New resource: Australia's COVID-19 vaccine rollout

For easily accessible information relating to the COVID-19 vaccine rollout, the Australian Government Department of Health have created a new resource page. This page will be updated daily and describes the number of vaccine doses administered via the various providers, makes comparisons to international COVID-19 vaccine programs, and provides other sources of useful data.

To view this page please refer to the link below:

Australian Government Department of Health: Australia's COVID-19 vaccine rollout


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


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:

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