A recording of the 26th April CVU mini is now available

Thank you to all who attended our recent CVU miniseries event COVID-19 vaccine: reporting and management in Victoria on 26th April 2021.

This interactive webinar looked at the latest vaccine safety questions around COVID-19 vaccines, guidelines for referring patients for evaluation prior to vaccination (VicSIS), and reporting safety events related to COVID-19 vaccines.

A recording of this event is now available via our education portal.

To access this recording please follow the link below:

CVU mini - 26th April 2021


NEJM: Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons

Whilst there is currently limited safety data on the use of COVID-19 vaccines in pregnancy, immunisation in this patient group is not contraindicated. ATAGI advises that COVID-19 immunisation may be recommended after considering factors such exposure risk and underlying medical conditions.

The following study involving 35,691 pregnant participants who received mRNA COVID-19 vaccines did not show any safety signals regarding pregnancy or neonatal outcomes. Preliminary results showed that injection site pain was reported more commonly amongst pregnant women than non-pregnant women, and headache, myalgia, chills and fever were reported less commonly.

To read more, follow the link below:

NEJM: Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons


VACSIG Webinar Events: Register to attend

The Vaccination Special Interest Group (VACSIG) will be hosting a webinar on Wednesday 5 May featuring a panel of expert speakers including MVEC's Professor Jim Buttery and A/Prof Nigel Crawford. The topic for the webinar is COVID-19 vaccines and rare side effects - now blood clots/bleeding, what’s next?. This event is open to both ASID members and non-members. Further information and details on registration can be found via the link below:

VACSIG Webinar Wednesday 5 May


ATAGI reinforce recommendations on use of COVID-19 vaccines following review of vaccine safety data and benefits

As of April 23, 2021 a total of 6 cases of thrombosis with thrombocytopenia syndrome have been reported in Australia in people who have received dose 1 of COVID-19 AstraZeneca. Severity of cases have varied including 1 fatal outcome. In all reported cases, symptoms of TTS began 4-26 days after immunisation.

The latest statement from ATAGI reinforces the current advice:

  • Comirnaty™ is the prefered COVID-19 vaccine brand for administration in those < 50 years of age. COVID-19 AstraZeneca may be administered in this age group if the benefits of immunisation are deemed to outweigh any risks
  • Due to the ongoing potential for a COVID-19 outbreak, as well as an increased risk of severe disease and mortality associated with COVID-19 infection, the benefit of immunisation with COVID-19 AstraZeneca for adults > 50 years of age continues to outweigh the risks associated with the vaccine
  • TTS can occur at any age, however current evidence shows that the incidence of TTS is less for older adults than younger adults
  • ATAGI continues to recommend that people who received the first dose of COVID-19 AstraZeneca without any serious adverse event (eg. anaphylaxis or TTS) can receive the second dose. Current data suggests that the risk of TTS following receipt of a second dose of COVID-19 AstraZeneca is considerably lower. From more than 2 million second doses administered internationally, there has been 1 case of TTS reported following dose 2 of COVID-19 AstraZeneca (reported in the UK)

To read the statement in full refer to the link below:

ATAGI reinforce recommendations on use of COVID-19 vaccines following review of vaccine safety data and benefits


CVU mini event 26th April 2021 - Reminder to register

Our next Clinical Vaccinology Update (CVU) mini event: COVID-19 vaccine: reporting and management in Victoria will be held virtually on Monday 26th April 2021, at 7pm AEST.

To view the full program and to register for this event, please visit our Events page.

A recording of COVID-19 vaccine: reporting and management in Victoria will be available on our Education Portal following the event.


TGA: Wider storage and transportation conditions for the Pfizer COVID-19 vaccine now approved

The Therapeutic Goods Administration (TGA) have approved wider storage and transportation conditions for Comirnaty™ (the Pfizer COVID-19 vaccine).

Long-term storage of Comirnaty™  still requires ultra-cold temperatures of -90°C to -60°C. Unopened vials can be stored and transported at domestic freezer temperatures (-25°C to -15°C) for up to 2 weeks. Vials stored or transported at domestic freezer temperatures can be returned to ultra-cold longer term storage within the original shelf life of the product. Unopened vials can be stored for up to 5 days at temperatures of 2°C to 8°C. Once thawed, Comirnaty™ cannot be refrozen.

