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:

MVEC: Zoster

MVEC: Zoster vaccine (Zostavax®) FAQ’s


New immunisation reference page: COVID-19 vaccine platforms

Multiple different vaccine technologies or 'platforms' are being trialled by the over 200 COVID-19 vaccine candidates currently in development in an effort to limit the spread of the SARS-CoV-2 virus. Our new reference page provides a summary of the different approaches, including the newer or 'novel' platforms, and highlights the COVID-19 vaccine candidates in the most advanced stages of clinical trials.

To learn more follow the link below:

MVEC: COVID-19 vaccine platforms


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:

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


New immunisation reference page: Hypotonic-hyporesponsive episode (HHE)

A hypotonic-hyporesponsive episode (HHE) is the sudden onset of muscle limpness, reduced responsiveness or unresponsiveness, and pallor or cyanosis occurring after vaccination in early childhood. The episode usually occurs within 48 hours of vaccination and resolves spontaneously without treatment. Our new reference page describes HHE, its incidence and its impact on future vaccination.

To read more please follow the link below:

MVEC: Hypotonic-hyporesponsive episode (HHE)


MVEC animation: The Road to a COVID-19 Vaccine

With Australia looking towards a COVID-19 vaccine program beginning in early 2021, MVEC have created the following animation for sharing with a wider audience, to help explain the process of developing a safe and effective COVID-19 vaccine in a compressed timeframe.

For more information on the vaccine development process please refer to our immunisation reference page here.

For information on the provisional vaccine registration pathway in Australia please refer to our reference page here.


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.

To read the article in full follow the link below:

The Conversation: How did the University of Queensland/CSL vaccine fail due to 'false positive' HIV tests? A vaccine expert explains


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