Short-term Adverse Events Following Immunization With Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) Vaccine for Mpox.

This study uses data collected by Australia's vaccine safety surveillance system to examine the adverse event profile of the modified vaccinia Ankara­Bavarian Nordic vaccine.

The short term safety of COVID-19 vaccines in Australia: AusVaxSafety active surveillance, February - August 2021.

OBJECTIVE: To assess the short term safety of the COVID-19 vaccines Comirnaty (Pfizer-BioNTech BNT162b2) and Vaxzevria (AstraZeneca ChAdOx1) in Australia. DESIGN: Prospective observational cohort study; online surveys by AusVaxSafety, a national active vaccine safety surveillance system, three and eight days after vaccination. SETTING, PARTICIPANTS: People aged 16 years or more who received COVID-19 vaccines at sentinel vaccination hubs, general practices, or Aboriginal Community Controlled Health Organisation clinics, 22 February - 30 August 2021. MAIN OUTCOME MEASURES: Primary outcome: proportion of respondents who reported any adverse event following immunisation (AEFI) 0-3 days after vaccination. SECONDARY OUTCOMES: proportions of respondents who reported specific adverse events or medical review for AEFI within seven days of vaccination; impact on usual daily activities; recovery. RESULTS: 4 851 480 people received COVID-19 vaccines at participating sentinel sites during the study period (25% of all COVID-19 vaccine doses administered in Australia to 30 August 2021). 3 035 983 people responded to both surveys (response rate, 62.6%); 35.9% of respondents reported one or more AEFI 0-3 days after Comirnaty dose 1, 54.7% after Comirnaty dose 2, 52.8% after Vaxzevria dose 1, and 22.0% after Vaxzevria dose 2. Local pain, fatigue, headache, and myalgia were the most frequently reported symptoms. After adjusting for demographic characteristics, vaccination site type, jurisdiction, and self-reported medical conditions, the odds of reporting any AEFI were higher for women than men (range of adjusted odd ratios [aORs], by vaccine and dose, 1.53-1.84), for people with a history of anaphylaxis (aOR range, 1.28-1.45), and for people reporting certain underlying conditions, including obesity (aOR range, 1.15-1.75), immunodeficiency (aOR range, 1.04-2.24), or chronic inflammatory disease (aOR range, 1.05-1.75). 0.9% of respondents sought medical advice in the three days following vaccination, most frequently after Comirnaty dose 2 (1.4%) and Vaxzevria dose 1 (1.2%). CONCLUSION: AusVaxSafety active surveillance affirms the short term safety profile of Comirnaty and Vaxzevria vaccines in a large population sample during the first six months of the Australian COVID-19 vaccination program.

Improved childhood immunization coverage using the World Health Organization's Tailoring Immunization Programmes guide (TIP) in a regional centre in Australia.

In 2017 the World Health Organization's Tailoring Immunization Programmes guide (TIP) was used to identify pockets of low immunization coverage in Australia. The regional centre of Maitland had high numbers and rates of children who were overdue for scheduled vaccinations (2016, n = 344, 37.7%). Families were not opposed to immunization but had conflicting priorities or experienced service access barriers. A tailored strategy was developed including friendly, personalised reminders, outreach appointments and home visiting for those families most in need. Research translation was not quick and easy. A process evaluation identified areas where more support was needed to advance the strategy. Coverage rates have increased from 62.3% (2016) to 86.2% (2020). The number of overdue children has decreased even during COVID-19 restrictions when health services expected families would avoid primary care services. The TIP approach is valuable for improving childhood immunization coverage and is being utilised in other communities with low coverage.

Safety of live attenuated herpes zoster vaccine in Australian adults 70-79 years of age: an observational study using active surveillance.

