Guidance for differentiating anaphylaxis from acute stress response for vaccine providers and Emergency Departments

Anaphylaxis following immunisation is extremely rare but can be life-threatening if not managed effectively. There are many conditions with similar presentations to anaphylaxis without being true anaphylaxis (eg. vasovagal, anxiety, vocal cord dysfunction) which can make the diagnosis difficult.

The Department of Health and the VicSIS network have put together Guidance for differentiating anaphylaxis from acute stress response for vaccine providers and Emergency Departments. This helpful resource provides a comparison of signs and symproms, as well as highlights the importance of measuring tryptase levels in patients with suspected anaphylaxis.

This guidance can be found in the resources section of the below reference page:

MVEC: COVID-19 vaccines and allergy


New immunisation reference page: COVID-19 vaccines in people with immunocompromise

Despite vaccination being recommended, there is currently minimal data on the safety and efficacy of COVID-19 vaccines in the immunocompromised population. In principle, there are no theoretical safety risks and no vaccine safety signals have been identified for vaccinated people with immunocompromise to date.  Similar to responses following the administration of other inactivated vaccines in immunocompromised people, a reduced efficacy may occur following vaccination against COVID-19. 

Our new reference page collates the various recommendations and guidance available for a broad group of immunocompromising conditions and therapies, as well as providing specific recommendations and/or links where available

To read more, follow the link below:

MVEC: COVID-19 vaccines in people with immunocompromise


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


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


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 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


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


Updated ATAGI statements on a specific clotting condition being reported after COVID-19 vaccination

Following a report in Australia of a rare blood clotting condition in a person who received COVID-19 AstraZeneca, ATAGI have released a statement for consumers and an updated statement for health providers.

Internationally, a small number of cases of thrombosis (blood clots) with associated thrombocytopenia (low platelet count) have been reported in the time period 4-20 days following vaccination. These cases have either presented as central venous sinus thrombosis (CVST) or thrombosis in other sites, such as intra-abdominal venous systems.

Vaccination against COVID-19 disease continues to be of high importance in groups who are most at risk of disease exposure or disease complications. Common or expected side effects of vaccination include headache, muscle aches, fever and chills, with onset typically beginning within the first 24 hours and symptoms lasting 1-2 days.

Health care providers and vaccine recipients are encouraged to be alert for any new, severe, persistent headache or other significant symptoms, such as severe abdominal pain, features of raised intracranial pressure (severe headache, vomiting, confusion) or neurological deficits with an onset between 4 to 20 days after vaccination. In suspected cases a referral to hospital is recommended and the appropriate investigations (full blood count, D-dimer, fibrinogen) and imaging completed.

Patients suspected to have this condition should not receive heparin or platelets.

As a precaution, anyone with a past history of CVST or heparin induced thrombocytopenia (HIT) is not recommended to receive the COVID-19 vaccine until further information is available. Investigations internationally and within Australia are ongoing.

To read the statement for consumers in full please refer to the link below:

ATAGI statement for consumers on a specific clotting condition being reported after COVID-19 vaccination

To read the the updated advice for health providers please refer to the link below:

Updated ATAGI statement for healthcare providers on a specific clotting condition being reported after COVID-19 vaccination


Information about COVID-19 vaccines for Aboriginal and Torres Strait Islander people

The National Aboriginal Community Controlled Health Organisation (NACCHO) and NCIRS have joined together to develop new resources on COVID-19 vaccines for Aboriginal and Torres Strait Islander people. This information includes frequently asked questions surrounding the safety and effectiveness of available vaccines, as well as the immunisation recommendations for special risk groups.

To access these resources please follow the link below:

NACCHO: COVID-19 Vaccine Updates and Information

Further information on the immunisation recommendations for Aboriginal and Torres Strait Islander people can be found on our reference page:

MVEC: Aboriginal and Torres Strait Islander immunisation recommendations