TGA COVID-19 resource hub
The Therapeutic Goods Administration (TGA) have developed a dedicated COVID-19 resource hub to host information for consumers, health care professionals and sponsors. This hub details the COVID-19 vaccine approval process for Australia, common questions relating to COVID-19 vaccine safety, quality and effectiveness, as well as the regulatory processes and requirements.
To view this page please follow the link below:
Therapeutic Goods Administration: COVID-19 vaccines
Aljazeera: COVID-19 vaccines explained in maps and charts
The following article gives an overview of the various vaccine platforms being utilised to develop a COVID-19 vaccine, and outlines which vaccines are currenly in human trials.
To read more follow the link below.:
Aljazeera: COVID-19 vaccines explained in maps and charts
NCIRS webinar- SARS-CoV-2 vaccine development: Is a finish line in sight?
The National Centre for Immunisation Research and Surveillance (NCIRS), have recently hosted a webinar titled: SARS-CoV-2 vaccine development: Is a finish line in sight?
Associate Professor Chris Blythe and Dr Melanie Saville present the current COVID-19 vaccine development landscape, Coalition for Epidemic Preparedness Innovations (CEPI) and the COVAX response, and the ethical and logistical implications of global vaccine implementation.
To view this webinar please follow the link below:
NCIRS- SARS-CoV-2 vaccine development: Is a finish line in sight?
MMWR：免疫实践咨询委员会关于分配 COVID-19 疫苗初始供应的道德原则 - 美国，2020 年
Once a COVID-19 vaccine has been approved for use, it is expected that the initial supply will be limited. The Advisory Committee on Immunization Practices (ACIP) in the United States, has published it's approach for recommending and allocating COVID-19 vaccines to the American population. In addition to scientific data, decisions on the allocation of COVID-19 vaccines will be based around 4 ethical principles. These include: the need to maximise benefit and minimise harm, promote justice, mitigate health inequities and promote transparency.
要阅读全文，请参阅以下链接：
Complete program for the December CVU now available
The next Clinical Vaccinology Update will be held virtually on December 7.
We are excited to welcome both local and international presenters covering a wide range of immunisation topics including COVID-19 vaccine updates, vaccine communication and confidence, influenza vaccines, Zostavax® and measles.
To view the complete program and to purchase tickets, please follow the link below to our Events page:
Clinical Vaccinology Update: December 7 2020
COVID19 疫苗之路的最后一集：Walter Orenstein 教授
在本播客系列的最后一集中，我们的主持人 Nigel Crawford 副教授与 Walter Orenstein 教授进行了交谈。 Orenstein 博士是埃默里大学医学、流行病学、全球健康和儿科学教授；埃默里疫苗中心副主任兼埃默里疫苗政策与开发部主任。 Orenstein 博士是疫苗学专家，曾在美国疾病控制和预防中心工作，担任美国免疫规划署署长，目前是多个 WHO 小组的成员。此外，他还是疫苗教科书 Plotkin's Vaccines 的共同编辑，7日 版。在这一集中，他们讨论了：
- 在 SARS-CoV-2 大流行和疫苗开发的背景下可以从 Plotkin 的疫苗中吸取的教训
- 最近的新闻稿显示了由辉瑞/BioNTech 和 Moderna 开发的两种 mRNA COVID-19 候选疫苗的有希望的早期结果
- 一旦使用疫苗，持续监测疫苗的安全性和有效性的关键作用
- 当疫苗可用时可能最优先的群体
- 儿童在 SARS-CoV-2 传播中的作用以及他们是否需要接种疫苗
- SARS-CoV-2 疫苗保护相关性的重要性
- 需要监测疫苗相关的增强型疾病 (VAED)
- 免疫接种提供者支持免疫接种后不良事件 (AEFI) 报告的重要性
- 沟通在支持疫苗接受和采用方面的重要性
- 研制 COVID-19 疫苗的关键后续步骤：更好地了解需要多少剂量以及何时需要，确定优先次序，以便最有效地使用疫苗（具有明确的分配系统）；并向公众传达社会疏远和戴口罩将持续一段时间，因为不会立即达到正常水平，即使有令人兴奋的新型有效 COVID-19 疫苗
链接：
- 普洛特金的疫苗，7日 编辑
- 辉瑞/BioNTech 完成 COVID-19 候选疫苗的第 3 阶段研究，满足所有主要疗效终点
- Moderna 的 COVID-19 候选疫苗在 3 期 COVE 研究的第一次中期分析中达到了其主要疗效终点
你可以在这里收听这一集：
喇叭 - 苹果 - Spotify 音乐
The Lancet - Emergency use authorisation for COVID-19 vaccines: lessons from Ebola
In order to increase public acceptance of an emergency use authorisation for COVID-19 vaccines, the following article in The Lancet suggests that lessons can be learnt from previous experiences with Ebola virus vaccines in Guinea and the Democratic Republic on the Congo.
Emergency use authorisation allows the public to access promising medicinal products prior to licensing and registration. In the setting of a public health emergency, their use may be ethically justified if certain conditions are met.
By having a transparent evaluation process, ensuring that it meets a favourable benefit-risk ratio based on quality and safety data, and having an accountable system of regulatory oversight and monitoring, the ethical quality and overall acceptance of a COVID-19 vaccine can be improved.
要阅读更多信息，请点击以下链接：
The Lancet - Emergency use authorisation for COVID-19 vaccines: lessons from Ebola
The Conversation: Moderna’s COVID vaccine reports 95% efficacy
The American biotech company Moderna has released early data from phase III clinical trials, announcing that its COVID-19 vaccine has an efficacy level of 94.5%.
Like Pfizer's vaccine, the Moderna vaccine is also an mRNA (messenger RNA) vaccine, however will be easier to distribute as its temperature requirements are 4℃ for 30 days (rather than -70℃ as in the case of the Pfizer vaccine); and for storage requirements beyond 30 days it needs to be kept at -20℃.
The stage III trial involved 30,000 participants, out of those 95 people developed COVID-19 in the week after the final vaccination, with 90 of those being in the placebo group and only 5 in the group who received the COVID vaccine.
It is unknown how long protection from this vaccine lasts and how effective it is in the elderly, pregnant women or those with a chronic illness; however, in results Moderna published in September the vaccine produced a similar amount of antibodies in adults over 70 as adults under 70 years of age. It did however induce fewer T cells in people aged over 71, so at this stage it is not know whether this will result in lower protection or shorter lasting immunity in the elderly.
疫苗播客
随着 2020 年接近尾声，人们乐观地认为，安全有效的 SARS-CoV-2 (COVID-19) 疫苗将很快获得批准，以控制大流行。在我们的 3 部分视频广播系列中，我们讨论了如何在如此紧迫的时间内开发疫苗、正在使用的各种疫苗平台及其各自的优缺点，以及为不同的优先群体提供免疫接种。我们将探讨临床试验的初步结果，并讨论即使在疫苗获批使用后仍将进行的持续安全监测。
COVID-19 vaccination policies, programs and prioritisation for Australia
Details on Australia's COVID-19 vaccination policies, programs and prioritisation have been released.
Follow the links below for further information:
- Australian Government Department of Health: ATAGI - preliminary advice on general principles to guide the prioritisation of target populations in a COVID-19 vaccination program in Australia
- Australian Government Department of Health: COVID-19 vaccination prioritisation
- Australian Government Department of Health: Australian COVID-19 Vaccination Policy