OBJECTIVES: 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. DESIGN AND SETTING: ZVL was funded in Australia for adults aged 70 years from November 2016, with a time-limited catch up programme for those up to 79 years. This cohort study monitored safety in the first two programme years through active surveillance at 246 sentinel surveillance immunisation sites. PARTICIPANTS: Adults aged 70-79 years vaccinated with ZVL who responded to an opt-out survey sent via automated short message service (SMS) 3 days following vaccination (n=17 458) or contributed supplementary data through a separate, opt-in online survey at 16 and 24 days following vaccination (n=346). PRIMARY AND SECONDARY OUTCOME MEASURES: Rates of overall and prespecified adverse events following immunisation (AEFI) by sex, concomitant vaccination and underlying medical condition. Signal detection methods (fast initial response cumulative summation and Bayesian updating analyses) were applied to reports of medical attendance. RESULTS: The median age of participants was 72 years; 53% were female. The response rate following automated SMS was high (73% within 7 days of vaccination). Females were more likely than males to report any adverse event within 7 days of vaccination (RR 2.07, 95% CI 1.86 to 2.31); injection site reaction was the most commonly reported (2.3%, n=377). Concomitant vaccination was not associated with higher adverse event rates (RR 1.05, 95% CI 0.93 to 1.18). Rates of medical attendance were low (0.3%) with no safety signals identified. Supplementary opt-in survey data on later onset adverse events did not identify any difference in AEFI rates between those with and without underlying medical conditions. CONCLUSIONS: ZVL has a very good safety profile in the first week after vaccination in older adults. Active, participant-based surveillance in this primary care cohort is an effective method to monitor vaccine safety among older adults and will be used as a key component of COVID-19 vaccine safety surveillance in Australia.

What gets measured gets noticed. Tracking surgical site infection post caesarean section through community surveillance: A post intervention study protocol.

AIM: This study aims to evaluate the effectiveness of HealthTracker, a surgical site infection surveillance system that aims to improve the notification of surgical site infection for women after giving birth by caesarean section. DESIGN: This protocol is an intervention study to evaluate the effectiveness of the surveillance system called "HealthTracker" in monitoring surgical site infections post caesarean section. METHODS: This study will use a mobile web application to automatically send a text message inviting all women who give birth to a live baby by caesarean section over six months during 2020-2021, at an Australian tertiary referral hospital. The text message invites women to complete a web-based validated Wound Healing Questionnaire. The estimated number of eligible women in six months is 700 (caesarean section rate: 34% of 4,000 births annually). INTERVENTION: the proposed "HealthTracker" surveillance system facilitates active patient-reported surgical site infection identification through an automated mobile text message linking women to an individualized online Wound Healing Questionnaire. DISCUSSION: This project aims to provide a consistent, reliable and cost effective surgical site infection surveillance tool to improve post caesarean section surgical site infection reporting, can be scaled for broader utilization and will provide valuable information to decision makers regarding surgical site infection prevention. IMPACT: Study findings will provide insights into whether HealthTracker is an efficient and cost effective platform for a systematic and consistent approach to surgical site infection surveillance that can be adopted more broadly, across the local health organization, the State and across other surgical specialty areas. This information will equip hospitals and clinicians with knowledge to better identify patient outcomes related to SSI post discharge from hospital and inform decision making related to preventative strategies, providing the necessary momentum to introduce practice change initiatives aimed at reducing surgical site infection rates. TRIAL REGISTRATION: ACTRN12620001233910.

Comparative Postmarket Safety Profile of Adjuvanted and High-Dose Influenza Vaccines in Individuals 65 Years or Older.

