AstraZeneca COVID-19 vaccine causes thrombosis or death?

AstraZeneca COVID-19 vaccine causes thrombosis or death? Emergency stop in many countries around the world! WHO has launched an investigation.

Recently, due to people experiencing thrombosis or death after being vaccinated with the COVID-19 vaccine produced by the British company AstraZeneca, many countries around the world have announced the suspension of the AstraZeneca vaccine.

On March 11, local time, the European Medicines Agency (EMA) responded to the recent risk of AstraZeneca’s COVID-19 vaccine, saying that its safety committee, PRAC, is investigating cases of thromboembolic events, and emphasized that “the benefits of the vaccine are still greater than risk”.

01 Many countries suspend vaccination against AstraZeneca

In Europe, Austria, Denmark, Norway, Iceland, Italy, Spain, Bulgaria, Estonia, Lithuania, Latvia, Luxembourg and other countries have announced the suspension of AstraZeneca vaccination in the past few days.

• On the 7th local time, the Austrian Federal Department of Health and Security pointed out on its official website that due to the death of a vaccinator due to abnormal blood clotting, the same batch of AstraZeneca vaccine (number ABV5300) was suspended.
• The ABV5300 batch contains one million doses of vaccine and has been delivered to 17 EU countries, including Austria, Bulgaria, Cyprus, Denmark, Estonia, France, Greece, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Spain And Sweden.
• On the 11th local time, Denmark, Norway and Iceland respectively announced the suspension of AstraZeneca vaccination due to the occurrence of thrombosis after inoculation of the COVID-19 vaccine produced by the British company AstraZeneca. The Danish health department stated that one vaccinator in the country had died.
• On the 11th local time, due to the death of AstraZeneca vaccine in Sicily, Italy, the Italian Food and Drug Administration decided to suspend the use of the same batch of AstraZeneca vaccine. According to Italian media reports, the batch of vaccines totaled about 500,000 doses, which have been distributed nationwide.
• On the 12th local time, Bulgaria suspended AstraZeneca vaccination. Bulgarian Prime Minister Borisov stated that the suspension of AstraZeneca vaccination will be maintained until the European Medicines Agency issues a written statement guaranteeing the safety of AstraZeneca vaccine.
• On the 12th local time, several regions in Spain have announced the suspension of AstraZeneca’s COVID-19 vaccine, including Castile-León, Andalusia, Canary, Asturias and other regions.

In addition, affected by the suspension of AstraZeneca’s COVID-19vaccination incident in many European countries, the Thai government announced on the 12th that it will suspend the AstraZeneca COVID-19 vaccination plan originally scheduled to start on the same day.

On the same day, there were reports in South Korea that a total of 7,648 suspected adverse reactions after vaccination had been reported. Among them, 7567 cases were related to AstraZeneca vaccine, accounting for 98.9% of the total, and the remaining 81 cases were related to Pfizer vaccine. South Korea currently uses two COVID-19 vaccines, namely the vaccine jointly developed by AstraZeneca in the United Kingdom and the University of Oxford, and the vaccine jointly developed by Pfizer in the United States and BioNTech in Germany.

It is worth mentioning that although many countries have announced the temporary suspension of the AstraZeneca vaccine, British Prime Minister Johnson still supports the vaccine in his country, and even stepped forward. The British drug regulatory agency also said that it failed to confirm that there is evidence that there is a problem with the AstraZeneca vaccine, and pointed out that the public should continue to get the vaccine.

02 The benefits of vaccines still outweigh the risks?

On the 12th local time, AstraZeneca said in a statement that their safety data analysis showed that there was no evidence that AstraZeneca vaccine vaccinators would have an increased risk of thrombosis or pulmonary embolism. AstraZeneca also stated that it will fully support the ongoing investigation.

On the same day, WHO Director-General Tedros Adhanom Ghebreyesus said that WHO has learned that some countries have suspended vaccination against AstraZeneca. The WHO Global Vaccine Safety Advisory Committee is carefully evaluating the safety of AstraZeneca’s vaccines, and will immediately report the results of the investigation after full understanding, and whether AstraZeneca’s vaccine use recommendations will be revised.

On March 11, local time, the European Medicines Agency (EMA) responded to the above-mentioned AstraZeneca vaccine risk event, stating that its safety committee, PRAC, is investigating cases of thromboembolic events, and emphasized that “the benefits of the vaccine are still greater than the risks.”

EMA stated that although quality defects are considered unlikely at this stage, it is studying the quality of the relevant batches. At the same time, it is believed that there is currently no indication that vaccination causes these diseases, and these diseases are not classified as side effects.

The EMA Pharmacovigilance Risk Assessment Committee (PRAC) stated that they have been reviewing all reported thromboembolic events and other blood clot-related conditions after vaccination with AstraZeneca. Currently, no thromboembolic events have occurred in the vaccinated population than the general population. Medium to high. Therefore, PRAC’s position is that the current benefits of the vaccine still outweigh its risks, and the vaccination can be continued while investigating thromboembolic events.

It is understood that as of March 10, 2021, 30 thromboembolic events have been reported in the European Economic Area, and nearly 5 million people in the region have been vaccinated with AstraZeneca.

It is worth mentioning that on the 12th local time, EMA stated in a statement that PRAC “has recommended to update the product information of AstraZeneca’s COVID-19 vaccine and include allergic reactions in the list of side effects”.
This product information update is based on a review of 41 suspected allergic reaction reports in approximately 5 million vaccinations in the UK. After carefully reviewing the data, PRAC believes that some of the allergic reactions in the report may be related to the vaccine.

03 AstraZeneca vaccine on rough roads

In fact, the vaccine from AstraZeneca has had twists and turns from research and development to clinical trials.

On October 22, 2020, the Brazilian health regulatory agency ANVISA announced on Wednesday local time in Brazil that a subject who participated in the clinical trial of the COVID-19 vaccine jointly developed by the University of Oxford and AstraZeneca in the United Kingdom has unfortunately died. However, follow-up news stated that the Brazilian volunteer was not vaccinated with the COVID-19 vaccine, and was injected with a placebo, mainly as a control group to participate in the trial.

This is not the first time that AstraZeneca’s COVID-19 vaccine clinical trials have appeared. In early September, the clinical trial of AstraZeneca’s COVID-19 vaccine was suspended due to suspected serious adverse reactions in a vaccine subject. On September 12, the British Medicines Agency (MHRA) confirmed its safety before its clinical trials in the UK resumed. However, trials in other regions have not resumed, especially large-scale clinical trials in the United States are still suspended.

In response to the suspension of the aforementioned clinical trials, on September 9 last year, AstraZeneca said in response to an interview with 21st Century Business Herald, “We have initiated a standard review process for the ongoing global randomized controlled trial of the new coronavirus vaccine at Oxford University. We voluntarily suspend vaccination to ensure that the independent committee checks the safety data of the vaccine. This is a routine operation to ensure the integrity of our experiment, and it is taken when any potential, unexplainable disease occurs in a trial Necessary steps.”

AstraZeneca said, “In large clinical trials, this happens occasionally, but we must conduct careful and independent inspections. We are working hard to speed up the verification of this single event and minimize any changes in the research process. Potential impact.”

(source:internet, reference only)

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