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:
MVEC: Provisional registration of COVID-19 vaccine(s) in Australia
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 here.
To access the SAFEVAC database, please click here.
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 Vodcast series - COVID-19 vaccines
As 2020 draws to a close there is optimism that a safe and effective vaccine for SARS-CoV-2 (COVID-19) will soon be approved to control the pandemic. With over 200 vaccine candidates currently in various stages of clinical trials across the globe, Australia has signed advance purchase agreements with 4 different vaccines.
In our 3-part vodcast series, COVID-19 vaccines, Dr Daryl Cheng and Dr Daniela Say discuss how it is possible to develop a vaccine in such a compressed timeline, the various vaccine platforms being utilised in clinical trials and their individual advantages and disadvantages, as well as the different priority groups to be offered immunisation. Daryl and Daniela touch on the preliminary results from clinical trials and what they show us in terms of vaccine safety and effectiveness, as well as discuss the ongoing safety monitoring that will occur even once a vaccine has been approved for use.
You can view the vodcasts via the link below:
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
CVU registrations close Tuesday December 1, 2020
Our first virtual Clinical Vaccinology Update (CVU) will be held on December 7, 2020 and will host various local and international presenters. The topics covered include COVID-19 vaccines, influenza, vaccine safety, and vaccine communication.
Registrations to attend are closing soon. Be sure to purchase your tickets by tomorrow December 1, 2020 so you don't miss out!
Tickets can be purchased by heading to our Event page
Your unique webinar link will be sent to out via email in the coming days so please look out for it.