Importance: Every year, influenza vaccines are administered to millions of people worldwide to reduce morbidity and mortality from influenza. As new vaccine formulations are increasingly used, monitoring and comparing safety, in addition to vaccine effectiveness, in target populations are essential. Objective: To assess the postmarketing safety profile of 2018 Southern Hemisphere influenza vaccines, particularly 2 new enhanced trivalent inactivated influenza vaccines: an adjuvanted trivalent inactivated influenza vaccine (aIIV3) and high-dose trivalent inactivated influenza vaccine (HD-IIV3), among Australian individuals 65 years or older. Design, Setting, and Participants: This cohort study used solicited short message service-based self-reported survey data on adverse events occurring within 3 to 5 days after receipt of an influenza vaccination. Participants included individuals 65 years or older who received routinely recommended influenza vaccines at 1 of 265 sentinel immunization sites, including primary care, hospital, and community-based clinics, participating in Australia's AusVaxSafety active vaccine safety surveillance system from April 1 to August 31, 2018. Data were analyzed from September 1, 2018, to June 30, 2019. Exposure: Any licensed 2018 influenza vaccine administered in clinical practice. Main Outcomes and Measures: Rates (overall, by brand, and by concomitant vaccine receipt) of adverse events, including medical attendance as a proxy for serious adverse events. Results: Of 72 013 individuals 65 years or older who received an influenza vaccine in 2018, 50 134 individuals (69.6%) responded to the initial survey regarding adverse events experienced after vaccination (median [interquartile range] age, 71 [68-76] years; 27 056 [54.0%] women). Most individuals received an enhanced trivalent inactivated influenza vaccine, including 28 003 individuals (55.9%) who received aIIV3 and 19 306 individuals (38.5%) who received HD-IIV3; 2208 individuals (4.4%) received a quadrivalent inactivated influenza vaccine. Individuals who received HD-IIV3 reported significantly higher rates of any adverse event compared with individuals who received aIIV3 (1716 individuals [8.9%] vs 1796 individuals [6.4%]; P < .001) as well as specific adverse events, including fever (195 individuals [1.1%] vs 164 individuals [0.6%]; P < .001), injection site pain (383 individuals [2.1%] vs 350 individuals [1.3%]; P < .001), and injection site swelling or redness (256 individuals [1.4%] vs 248 individuals [0.9%]; P < .001). Adverse event rates reported by those receiving any quadrivalent inactivated influenza vaccine were similar to rates reported by those receiving aIIV3. Rates of medical care seeking for adverse events associated with aIIV3 and HD-IIV3 were low and comparable (80 individuals [0.3%] vs 56 individuals [0.3%]; P = .91). Conclusions and Relevance: The findings of this large-scale participant-based postmarketing assessment of the safety of 2 new enhanced influenza vaccines used in individuals 65 years or older provide reassuring near-real-time and cumulative data to inform and support confidence in ongoing vaccine use.

Participant-Centered Online Active Surveillance for Adverse Events Following Vaccination in a Large Clinical Trial: Feasibility and Usability Study.

BACKGROUND: Active participant monitoring of adverse events following immunization (AEFI) is a recent development to improve the speed and transparency of vaccine safety postmarketing. Vaxtracker, an online tool used to monitor vaccine safety, has successfully demonstrated its usefulness in postmarketing surveillance of newly introduced childhood vaccines. However, its use in older participants, or for monitoring patients participating in large clinical trials, has not been evaluated. OBJECTIVE: The objective of this study was to monitor AEFIs in older participants enrolled in the Australian Study for the Prevention through the Immunisation of Cardiovascular Events (AUSPICE) trial, and to evaluate the usefulness and effectiveness of Vaxtracker in this research setting. METHODS: AUSPICE is a multicenter, randomized, placebo-controlled, double-blinded trial in which participants aged 55 to 61 years were given either the pneumococcal polysaccharide vaccine (23vPPV) or 0.9% saline placebo. Vaxtracker was used to monitor AEFIs in participants in either treatment arm through the administration of two online questionnaires. A link to each questionnaire was sent to participants via email or short message service (SMS) text message 7 and 28 days following vaccination. Data were collated and analyzed in near-real time to identify any possible safety signals indicating problems with the vaccine or placebo. RESULTS: All 4725 AUSPICE participants were enrolled in Vaxtracker. Participant response rates for the first and final survey were 96.47% (n=4558) and 96.65% (n=4525), respectively. The online survey was completed by 90.23% (4083/4525) of Vaxtracker participants within 3 days of receiving the link. AEFIs were reported by 34.40% (805/2340) of 23vPPV recipients and 10.29% (240/2332) of placebo recipients in the 7 days following vaccination. Dominant symptoms for vaccine and placebo recipients were pain at the injection site (587/2340, 25.09%) and fatigue (103/2332, 4.42%), respectively. Females were more likely to report symptoms following vaccination with 23vPPV compared with males (433/1138, 38.05% versus 372/1202, 30.95%; P<.001). CONCLUSIONS: Vaxtracker is an effective tool for monitoring AEFIs in the 55 to 61 years age group. Participant response rates were high for both surveys, in both treatment arms and for each method of sending the survey. This study indicates that administration of 23vPPV was well-tolerated in this cohort. Vaxtracker has successfully demonstrated its application in the monitoring of adverse events in near-real time following vaccination in people participating in a national clinical trial. TRIAL REGISTRATION: Australian New Zealand Trial Registry Number (ACTRN) 12615000536561; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368506.