Once diluted, Comirnaty™ can be stored or transported at room temperatures  of up to 30°C for up to 6 hours either in vials or syringes.

The product information contains the most up-to-date storage and transport requirements.

The full TGA statement can be accessed via the link below:

TGA: Wider storage and transportation conditions for the Pfizer COVID-19 vaccine now approved 

 


Reuters: Canada’s Ontario to expand use of AstraZeneca COVID vaccine as epidemic rages

As a third wave of COVID-19 infections spreads across Canada, a change in recommendation for the COVID-19 vaccine rollout has been announced for Ontario. People who will turn 40 years of age this year can now be offered the AstraZeneca COVID-19 vaccine.

Last month, Health Canada (the medicines regulatory board) advised that administration of the AstraZeneca COVID-19 vaccine be limited to those over 55 years of age. This age limit was put in place following reports globally of serious blood clots and bleeding in people who had received COVID-19 AstraZeneca.

With 4,250 new cases of COVID-19 infection diagnosed in Ontario on Sunday and a total of 737 patients requiring intensive care, the benefits of immunising a younger age group is now deemed to outweigh any risk of side effects.

It is recommended that following immunisation, anyone who experiences shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms like severe headaches or blurred vision, or skin bruising or tiny blood spots under the skin beyond the site of the injection seek medical attention.

To read more about the change in recommendation refer to the below link:

Reuters: Canada’s Ontario to expand use of AstraZeneca COVID vaccine as epidemic rages


New resource: Weighing up the potential benefits against risk of harm from COVID-19 AstraZeneca

The Australian Government Department of Health have released a document entitled ‘Weighing up the potential benefits against risk of harm from COVID-19 AstraZeneca.’ The document provides information to assist patients in making an informed decision about whether or not to be vaccinated with the COVID-19 AstraZeneca vaccine.

Whilst ATAGI advises that AstraZeneca and Pfizer COVID-19 vaccines are recommended in all adults, the Pfizer vaccine is preferred in people aged under 50 years due to the risk of the very rare side-effect thrombosis with thrombocytopenia syndrome (TTS), which can occur following the first dose of COVID-19 AstraZeneca. This recommendation has been made based on evidence that TTS appears to be less likely in older adults.

COVID-19 AstraZeneca can be given to people aged under 50 where benefits are likely to outweigh the risks and an individual has made an informed decision based on an understanding of the risks and benefits. This document provides information on making this decision and how ATAGI measure potential benefits vs risks in different scenarios.

The full document can be accessed via the link below:


New immunisation reference page: Adverse events following COVID-19 immunisation

All immunisations are medications and all medications do have side effects. For each vaccine there is a known list of common or expected adverse events following immunisation (AEFI) and then a smaller list of serious side effects. Reporting significant adverse events is important to allow for signal detection and investigation as part of post-licensure vaccine safety monitoring.

Our new reference page explores what sort of reactions are common and expected following COVID-19 immunisation, and what sort of reactions warrant reporting.

For more information please refer to the following:

MVEC: COVID-19 vaccine adverse events


Registrations now open for two MVEC webinars in April

The Melbourne Vaccine Education Centre are excited to announce two new webinar events in April.

Join us for a special clinical feature event on Thrombosis with thrombocytopenia syndrome (TTS) & COVID-19 AstraZeneca on Tuesday 20th April 2021. Our expert panel will be giving background on what this new syndrome is and exploring its association with the vaccine. We will also discuss the risk-versus-benefit assessment and how this new recommendation will impact confidence in the vaccine rollout.
The panel will be answering your questions in our live Q&A format on the night. We encourage you to submit questions ahead of the event via our events page.

The next Clinical Vaccinology Update (CVU) mini COVID-19 Vaccines: Shots, clots and reports will be held virtually on Monday 26th April 2021. This session will provide an interactive update on the latest vaccine safety questions around COVID-19 vaccines, as well as a discussion of key guidelines for reporting safety concerns and incidents related to COVID-19 vaccines.

To read more about our upcoming webinar events and to register, please visit our events page.