The Conversation: How did the University of Queensland/CSL vaccine fail due to 'false positive' HIV tests? A vaccine expert explains
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.
The following article confirms that no safety concerns had been identified. It suggests that researchers acted appropriately to limit unnecessary anxiety over inaccurate test results and to reinforce public confidence in a future COVID-19 vaccine program.
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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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MVEC eLearning: Vaccination Procedures
MVEC are excited to launch our first eLearning package. Our eLearning packages are designed to allow immunisation providers consolidate and evaluate their technical skills. Targeted resources are available to assist with our eLearning and a certificate of completion will be made available upon completion of the corresponding eLearning quiz.
Vaccination Procedures provides an overview into the vaccination process including pre-immunisation assessment, the cold chain, vaccine administration technique and post vaccination procedures.
You can access Vaccination Procedures via the एमवीईसी शिक्षा पोर्टल or via the following link:
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
New immunisation reference page: Provisional registration of COVID-19 vaccine(s) in Australia
There is lots of interest nationally and internationally regarding the process for regulation of COVID-19 vaccines and concerns that things may be moving ‘too fast’ and steps may be missed. There is also some confusion regarding how these vaccine regulatory processes may vary between countries. Our new reference page outlines the role of the regulatory bodies in Australia in ensuring that any vaccine(s) meets safety and efficacy requirements, what the Australian provisional registration pathway looks like, and how this differs from the vaccine approval processes being used in the USA and Europe.
To read more please refer to:
एमवीईसी: ऑस्ट्रेलिया में सीओवीआईडी-19 वैक्सीन का अनंतिम पंजीकरण
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:
Contain This: A new podcast by the Indo-Pacific Centre for Health Security
"Contain This" is a podcast produced by the Indo-Pacific Centre for Health Security looking at global health security trends. The Centre has recently kicked off a new series on COVID-19 vaccines as it plans the $500 million Regional Vaccine Access and Health Security Initiative targeting Southeast Asian and Pacific island countries.
To listen to discussion on topics such as vaccine uptake, financing, priority groups, as well as safety and efficacy, please refer to the link below:
Contain This: The Latest In Global Health Security
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 यहाँ.
To access the SAFEVAC database, please click यहाँ.
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