CVU mini event 12th April 2021 - Registrations closing soon

Our next Clinical Vaccinology Update (CVU) mini event: Hot topics in vaccine science, will be held virtually on Monday 12th April, 2021 at 7pm AEST.

To view the full program and to register for this FREE event, please visit our Events page.

A recording of Hot topics in vaccine science will be available on our Education Portal following the event.


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


Falsified COVID-19 Vaccine BNT162b2 identified in the WHO region of the Americas

The World Health Organization (WHO) have released a medical product alert pertaining to a falsified COVID-19 vaccine identified as "BNT162b2" that has been detected in Mexico in February 2021, and which has been confirmed as falsified to the WHO. This product has been supplied and administered to patients external to authorised vaccination programs.

The alert has been issued as this falsified COVID-19 vaccine may still be in circulation which poses a risk to public health. Further details of the falsified vaccine and advice from the WHO can be found via the link to the full medical product alert below:

WHO: Falsified COVID-19 Vaccine BNT162b2 identified in the WHO region of the Americas


New immunisation reference page: COVID-19 vaccines and allergy

Suspected hypersensitivity reactions, particularly non-urticarial skin rashes following immunisation, are common, however true vaccine allergy, where a person is contraindicated from being immunised with the same vaccine in the future, is rare (in most studies reported as less than 1 case per million doses).

Post-licensure surveillance of COVID-19 vaccines show anaphylaxis following administration of COVID-19 AstraZeneca occurring at similar rates to routine vaccines.  Anaphylaxis following Comirnaty™ (Pfizer/BioNTech), while still extremely rare, occurs at a slightly higher rate of approximately 4.7 cases per million doses.

A confirmed vaccine allergy usually requires a specialist consultation with a vaccine allergy specialist, often with specific testing or a vaccine challenge under supervision.

Find out more about allergies to COVID-19 vaccines, allergies to components of COVID-19 vaccines, and management of these allergies in our new immunisation reference page, COVID-19 vaccines and allergy.

 

 


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:

 


ATAGI statement for health care providers on suitability of COVID-19 vaccination in people with history of clotting conditions

ATAGI have released a statement for health providers (25 March 2021) on the suitability of COVID-19 vaccination in people with a history of clotting conditions.

ATAGI note the World Health Organization (WHO), European Medicines Agency (EMA) and the Therapeutic Goods Administration (TGA) have reviewed data from the millions of people who have received the AstraZeneca COVID-19 vaccine worldwide which demonstrates no increase in rates of general thromboembolic events post receiving this vaccine. Investigations are ongoing into whether or not there is a link with cerebral venous sinus thrombosis (CVST).

There have been no reported cases of CVST in Australia to date following vaccination.

The statement emphasizes that the benefits of the vaccine far outweigh this potential risk.

ATAGI continues to recommend vaccination with the AstraZeneca COVID-19 vaccine or Comirnaty (the Pfizer COVID-19 vaccine), including for people with a history of clotting conditions such as deep vein thrombosis (DVT), pulmonary embolism, thrombocytopenia, thrombophilic disorders, people on anticoagulants, people with a history of cardiovascular disease or people with risk factors for thrombosis such as smokers or those taking oral contraceptives.

For now, as a precautionary measure until further information from investigations in Europe is available, ATAGI recommend vaccination with any COVID-19 vaccine is deferred in people with a confirmed medical history of CVST and people with confirmed medical history of heparin induced thrombocytopenia (HIT).

Healthcare workers should continue to be alert for persistent, unexpected and/or severe adverse events, particularly in the 1-2 weeks following immunisation as with any vaccine, and report to their local vaccine safety service as required.

Read the full statement via the link below

ATAGI statement for health care providers on suitability of COVID-19 vaccination in people with history of clotting conditions

 


The BMJ opinion: Restoring confidence after the covid-19 Oxford/AstraZeneca vaccine pause will be an uphill battle

In the past week several countries suspended or delayed the rollout of the Oxford/AstraZeneca COVID-19 vaccine whilst the European Medicines Agency (EMA) safety committee investigated whether or not the vaccine was linked to reports of thromboembolic events.

The EMA’s investigation concluded that the vaccine is safe and effective and not associated with an increased risk of blood clots, and that they will continue to monitor this (whilst noting that there is a possible link with very rare cases of blood clots associated with thrombocytopenia).

Professor Julie Leask notes that people’s willingness to have a vaccine is influenced by its perceived safety, and the suspension of vaccination programs, even if temporary, has long-lasting effects on public confidence. Even if a causal link is found between the Oxford/AstraZeneca COVID-19 vaccine and these thromboembolic events, the risks of these are likely outweighed by the risks of COVID-19. Currently, approximately 20,000 people die from COVID-19 in the European WHO region each week.

She further notes the impacts suspensions like these can have beyond the aversion of harm that is behind them.

Professor Leask suggests early and frequent updates as events happen, communication with empathy, messaging that caters to different levels of health literacy and prioritisation of healthcare worker information and reiterates the importance of research and development into vaccine uptake.

Read more via the link below:

The BMJ opinion: Restoring confidence after the covid-19 Oxford/AstraZeneca vaccine pause will be an uphill battle


Statement of the WHO Global Advisory Committee on Vaccine Safety (GACVS) COVID-19 subcommittee on safety signals related to the AstraZeneca COVID-19 vaccine

The WHO Global Advisory Committee on Vaccine Safety (GACVS) subcommittee on safety signals related to AstraZeneca COVID-19 vaccine have released a statement on recent reports of thromboembolic and thrombocytopenic events following vaccination with the AstraZeneca COVID-19 vaccine.

The committee notes that as of 17 March 2021 there have more than 120 million cases of COVID-19 infections and more than 2 million deaths worldwide. To date, more than 20 million doses of the AstraZeneca vaccine have been administered in Europe and more than 27 million doses of the Covishield, the AstraZeneca vaccine by the Serum Institute of India, have been administered in India.

They found that the vaccine continues to have a positive risk/benefit profile and that clotting conditions such as deep venous thrombosis or pulmonary embolism events have not increased following receiving this vaccine. In relation to reports of rare thromboembolic events such as cerebral venous sinus thrombosis, they note a causal relationship has not been established (the European Medicines Agency [EMA] have reviewed 18 cases of CVST out of more than 20 million doses of the AstraZeneca COVID-19 vaccine in Europe).  The committee recommend that countries continue to monitor the safety of all COVID-19 vaccines and that healthcare workers should be educated in recognising signs and symptoms of adverse events following vaccination and agree with the EMA’s plans to investigate these events further.

Read the full statement below, including links to the EMA statement and the UK MHRA statement

WHO: Statement of the WHO Global Advisory Committee on Vaccine Safety (GACVS) COVID-19 subcommittee on safety signals related to the AstraZeneca COVID-19 vaccine


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