Search

Abstract: This report summarises Australia's spontaneous surveillance data for adverse events following immunisation (AEFI) for 2021 reported to the Therapeutic Goods Administration (TGA) and describes reporting trends over the 22-year period 1 January 2000 to 31 December 2021. This report excludes AEFI reports featuring pandemic coronavirus disease 2019 (COVID-19) vaccines, which are reported separately. There were 3,452 AEFI reports for non-COVID-19 vaccines administered in 2021, an annual AEFI reporting rate of 13.4 per 100,000 population compared with 14.9 per 100,000 population in 2020. This small decrease in the AEFI reporting rate in 2021 could potentially be related to an increased focus on COVID-19 vaccines and related AEFI, which are not included in this report. AEFI reporting rates for individual vaccines in 2021 were similar to 2020, as were the most commonly reported adverse events. Of the six deaths following vaccination in 2021 reported to the TGA, none were found to have a causal relationship with vaccination., (© Commonwealth of Australia CC BY-NC-ND.)

Abstract: This report summarises Australia's spontaneous (passive) surveillance data for adverse events following immunisation (AEFI) for coronavirus disease 2019 (COVID-19) vaccines in 2021 reported to the Therapeutic Goods Administration (TGA). The TGA strongly promoted and facilitated adverse event reporting in preparation for, and during, the COVID-19 vaccine rollout as a core component of the most intensive vaccine safety monitoring ever conducted in Australia. There were 111,348 AEFI reports for COVID-19 vaccines administered in 2021, an annual AEFI reporting rate of 271.4 per 100,000 doses of COVID-19 vaccines administered to people aged ≥ 12 years. The annual AEFI reporting rate for non-COVID-19 vaccines in 2021 was 30.6 per 100,000 doses administered to people of all ages. Overall, the most frequently reported symptoms were headache, adverse events classified as 'gastrointestinal nonspecific symptoms and therapeutic procedures', myalgia, pyrexia and fatigue, which were consistent with common expected adverse events following COVID-19 vaccines used in Australia. The most commonly reported adverse events of special interest were myocarditis and/or pericarditis, followed by thrombosis and thromboembolism, and anaphylaxis. Of all COVID-19 vaccine AEFI reports, 762 (0.7%) included a fatal outcome, of which over 80% were in people aged ≥ 60 years. Thirteen deaths reported in 2021 were assessed as likely to be causally linked to vaccination. This report confirms the value of spontaneous post-marketing vaccine pharmacovigilance, especially in the context of new vaccines using novel vaccine technologies and near whole-of-population pandemic vaccination programs. The most frequently reported AEFI for COVID-19 vaccines were common, mild and temporary (lasting 1 or 2 days), and consistent with clinical trial and active surveillance data. Ongoing safety monitoring detected rare, unexpected conditions, such as myocarditis/pericarditis and thrombosis with thrombocytopenia syndrome (TTS), which were investigated and confirmed as safety signals, resulting in changes to vaccine recommendations and product information. The outcomes of TGA monitoring were published in weekly vaccine safety reports. Overall, COVID-19 vaccine safety monitoring provided critical information on the risks of vaccine related adverse events that enabled decisionmakers to undertake informed risk-benefit assessments., (© Commonwealth of Australia CC BY-NC-ND.)

