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:
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
WHO: COVID-19 subcommittee of the WHO Global Advisory Committee on Vaccine Safety (GACVS) reviews cases of mild myocarditis reported with COVID-19 mRNA vaccines
The WHO Global Advisory Committee on Vaccine Safety (GACVS) COVID-19 subcommittee has released a statement following the review of a small number of cases of myocarditis reported in individuals who have received COVID-19 mRNA vaccines.
Cases have predominantly been reported in adolescents and young adults, with a typical symptom onset occurring within 4 days of vaccination. Reports were more common following receipt of a second dose of the vaccine. GACVS notes that most cases of myocarditis appear to be mild.
The COVID-19 subcommittee reiterates that the benefit of vaccination in reducing deaths and hospitalisations due to COVID-19 disease outweighs potential risk of vaccine side effects.
To read more follow the link below:
Joint statement from ATAGI and THANZ on Thrombosis with Thrombocytopenia Syndrome (TTS) and the use of COVID-19 Vaccine AstraZeneca
ATAGI and the Thrombosis and Haemostasis Society of Australia and New Zealand (THANZ) have released a joint statement surrounding the administration of COVID-19 AstraZeneca and Thrombosis with Thrombocytopenia Syndrome (TTS).
Following close monitoring of local and international data it has been noted that the risk of TTS is not likely to be increased in people who:
- Have a history of blood clots in typical sites
- Have an increased clotting tendency that is not immune mediated
- Have a family history of blood clots
- Have a history of ischaemic heart disease
- Currently have or has a history of thrombocytopenia
- Are receiving anticoagulation therapy
Comirnaty™ is the preferred COVID-19 vaccine for people who:
- Have a history of idiopathic splanchnic vein thrombosis
- Have a history of antiphospholipid syndrome with thrombosis
- Individuals < 50 years of age
- Have a history of cerebral venous sinus thrombosis (CVST)
- Have a history of heparin-induced thrombocytopenia (HIT)
- Have a contraindication to COVID-19 AstraZeneca (including anaphylaxis to a previous dose or anaphylaxis to a component of COVID-19 AstraZeneca, TTS occurring after a dose of COVID-19 AstraZeneca or other serious adverse event following receipt of COVID-19 AstraZeneca)
To read the statement in full please refer to the following link:
ABC news: Multilingual women are countering vaccine hesitancy in Victoria's culturally diverse communities
In an effort to improve communication and address vaccine misinformation within culturally diverse communities, the Victorian Department of Health has partnered with the Multicultural Centre for Women's Health and other women's health organisations to deliver a range of information in various languages. Multilingual health educators will be actively engaging within the community by doorknocking public housing, holding online education sessions and answering questions about COVID-19 vaccines, the virus and other health related issues.
To read more about this program follow the link below:
The Guardian: Vaccinate vulnerable global poor before children in rich countries, WHO says
The World Health Organization's director-general, Tedros Adhanom, has urged wealthy countries to donate COVID-19 vaccines to poorer nations.
Of the 1.4 billion doses of COVID-19 vaccines administered globally, 44% of those have been administered in high-income countries. Only 0.3% of vaccines have reached the 29 lowest income countries, where 9% of the world's population call home. The WHO has warned that this inequity in vaccine access could result in 2021 experiencing more death than in the first year of the pandemic. With wealthy countries now looking to vaccinate adolescents and children, the WHO are encouraging these countries to instead donate their vaccines through COVAX. This would allow poorer nations to access vaccines and protect their healthcare workers and vulnerable priority groups.
To read more, follow the link below:
The Guardian: Vaccinate vulnerable global poor before children in rich countries, WHO says
New immunisation reference page: COVID-19 vaccination in children
COVID-19 infections have generally produced more severe disease outcomes in adults and the older population, with children generally experiencing milder symptoms. For this reason, initial COVID-19 vaccine clinical trials and vaccine rollouts focused on the adult population. However, it is recognised that in order to achieve herd immunity within the community, the vaccination of children needs to be considered.
Our new reference page outlines the importance of conducting paediatric focused COVID-19 vaccine clinical trials and summarises the trials that are currently underway.
To read more follow the link below:
MVEC: COVID-19 vaccination in children