Surveillance of adverse events following immunisation in Australia, COVID-19 vaccines, 2021.

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.

Surveillance of adverse events following immunisation in Australia annual report, 2021.

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.

The development and evaluation of a vaccination pathway for children with intellectual and developmental disability and needle fear.

This qualitative study describes the development and evaluation of a clinical pathway to facilitate the implementation of catch-up vaccinations for children with significant needle fear, particularly in children with developmental disabilities. The Specialist Immunization Team, based at a tertiary level teaching children's hospital, participated in process mapping activities using Motivational Interviewing (MI) techniques and reflective discussions. Team members developed a clinical pathway by incorporating parental feedback from semistructured interviews and clinical expertise from within the team, facilitated by colleagues from the Child Development Unit. A process map was developed that included process strengths and touch points with an action plan that was discussed and agreed upon. A repeat process mapping activity was conducted 16 months later. Reports from parental feedback included: positive, efficient, and successful experiences of having their child undergo catch-up vaccinations. The experience empowered families for further procedures. Team members reported improvements in triaging appropriate children for the pathway, and an increase in confidence to interact and manage behaviors of children with significant anxiety and challenging behaviors. They also reported an increase in successful vaccinations with improved clinical judgment of facilitating the sedation pathway. This study demonstrates that using group facilitation using motivational interviewing in reflective discussions and process mapping utilizing parent and staff feedback in service improvement activities results in efficient and successful service delivery with improved patient outcomes.

The clinicopathological features of thrombosis with thrombocytopenia syndrome following ChAdOx1-S (AZD1222) vaccination and case outcomes in Australia: a population-based study.

Background: Thrombosis with thrombocytopenia syndrome (TTS) associated with viral vector COVID-19 vaccines, including ChAdOx1-S (AstraZeneca AZD1222) vaccine, can result in significant morbidity and mortality. We report the clinicopathological features of TTS following ChAdOx1-S vaccination and summarise the case outcomes in Australia. Methods: In this cohort study, patients diagnosed with TTS in Australia between 23 March and 31 December 2021 were identified according to predefined criteria. Cases were included if they met the Therapeutic Goods Administration (TGA) probable and confirmed case definitions and were reclassified using Centres for Disease Control and Prevention (CDC) definition for analysis. Data were collected on patient baseline characteristics, clinicopathological features, risk factors, treatment and outcomes. Findings: A total of 170 TTS cases were identified, with most occurring after the first dose (87%) of ChAdOx1-S. The median time to symptom onset after vaccination and symptom onset to admission was 11 and 2 days respectively. The median age of cases was 66 years (interquartile range 55-74). All except two patients received therapeutic anticoagulation and 66% received intravenous immunoglobulin. Overall, 85.3% of cases were discharged home after a median hospitalisation of 6 days, 9.4% required ongoing rehabilitation and 5.3% died. Eight deaths were related to TTS, with another dying from an unrelated condition while receiving treatment for TTS. Deaths occurred more commonly in those classified as Tier 1 according to the CDC definition and were associated with more severe thrombocytopenia and disease-related haemorrhage. Interpretation: TTS, while rare, can be severe and have catastrophic outcomes in some individuals. In Australia, the mortality rate was low compared to that reported in other high-income countries. Almost all received therapeutic anticoagulation with no bleeding complications and were successfully discharged. This emphasises the importance of community education and an established pathway for early recognition, diagnosis and treatment of TTS. Funding: Australian Commonwealth Department of Health and Aged Care. H.A Tran, N. Wood, J. Buttery, N.W. Crawford, S.D. Chunilal, V.M. Chen are supported by Medical Research Future Funds (MRFF) grant ID 2015305.

Use of adrenaline to manage suspected anaphylaxis following COVID-19 vaccination: An Australian retrospective cohort study.

