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.


A recording of the 12th April CVU mini is now available

Thank you to all who attended our recent CVU miniseries event Hot topics in vaccine science on 12th April 2021.

Presentation topics included Influenza vaccines for 2021, COVID-19 vaccine: vaccine allergy and rollout, as well as an update of the Novavax NVX-CoV2373. In addition to these topics, there was also an update on vaccine safety concerns around clotting syndromes associated with the COVID-19 AstraZeneca vaccine.

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

To access this recording please follow the link below:

CVU mini - 12th April 2021


CDC: Cases of Cerebral Venous Sinus Thrombosis with Thrombocytopenia after Receipt of the Johnson & Johnson COVID-19 Vaccine

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) in the United States have recommended a pause in the rollout of the Johnson & Johnson (J&J) COVID-19 vaccine. This recommendation comes following 6 reports of a rare type of blood clot (cerebral venous sinus thrombosis) in combination with a reduced number of platelets (thrombocytopenia) in individuals who have received the vaccine.

All 6 reports involved women aged 18–48 years, with symptoms developing 6–13 days following vaccination. Sadly one patient has died.

The CDC is urging all health care professionals to be on alert for symptoms of thrombotic events or thrombocytopenia in individuals who have recently received the J&J COVID-19 vaccine. It recognises that based on studies involving similar thrombotic events in those who were vaccinated with COVID-19 AstraZeneca, the use of heparin when treating such conditions should be avoided.

The CDC and FDA are currently reviewing all available information and will convene an emergency meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday April 14 2021, to further review these cases and assess potential implications on vaccine policy.

For more information and read the alert in full please follow the link below:

CDC: Cases of Cerebral Venous Sinus Thrombosis with Thrombocytopenia after Receipt of the Johnson & Johnson COVID-19 Vaccine


ABC News: ATAGI have told the Prime Minister to pull back on the AstraZeneca vaccine for under 50s and use Pfizer, but who are they?

The Australian Government’s recent decision to amend Australia’s vaccine program was based on the recommendation provided by ATAGI, following international evidence linking a rare blood-clotting condition to the AstraZeneca vaccine in younger people.

ATAGI is the Australian Technical Advisory Group on Immunisation. They provide recommendations to the Minister for Health regarding the National Immunisation Program (NIP) and other immunisation issues including immunisation research and immunisation policies, procedures and vaccine safety.  Comprising of 14 medical experts, the group is co-chaired by Associate Professor Christopher Blyth, a specialist in paediatric infectious diseases, and Professor Allen Cheng, who specialises in epidemiology and public health.

This article summarises the role of ATAGI, including their recent recommendations to the Government regarding the AstraZeneca vaccine.

To read more follow the link below:

ABC News: ATAGI have told the Prime Minister to pull back on the AstraZeneca vaccine for under 50s and use Pfizer, but who are they?

For more information on ATAGI, please refer to our MVEC reference page:

MVEC: ATAGI


Interim statement of the COVID-19 subcommittee of the WHO Global Advisory Committee on Vaccine Safety on AstraZeneca COVID-19 vaccine

The COVID-19 subcommittee of the World Health Organization (WHO) Global Advisory Committee on Vaccine Safety (GACVS) have released an interim statement on vaccine safety on AstraZeneca COVID-19 vaccine.

The subcommittee met on April 7th, 2021, and reviewed the latest information on rare cases of blood clots with thrombocytopenia from the European Medicines Agency (EMA) and the United Kingdom’s Medicines and other Health products Regulatory Agency (MHRA).

They found that a causal relationship between the vaccine and cases of blood clots with thrombocytopenia is plausible (but not confirmed) and warrants further studies. They will continue to review data and note the rarity of this condition, with low numbers reported in the 200 million people who have received this vaccine globally. The subcommittee further noted that 2.86 million people have died of COVID-19 around the world and rare events such as this should be assessed in the context of the risk of death from COVID-19 and the potential for the vaccine to prevent infection and death.

