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.

To read the article in full follow the link below:

The Conversation: People with severe allergies warned off Pfizer COVID vaccine for now. But that may change as more details emerge 

 

 


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 MVEC Education Portal 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:

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:

Vaccines and Related Biological Products Advisory Committee: FDA briefing document- Pfizer-BioNTech COVID-19 vaccine


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:

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

 


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

The AEFI-CAN database has been formerly renamed SAFEVAC, to better reflect what the database is: an Australian integrated database for the reporting of Adverse Events Following Immunisation (AEFI) and associated clinical visits, as well as vaccine errors.
The mission of SAFEVAC is to promote confidence in the National Immunisation Program (NIP) through enhancing national vaccine safety monitoring and rapid signal detection.

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: Yellow fever