BACKGROUND: The rate of anaphylaxis following COVID-19 vaccinations is estimated to be 2-11 cases per million doses administered. However, adrenaline is occasionally used in individuals who are later diagnosed with immunisation stress-related responses, as their initial presenting signs and symptoms can appear similar to that of anaphylaxis. This study aims to describe the clinical profile of individuals who had received adrenaline following a COVID-19 vaccine and their subsequent revaccination outcomes. METHODS: We examined notifications of cases who had received adrenaline following a COVID-19 vaccine in New South Wales, Australia. The cases were classified into Brighton Collaboration Case Definition (BCCD) for anaphylaxis, their clinical presentation, management and subsequent revaccination outcomes were compared. RESULTS: From 22 February 2021 to 30 September 2021, there were 222 cases where adrenaline was administered. Of these, 32 (14 %) fulfilled Level 1 BCCD, 59 (27%) Level 2, 2 (1%) Level 3, 97 (44%) Level 4 and 32 (14 %) Level 5. The most commonly reported symptoms were sensation of throat closure (n = 116, 52%), difficulty breathing (n = 82, 37%) and nausea (n = 55, 25 %). Of the 176 (79%) individuals who proceeded to further vaccination, 89 (51%) received the same vaccine formulation and only 14 (8%) experienced another allergic adverse event with 9 (5%) receiving adrenaline. CONCLUSION: Less than one in five individuals who received adrenaline met Level 1 BCCD criteria for anaphylaxis. Many reactions that were treated with adrenaline had little to no diagnostic certainty of anaphylaxis and in such cases repeat vaccination had a high likelihood of being tolerated. Increased awareness and education on objective signs and symptoms of anaphylaxis is required to ensure appropriate use of adrenaline.

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.

Background incidence rates of selected adverse events of special interest (AESI) to monitor the safety of COVID-19 vaccines.

BACKGROUND: Determining background rates of medical conditions identified as adverse events of special interest (AESI) that may occur following COVID-19 vaccination is important for contextualising and investigating potential vaccine safety signals. METHODS: We conducted a retrospective population-based cohort study using linked emergency department, hospitalisation and death data for 2017 and 2018 from Australia's most populous state, New South Wales. Incident cases of select neurological conditions, arterial or venous thromboembolic conditions, secondary thrombocytopenia, myocarditis/pericarditis, and unique events of anaphylaxis and generalised convulsions were identified using internationally agreed upon diagnostic (ICD-10) codes. State-specific rates per 100,000 person-years were calculated, with further stratification by age group and sex where clinically relevant to the condition, and the number of expected cases nationally in one and 6 weeks was estimated. RESULTS: Background rates of selected neurological conditions were low with the exception of generalised convulsions for which 1,599-1,872 cases were estimated nationally in a 1-week period in the absence of vaccination. Using a narrow case definition, rates of Guillain-Barré Syndrome (3.9 per 100,000 person-years) were higher than international rates reported elsewhere. Thromboembolic and cerebral venous sinus thrombosis event rates increased with age. Myocarditis occurred more commonly in males, and was highest in males aged 18-24 years, with an estimated 1-4 cases expected nationally in a 1-week period. CONCLUSIONS: Using routinely collected linked healthcare data provides localised estimates of background rates of new onset or periodic AESI which enables rapid estimation of observed-versus-expected rates of events reported following COVID-19 vaccination. This Australian-specific analysis contributes AESI background rates which can be compared with those from other countries to enhance understanding of geographic variability in the frequency of specific AESI in the absence of vaccination, and can be utilised for signal detection during program implementation.

Safety of Four COVID-19 Vaccines across Primary Doses 1, 2, 3 and Booster: A Prospective Cohort Study of Australian Community Pharmacy Vaccinations.

Four COVID-19 vaccines are approved for use in Australia: Pfizer-BioNTech BNT162b2 (Comirnaty), AstraZeneca ChAdOx1 (Vaxzevria), Moderna mRNA-1273 (Spikevax) and Novavax NVX-CoV2373 (Nuvaxovid). We sought to examine adverse events following immunisation (AEFI) at days 3 and 42 after primary doses 1, 2, 3 and booster. We conducted active vaccine safety surveillance from 130 community pharmacies in Australia integrated with AusVaxSafety, between August 2021-April 2022. Main outcomes: AEFI at 0-3 days post-vaccination; medical review/advice at 3 days and 42 days post-vaccination; SARS-CoV-2 breakthrough infection by day 42. Of 110,024 completed day 3 surveys (43.6% response rate), 50,367 (45.8%) reported any AEFI (highest proportions: Pfizer 42%, primary dose 3; AstraZeneca 58.3%, primary dose 1; Moderna 65.4% and Novavax 58.8%, both primary dose 2). The most common AEFI reported across all doses/vaccines were local reactions, systemic aches and fatigue/tiredness. Overall, 2172/110,024 (2.0%) and 1182/55,329 (2.1%) respondents sought medical review at days 3 and 42, respectively, and 931/42,318 (2.2%) reported breakthrough SARS-CoV-2 infection at day 42. We identified similar AEFI profiles but at lower proportions than previously reported for Pfizer, AstraZeneca, Moderna and Novavax COVID-19 vaccines. Moderna vaccine was the most reactogenic and associated with higher AEFI proportions across primary doses 2, 3, and booster.

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.

Surveillance of adverse events following immunisation in Australia annual report, 2020.

