Nuvaxovid NVX-CoV2373 vaccine safety profile: real-world data evidence after 100,000 doses, Australia, 2022 to 2023.

IntroductionNuvaxovid became available in Australia from February 2022, a year after the first COVID-19 vaccines. This protein-based vaccine was an alternative for people who had had an adverse event to and/or were hesitant to receive an mRNA or adenovirus-based COVID-19 vaccine. Although safety from clinical trials was reassuring, small trial populations, low administration rates and limited post-licensure intelligence meant potential rare adverse events were underinformed.

Systematic Review of Avian Influenza Virus Infection and Outcomes during Pregnancy.

Human cases of avian influenza A(H5N2) and A(H5N1) viruses associated with outbreaks in birds and mammals are increasing globally, raising concerns about the possibility of a future avian influenza pandemic. We conducted a systematic review examining 30 reported cases of avian influenza in pregnant women. We found high mortality rates for mothers (90.

Clinical phenotype of COVID-19 vaccine-associated myocarditis in Victoria, 2021-22: a cross-sectional study.

Objectives: To describe myocarditis as an adverse event after coronavirus disease 2019 (COVID-19) vaccination, including a detailed description of clinical phenotypes and diagnostic test results and differences by age, sex, and degree of troponin level elevation.

Study Design: Retrospective cross-sectional study.

Setting, Participants: Cases of suspected myocarditis following the administration of a COVID-19 vaccine in Victoria during 22 February 2021 - 30 September 2022 reported to Surveillance of Adverse Events Following Vaccination In the Community (SAEFVIC), with symptom onset within 14 days of vaccination, and deemed to be confirmed myocarditis according to the Brighton Collaboration Criteria.

Protocol for an embedded randomised controlled trial of Early versus Late Stopping of Antibiotics in children with Febrile Neutropenia (ELSA-FN).

In children with cancer, febrile neutropenia (FN) is one of the most common complications of treatment, a leading cause of unplanned and prolonged hospital admission and is the key driver of antibiotic exposure. Co-designed with key stakeholders, 'Early versus Late Stopping of Antibiotics in high-risk FN' (ELSA-FN) is a randomised controlled, non-inferiority trial that compares stopping antibiotics in clinically stable patients after 48 hours with the current standard of care, continuing antibiotics until absolute neutrophil recovery. As an Australian first, we will exploit the potential of electronic medical record (EMR) systems, embedding all key aspects of the trial including screening, consent, randomisation and data collection into standard clinical and EMR workflows.

Comprehensive humoral and cellular immune responses to COVID-19 vaccination in adults with cancer.

Background: The COVID-19 pandemic has significantly impacted people with cancer. Initial vaccine studies excluded patients with malignancy. Immunocompromised individuals remain vulnerable to SARS-CoV-2, necessitating detailed understanding of vaccine response.

Is neutrophil to lymphocyte ratio an accurate predictor of neonatal sepsis in premature infants?

Background: Sepsis is a significant cause of neonatal mortality. Both clinical and laboratory markers are often non- specific, and a blood culture contaminant may confuse management of the infant. This study aims to use an existing, inexpensive test, the neutrophil-to-lymphocyte ratio (NLR), to predict culture positivity and thus optimise antibiotic management.

Design and evaluation of a visual genomic explainer: a mixed-methods study.

Objective: To design and assess a visual genomic explainer focusing on plain language and engaging imagery. The explainer aimed to support doctors' comprehension of complex genomic concepts and results and act as a resource promoting the integration of genomic testing into mainstream care.

Design: Prospective genomic resource development and questionnaire.

Exploring Large Language Models for Detecting Online Vaccine Reactions.

Social media offers a rich source of real-time health data, including potential vaccine reactions. However, extracting meaningful insights is challenging due to the noisy nature of social media content. This paper explores using large language models (LLMs) and prompt engineering to detect personal mentions of vaccine reactions.

Detailed review of mortality reported following COVID-19 vaccination in Victoria, Australia: 2021-2023.

Introduction: The scale of the COVID-19 vaccine program, and appropriate focus on older individuals, emphasised monitoring of mortality as an important part of COVID-19 vaccine safety surveillance, noting many deaths temporally associated with vaccination may not be causally related. This cross-sectional study describes Victoria's vaccine safety service (SAEFVIC) process of reviewing mortality reports following COVID-19 vaccination, summarises report characteristics and identifies trends in mortality reporting.

Methods: Mortality cases reported to SAEFVIC following COVID-19 vaccination from 22 February 2021 to 22 February 2023 were included.

Establishing the Vaccine Safety Health Link: A large, linked data resource for the investigation of vaccine safety concerns.

Objective: Post-licensure vaccine safety surveillance of adverse events following immunisation is critical to ensure public safety and confidence in vaccines. This paper aims to describe the governance structure and data linkage methodology behind the establishment of the largest linked vaccine safety surveillance data resource in Australia - The Vaccine Safety Health Link (VSHL).

Methods: The Vaccine Safety Health Link contains linked records from the Australian Immunisation Register with records from hospital, perinatal, mortality, and notifiable disease datasets in near real-time.

Pandemic Incident Management for Vaccine Safety Challenges: Victoria's Alert Advisory Group Experience.

Safe vaccines are critical for biosecurity protection, yet adverse events-rightly or wrongly attributed to immunization-potentially cause rapid loss of confidence, reduced vaccine uptake, and resurgence of preventable disease. Effective vaccine safety incident management is essential to provide assessment and lead appropriate actions to ensure vaccination programs are safe and mitigate unwarranted crisis escalation that could damage vaccine programs and the effective control of vaccine preventable disease outbreaks or pandemics. Incident management systems (IMS) are used globally to direct emergency management response, particularly for natural disasters of fire, flood, and storm.

Near Real-Time Syndromic Surveillance of Emergency Department Triage Texts Using Natural Language Processing: Case Study in Febrile Convulsion Detection.

Background: Collecting information on adverse events following immunization from as many sources as possible is critical for promptly identifying potential safety concerns and taking appropriate actions. Febrile convulsions are recognized as an important potential reaction to vaccination in children aged <6 years.

Objective: The primary aim of this study was to evaluate the performance of natural language processing techniques and machine learning (ML) models for the rapid detection of febrile convulsion presentations in emergency departments (EDs), especially with respect to the minimum training data requirements to obtain optimum model performance.

Kawasaki Disease and Respiratory Viruses: Ecological Spatiotemporal Analysis.

Background: Kawasaki disease is an uncommon vasculitis affecting young children. Its etiology is not completely understood, although infections have been frequently postulated as the triggers. Respiratory viruses, specifically, have often been implicated as causative agents for Kawasaki disease presentations.

Validation of the newly proposed Brighton Collaboration case definition for vaccine-induced immune thrombocytopenia and thrombosis.

Vaccine-induced immune thrombocytopenia and thrombosis (VITT) is a newly recognized syndrome mediated by anti-platelet factor 4 antibodies induced by Covid-19 adenovirus-vectored vaccines including ChAdOx1 nCoV-19 and Ad26.COV2.S.

Laboratory-confirmed respiratory viral infection triggers for acute myocardial infarction and stroke: Systematic review protocol.

Background: Cardiovascular disease contributes substantially to global mortality and morbidity. Respiratory tract infections, particularly influenza, may trigger an increase in the short-term risk of acute myocardial infarction (AMI) and stroke. Recent studies have also linked this risk to other respiratory viruses, including respiratory syncytial virus (RSV) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Exploring the Health-Related Quality of Life and the Lived Experience of Adolescents Following Invasive Meningococcal Disease.

Background: Data on the health-related quality of life (HRQoL) for invasive meningococcal disease (IMD) survivors, particularly among adolescents and young adults (AYAs), are limited. This study aimed to investigate the in-depth experiences and impacts of IMD on AYAs.

Methods: Participants were recruited from two Australian states, Victoria and South Australia.

Opportunities and Barriers to Pediatric Antimicrobial Stewardship by Community Pharmacists.

Community Pharmacists (CPs) are easily accessible and can advocate for the appropriate use of antibiotics in children. Semi-structured interviews were conducted with 47 CPs and 46 parents/caregivers. Both groups expressed challenges to intervening when antibiotics have already been prescribed and highlighted the need for more support for CPs to make informed decisions.

Letter to the Editor: A comparison of post-COVID vaccine myocarditis classification using the Brighton Collaboration criteria versus (United States) Centers for Disease Control criteria: an update.

(No abstract provided).

Safety of Hepatitis B Vaccines (Monovalent or as Part of Combination) in Preterm Infants: A Systematic Review.

: The World Health Organization (WHO) recommends vaccination against hepatitis B as soon as possible following birth for all infants, regardless of prematurity. Hepatitis B vaccination at birth is clearly justified, represents a crucial step in the global control of perinatally acquired hepatitis B and there are no safety concerns in infants born at term. However, there is limited information on the safety of the hepatitis B vaccine in preterm infants, whose immune responses and morbidity risk differ from those in infants born at term.

Audiovestibular adverse events following COVID-19 vaccinations.

Introduction: Evidence regarding audiovestibular adverse events post COVID-19 vaccination to date has been inconclusive regarding a potential association. This study aimed to determine if there was an increase in audiovestibular events following COVID-19 vaccination in South-eastern Australia during January 2021-March 2023.

Methods: A multi-data source approach was applied.

Exploring the Infectious Contribution to Intussusception Causality Using the Effects of COVID-19 Lockdowns in Australia: An Ecological Study.

Background: Intussusception is the primary cause of acute bowel obstruction in infants. The majority of cases <2 years of age are classed as idiopathic, with viral infection implicated as one of the causes. Coronavirus disease 2019 (COVID-19) public health measures led to significant decreases in communicable disease prevalence.