TGA：现已批准辉瑞 COVID-19 疫苗更广泛的储存和运输条件
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.
这 产品信息 contains the most up-to-date storage and transport requirements.
The full TGA statement can be accessed via the link below:
TGA：现已批准辉瑞 COVID-19 疫苗更广泛的储存和运输条件
路透社：疫情肆虐，加拿大安大略省将扩大阿斯利康新冠疫苗的使用
As a third wave of COVID-19 infections spreads across Canada, a change in recommendation for the COVID-19 vaccine rollout has been announced for Ontario. People who will turn 40 years of age this year can now be offered the AstraZeneca COVID-19 vaccine.
Last month, Health Canada (the medicines regulatory board) advised that administration of the AstraZeneca COVID-19 vaccine be limited to those over 55 years of age. This age limit was put in place following reports globally of serious blood clots and bleeding in people who had received COVID-19 AstraZeneca.
With 4,250 new cases of COVID-19 infection diagnosed in Ontario on Sunday and a total of 737 patients requiring intensive care, the benefits of immunising a younger age group is now deemed to outweigh any risk of side effects.
It is recommended that following immunisation, anyone who experiences shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms like severe headaches or blurred vision, or skin bruising or tiny blood spots under the skin beyond the site of the injection seek medical attention.
To read more about the change in recommendation refer to the below link:
路透社：疫情肆虐，加拿大安大略省将扩大阿斯利康新冠疫苗的使用
新资源：权衡 COVID-19 阿斯利康的潜在益处和危害风险
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:
CDC: Cases of Cerebral Venous Sinus Thrombosis with Thrombocytopenia after Receipt of the Johnson & Johnson COVID-19 Vaccine
The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) in the United States have recommended a pause in the rollout of the Johnson & Johnson (J&J) COVID-19 vaccine. This recommendation comes following 6 reports of a rare type of blood clot (cerebral venous sinus thrombosis) in combination with a reduced number of platelets (thrombocytopenia) in individuals who have received the vaccine.
All 6 reports involved women aged 18–48 years, with symptoms developing 6–13 days following vaccination. Sadly one patient has died.
The CDC is urging all health care professionals to be on alert for symptoms of thrombotic events or thrombocytopenia in individuals who have recently received the J&J COVID-19 vaccine. It recognises that based on studies involving similar thrombotic events in those who were vaccinated with COVID-19 AstraZeneca, the use of heparin when treating such conditions should be avoided.
The CDC and FDA are currently reviewing all available information and will convene an emergency meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday April 14 2021, to further review these cases and assess potential implications on vaccine policy.
For more information and read the alert in full please follow the link below:
美国广播公司新闻：ATAGI 已告诉首相停止对 50 岁以下人群使用阿斯利康疫苗并使用辉瑞，但他们是谁？
The Australian Government’s recent decision to amend Australia’s vaccine program was based on the recommendation provided by ATAGI, following international evidence linking a rare blood-clotting condition to the AstraZeneca vaccine in younger people.
ATAGI is the Australian Technical Advisory Group on Immunisation. They provide recommendations to the Minister for Health regarding the National Immunisation Program (NIP) and other immunisation issues including immunisation research and immunisation policies, procedures and vaccine safety. Comprising of 14 medical experts, the group is co-chaired by Associate Professor Christopher Blyth, a specialist in paediatric infectious diseases, and Professor Allen Cheng, who specialises in epidemiology and public health.
This article summarises the role of ATAGI, including their recent recommendations to the Government regarding the AstraZeneca vaccine.
要阅读更多信息，请点击以下链接：
美国广播公司新闻：ATAGI 已告诉首相停止对 50 岁以下人群使用阿斯利康疫苗并使用辉瑞，但他们是谁？
For more information on ATAGI, please refer to our MVEC reference page:
世界卫生组织全球疫苗安全咨询委员会 COVID-19 小组委员会关于阿斯利康 COVID-19 疫苗的临时声明
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 7日, 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:
世界卫生组织全球疫苗安全咨询委员会 COVID-19 小组委员会关于阿斯利康 COVID-19 疫苗的临时声明
《时代报》：阿斯利康的决定增加了疫苗推出清晰度的需要
On Thursday evening, the Australian Government made amendments to Australia’s vaccine program based on international evidence linking a rare blood-clotting condition to the AstraZeneca vaccine in younger people, with Pfizer now being the preferred vaccine for people under the age of 50.
The Australian government has chosen not to be definitive in their advice; instead they have left the choice regarding which vaccine should be administered to individual Australians in consultation with their GP. The AstraZeneca vaccine will still be available for people under the age of 50 on a case-by-case basis, with vaccinations of elderly Australians continuing as planned.
As evidenced by these recent changes, providing timely, factual and transparent information – even if this information does not include clear rules or definitive advice – remains paramount in ensuring public trust in the Australian vaccination program.