This report summarises Australian spontaneous surveillance data for adverse events following immunisation (AEFI) for 2020, reported to the Therapeutic Goods Administration (TGA), and describes reporting trends over the 21-year period from 1 January 2000 to 31 December 2020. There were 3,827 AEFI records for vaccines administered in 2020, an annual AEFI reporting rate of 14.9 per 100,000 population. There was a slight (3.8%) decrease in the overall AEFI reporting rate in 2020 compared with 2019 (15.5 per 100,000 population). This decrease in the AEFI reporting rate in 2020 is potentially due to the impact of coronavirus disease 2019 (COVID-19) and was mainly from a decline in reported adverse events related to HPV, dTpa, and seasonal influenza vaccines. AEFI reporting rates for most individual vaccines in 2020 were similar to 2019. The most commonly reported adverse events were injection site reaction (37.1%); pyrexia (18.1%); rash (15.8%); vomiting (7.6%); pain (7.4%); headache (5.7%); and urticaria (5.1%). There were six deaths reported to the TGA. In one of the reports, the timing and clinical findings were consistent with a causal association with vaccination. In the remaining five reports, no clear causal relationship with vaccination was found.

Household transmission of COVID-19 in 2020 in New South Wales, Australia.

Households are high-risk settings for the transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This study examines factors associated with transmission among cases diagnosed with coronavirus disease 2019 (COVID-19) and their household contacts, in New South Wales (NSW), Australia, during July-October 2020. A register of all laboratory-confirmed COVID-19 cases was used to extract demographic and clinical information for cases and household contacts. Secondary attack rates (SARs) among household members were calculated and generalised estimating equations were used to estimate risks of transmission in relation to various characteristics of the primary case and the household contacts. In total, 229 households were included; they consisted of 229 primary cases and 659 close contacts. The overall household SAR was 22.5% (148/659). After adjusting for symptoms, age and sex of primary case, spouse status of household contacts and household size, the odds of secondary transmission were lower in primary cases who were asymptomatic at diagnosis than in symptomatic cases (odds ratio, OR: 0.13; 95% confidence interval (95% CI): 0.04-0.48); and higher in primary cases aged 60 years and over than in those aged 19-39 years (OR: 3.45; 95% CI: 1.53- 7.75). Being a spouse of the primary case was also associated with increased transmission compared to non-spouses (OR: 1.93; 95% CI: 1.24-3.02). After adjustments, there was no significant effect on transmission of the primary case's sex, or of the number of people in the household. This study documents demographic and clinical characteristics that increase transmission rates in households in the period prior to the introduction of SARS-CoV-2 variants. These data can be used as a baseline from which to compare household transmission in outbreaks dominated by new variants.

Status epilepticus following vaccination in children aged ≤24 months: A five-year retrospective observational study.

BACKGROUND: Status epilepticus is associated with significant morbidity and mortality. While vaccine-proximate status epilepticus (VP-SE) has rarely been associated with cases of Dravet syndrome, it is not known whether VP-SE differs clinically from non-vaccine proximate status epilepticus (NVP-SE). METHODS: Medical records of children aged ≤24 months, presenting to one of five Australian tertiary pediatric hospitals with their first episode of status epilepticus from 2013 to 2017 were identified using ICD-coded discharge diagnoses. Vaccination history was obtained from the Australian Immunisation Register. Hospitalization details, subsequent epilepsy diagnosis, and vaccination uptake were compared between VP-SE and NVP-SE cases. RESULTS: Of 245 first status epilepticus hospitalization with immunization records, 35 (14%) were VP-SE and 21 (60%) followed measles-containing vaccines. Vaccine-proximate status epilepticus cases had a median age of 12.5 months [IQR 7.1-14.73], 23 (66%) were in males, 15 (43%) were febrile status epilepticus and 17 (49%) had an infection confirmed. There were no significant differences in hospitalization duration (P = 0.50) or intensive care unit admission (P = 0.42) between children with VP-SE compared to children with NVP-SE. Children with no history of seizures at their first VP-SE had longer hospitalizations, were more likely to require intensive care unit admission, but were less likely to have a subsequent diagnosis of epilepsy than children with previous seizures at their first VP-SE. CONCLUSION: First VP-SE was predominantly associated with a measles-containing vaccine at 12-months of age. Seizure severity was no different between first VP-SE and first NVP-SE. In children with VP-SE, subsequent seizure admissions and epilepsy diagnosis were associated with having seizure prior to their first SE.

Usability, acceptability, and feasibility of a High-Density Microarray Patch (HD-MAP) applicator as a delivery method for vaccination in clinical settings.

