TGA: Vắc xin AstraZeneca ChAdOx1-S COVID-19
The TGA (Therapeutic Goods Association) have provided an update regarding the AstraZeneca COVID-19 vaccine in light of preliminary reviews by the European Medicines Agency (EMA) and United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), regarding the risk of blood clots in people who have received the AstraZeneca COVID-19 vaccine.
The findings of these reviews are that the benefits of the vaccine continue to outweigh the risks. The EMA’s safety meeting noted that the number of people with blood clots in large clinical trials and who have received the vaccine in global rollouts were less than is expected in the general population. 20 million people have received the vaccine in Europe and several more million in other parts of the world.
They noted there have been a very small amount of people who have experienced very rare clotting conditions – disseminated intravascular coagulation (DIC) with thrombocytopenia; and cerebral venous sinus thrombosis (CSVT). A causal link with the vaccine has not been established and these conditions are also seen in the general population.
Both the EMA and the MHRA are continuing to review cases of these rare clotting conditions.
The TGA has not received any reports of blood clots following vaccination with the AstraZeneca COVID-19 vaccine in Australia (as of 18 March 2021) and advise people to continue to receive the vaccine when eligible. Monitoring of the safety of this vaccine will continue and if there are any safety concerns these will be communicated to the public.
Please refer to the full alert below for more information:
TGA: Vắc xin AstraZeneca ChAdOx1-S COVID-19
WHO statement on AstraZeneca COVID-19 vaccine safety signals
The World Health Organization (WHO) have released a statement following the recent reports of rare blood coagulation disorders in people who have received COVID-19 AstraZeneca.
In large immunisation campaigns it is expected that countries will signal adverse events to vaccination. Signals do not necessarily mean that the vaccine caused the events, but investigations into them are important. This signal detection confirms that the safety surveillance systems that are in place globally are effective and the proper processes are in place.
The Global Advisory Committee on Vaccine Safety is currently assessing all available safety data for COVID-19 AstraZeneca. Outcomes of the review will be communicated to the public as soon as they become available.
At this time, WHO recommends that vaccination with COVID-19 AstraZeneca continues as the benefits of immunisation outweigh potential risks.
To read the statement in full please follow the link below:
WHO statement on AstraZeneca COVID-19 vaccine safety signals
The Conversation: Data suggest no increased risk of blood clots from the AstraZeneca vaccine. Australia shouldn’t pause its rollout
With some European countries opting to pause the rollout of COVID-19 AstraZeneca in response to reports of blood clots, Australian experts have cautioned against any pauses whilst investigations are underway.
Thromboembolic events occur in approximately 17,000 Australians per year. In a global vaccine rollout it is therefore expected that some people will develop a blood clot coincidentally after they have received the vaccine. This does not meant that the vaccine caused it.
Since COVID-19 AstraZeneca vaccinations began, there have been 30 thromboembolic events reported (as of March 10, 2021) in approximately 5 million vaccine recipients. This is lower than the natural rate expected to occur.
All adverse events must be thoroughly investigated. The robust safety surveillance systems in Australia are established to effectively identify any signals requiring follow up. Extreme caution is urged when considering a pause in rollout while investigations are underway as this can damage vaccine confidence.
To read more, please read the article below:
The bmj: Covid-19: Booster dose will be needed in autumn to avoid winter surge, says government adviser
Anthony Harnden, Deputy Chair of the Joint Committee on Vaccination and Immunisation (JCVI) in the UK, has suggested that booster doses of COVID-19 vaccines are likely to be required.
With minimal data surrounding the duration of protection provided by COVID-19 vaccines and the emergence of new strain variants, the UK is considering commencing booster doses from August of this year.
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The Guardian: Israel says 600 children given Covid jab had no serious side-effects
Following an expansion of Israel's COVID-19 vaccination program, around 600 children (≥ 12 years) have received the Pfizer/BioNTech COVID-19 vaccine. Reported side-effects in this age group have been minor and the vaccine has been well tolerated.
