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 थ्रोम्बोसाइटोपेनिया सिंड्रोम के साथ घनास्त्रता 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:
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:
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:
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.
अधिक पढ़ने के लिए नीचे दिए गए लिंक का अनुसरण करें:
For more information on ATAGI, please refer to our MVEC reference page:
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 7वां, 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:
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.
अधिक पढ़ने के लिए नीचे दिए गए लिंक का अनुसरण करें:
The Age: AstraZeneca decision adds to need for vaccine rollout clarity
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 थ्रोम्बोसाइटोपेनिया सिंड्रोम (टीटीएस) के साथ घनास्त्रता 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