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ATAGI 针对阿斯利康疫苗的声明，回应新的疫苗安全担忧
Following investigations nationally and internationally into a rare blood clotting condition known as 血栓形成伴血小板减少症候群 (TTS) occurring in people who have received COVID-19 AstraZeneca, ATAGI have provided updated advice for the administration of COVID-19 vaccines in Australia.
ATAGI recommends that Comirnaty™ is the preferred brand for immunisation of those under 50 years of age who have not already received dose 1 of COVID-19 AstraZeneca, with COVID-19 AstraZeneca available for immunisation of those over 50 years of age. Individuals who have had their first dose of COVID-19 AstraZeneca without any serious adverse events can proceed with the second dose. COVID-19 AstraZeneca can continue to be used in adults aged under 50 years where the benefits are likely to outweigh the risks for an individual (an informed decision can be made following a discussion on the risks and benefits).
TTS is a newly described serious condition, which presents with unusual blood clots (thrombosis) in the brain or other parts of the body, accompanied by a low number of platelets (thrombocytopenia). It has been noted to develop 4-20 days following vaccination with COVID-19 AstraZeneca. Global reports show TTS may occur in approximately 4-6 people per million doses delivered, with 1 case recorded in Australia to date. It is noted to predominantly occur in younger adults however there have been some cases reported in older vaccine recipients. So far there has been no pre-existing conditions or biological factors identified that may predispose or decrease the risk of someone developing TTS. The exact mechanism leading to this condition is not fully understood however antibodies (anti-PF4 antibodies) that activate platelets have been detected in some people who have developed TTS. These antibodies have also been detected in people with similar symptoms following administration of the drug heparin (heparin induced thrombocytopenia).
ATAGI has made this recommendation after considering the current level of community transmission of COVID-19 disease in Australia, as well as the likely severity of disease according to age if exposed to COVID-19. Should the level of risk change or more information becomes available these recommendations may change. ATAGI continues to recommend all adults be vaccinated against COVID-19 as the virus continues to cause severe disease globally.
To read the advice in full refer to:
《时代报》：维多利亚医院寻找与阿斯利康有关的罕见血栓
Victorian hospitals are retrospectively reviewing patient records to determine if there have been further cases of patients presenting with a rare blood clotting disorder, temporally associated with the administration of COVID-19 AstraZeneca. A 44 year old health care worker in Victoria recently presented with abdominal pain, low platelet count and thrombosis, 12 days after being immunised. This follows reports of similar cases internationally where investigations by medical regulators are ongoing.
Professor Jim Buttery from SAEFVIC (Victoria's vaccine safety service) suggests that it is unlikely that there would be many undetected cases due to the clotting disorder being so rare.
The TGA and ATAGI have recommended the continued rollout of the AstraZeneca vaccine whilst investigations continue, and considers the benefit of vaccination outweighs any potential risks. ATAGI has urged anyone receiving COVID-19 AstraZeneca to be on alert for severe persistent headaches that are not resolved with over the counter pain relief. Health care professionals are advised that the threshold for reporting adverse events is low, with all serious adverse events thoroughly reviewed by an expert panel.
要阅读更多信息，请点击以下链接：
更新了 ATAGI 关于 COVID-19 疫苗接种后报告的特定凝血状况的声明
Following a report in Australia of a rare blood clotting condition in a person who received COVID-19 AstraZeneca, ATAGI have released a statement for consumers and an updated statement for health providers.
Internationally, a small number of cases of thrombosis (blood clots) with associated thrombocytopenia (low platelet count) have been reported in the time period 4-20 days following vaccination. These cases have either presented as central venous sinus thrombosis (CVST) or thrombosis in other sites, such as intra-abdominal venous systems.
Vaccination against COVID-19 disease continues to be of high importance in groups who are most at risk of disease exposure or disease complications. Common or expected side effects of vaccination include headache, muscle aches, fever and chills, with onset typically beginning within the first 24 hours and symptoms lasting 1-2 days.
Health care providers and vaccine recipients are encouraged to be alert for any new, severe, persistent headache or other significant symptoms, such as severe abdominal pain, features of raised intracranial pressure (severe headache, vomiting, confusion) or neurological deficits with an onset between 4 to 20 days after vaccination. In suspected cases a referral to hospital is recommended and the appropriate investigations (full blood count, D-dimer, fibrinogen) and imaging completed.
Patients suspected to have this condition should not receive heparin or platelets.
As a precaution, anyone with a past history of CVST or heparin induced thrombocytopenia (HIT) is not recommended to receive the COVID-19 vaccine until further information is available. Investigations internationally and within Australia are ongoing.
To read the statement for consumers in full please refer to the link below:
To read the the updated advice for health providers please refer to the link below: