EMA starts first rolling review of a COVID-19 vaccine in the EU
The European Medicines Agency (EMA) has begun a "rolling review" of the AstraZeneca Oxford SARS-CoV-2 vaccine candidate. Normal regulatory processes for medicines involve the submission of all safety and efficacy data to the Agency at the completion of clinical trials. A "rolling review" means that the Agency can begin evaluating data as it becomes available. By employing this method of approval, the regulation process will maintain its usual quality and safety standards, but be shorter than the usual process due to the time gained by reviewing data as it becomes available.
To learn more please read below:
EMA starts first rolling review of a COVID-19 vaccine in the EU
Frontiers in Immunology: Progress and Pitfalls in the Quest for Effective SARS-CoV-2 (COVID-19) Vaccines
With over 200 COVID-19 vaccine candidates currently in pre-clinical and clinical trials, the following article reviews what we know about the immune response to SARS-CoV-2 infection and explores the various vaccine platforms being utilised to develop a safe and effective vaccine. Potential issues including adverse effects and the need for mass production are also discussed, as well as the challenges of rapid and equitable vaccine delivery.
Read the article in full here:
新冠疫苗之路第15集：林恩·吉拉姆教授
在第 15 集中，我们的主持人 Nigel Crawford 副教授与 Lynn Gillam 教授进行了对话。林恩是一位接受过哲学和生物伦理学培训的临床伦理学家。她是墨尔本大学墨尔本人口与全球健康学院健康公平中心的教授；澳大利亚墨尔本皇家儿童医院儿童生物伦理中心学术主任。儿童生物伦理中心为临床医生提供有关患者护理问题的道德决策等支持。 Nigel 和 Lynn 将利用美国堪萨斯城儿童慈善医院的 John Lantos 博士在最近举行的生物伦理学电子会议上提出的观点框架，讨论 SARS-CoV-2 疫苗中提出的一些伦理问题儿童生命伦理中心主办：
- 认识到不做某事或不进行研究本身就是一个决定的重要性
- “太快不安全”的概念——有些步骤需要花他们一直采取的时间，有些事情可以更快地完成，认识到如果你什么都不做，你就会允许伤害发生
- 伦理委员会的作用和疫苗的开发方式，即在研究中使用更年轻、更健康的参与者，而不是患有最严重疾病的个人
- 儿童和老年人参与临床试验以及其伦理考虑的主要差异
- 当 SARS-CoV-2 疫苗上市时，全球公平获取疫苗的机会是什么？谁首先获得这些疫苗？应该如何做出这些决定？
- 公民陪审团在决定谁在大流行情况下优先获得疫苗方面的作用
- 强制接种疫苗
- 胎儿胚胎细胞系在疫苗开发中的应用
链接
- 澳洲金融评论：疫苗让人类面临下一次道德考验
- MVEC：用于疫苗开发平台的胎儿胚胎细胞
- 墨尔本大学：澄清可能的 COVID-19 疫苗的伦理问题
- BMC 公共卫生：让公众参与大流行病规划：一种深思熟虑的方法
- 社会科学与医学：公民陪审团在卫生政策决策中的运用：系统评价
- RCH Grand Rounds：不让大流行白白浪费——新冠危机如何带来更好的医疗保健服务
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喇叭 - 苹果 - Spotify 音乐
NEJM: Evaluating and Deploying Covid-19 Vaccines — The Importance of Transparency, Scientific Integrity, and Public Trust
The following article published in the New England Journal of Medicine, discusses the importance of adhering to well-established and transparent regulatory processes when it comes to approving a COVID-19 vaccine. Reassuring the public with robust scientific evaluation from independent bodies, without interference from governments for the purposes of political advantage, is essential to promote public confidence and ensure the success of vaccination programs.
Read the article in full here:
New immunisation reference page: Identifying AEFI in diverse skin colour
The assessment of skin for clinical signs and symptoms is important when identifying adverse events following immunisation (AEFI). Since most dermatological assessment guidelines commonly refer to the presentation of symptoms in patients with light skin tones, the identification of AEFI in a timely manner in diverse skin colours can be challenging for immunisation providers.
