SAEFVIC Rapid report: a new reporting pathway for COVID-19 vaccine AEFI

Reporting adverse events following immunisation (AEFI) is not mandatory in Victoria, however doing so allows the rapid investigation of any potential vaccine or system problems. This helps to ensure a safe and effective immunisation program and it maintains community confidence in vaccines.

The new SAEFVIC Rapid reporting pathway has been launched for reporting any common or expected side effects following a COVID-19 vaccine. Reporting via this pathway will not result in follow up of clinical symptoms however it will contribute to data collection and assist health authorities to understand the frequency of symptoms occurring. Should the vaccinee experience significant side effects, completing the SAEFVIC Extended report is recommended.

For more information on SAEFVIC, symptoms that should be reported, and instructions on how to report, please visit our immunisation reference page below:

MVEC: Surveillance of Adverse Events Following Vaccination in the Community (SAEFVIC)


The Conversation: Let’s hold off vaccinating children and teens against COVID-19. Prioritising adults is our best shot for now

Some countries who have successfully vaccinated a high proportion of their adult population are now shifting the focus of their COVID-19 vaccine rollout towards children and adolescents.

The following article reviews various international vaccine strategies for the younger population, and explores COVID-19 vaccine safety, including expected vaccine side effects and reports of myocarditis and pericarditis in adolescents. It looks at the potential impact that vaccination of children could have on transmission, herd immunity and keeping schools open.

The World Health Organization (WHO) recognises that globally the vaccine rollout has been slow and inequitable. Low income countries have insufficient vaccine supplies to protect high-priority groups.

In Australia where rates of COVID-19 community transmission is low, it is important that efforts remain on maximising vaccine coverage for adults and those who are at highest risk of severe COVID-19 disease.

To read more, follow the link below:

The Conversation: Let’s hold off vaccinating children and teens against COVID-19. Prioritising adults is our best shot for now

 

 


Australia's COVID-19 vaccine coverage update- July 5 2021

The Australian Government Department of Health continue to publish information relating to the COVID-19 vaccine rollout; including data on population coverage.

Latest figures show that 71.64% of Victorians aged 70 years and over have received their first dose of COVID-19 vaccine, with 16% having completed both recommended doses.

To view these statistics and read other information relating to vaccine distribution and uptake, please refer to:

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


New immunisation reference page: Myocarditis and pericarditis following mRNA COVID-19 vaccines

Myocarditis is an inflammatory disease of the heart muscle, whilst pericarditis is an inflammatory disease of the lining of the heart muscle. They are rare conditions, most commonly associated with viral infections (including SARS-CoV-2) but can also be triggered by other factors such as medications and autoimmune conditions. Globally, an increased number of cases above an expected population rate of myocarditis and pericarditis have been reported in individuals who have received mRNA COVID-19 vaccines (eg. Comirnaty™ and Moderna).

Our new reference page discusses the temporal association of myocarditis and pericarditis with mRNA COVID-19 vaccination, symptoms, investigations, as well as the implications on future COVID-19 vaccination.

To read more follow the link below:

MVEC: Myocarditis and pericarditis following mRNA COVID-19 vaccines

 

 


New immunisation reference page: Moderna COVID-19 vaccine

Following the announcement by the Australian Government that 25 million doses (as well as additional variant specific versions) of Moderna's COVID-19 vaccine, Elasomeran, had been secured for the Australian population, this vaccine was last week granted provisional determination by the TGA.

Our new reference page explores the various clinical trials involving Elasomeran, as well as details the immunogenicity, efficacy and safety data available for this vaccine.

To read more follow the link below:

MVEC: Moderna COVID-19 vaccine


TGA grants provisional determination for the Moderna COVID-19 vaccine, Elasomeran

The Therapeutic Goods Administration (TGA) has granted provisional determination to Moderna Australia Pty Ltd for their COVID-19 vaccine candidate, Elasomeran. It is being considered for use in those aged 12 years or older for active immunisation to prevent COVID-19 disease. It is an mRNA vaccine requiring two doses, given 28 days apart.