Improving child immunisation rates in a disadvantaged community in New South Wales, Australia: a process evaluation for research translation.

The World Health Organization's Tailoring Immunization Programmes approach was used to develop a new strategy to increase child vaccination coverage in a disadvantaged community in New South Wales, Australia, including reminders, outreach and home visiting. After 18 months, the strategy hasn't been fully implemented. A process evaluation was conducted to identify barriers and facilitators for research translation. Participants included child health nurses, Population Health staff, managers and general practitioners. The Capability-Opportunity-Motivation model of behaviour change (COM-B) was used to develop questions. Twenty-four participants took part in three focus groups and four interviews. Five themes emerged: (i) designing and adopting new ways of working is time-consuming and requires new skills, new ways of thinking and changes in service delivery; (ii) genuine engagement and interaction across fields and institutions helps build capacity and strengthen motivation; (iii) implementation of a new strategy requires clarity; who's doing what, when and how?; (iv) it is important not to lose sight of research findings related to the needs of disadvantaged families; and (v) trust in the process and perseverance are fundamental. There was strong motivation and opportunity for change, but a need to enhance service capability. Areas requiring support and resources were identified.

Active surveillance of 2017 seasonal influenza vaccine safety: an observational cohort study of individuals aged 6 months and older in Australia.

OBJECTIVE: To actively solicit adverse events experienced in the days following immunisation with quadrivalent inactivated influenza vaccine using Australia's near real-time, participant-based vaccine safety surveillance system, AusVaxSafety. DESIGN AND SETTING: Observational cohort study conducted in 194 sentinel surveillance immunisation sites (primary care, hospital and community-based clinics) across Australia. PARTICIPANTS: Individuals aged ≥6 months who received a routine seasonal influenza vaccine at a participating site (n=102 911) and responded to a survey (via short message service or email) sent 3 days after vaccination about adverse events experienced (n=73 892; 71.8%). MAIN OUTCOME MEASURE: Near real-time and cumulative participant-reported rates of any adverse event, fever or medical attendance experienced within 3 days after vaccination overall, by brand, age, pregnancy status and concomitant vaccine receipt. RESULTS: Participant median age was 57 years (range: 6 months to 102 years); 58.1% (n=42 869) were female and 2.7% (n=2018) were pregnant. Near real-time fast initial response cumulative summation and Bayesian analyses of weekly event rates did not demonstrate a safety signal. Children aged 6 months to 4 years had higher event rates (522/6180; 8.4%) compared with older ages; participants aged ≥65 years reported fewer events (1695/28 154; 6.0%). There were no clinically significant differences in safety between brands, by age group or overall. Cumulative data analysis demonstrated that concomitant vaccination was associated with increased rates of fever (2.1% vs 0.8%) and medical attendance (0.8% vs 0.4%), although all rates were low and did not exceed expected levels. CONCLUSIONS: Novel, postmarketing AusVaxSafety surveillance demonstrated comparable and expected safety outcomes for the 2017 quadrivalent inactivated influenza vaccine brands used in Australia. These near real-time, participant-reported data are expected to encourage confidence in vaccine safety and promote uptake.

Tailoring immunisation service delivery in a disadvantaged community in Australia; views of health providers and parents.

