TGA: AstraZeneca ChAdOx1-S COVID-19 vaccine
The TGA (Therapeutic Goods Association) have provided an update regarding the AstraZeneca COVID-19 vaccine in light of preliminary reviews by the European Medicines Agency (EMA) and United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), regarding the risk of blood clots in people who have received the AstraZeneca COVID-19 vaccine.
The findings of these reviews are that the benefits of the vaccine continue to outweigh the risks. The EMA’s safety meeting noted that the number of people with blood clots in large clinical trials and who have received the vaccine in global rollouts were less than is expected in the general population. 20 million people have received the vaccine in Europe and several more million in other parts of the world.
They noted there have been a very small amount of people who have experienced very rare clotting conditions – disseminated intravascular coagulation (DIC) with thrombocytopenia; and cerebral venous sinus thrombosis (CSVT). A causal link with the vaccine has not been established and these conditions are also seen in the general population.
Both the EMA and the MHRA are continuing to review cases of these rare clotting conditions.
The TGA has not received any reports of blood clots following vaccination with the AstraZeneca COVID-19 vaccine in Australia (as of 18 March 2021) and advise people to continue to receive the vaccine when eligible. Monitoring of the safety of this vaccine will continue and if there are any safety concerns these will be communicated to the public.
Please refer to the full alert below for more information:
TGA: AstraZeneca ChAdOx1-S COVID-19 vaccine
Registrations now open for the April CVU mini event
The next Clinical Vaccinology Update (CVU) miniseries event, Hot Topics in Vaccine Science, will be held virtually on Monday 12th April 2021.
We are excited to welcome our panel who will be presenting on COVID-19 vaccine allergy and rollout, influenza vaccines for 2021, as well as an update of the Novovax NVX-CoV2373 vaccine candidate.
A full program of this free event can be found via our Events page and the link below:
New immunisation reference page: The VicSIS (Victorian Specialist Immunisation Services) Network
Current vaccine safety clinics managed by SAEFVIC have historically had a paediatric focus. With the rollout of COVID-19 vaccines within Australia and the initial priority groups involving adults, the VicSIS (Victorian Specialist Immunisation Services) network has been created to enhance adult immunisation services in Victoria to address queries and safely vaccinate under supervision, if required. These services can provide specialist immunisation support and provide a link between the key stakeholders, the Department of Health, SAEFVIC and hospital sites that form part of the network.
The VicSIS network will provide specialist vaccination services for people who have experienced an adverse event following immunisation (AEFI) with a COVID-19 vaccine, or those who are identified as at risk of an AEFI (for example, people with a history of anaphylaxis). Most people are able to proceed with future vaccines following an AEFI. Clinical consults will be offered in which individual recommendations will be developed.
Find out more about where the VicSIS clinics are located and how to refer to them in our new immunisation reference page, linked below.
MVEC: The VicSIS (Victorian Specialist Immunisation Services) Network
WHO statement on AstraZeneca COVID-19 vaccine safety signals
The World Health Organization (WHO) have released a statement following the recent reports of rare blood coagulation disorders in people who have received COVID-19 AstraZeneca.
In large immunisation campaigns it is expected that countries will signal adverse events to vaccination. Signals do not necessarily mean that the vaccine caused the events, but investigations into them are important. This signal detection confirms that the safety surveillance systems that are in place globally are effective and the proper processes are in place.
The Global Advisory Committee on Vaccine Safety is currently assessing all available safety data for COVID-19 AstraZeneca. Outcomes of the review will be communicated to the public as soon as they become available.
At this time, WHO recommends that vaccination with COVID-19 AstraZeneca continues as the benefits of immunisation outweigh potential risks.
To read the statement in full please follow the link below:
WHO statement on AstraZeneca COVID-19 vaccine safety signals
The Conversation: Data suggest no increased risk of blood clots from the AstraZeneca vaccine. Australia shouldn’t pause its rollout
With some European countries opting to pause the rollout of COVID-19 AstraZeneca in response to reports of blood clots, Australian experts have cautioned against any pauses whilst investigations are underway.
Thromboembolic events occur in approximately 17,000 Australians per year. In a global vaccine rollout it is therefore expected that some people will develop a blood clot coincidentally after they have received the vaccine. This does not meant that the vaccine caused it.
Since COVID-19 AstraZeneca vaccinations began, there have been 30 thromboembolic events reported (as of March 10, 2021) in approximately 5 million vaccine recipients. This is lower than the natural rate expected to occur.
All adverse events must be thoroughly investigated. The robust safety surveillance systems in Australia are established to effectively identify any signals requiring follow up. Extreme caution is urged when considering a pause in rollout while investigations are underway as this can damage vaccine confidence.
To read more, please read the article below:
The bmj: Covid-19: Booster dose will be needed in autumn to avoid winter surge, says government adviser
Anthony Harnden, Deputy Chair of the Joint Committee on Vaccination and Immunisation (JCVI) in the UK, has suggested that booster doses of COVID-19 vaccines are likely to be required.
With minimal data surrounding the duration of protection provided by COVID-19 vaccines and the emergence of new strain variants, the UK is considering commencing booster doses from August of this year.
To read more follow the link below:
A recording of the March CVU mini is now available
Thank you to all who attended our recent CVU miniseries event COVID-19 vaccines: Engagement, Communication and Safety on 9th March 2021.
Presentation topics included COVID-19 vaccine stakeholder engagement and participation, vaccine communication and hesitancy, and an update on the Victorian Specialist Immunisation Service (VicSIS) and international vaccine safety.
A free recording of this event is now available via our education portal.
To access this recording please follow the link below:
The Guardian: Israel says 600 children given Covid jab had no serious side-effects
Following an expansion of Israel's COVID-19 vaccination program, around 600 children (≥ 12 years) have received the Pfizer/BioNTech COVID-19 vaccine. Reported side-effects in this age group have been minor and the vaccine has been well tolerated.
Due to the emergence of more transmissible strains of COVID-19, experts have now suggested that in order to achieve herd immunity closer to 90% coverage will be required. In a population of 9 million people, with approximately 1/4 of those aged under 16 years, lowering the age limit for COVID-19 vaccination is an important development for Israel.
To read more follow the link below:
The Guardian: Israel says 600 children given Covid jab had no serious side-effects
TGA: AstraZeneca ChAdOx1-S COVID-19 vaccine
Denmark, Iceland and Norway have temporarily paused the distribution of COVID-19 AstraZeneca as a precautionary measure in response to reports of blood clots following immunisation (including 1 death in Denmark). The European Medicines Agency's safety committee is conducting a rapid review into the events.
The Therapeutic Goods Administration (TGA) have advised that a link has not been confirmed and to date there have been no reports of similar events in Australia. Extensive international vaccination programs have not indicated an increased risk of blood clots associated with the vaccine.
Vaccination with COVID-19 AstraZeneca continues in other countries including the United Kingdom and France.
Please refer to the full alert below for more information:
TGA: AstraZeneca ChAdOx1-S COVID-19 vaccine
Save the date for our April CVU mini event: Monday 12 April 2021
MVEC invites you to Save the Date for our next CVU mini!
Date: Monday 12 April, 2021
Time: 7:00pm - 8:30pm AEST
Further details and registration information will be available soon on our Events page and Education Portal.
To keep up to date with our latest news, including upcoming events, you can subscribe to our weekly newsletter.