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 关于使用 COVID-19 疫苗阿斯利康的修订建议声明，2021 年 6 月 17 日
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 关于使用 COVID-19 疫苗阿斯利康的修订建议声明，2021 年 6 月 17 日
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.
要了解更多信息，请点击以下链接：
MVEC: COVID-19 mixed vaccine schedules
流感疫苗和 COVID-19 疫苗接种 - 对住宅老年护理和残疾人护理机构的居民和工作人员的建议发生变化
由于当前维多利亚州爆发了 COVID-19 疫情，澳大利亚首席卫生官 Paul Kelly 已建议更改针对某些群体的流感和 COVID-19 疫苗接种时间的建议。
为了确保住院老年护理机构和残疾人护理机构的所有居民和工作人员尽快接种疫苗，之前流感疫苗和 COVID-19 疫苗之间 14 天的最短间隔不再适用于该群体。
缩短这一时间不会对任何一种疫苗的有效性产生任何影响，并将为最弱势群体提供快速保护。流感疫苗和 COVID-19 疫苗不应在同一天接种。
要阅读更多信息，请点击以下链接：
首席医疗官保罗·凯利教授和埃里克·杨准将于 2021 年 5 月 27 日举行的新闻发布会
Nature：混合搭配新冠疫苗可引发有效的免疫反应
一项涉及 663 名参与者的试验的初步结果已经发布，该试验接受了混合时间表的 COVID-19 疫苗品牌。接受第一剂阿斯利康 (AstraZeneca) 疫苗的参与者在至少 8 周后接受辉瑞 (Pfizer) 疫苗的第二剂疫苗。
第 2 剂接种后产生的抗体水平高于第 1 剂接种后产生的抗体水平。与阿斯利康 COVID-19 疫苗的标准 2 剂疗程相比，产生的免疫反应也更强。混合方案所报告的副作用与接受相同品牌方案的患者所经历的副作用相似。这与英国的一项类似研究形成鲜明对比，该研究显示混合接种 COVID-19 疫苗后常见副作用的报告较多。
要阅读全文，请参阅以下链接：
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.
要阅读更多信息，请点击以下链接：
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 血栓形成伴血小板减少症候群 (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)
要阅读该声明全文，请参阅以下链接：
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.
要了解更多信息，请点击以下链接：
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.
要阅读更多信息，请点击以下链接：
MVEC: COVID-19 vaccination in children