In 2014 the Australian immunisation target was raised from 90% to 95% of children to be fully immunised. A national priority is to identify geographic areas of low coverage and implement strategies to improve immunisation rates. Using The World Health Organization's Tailoring Immunization Programmes (TIP) Guidelines, the aim of this study was to identify areas of low immunisation coverage for children in the Hunter New England Local Health District, New South Wales, and to gain a deeper understanding of the factors influencing immunisation in those areas in order to develop tailored strategies for increasing immunisation coverage. Data from the Australian Immunisation Register was used to identify geographic areas of low coverage. Data from interviews and focus groups with parents and service providers were used to gain a deeper understanding of the factors influencing immunisation in those areas. The regional city of Maitland in New South Wales was identified as having a persistently high number and relatively high proportion of children not fully immunised (n = 427, 15.4% in 2016). Themes from 59 stakeholder interviews and focus groups included; (i) limited engagement with health services unless the need is urgent, (ii) multi-dimensional access barriers to immunisation services in Maitland, (iii) a flexible, supportive family centred, primary health care approach, utilising strong partnerships, is most likely to be effective in increasing childhood immunisation rates in Maitland, (iv) data can be used more effectively to inform service providers about trends and individual children not fully immunised. TIP guidelines proved useful for identifying areas of low coverage and providing an understanding of determining factors and the strategies most likely to be effective. Understanding the complex problems many parents face and the access barriers that contribute to low immunisation coverage is essential in developing appropriate solutions. Finding ways to support parents and remove those barriers can contribute to higher coverage. In Maitland, targeted outreach and home visiting has been implemented in consultation with community and health service representatives to ensure that the children from socially disadvantaged populations identified do not miss out on vaccination.

Active SMS-based influenza vaccine safety surveillance in Australian children.

INTRODUCTION: Australia's novel, active surveillance system, AusVaxSafety, monitors the post-market safety of vaccines in near real time. We 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. METHODS: Parent/carer reports of AEFI occurring within 3 days of their child receiving an influenza vaccine in sentinel immunisation clinics were solicited by Short Message Service (SMS) and/or email-based survey. Retrospective data from 2 years were combined to examine specific AEFI rates, particularly fever and medical attendance as a proxy for serious adverse events (SAE), with and without concomitant vaccine administration. As trivalent influenza vaccines (TIV) were funded in Australia's National Immunisation Program (NIP) in 2015 and quadrivalent (QIV) in 2016, respectively, we compared their safety profiles. RESULTS: 7402 children were included. Data were reported weekly through each vaccination season; no safety signals or excess of adverse events were detected. More children who received a concomitant vaccine had fever (7.5% versus 2.8%; p < .001). Meningococcal B vaccine was associated with the highest increase in AEFI rates among children receiving a specified concomitant vaccine: 30.3% reported an AEFI compared with 7.3% who received an influenza vaccine alone (p < .001). Reported fever was strongly associated with medical attendance (OR: 42.6; 95% Confidence Interval (CI): 25.6-71.0). TIV and QIV safety profiles included low and expected AEFI rates (fever: 4.3% for TIV compared with 3.2% for QIV (p = .015); injection site reaction: 1.9% for TIV compared with 3.0% for QIV (p < .001)). There was no difference in safety profile between brands. DISCUSSION: Active participant-reported data provided timely vaccine brand-specific safety information. Our surveillance system has particular utility in monitoring the safety of influenza vaccines, given that they may vary in composition annually.

Participant-centred active surveillance of adverse events following immunisation: a narrative review.

The importance of active, participant-centred monitoring of adverse events following immunisation (AEFI) is increasingly recognised as a valuable adjunct to traditional passive AEFI surveillance. The databases OVID Medline and OVID Embase were searched to identify all published articles referring to AEFI. Only studies which sought participant response after vaccination were included. A total of 6060 articles published since the year 2000 were identified. After the application of screening inclusion and exclusion criteria, 25 articles describing 23 post-marketing AEFI systems were identified. Most countries had a single system: Ghana, Japan, China, Korea, Netherlands, Singapore, Brazil, Cambodia, Sri Lanka, Turkey and Cameroon except the USA (2), Canada (4) and Australia (6). Data were collected from participants with and without AEFI in all studies reviewed with denominator data enabling AEFI rate calculations. All studies considered either a single vaccine or specified vaccines or were time limited except one Australian system, which provides continuous automated participant-centred active surveillance of all vaccines. Post-marketing surveillance systems using solicited patient feedback are emerging as a novel AEFI monitoring tool. A number of exploratory systems utilising e-technology have been developed and their potential for scaling up and application in low and middle income countries deserves further investigation.