Objectives: To examine the reported incidence and features of disseminated varicella zoster virus (VZV) infection following live attenuated herpes zoster vaccine live (ZVL: Zostavax, Merck) in immunocompromised people in Australia., Design and Setting: ZVL was funded in 2016 in Australia for people aged 70 years, with a catch-up programme for those 71-79 years. From 2016 to 2020, three deaths due to disseminated vaccine-strain VZV infection occurred following inadvertent ZVL administration in individuals with varying levels of immunocompromise. This descriptive study examined 4 years of national surveillance data reported to the Therapeutic Goods Administration's Adverse Event Monitoring System (AEMS). Denominator data for rates were from doses recorded in the Australian Immunisation Register., Participants: Individuals vaccinated between 1 November 2016 and 31 December 2020 who experienced adverse event(s) following immunisation (AEFI) after ZVL recorded in the AEMS., Primary and Secondary Outcome Measures: Rates and outcomes of confirmed (Oka strain positive) or probable disseminated VZV infection, and inadvertent administration of ZVL in immunocompromised individuals., Results: 854 AEFI were reported from 1 089 966 doses of ZVL administered (78.4 per 100 000 doses). Of those, 14 were classified as confirmed (n=6, 0.55 per 100 000) or probable (n=8) disseminated VZV infection. The confirmed cases were all hospitalised, and most (5/6) were immunocompromised; three cases died. Thirty-seven individuals were reported as vaccinated despite a contraindication due to immunocompromise (3.4 per 100 000), with 12/37 (32%) hospitalised., Conclusions: Disseminated VZV is potentially life-threatening and occurs mostly in those with severe immunocompromise. Inadvertent administration of ZVL to immunocompromised individuals has occurred despite initial provider guidance and education. Multiple additional strategies to assist providers to identify contraindications have been implemented to prevent adverse outcomes., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., (© 2022 The Authors. Medical Journal of Australia published by John Wiley & Sons Australia, Ltd on behalf of AMPCo Pty Ltd.)

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., (© Commonwealth of Australia CC BY-NC-ND.)

Abstract: This report summarises Australian spontaneous surveillance data for adverse events following immunisation (AEFI) for 2019 reported to the Therapeutic Goods Administration (TGA) and describes reporting trends over the 20-year period from 1 January 2000 to 31 December 2019. There were 3,782 AEFI records for vaccines administered in 2019, an annual AEFI reporting rate of 14.9 per 100,000 population. There was an 11.8% decrease in the overall AEFI reporting rate in 2019 compared to 2018 (16.9 per 100,000 population). This decrease in the AEFI reporting rate in 2019 was mainly attributable to a decline in reported adverse events related to the human papillomavirus (HPV), dTpa, meningococcal ACWY and seasonal influenza vaccines. AEFI reporting rates for most individual vaccines in 2019 were similar to 2018. The most commonly-reported adverse events were injection site reaction (35.8%), rash (16.6%), pyrexia (15.3%), vomiting (8.1%), urticaria (5.8%), pain (5.8%) and headache (5.7%). There were five deaths reported to the TGA. In one report, the timing and clinical findings were consistent with a causal association with vaccination. In the remaining four reports, no clear causal relationship with vaccination was found., (© Commonwealth of Australia CC BY-NC-ND.)

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., Competing Interests: Competing interests: All authors except AP are either located at organisations that hold the AusVaxSafety contract from the Australian Government Department of Health or are subcontract holders., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: 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., Methods: De-identified AEFI reports were solicited from vaccine recipients via automated SMS survey (using SmartVax software) following routine vaccination with IIV and/or dTpa at 219 national sentinel surveillance sites from 2015 to 2018. AEFI rates were compared by vaccine group (IIV alone, dTpa alone, or IIV and dTpa together), vaccine brand, trimester (IIV only) and vaccination period (April to August 2016-2018; IIV only). Women who had two vaccination encounters during surveillance were identified and AEFI rates compared for each dose., Results: Among 13,758 participants, overall AEFI rates were lower following IIV (4.9%) than dTpa (6.4%) or IIV and dTpa given concomitantly (7.4%). The AEFI profile was similar for both vaccines, with injection site reactions, tiredness, and headache most commonly reported. Injection site pain and swelling/redness were significantly more common in women who received dTpa than IIV. Reports of medical attendance following immunisation were similar (0.3%) for each vaccine group. AEFI rates did not differ by IIV brand (FluQuadri®, Fluarix® Tetra), dTpa brand (Boostrix®, Adacel®), or by trimester. Among women with sequential dTpa vaccinations, 6.0% (7/116) had an AEFI following their second dTpa dose., Conclusions: Self-reported AEFI rates did not differ by trimester (IIV), or by vaccine brand (IIV or dTpa). Concomitant influenza and pertussis vaccination was associated with more frequent, but low rates of minor, expected AEFI. These real world 'citizen science-based' data provide further reassuring evidence of the safety of maternal vaccination., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Background: Australia introduced a funded shingles vaccination program for older adults in November 2016, administered predominantly in primary care clinics. MedicineInsight, a nationally representative primary care database, was used to investigate the risk of pre-specified outcomes following live attenuated herpes zoster vaccine (ZVL) in Australia., Methods: Individuals aged 70-79 years who received ZVL between 1 November 2016 and 31 July 2018 were identified from MedicineInsight. The self-controlled case series (SCCS) method was used to estimate the seasonally-adjusted relative incidence (RI) of seven pre-specified outcome events (injection site reaction (ISR) [positive control], burn [negative control], myocardial infarction (MI), stroke, rash, rash with an antiviral prescription, and clinical attendance) during a plausible post-vaccination at-risk window compared with times distant from vaccination. Sensitivity analyses examined the effect of common concomitant vaccinations and restriction to first outcome events., Results: A total of 332,988 vaccination encounters among 150,054 individuals were identified during the study period; over 2 million clinical attendances were observed. There was an increased RI of ISR in the seven days following ZVL (RI = 77.4, 95% CI 48.1-124.6); the RI of clinical attendance (RI = 0.94, 95% CI 0.94-0.95) and stroke (RI = 0.58, 95% CI 0.44-0.78) were lower in the 42 days following administration of ZVL compared to control periods. There was no evidence of a change in the RI of MI (RI = 0.74, 95% CI 0.41-1.33), rash (RI = 0.97, 95% CI 0.88-1.08), or rash with antiviral prescription (RI = 0.83, 95% CI 0.62-1.10) in the 42 days following ZVL compared to control periods., Conclusion: No new safety concerns were identified for ZVL in this study based on a novel, Australian primary care data source. An expected increased risk of ISR was identified; findings in relation to cardiovascular disease were reassuring but require confirmation using additional data, including hospital records., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Kendal Chidwick is an employee of NPS MedicineWise. The other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)