Granting provisional determination means that Moderna Australia Pty Ltd is now eligible to apply for provisional registration. Following the provisional pathway provides a formal and transparent mechanism for speeding up the registration of promising new medicines with preliminary clinical data.

Provisional determination is only granted once the TGA has considered all eligibility criteria, including evidence of a plan to submit comprehensive clinical data.

You can read the press release from the TGA below:

TGA grants provisional determination for the Moderna COVID-19 vaccine, Elasomeran

For more information on the process of COVID-19 vaccine provisional approval please refer to our reference page:

MVEC: Provisional registration of COVID-19 vaccine(s) in Australia


ATAGI statement on revised recommendations on the use of COVID-19 Vaccine AstraZeneca, 17 June 2021

ATAGI has revised the recommendations for COVID-19 vaccination within Australia.

Due to a higher risk and severity of thrombosis with thrombycytopenia syndrome (TTS) related to the use of COVID-19 AstraZeneca, Comirnaty™ is now the preferred COVID-19 vaccine for individuals aged 16-59 years. Due to the risk of severe outcomes related to COVID-19 disease for individuals aged 60 years and over, the benefits of vaccination in preventing disease outweighs the risk of developing TTS.

Individuals aged less than 60 years who have received their first dose of COVID-19 AstraZeneca without any serious adverse events (eg. anaphylaxis or TTS) should continue to receive their second dose.

For more information please refer to the link below:

ATAGI statement on revised recommendations on the use of COVID-19 Vaccine AstraZeneca, 17 June 2021

 

 


New immunisation reference page: COVID-19 mixed vaccine schedules

With the emergence of variant COVID-19 strains, global vaccine supply issues, and the need to rapidly immunise the population, a number of clinical trials are investigating the option of “mixed schedules”. Mixed schedules have been used previously in other vaccination strategies and involve the administration of different vaccine brands to complete a vaccine course.

Our new reference page explores the clinical trials underway which aim to determine the safety of mixed scheduling, the immunogenicity, as well as the recommendations for intervals between doses.

Due to a lack of available data, mixed vaccine schedules are not currently approved in Australia however are in use in Canada and across Europe.

To read more, follow the link below:

MVEC: COVID-19 mixed vaccine schedules

 


Flu vaccine and COVID-19 vaccination- change in recommendation for residents and staff in residential aged care and disability care settings

Due to the current COVID-19 outbreak in Victoria, Australia's Chief Health Officer Paul Kelly, has advised of a changed recommendation to the timing of influenza and COVID-19 vaccines for certain groups.

In order to ensure that all residents and staff in residential aged care and disability care settings are vaccinated as soon as possible, the previous 14 day minimum interval between influenza and COVID-19 vaccines no longer applies for this group.

Shortening this time frame will not have any impact on the effectiveness of either vaccine and will result in the rapid protection of the most vulnerable. Influenza and COVID-19 vaccines should not be administered on the same day.

To read more follow the link below:

Chief Medical Officer, Professor Paul Kelly and Commodore Eric Young's press conference on 27 May 2021


Nature: Mix-and-match COVID vaccines trigger potent immune response

Preliminary results from a trial involving 663 participants receiving a mixed schedule of COVID-19 vaccine brands has been released. Participants who had received their first COVID-19 vaccine as AstraZeneca were then offered their second dose as Pfizer at least 8 weeks later.

Higher antibody levels were produced following dose 2 than had been produced following receipt of dose 1. The immune response generated was also stronger compared with a standard 2 dose course of the AstraZeneca COVID-19 vaccine. The side effects reported following a mixed schedule were similar to those experienced by those who received a same brand schedule. This is in contrast to a similar study in the UK which showed higher reports of common side effects following a mixed schedule of COVID-19 vaccination.

To read the article in full refer to the link below:

Nature: Mix-and-match COVID vaccines trigger potent immune response