BACKGROUND: High-density microarray patch (HD-MAP) vaccines may increase vaccine acceptance and use. We aimed to ascertain whether professional immunizers (PIs) and other healthcare workers (HCWs) in Australia, a High-Income Country (HIC), found the HD-MAP applicator usable and acceptable for vaccine delivery. METHODS: This feasibility study recruited PIs and HCWs to administer/receive simulated HD-MAP administration, including via self-administration. We assessed usability against essential and desirable criteria. Participants completed a survey, rating their agreement to statements about HD-MAP administration. A subset also participated in an interview or focus group. Survey data were analyzed using descriptive statistics, and interviews were transcribed and subject to thematic analysis. RESULTS: We recruited 61 participants: 23 PIs and 38 HCWs. Findings indicated high usability and acceptability of HD-MAP use across both groups by a healthcare professional or trained user and for self-administration with safety measures in place. Most administrations met essential criteria, but PIs, on average, applied the HD-MAP for slightly less time than the required 10-seconds, which the HCWs achieved. PIs perceived safety concerns about home administration but found layperson self-administration acceptable in an emergency, pandemic, and rural or remote settings. CONCLUSIONS: Participants found HD-MAP administration usable and acceptable. Usability and acceptability are likely to be improved through end-user education and training.

Professional immunizers and healthcare workers found high-density microarray patch devices highly usable and acceptable to administer vaccines.HD-MAPs may have advantages over intramuscular injections in clinical settings and in pandemics.Vaccination with HD-MAP may improve acceptance for those with needle-related anxiety.

Status epilepticus outcomes among vaccinated and unvaccinated children: A population-based study.

AIM: To determine the proportion of first status epilepticus (SE) cases that are vaccine-proximate (VP-) and compare clinical outcomes to non-vaccine-proximate (NVP-) cases. METHODS: Birth records for 1,440,807 Australian children born in 1998-2012, were probabilistically linked to hospitalizations, deaths, and vaccination history available to 2013. First SE coded hospitalizations were categorized as VP-SE or NVP-SE; clinical severity and post-SE vaccination coverage were compared. SE rates were calculated. RESULTS: Of 867 first SE cases (7.9 per 100,000 person-years), 31 (3.6%) were VP-SE; 16 followed dose-1 measles vaccine (1.2 SE per 100,000 doses). Compared with NVP-SE, VP-SE cases were younger (1.0 vs 2.6 years, P < 0.0001) and had longer hospitalizations (4 vs 3 days, P = 0.005). There was no difference in the proportion of VP-SE cases with a coinfection diagnosis compared to NVP-SE (25.8% vs 19.9%, P = 0.42). Controlling for age and history of hospitalization for a neurological condition, intensive care unit (ICU) admission had a stronger association with coinfection (aOR 2.52 (95%CI 1.78-3.57)) than having VP-SE (aOR 1.41 (0.66-3.01)). Groups had similar SE recurrence rates at 12-months (12.9% VP vs 16.9% NVP, P = 0.56) and reduced vaccine uptake following initial SE (from 93.5% to 56.3%). CONCLUSION: Proportionally few first SE cases were VP-SE, with higher ICU admission rates mostly explained by younger age and higher coinfection rates. Vaccination plans are needed to improve vaccine uptake following SE.

Respiratory Syncytial Virus-Associated Neurologic Complications in Children: A Systematic Review and Aggregated Case Series.

OBJECTIVES: To describe the features and frequency of respiratory syncytial virus (RSV)-associated severe acute neurologic disease in children. STUDY DESIGN: We performed a systematic review of the literature to identify reports of severe acute neurologic complications associated with acute RSV infection in children aged <15 years (PROSPERO Registration CRD42019125722). Main outcomes included neurologic, clinical, and demographic features of cases and the frequency of disease. We aggregated available case data from the published literature and from the Australian Acute Childhood Encephalitis (ACE) study. RESULTS: We identified 87 unique studies from 26 countries describing a spectrum of RSV-associated severe acute neurologic syndromes including proven encephalitis, acute encephalopathy, complex seizures, hyponatremic seizures, and immune-mediated disorders. The frequency of RSV infection in acute childhood encephalitis/encephalopathy was 1.2%-6.5%. We aggregated data from 155 individual cases with RSV-associated severe acute neurologic complications; median age was 11.0 months (IQR 2.0-21.5), most were previously healthy (71/104, 68%). Seizure was the most frequently reported neurologic feature (127/150, 85%). RSV was detected in the central nervous system of 12 cases. Most children recovered (81/122, 66%); however, some reports described partial recovery (33/122, 27%) and death (8/122, 7%). CONCLUSIONS: RSV-associated neurologic complications have been widely reported, but there is substantial heterogeneity in the design and quality of existing studies. The findings from our study have implications for the investigation, management, and prevention of RSV-associated neurologic complications. Further, this systematic review can inform the design of future studies aiming to quantify the burden of childhood RSV-associated neurologic disease.