Opportunities to increase rates of human papillomavirus vaccination in the New South Wales school program through enhanced catch-up.

Background The National Human Papillomavirus (HPV) Vaccination Program provides HPV vaccine to high school students through school-based vaccination. We aimed to: 1) assess the vaccine completion rates achieved when general practice is used for completing doses missed at school; 2) estimate the extent of under-notification by general practices of vaccine doses administered; and 3) assess the reasons reported by parents of students for non-completion of HPV vaccination. METHODS: A postal survey was conducted of parents and carers of students and identified, using school-program records, as incompletely vaccinated in a large regional area of northern NSW vaccinated during 2010. Information about additional HPV vaccine doses received or reasons for non-completion were sought. Responses were analysed and records cross-checked against the National HPV Vaccination Program Register. RESULTS: Of 660 parents or carers contacted, 207 (31.4%) responded. We found: 1) completion rates increased, an additional 122/207 (45.2%) students had completed all three doses of HPV through their general practitioner (GP); 2) under-notification of GP doses to the National HPV Vaccination Program Register was an issue with only 5/165 (3.0%) reported; 3) the main reason for non-completion was being unaware of the opportunity to catch-up at a GP. CONCLUSIONS: Underreporting by GPs of HPV vaccine doses administered and failure to complete courses identifies two opportunities to increase HPV vaccine coverage. These could be addressed by extending provision of catch-up HPV doses in school and by developing practice software solutions for automatic notification of doses from GPs. Reasons given by parents for non-completion, mostly logistical barriers, indicate a high degree of acceptance of HPV vaccination.

Closing the gap in Australian Aboriginal infant immunisation rates -- the development and review of a pre-call strategy.

BACKGROUND: Improving timely immunisation is key to closing the inequitable gap in immunisation rates between Aboriginal children and non-Indigenous children. Aboriginal Immunisation Officers were employed in Hunter New England Local Health District (HNELHD), New South Wales (NSW), Australia, to telephone the families of all Aboriginal infants prior to the due date for their first scheduled vaccination. METHODS: Aboriginal Immunisation Officers contacted the families of Aboriginal children born in the Hunter New England Local Health District (HNELHD) by telephone before their due immunisation date (pre-call) to provide the rationale for timely immunisation, and to facilitate contact with culturally safe local immunisation services if this was required. The impact of this strategy on immunisation coverage rates is reviewed. RESULTS: For the period March 2010 to September 2014 there was a significant increase in immunisation coverage rate for Aboriginal children at 12 months of age in HNELHD (p < 0.0001). The coverage in the rest of NSW Aboriginal children also increased but not significantly (p = 0.218). Over the full study period there was a significant decrease in the immunisation coverage gap between Aboriginal children and non-Indigenous children in HNELHD (p < 0.0001) and the rest of NSW (p = 0.004). The immunisation coverage gap between Aboriginal and non-Indigenous infants decreased at a significantly faster rate in HNELHD than the rest of NSW (p = 0.0001). By the end of the study period in 2014, immunisation coverage in HNELHD Aboriginal infants had surpassed that of non-Indigenous infants by 0.8 %. CONCLUSIONS: The employment of Aboriginal immunisation officers may be associated with closing of the gap between Aboriginal and non-Indigenous infants' immunisation coverage in HNELHD and NSW. The pre-call telephone strategy provided accelerated benefit in closing this gap in HNELHD.

Real-time safety surveillance of seasonal influenza vaccines in children, Australia, 2015.

Increased febrile reactions in Australian children from one influenza vaccine brand in 2010 diminished confidence in influenza immunisation, highlighting the need for improved vaccine safety surveillance. AusVaxSafety, a national vaccine safety surveillance system collected adverse events in young children for 2015 influenza vaccine brands in real time through parent/carer reports via SMS/email. Weekly cumulative data on 3,340 children demonstrated low rates of fever (4.4%) and medical attendance (1.1%). Fever was more frequent with concomitant vaccination.