Statement of the WHO Global Advisory Committee on Vaccine Safety (GACVS) COVID-19 subcommittee on safety signals related to the AstraZeneca COVID-19 vaccine
The WHO Global Advisory Committee on Vaccine Safety (GACVS) subcommittee on safety signals related to AstraZeneca COVID-19 vaccine have released a statement on recent reports of thromboembolic and thrombocytopenic events following vaccination with the AstraZeneca COVID-19 vaccine.
The committee notes that as of 17 March 2021 there have more than 120 million cases of COVID-19 infections and more than 2 million deaths worldwide. To date, more than 20 million doses of the AstraZeneca vaccine have been administered in Europe and more than 27 million doses of the Covishield, the AstraZeneca vaccine by the Serum Institute of India, have been administered in India.
They found that the vaccine continues to have a positive risk/benefit profile and that clotting conditions such as deep venous thrombosis or pulmonary embolism events have not increased following receiving this vaccine. In relation to reports of rare thromboembolic events such as cerebral venous sinus thrombosis, they note a causal relationship has not been established (the European Medicines Agency [EMA] have reviewed 18 cases of CVST out of more than 20 million doses of the AstraZeneca COVID-19 vaccine in Europe). The committee recommend that countries continue to monitor the safety of all COVID-19 vaccines and that healthcare workers should be educated in recognising signs and symptoms of adverse events following vaccination and agree with the EMA’s plans to investigate these events further.
Read the full statement below, including links to the EMA statement and the UK MHRA statement
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
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:
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.
Additional module added to Victorian COVID-19 eLearning Competency
An additional module titled Preparing Comirnaty™ (Pfizer BNT162b2) COVID-19 Vaccine has been added to the Victorian COVID-19 eLearning Competency.
Please note the advice contained in this module is specific to the COVID-19 mRNA Vaccine BNT162b2 (Comirnaty™).
If you have already completed the Victorian COVID-19 eLearning Competency you can login and access this additional module via your profile in the MVEC Education Portal.
Swollen Lymph Nodes Under Armpit After COVID-19 Vaccine May Mimic Breast Cancer Symptoms
The Society of Breast Imaging (SBI) in the United States is recommending women wait at least four weeks after receiving a COVID-19 vaccine to schedule a mammogram due to the potential side-effect of swollen or tender lymph nodes in the armpit. Changes in the lymph nodes can be a sign of breast cancer and the concerns are this could lead to false readings on mammograms leading to further unnecessary testing.
This advice was issued based on the rates of swelling and tenderness in the lymph nodes post the Moderna COVID-19 vaccine and Pfizer BioNTech COVID-19 vaccine in the United States. Whilst rare in people who have received the Pfizer BioNTech vaccine (which is currently provisionally registered for use in Australia), the SBI notes the incidence rates are most likely higher than reported and accordingly issued the aforementioned advice to separate mammograms from COVID-19 vaccines by four to six weeks.
Read more via the link below:
Incidents after vaccination with AstraZeneca's COVID-19 vaccine
Following reports of 2 temporally associated severe adverse events following immunisation (AEFI), the Austrian Federal Office for Safety in Health Care (the national regulatory body for medicines) have halted the supply and distribution of a specific batch of COVID-19 AstraZeneca.
It is important to note that data from clinical trials shows no evidence of a casual relationship and this halt is being utilised as a precautionary measure only. An immediate review of international reports of similar AEFI show no signals for concern. Vaccine rollout using alternate batches of COVID-19 AstraZeneca continues and further investigations are ongoing.
To read the official announcement follow the link below:
Learning from Errors with the New COVID-19 Vaccines
In December 2020 COVID-19 vaccination commenced across the US. This article published by the Institute for Safe Medication Practices, discusses various reports of administration and preparation errors that have occurred since the rollout began.
Given the scope of the global COVID-19 vaccination campaign, it is expected that there will be mistakes made. As Australia begins its national rollout, a key learning is ensuring that all COVID-19 vaccine errors and adverse reactions are reported to the relevant authorities to help prevent these types of errors occurring here.
To read more follow the link below:
ISMP: Learning from Errors with the New COVID-19 Vaccines