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

 


New immunisation reference page: COVID-19 weekly vaccine update

The rapid development of multiple COVID-19 vaccines globally has been a tremendous success story for public health. However, it can prove challenging to stay up to date with the increasing literature on various aspects of these vaccines. The COVID-19 weekly vaccine update summarises the data available on COVID-19 vaccines and includes: the specifications of COVID-19 vaccines, vaccine efficacy and effectiveness including against variants of concern; comorbidities and the elderly; vaccine safety; the pipeline for vaccine development; and the WHO SAGE timeline for vaccine authorisation. Each week, the document is updated and contains newly released information on the vaccines.

To subscribe to the update, email [email protected]

Alternatively you can access the update via our reference page below:

MVEC: COVID-19 weekly vaccine update


ATAGI- COVID-19 vaccine guidance for patients with immunocompromise

ATAGI have published recommendations for the vaccination of immune compromised patients with COVID-19 vaccines, Comirnaty™ and COVID-19 AstraZeneca.

COVID-19 vaccination is recommended for all immunocompromised people due to an increased risk of developing severe disease if infected with SARS-CoV-2. Administration of COVID-19 vaccines should be planned with the treating specialist and in some instances the timing of immune suppressive therapies may be altered to maximise immune responses to vaccination. Reducing the interval between COVID-19 vaccine doses to allow for planning of treatments can also be considered.

To view these recommendations please refer to

For other information on the immunisation of immune compromised people please refer to:

MVEC: Immunosuppression and vaccines


Updated immunisation reference pages: Influenza vaccine recommendations and FAQ's

MVEC's recommendations for influenza vaccination in 2021 have been updated. Information contained in these pages includes dosing and brand advice (including information on cell-based vaccines), co-administration of influenza vaccines and other vaccines, recommendations in pregnancy and immunosuppression, as well as eligibility for funded doses.

Our FAQ's provide answers to commonly asked questions relating to influenza vaccines and their administration.

For more information please follow the links below:

 


TGA: AstraZeneca COVID-19 vaccine update- Expert review finds no evidence of increased risk of anaphylaxis

An independent panel of experts from the TGA's Advisory Committee on Vaccines (ACV) and the Australian Technical Advisory Group on Immunisation (ATAGI) have reviewed the recent reports of 4 cases of anaphylaxis in Queensland in people who have received COVID-19 AstraZeneca.

Utilising the internationally-accepted Brighton Collaboration case definition, it has been concluded that only 1 of the 4 reported cases meets the criteria for anaphylaxis. Whilst the other adverse events reported are not classified as anaphylaxis, they may still represent allergic reactions or immediate stress responses and therefore close monitoring and follow up is warranted.

The findings of this review confirm that the incidence of anaphylaxis following receipt of COVID-19 AstraZeneca does not occur at a rate higher than that expected for any vaccine.

To see the full alert from the TGA please follow the link below:

TGA: AstraZeneca COVID-19 vaccine update- Expert review finds no evidence of increased risk of anaphylaxis


WHO statement on AstraZeneca COVID-19 vaccine safety signals

The World Health Organization (WHO) have released a statement following the recent reports of rare blood coagulation disorders in people who have received COVID-19 AstraZeneca.

In large immunisation campaigns it is expected that countries will signal adverse events to vaccination. Signals do not necessarily mean that the vaccine caused the events, but investigations into them are important. This signal detection confirms that the safety surveillance systems that are in place globally are effective and the proper processes are in place.

The Global Advisory Committee on Vaccine Safety is currently assessing all available safety data for COVID-19 AstraZeneca. Outcomes of the review will be communicated to the public as soon as they become available.

At this time, WHO recommends that vaccination with COVID-19 AstraZeneca continues as the benefits of immunisation outweigh potential risks.

To read the statement in full please follow the link below:

WHO statement on AstraZeneca COVID-19 vaccine safety signals