The subcommittee noted mild side effects are common in the 2-3 days post vaccination, however people with severe symptoms between 4-20 days post immunisation such as shortness of breath, chest pain, leg swelling, neurological symptoms or persistent abdominal pain should seek medical attention immediately. They note active surveillance should be considered and have developed template protocols for countries to adopt.

The subcommittee will continue to monitor the rollout of COVID-19 vaccines and note the importance of addressing and investigating safety concerns.

To read the full statement, please refer to the link below:

Interim statement of the COVID-19 subcommittee of the WHO Global Advisory Committee on Vaccine Safety on AstraZeneca COVID-19 vaccine

 


The Age: AstraZeneca decision adds to need for vaccine rollout clarity

On Thursday evening, the Australian Government made amendments to Australia’s vaccine program based on international evidence linking a rare blood-clotting condition to the AstraZeneca vaccine in younger people, with Pfizer now being the preferred vaccine for people under the age of 50.

The Australian government has chosen not to be definitive in their advice; instead they have left the choice regarding which vaccine should be administered to individual Australians in consultation with their GP. The AstraZeneca vaccine will still be available for people under the age of 50 on a case-by-case basis, with vaccinations of elderly Australians continuing as planned.

As evidenced by these recent changes, providing timely, factual and transparent information – even if this information does not include clear rules or definitive advice – remains paramount in ensuring public trust in the Australian vaccination program.

To read more follow the link below:

The Age: AstraZeneca decision adds to need for vaccine rollout clarity


New immunisation reference page: Thrombosis with thrombocytopenia syndrome

Thrombosis with thrombocytopenia syndrome (TTS) is a newly described serious condition which has been reported in people following receipt of dose 1 of COVID-19 AstraZeneca.

Our new reference page explores what is known about the syndrome including symptoms, rates of occurrence globally, risk factors and the types of investigations that should be performed in patients where TTS is suspected.

To read more please refer to the below link:

MVEC: Thrombosis with thrombocytopenia syndrome  

 


ATAGI statement on AstraZeneca vaccine in response to new vaccine safety concerns

Following investigations nationally and internationally into a rare blood clotting condition known as Thrombosis with Thrombocytopenia Syndrome (TTS) occurring in people who have received COVID-19 AstraZeneca, ATAGI have provided updated advice for the administration of COVID-19 vaccines in Australia.

ATAGI recommends that Comirnaty™ is the preferred brand for immunisation of those under 50 years of age who have not already received dose 1 of COVID-19 AstraZeneca, with COVID-19 AstraZeneca available for immunisation of those over 50 years of age. Individuals who have had their first dose of COVID-19 AstraZeneca without any serious adverse events can proceed with the second dose. COVID-19 AstraZeneca can continue to be used in adults aged under 50 years where the benefits are likely to outweigh the risks for an individual (an informed decision can be made following a discussion on the risks and benefits).

TTS is a newly described serious condition, which presents with unusual blood clots (thrombosis) in the brain or other parts of the body, accompanied by a low number of platelets (thrombocytopenia). It has been noted to develop 4-20 days following vaccination with COVID-19 AstraZeneca. Global reports show TTS may occur in approximately 4-6 people per million doses delivered, with 1 case recorded in Australia to date. It is noted to predominantly occur in younger adults however there have been some cases reported in older vaccine recipients. So far there has been no pre-existing conditions or biological factors identified that may predispose or decrease the risk of someone developing TTS.  The exact mechanism leading to this condition is not fully understood however antibodies (anti-PF4 antibodies) that activate platelets have been detected in some people who have developed TTS. These antibodies have also been detected in people with similar symptoms following administration of the drug heparin (heparin induced thrombocytopenia).

ATAGI has made this recommendation after considering the current level of community transmission of COVID-19 disease in Australia, as well as the likely severity of disease according to age if exposed to COVID-19. Should the level of risk change or more information becomes available these recommendations may change. ATAGI continues to recommend all adults be vaccinated against COVID-19 as the virus continues to cause severe disease globally.

To read the advice in full refer to:

ATAGI statement on AstraZeneca vaccine in response to new vaccine safety concerns