Due to the emergence of more transmissible strains of COVID-19, experts have now suggested that in order to achieve herd immunity closer to 90% coverage will be required. In a population of 9 million people, with approximately 1/4 of those aged under 16 years, lowering the age limit for COVID-19 vaccination is an important development for Israel.
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The Guardian: Israel says 600 children given Covid jab had no serious side-effects
TGA: Vắc xin AstraZeneca ChAdOx1-S COVID-19
Denmark, Iceland and Norway have temporarily paused the distribution of COVID-19 AstraZeneca as a precautionary measure in response to reports of blood clots following immunisation (including 1 death in Denmark). The European Medicines Agency's safety committee is conducting a rapid review into the events.
The Therapeutic Goods Administration (TGA) have advised that a link has not been confirmed and to date there have been no reports of similar events in Australia. Extensive international vaccination programs have not indicated an increased risk of blood clots associated with the vaccine.
Vaccination with COVID-19 AstraZeneca continues in other countries including the United Kingdom and France.
Please refer to the full alert below for more information:
TGA: Vắc xin AstraZeneca ChAdOx1-S COVID-19
Swollen Lymph Nodes Under Armpit After COVID-19 Vaccine May Mimic Breast Cancer Symptoms
The Society of Breast Imaging (SBI) in the United States is recommending women wait at least four weeks after receiving a COVID-19 vaccine to schedule a mammogram due to the potential side-effect of swollen or tender lymph nodes in the armpit. Changes in the lymph nodes can be a sign of breast cancer and the concerns are this could lead to false readings on mammograms leading to further unnecessary testing.
This advice was issued based on the rates of swelling and tenderness in the lymph nodes post the Moderna COVID-19 vaccine and Pfizer BioNTech COVID-19 vaccine in the United States. Whilst rare in people who have received the Pfizer BioNTech vaccine (which is currently provisionally registered for use in Australia), the SBI notes the incidence rates are most likely higher than reported and accordingly issued the aforementioned advice to separate mammograms from COVID-19 vaccines by four to six weeks.
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ATAGI advice on seasonal influenza vaccines in 2021
ATAGI have published recommendations for the influenza vaccine program in 2021. This advice includes vaccine brand and dose information, the timing of administration, funding eligibility criteria as well as the requirement for reporting all vaccine administration to the Đăng ký Chủng ngừa Úc (AIR).
To view the recommendations please follow the link below:
ATAGI advice on seasonal influenza vaccines in 2021
Incidents after vaccination with AstraZeneca's COVID-19 vaccine
Following reports of 2 temporally associated severe adverse events following immunisation (AEFI), các Austrian Federal Office for Safety in Health Care (the national regulatory body for medicines) have halted the supply and distribution of a specific batch of COVID-19 AstraZeneca.
It is important to note that data from clinical trials shows no evidence of a casual relationship and this halt is being utilised as a precautionary measure only. An immediate review of international reports of similar AEFI show no signals for concern. Vaccine rollout using alternate batches of COVID-19 AstraZeneca continues and further investigations are ongoing.
To read the official announcement follow the link below:
Rút kinh nghiệm từ những sai sót với vắc xin COVID-19 mới
Vào tháng 12 năm 2020, vắc xin COVID-19 bắt đầu được triển khai trên khắp Hoa Kỳ. Bài báo này được xuất bản bởi Viện Thực hành Thuốc An toàn, thảo luận về các báo cáo khác nhau về các lỗi chuẩn bị và quản lý đã xảy ra kể từ khi bắt đầu triển khai.
Với phạm vi của chiến dịch tiêm chủng COVID-19 toàn cầu, dự kiến sẽ có những sai sót. Khi Úc bắt đầu triển khai trên toàn quốc, một bài học quan trọng là đảm bảo rằng tất cả các sai sót và phản ứng bất lợi của vắc xin COVID-19 đều được báo cáo cho các cơ quan hữu quan để giúp ngăn chặn những loại sai sót này xảy ra tại đây.
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ISMP: Rút kinh nghiệm từ những sai sót với vắc xin COVID-19 mới