FDA report reveals phase 3 clinical trial data for the Pfizer and BioNTech COVID-19 vaccine candidate
In preparation for a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC), the FDA has made public the interim results of phase 3 clinical trials for the Pfizer and BioNTech COVID-19 vaccine candidate. This meeting will discuss the Emergency Use Authorisation (EUA) application and determine any recommendations for approval.
Phase 3 clinical trials were spread across the US, Argentina, Brazil, Germany, South Africa and Turkey. The Pfizer and BioNTech vaccine candidate utilises a messenger RNA (mRNA) platform and its' studies involved participants aged 16 to 85 years. Findings have shown that the vaccine candidate has an acceptable safety profile and following the administration of 2 doses, has an efficacy rate of 95%.
To read the document in full please refer to the link below:
The Lancet: Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa and the UK
The Oxford Vaccine Trial group have published interim results for phase 3 clinical trials of their COVID-19 vaccine candidate (ChAdOx1 vCoV-19). This vaccine utilises a viral vector platform and previous phase 1/2 studies have shown an acceptable safety profile. Participants in the phase 3 trials, held across the UK, Brazil and South Africa, were aged 18y or older. Findings have shown that when participants received 2 equal doses, vaccine efficacy was 62.1%. Participants who received a lower dose followed by a standard dose, vaccine efficacy was 90.0%.
To read the article and view these results in full, follow the link below:
包含这个：印太卫生安全中心的新播客
“Contain This”是印太卫生安全中心制作的播客，着眼于全球卫生安全趋势。该中心最近启动了一个新的 COVID-19 疫苗系列，因为它计划针对东南亚和太平洋岛国的 $5 亿区域疫苗获取和健康安全倡议。
要听取有关疫苗接种、融资、优先群体以及安全性和有效性等主题的讨论，请参考以下链接：
SAFEVAC- the adverse event reporting database for Victoria
Currently AEFI reporting can only be completed via SAFEVAC if the vaccine was administered in Victoria or Western Australia (reports followed up by SAEFVIC or WAVSS respectively). Some other jurisdictions use the database for internal management of reports.
For more information on SAEFVIC, the Victorian vaccine safety service, please visit our MVEC page 这里.
To access the SAFEVAC database, please click 这里.
UK authorises Pfizer/BioNTech COVID-19 vaccine
Following a thorough analysis of data produced from rigorous clinical trials, the independent Medicines and Healthcare products Regulatory Agency (MHRA) in the UK have concluded that the Pfizer/BioNTech COVID-19 vaccine meets the strict standards of safety, quality and effectiveness required. As such, the UK government has announced it's approval with plans to make the vaccine available from as early as next week. Final advice on priority groups is still being determined by the Joint Committee on Vaccinations and Immunisations (JCVI).
To read the press release please refer to the link below:
UK authorises Pfizer/BioNTech COVID-19 vaccine
New immunisation reference page: Yellow fever
Yellow fever is an acute viral haemorrhagic disease transmitted by infected mosquitos. It occurs in the tropical and subtropical regions of Africa, the Caribbean and Central/South America. Vaccination against yellow fever is a requirement for travel to and from certain countries. For more information, including how to access a yellow fever vaccination, please view our reference page below:
MVEC 播客系列 - COVID-19 疫苗
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。目前全球有 200 多种候选疫苗处于临床试验的各个阶段，澳大利亚已与 4 种不同的疫苗签署了预购协议。
在我们的 COVID-19 疫苗 3 部分视频广播系列中，Daryl Cheng 博士和 Daniela Say 博士讨论了如何在如此紧迫的时间内开发疫苗、临床试验中使用的各种疫苗平台及其各自的优缺点，以及要提供免疫接种的不同优先群体。 Daryl 和 Daniela 谈到了临床试验的初步结果以及它们在疫苗安全性和有效性方面向我们展示的内容，并讨论了即使疫苗获准使用也会进行的持续安全监测。
您可以通过以下链接查看播客：
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