Our new reference page details how symptoms such as pallor, cyanosis, erythema and urticaria may appear in diverse skin colours and discusses alternate methods of recognition. For more information please follow the link below:
MVEC: Identifying AEFI in diverse skin colour
新冠疫苗之路第 14 集：布鲁斯·杰林博士
在第 14 集中，我们的主持人 Nigel Crawford 副教授与 Bruce Gellin 博士进行了对话。布鲁斯是华盛顿萨宾疫苗研究所全球免疫部门的主席。萨宾疫苗研究所的使命是让疫苗更容易获得、促进创新并在全球范围内扩大免疫接种范围。 Bruce 于 2017 年担任这一职务，在此之前，他担任美国卫生与公众服务部国家疫苗计划办公室副助理部长，并担任世界卫生组织的技术和政策顾问，重点关注流感疫苗和全球疫苗接种问题。疫苗犹豫问题。布鲁斯还曾在疾病控制和预防中心 (CDC) 工作，为全球疫苗和免疫联盟提供咨询，并且是美国疫苗和免疫接种方面的主要发言人之一。他和奈杰尔在疫苗信心的背景下讨论了以下内容：
- 牛津阿斯利康试验最近停止，以及现有系统如何完全发挥作用
- “刀具事件”及其对疫苗安全性的持续影响，特别是从生产角度来看
- 确保免疫提供者了解疫苗开发过程非常重要，就好像他们不了解并且持怀疑态度一样，这会对疫苗的吸收产生巨大影响
- 公开披露在疫苗开发途径中的重要性
- 萨宾疫苗研究所如何应对疫苗犹豫的挑战
- 萨宾针对医护人员的“Boost”计划
- 疫苗使用后如何进行监测，也称为 IV 期监测
链接：
- 萨宾疫苗研究所
- 对话：停止牛津疫苗试验并不意味着它不安全——这表明他们正在遵循正确的程序
- 保罗·奥菲特的《刀具事件》
- 萨宾疫苗研究所：免疫倡导者
- 萨宾疫苗研究所：Boost
- 《柳叶刀》：绘制疫苗信心的全球趋势并调查疫苗接种的障碍：一项大规模回顾性时间模型研究
- 《柳叶刀》：是时候认真对待疫苗信心了
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喇叭 - 苹果 - Spotify 音乐
New immunisation reference page: Injection site nodules
Injection site nodules are a rare but known adverse event following immunisation. They can occur following any vaccine and are most commonly asymptomatic and self resolving. Our new reference page describes what injection site nodules are and the implications on future immunisations.
To learn more follow the link below:
COVID19 Road to a vaccine episode 13: Professor Kim Mulholland
In episode 13, our host, Associate Professor Nigel Crawford, speaks to Professor Kim Mulholland. Kim is a paediatrician and Professor of Child Health from the Murdoch Children’s Research Institute, the University of Melbourne department of Paediatrics and the London School of Hygiene and Tropical Medicine. With post-graduate training in immunology, respiratory medicine and tropical medicine, his vast experience includes developing a program of research covering all aspects of childhood pneumonia which helped guide WHO policies. He has been involved in the oversight of many vaccine trials and has served on steering committees or DSMBs for a range of vaccines including pneumococcal, dengue, RSV and COVID-19. He and Nigel discuss:
- global issues brought about by the SARS-CoV-2 pandemic and some of the surprising ways the virus has spread globally
- what we can learn from seroprevalence in countries such as India
- vaccine nationalism and the push for global solidarity
- the role of Australia in the pacific region in regards to vaccine preparedness
- global, equitable access to COVID-19 vaccines
链接：
- Developing a Low-Cost and Accessible COVID-19 Vaccine for Global Health
- WHO Chief Urges Nations to Join in Preventing ‘Vaccine Nationalism’
- Africa declared free of wild polio
- The Meningitis Vaccine Project: A groundbreaking partnership
- GAVI vaccine alliance
Listen here:
喇叭 - 苹果 - Spotify 音乐
Check your knowledge on cold chain with MVEC's new quiz
MVEC and the Victorian DHHS Immunisation section have developed a new quiz for immunisation providers, aiming to check their knowledge on vaccine cold chain. Adherence to cold chain guidelines is essential to ensure that any vaccine administered to patients is safe and efficacious.
To access this quiz please head to the MVEC 教育门户 or click on the link below:
Halting the Oxford vaccine trial doesn't mean it's not safe- it shows they're following the right process
Due to a single event of an unexplained illness, the AstraZeneca Oxford group have announced a voluntary pause on all vaccinations across all sites of their COVID-19 vaccine candidate clinical trial. This pause will allow an independent committee to review the safety data and investigate the incident.
The following article, published in The Conversation, outlines how this halt doesn't necessarily indicate that the vaccine is not safe, but reflects the robust processes for clinical trials. It is important to recognise that whilst these clinical trials are moving at pandemic speed, safety is not being compromised.