Zostavax vaccine: Safety advisory - risk of disseminated varicella zoster virus (vaccine strain) infection
Following a third report of fatal disseminated vaccine strain varicella-zoster virus infection following Zostavax administration, the Therapeutic Goods Administration (TGA) is reminding health professionals that Zostavax should not be used in people with compromised immune function.
Further details on the alert can be seen here:
Zostavax vaccine: Safety advisory
For more information on Zostavax® and access to the Zostavax® GP decision aid please review the MVEC pages below:
微血管内皮细胞： 带状疱疹
微血管内皮细胞： Zoster vaccine (Zostavax®) FAQ’s
FDA report reveals phase 3 clinical trial data for the Moderna 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 Moderna COVID-19 vaccine candidate. This meeting will discuss the Emergency Use Authorisation (EUA) application and determine any recommendations for approval.
Phase 3 clinical trials for this vaccine were spread across 99 sites in the United States and participants were aged 18 years or older. The Moderna vaccine utilises a messenger RNA (mRNA) platform. Interim results show an acceptable safety profile. Following the administration of 2 doses, 28 days apart, it is reported that this vaccine has an efficacy rate of 94.5%.
To read the document in full please refer to the link below:
对话：昆士兰大学/CSL 疫苗为何因 HIV 检测“假阳性”而失败？疫苗专家解释
Further clinical trials of the UQ/CSL COVID-19 vaccine candidate have been called off after phase 1 results showed that participants had returned 'false positive' HIV tests. The UQ/CSL vaccine utilises molecular clamp technology involving components of a HIV protein. These components are unable to cause a HIV infection, however participants were shown to be creating antibodies against HIV which then leads to a false positive HIV test result.
以下文章证实未发现任何安全问题。它表明研究人员采取了适当行动，以减少对不准确测试结果的不必要焦虑，并增强公众对未来 COVID-19 疫苗计划的信心。
要阅读全文，请点击以下链接：
对话：昆士兰大学/CSL 疫苗为何因 HIV 检测“假阳性”而失败？疫苗专家解释
The Conversation: People with severe allergies warned off Pfizer COVID vaccine for now. But that may change as more details emerge
As a precautionary measure, the UK medicines regulator have advised that people with a significant history of allergic reactions should not receive the Pfizer/BioNTech COVID-19 vaccine after 2 people experienced allergic reactions. The following article outlines how common allergies to vaccines are, why these types of reactions weren't noted in clinical trials and the role of ongoing safety surveillance and monitoring.
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Australian Government Department of Health: COVID-19 vaccines
The Australian Government Department of Health have developed a dedicated resource for COVID-19 vaccines. This site will host news and information for Australians about the development, approval process and plans for COVID-19 vaccines.
To access this resource, please follow the link below:
Australian Government Department of Health: COVID-19 vaccines
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