cases for 2019 across all conditions under surveillance. Key outcomes of PAEDS included: contribution to national AFP surveillance to reach the World Health Organization reporting targets for detection of poliomyelitis cases; demonstration of high influenza activity in 2019 and influenza-associated deaths in ACE cases; identification of key barriers to influenza vaccination of children hospitalised for acute respiratory illness; reporting of all IS cases associated with vaccine receipt to relevant state health department; and showing a further reduction nationally in varicella cases. Enhanced pertussis surveillance continued to capture controls to support vaccine efficacy estimation. Invasive meningococcal disease surveillance showed predominance of serotype B and a reduction in cases nationally. Surveillance for invasive group A streptococcus captured severe cases in children. Monitoring of Kawasaki disease incidence and gram-negative bloodstream infections commenced. CONCLUSIONS: PAEDS continues to provide unique policy-relevant data on serious paediatric conditions using sentinel hospital-based enhanced surveillance. Keywords: paediatric, surveillance, child, hospital, vaccine preventable diseases, adverse event following immunisation, acute flaccid paralysis, encephalitis, influenza, intussusception, pertussis, varicella zoster virus, meningococcal, group A streptococcus, Kawasaki, bloodstream infections.

From program suspension to the pandemic: A qualitative examination of Australia's vaccine pharmacovigilance system over 10 years.

BACKGROUND: In 2010, the Australian seasonal influenza vaccination program for children under 5 years of age was suspended due to an unexpected increase in fever and febrile convulsions causally associated with one particular influenza vaccine brand. A subsequent national review made seven recommendations to improve vaccine pharmacovigilance. Ten years on, in advance of implementing the COVID-19 immunisation program, we evaluated views on the capacity of Australia's vaccine pharmacovigilance system to promptly detect, examine and communicate a signal. METHODS: Semi-structured interviews were conducted between July and October 2020 with individuals with expertise in vaccine safety in Australia using an interview guide informed by key Australian and international frameworks. Interviews were digitally recorded and transcribed verbatim. Thematic analysis was used to code data using a deductive approach. RESULTS: Interviews with seventeen participants enabled six themes to be identified. Participants described improvement and significant innovation within Australia's vaccine pharmacovigilance system over the decade since 2010, particularly through establishment of a new active, cohort event monitoring system using short message service surveys. Participants thought Australia had a good foundation for COVID-19 vaccine safety surveillance; implementation of the COVID-19 immunisation program was seen as a potential driver for ongoing enhancement through: a) improved integration of the active surveillance and spontaneous reporting systems, and; b) development of population-level active surveillance, including through data linkage. Transparent communication was considered essential to address the unprecedented challenges of COVID-19 and broader vaccine safety concerns. CONCLUSIONS: Vaccine safety experts in Australia convey confidence in the innovative pharmacovigilance systems implemented over the past 10 years. While Australia has a multifaceted system incorporating both active surveillance and spontaneous reporting systems, COVID-19 vaccine implementation represents an opportunity to enhance current systems and to develop new, systematic approaches to vaccine pharmacovigilance that should make both a local and global contribution.