Revaccination outcomes of children with vaccine proximate seizures.

BACKGROUND: Seizures, whether febrile or afebrile, occurring within 14 days following vaccination can be considered as vaccine proximate seizures (VPSs). While the attributable risk and clinical severity of first febrile VPS is well known, the risk and clinical outcomes of VPS recurrence is less well defined. METHODS: We conducted a retrospective review of revaccination management and outcomes in children who experienced a VPS as their first seizure seen in Australian Specialist Immunisation Clinics between 2013 and 2017. Vaccination outcomes were compared between children who had a VPS as their only seizure (VPS only) and children who had further non-vaccine proximate seizures following their initial VPS (VPS+) prior to review at the clinic. RESULTS: We identified 119 children with a VPS as their first seizure, of which 61 (51%) went on to have other seizures (VPS+). Children with VPS+ were more likely to present at a younger age (6.2 vs 12.5 months, P = 0.03), with afebrile seizures (42.6% vs 15.5%, P = 0.002) compared to VPS only children. VPS recurrence on revaccination was uncommon in both groups, but more common in VPS+ children (12.5% vs 2.4%, P = 0.07). Having an epilepsy diagnosis, specifically Dravet syndrome, was associated with VPS recurrence (P < 0.001). Of the four children with Dravet syndrome who had VPS recurrence, all had status epilepticus following revaccination. CONCLUSION: In children who presented with a single VPS as their only seizure, VPS recurrence on revaccination was uncommon. Children who had multiple non-vaccine proximate seizures following their initial VPS (VPS+) were more likely to present with afebrile VPS, at a younger age and have a VPS recurrence with vaccination. In these children, particularly those aged < 12 months, assessment and investigation for diagnosis of Dravet syndrome should be considered and additional precautions for revaccination undertaken as they are at highest risk of VPS recurrence.

Longer term outcomes following serogroup B invasive meningococcal disease.

AIM: To characterise the physical, psychological, and quality of life burden associated with serogroup B invasive meningococcal disease (IMD) in children. METHODS: Children aged up to 14 years at the time of serogroup B IMD, who were admitted to intensive care units of two tertiary paediatric hospitals in New South Wales, Australia between January 2009 and December 2013 were recruited. Children underwent clinical and neuropsychological assessments up to 6 years post-disease. RESULTS: Eleven children were assessed, with a median age of 16 months (range 4-46 months) at time of disease. The median follow-up time was 50 months (range 10-67 months). Seven (63.6%) cases had one or more long-term sequelae involving permanent and evolving physical disability. Three cases had ongoing medical conditions including two with seizures and one with ataxia and hypermetropia. Five required ongoing medical and allied health care. Other complications identified included anxiety, speech delay, low average full-scale IQ score (median 85, interquartile range 89-103) and borderline memory impairment. CONCLUSIONS: Serogroup B IMD is associated with significant long-term morbidity and burden on the child and family with substantial economic implications. The impact of this on the total cost of IMD needs to be further quantified, and better considered in vaccine cost-effectiveness analyses.

Seizures following vaccination in children: Risks, outcomes and management of subsequent revaccination.

BACKGROUND: Seizures and status epilepticus can occur within 14 days following administration of inactivated and live-attenuated vaccines. These vaccine-proximate seizures can undermine parental confidence in vaccine safety and affect further vaccination decisions. Vaccine-proximate status epilepticus (VP-SE) is uncommon but may be the first manifestation of genetic developmental epileptic encephalopathies, including Dravet syndrome. OBJECTIVE: The aim of this article is to review current literature on the risks and outcomes of vaccine-proximate seizures and, using two clinical scenarios, outline management of subsequent revaccination. DISCUSSION: Vaccine-proximate seizures require careful evaluation of the vaccine(s) involved, seizure type and duration to determine a safe course for revaccination. Vaccine-proximate febrile seizures (VP-FSs) have similar outcomes to other febrile seizures and are not associated with increased developmental or behavioural concerns. Vaccination for children with VP-FSs can occur safely in the community. However, VP-SE cases warrant prompt specialist review, consideration of genetic epilepsy testing and referral to a specialist immunisation clinic for subsequent vaccination under medical supervision.