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 

 


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:


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

 


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.

 

 


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


New immunisation reference page: The VicSIS (Victorian Specialist Immunisation Services) Network

Current vaccine safety clinics managed by SAEFVIC have historically had a paediatric focus. With the rollout of COVID-19 vaccines within Australia and the initial priority groups involving adults, the VicSIS (Victorian Specialist Immunisation Services) network has been created to enhance adult immunisation services in Victoria to address queries and safely vaccinate under supervision, if required. These services can provide specialist immunisation support and provide a link between the key stakeholders, the Department of Health, SAEFVIC and hospital sites that form part of the network.

The VicSIS network will provide specialist vaccination services for people who have experienced an adverse event following immunisation (AEFI) with a COVID-19 vaccine, or those who are identified as at risk of an AEFI (for example, people with a history of anaphylaxis). Most people are able to proceed with future vaccines following an AEFI. Clinical consults will be offered in which individual recommendations will be developed.

Find out more about where the VicSIS clinics are located and how to refer to them in our new immunisation reference page, linked below.

MVEC: The VicSIS (Victorian Specialist Immunisation Services) Network


Additional module added to Victorian COVID-19 eLearning Competency

An additional module titled Preparing Comirnaty™ (Pfizer BNT162b2) COVID-19 Vaccine has been added to the Victorian COVID-19 eLearning Competency.

Please note the advice contained in this module is specific to the COVID-19 mRNA Vaccine BNT162b2 (Comirnaty™).

If you have already completed the Victorian COVID-19 eLearning Competency you can login and access this additional module via your profile in the MVEC Education Portal.