This report summarises Australian spontaneous surveillance data for adverse events following immunisation (AEFI) for 2018 reported to the Therapeutic Goods Administration and describes reporting trends over the 19-year period 1 January 2000 to 31 December 2018. There were 4221 AEFI records for vaccines administered in 2018, an annual AEFI reporting rate of 16.9 per 100,000 population. There was a 2.9% increase in the overall AEFI reporting rate in 2018 compared to 2017. This slight increase in reported adverse events in 2018 was likely due to new additions to the National Immunisation Program schedule, namely meningococcal ACWY vaccination for children aged 12 months, enhanced immunogenicity trivalent influenza vaccines for adults aged ≥65 years, and state- and territory-funded seasonal influenza vaccination programs for children aged 6 months to <5 years. AEFI reporting rates for most individual vaccines in 2018 were similar to 2017. The most commonly reported adverse events were injection site reaction (34%), pyrexia (15%), rash (15%), vomiting (8%), headache (6%) and pain (6%). Two deaths were reported to the TGA but no clear causal relationship with vaccination was found., (© Commonwealth of Australia CC BY-NC-ND.)

Objectives: To determine how soon after commencement of the seasonal influenza vaccination programme, the AusVaxSafety active vaccine safety surveillance system, currently in use across Australia, would have detected a safety signal had it been operating in 2010 when there was an unprecedented number of febrile seizures in young children associated with one specific influenza vaccine brand, Fluvax (CSL Biotherapies)., Design: Simulation study., Setting: Western Australian vaccine influenza coverage and adverse event surveillance data., Outcome Measures: Simulated solicited responses from caregivers who would have received an SMS survey about adverse events experienced following seasonal influenza vaccination of their children aged 6 months to <5 years., Participants: None., Results: We estimated a >90% probability of a safety signal being detected by AusVaxSafety based on solicited reports for either fever or medical attendance at or before the week ending 28 March 2010, 3 weeks after the start of vaccine distribution. Suspension of the national paediatric influenza vaccination programme as a result of the passive adverse events surveillance operating at the time did not occur until 23 April 2010., Conclusions: 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., Competing Interests: Competing interests: All authors are either located at organisations that hold the AusVaxSafety contract from the Australian Government Department of Health or subcontract holders., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., Competing Interests: Competing interests: All authors are either located at organisations that hold the AusVaxSafety contract from the Australian Government Department of Health or are subcontract holders., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)