Contents
- The COVID-19 AstraZeneca vaccine and thrombosis – anxiety is growing
- The COVID-19 AstraZeneca vaccine and thrombosis. What did clinical trials show?
- The COVID-19 AstraZeneca vaccine and thrombosis. The situation under real conditions
- EMA: The benefits of vaccinating with AstraZeneka far outweigh the risks
The COVID-19 vaccine AstraZeneca can actually cause thrombosis? This question is asked by many of us. Especially if we hear information that another country has decided to suspend the administration of this preparation, and the European Medicines Agency is investigating this matter. What is known about AstraZeneca and the risk of thrombosis?
- Following cases of thromboembolism, more and more countries are suspending the use of AstraZeneca
- Clinical trials with AstraZeneca have not shown an increased risk of thrombosis
- Data analysis of 17 million people bitten against COVID-19 with AstraZeneca did not show that there is an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia
- The EMA, which is investigating the case, continues to hold the position that the benefits of AstraZeneca’s COVID-19 vaccine outweigh the risks of side effects
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The COVID-19 AstraZeneca vaccine and thrombosis – anxiety is growing
The AstraZeneca COVID-19 vaccine and speculation that it is related to cases of thrombosis is one of the hottest topics right now. Many people waiting for vaccinations with this preparation feel more and more doubts. Michał Dworczyk admitted that after the information on AstraZeneca vaccines in recent days, no vaccinations are offered to “several dozen percent of people”.
There is also concern about the information about other countries that have decided to partially or completely suspend vaccination with AstraZeneca until the doubts are resolved (many of them indicate that this step is a preventive measure).
- Where was vaccination with AstraZeneca stopped? [LIST OF COUNTRIES]
As The New York Times points out, the cascade of decisions to stop the use of AstraZeneca followed reports of four serious cases in Norway which were reported among healthcare workers vaccinated with the preparation. There were more reports of thrombosis in people vaccinated with AstraZeneca. Seven cases of venous sinus thrombosis were reported in Germany (three people died). on the death of a 60-year-old Danish and a 57-year-old man in Italy. On Wednesday, the Spanish health ministry announced the death of a 43-year-old woman shortly after receiving the AstraZeneca vaccine.
With all this news, some countries decided to suspend the administration of the AstraZeneca COVID-19 vaccine.
- Should Poland suspend AstraZeneca vaccinations? Prof. Simon answers
Are there really good reasons for concern? Let’s see what is known about the relationship between AstraZeneca and the risk of blood clots.
The COVID-19 AstraZeneca vaccine and thrombosis. What did clinical trials show?
The researchers remind that vaccines are the most carefully controlled medicinal products on the market – their effectiveness and safety are rigorously and very carefully tested. Also in terms of possible side effects. – If one test person develops adverse reactions, it is necessary to find out whether they were really related to the vaccine – because it does not necessarily have to be. Until a cause-and-effect relationship is found or ruled out, the tests cannot be continued – said virologist Dr. hab. n. med. Tomasz Dzieciatkowski.
- Full interview: How is vaccine efficacy and safety studied? Expert: It never ends
Clinical trials of the Astra Zeneca COVID-19 vaccine included a total of 60 people from different countries, ages, racial and ethnic groups. There was no evidence of an increased risk of thrombosis. This is highlighted by the International Society for Thrombosis and Haemostasis (ISTH). Dr. David Wohl, director of the vaccine clinic at the University of North Carolina, also touched on the topic at the NYT. The scientist emphasized that in the large clinical trials that led to the approval of COVID-19 vaccines on the market, he saw no evidence that any of them caused thrombosis.
The COVID-19 AstraZeneca vaccine and thrombosis. The situation under real conditions
Dr. David Wohl notes that the results of clinical trials may differ slightly from how the preparation works in real conditions, which include, for example, a greater variety of people and behavior. AstraZeneca, however, conducted an analysis covering the data of 17 million people from Great Britain and European Union countries, who were attacked against COVID-19 by its production. The results were shared on March 14.
“An in-depth (data) analysis did not show that there is an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia, regardless of age group, gender, vaccine batch or country,” the company said in a statement.
It is worth mentioning here that even with large clinical trials, events that occur very rarely cannot be ruled out. – If only one in 200 people has a side effect of those who receive the vaccine, a clinical trial involving literally millions of people would be needed to make sure they are “caught” in numbers, said Australian epidemiologist Gideon Meyerowitz-Katz. In his opinion, this could be a problem.
– After all, we use vaccines at the population level. Something that happens to one in 200 people, it may seem incredibly rare, and it is, but if we vaccinate 80 million people, it could happen dozens of times. However, the researcher adds that by monitoring people who have been vaccinated, you can see if there are any signs of risk in the population that has received the vaccine.
By March 15, AstraZeneca had been administered to a total of 17 million people in European countries. In total, about 91 million inhabitants of our continent have been vaccinated.
- What are the people to be vaccinated with AstraZeneka to do? Here’s what the doctor advises
EMA: The benefits of vaccinating with AstraZeneka far outweigh the risks
The conclusion from the above information is that the current number of reported thrombotic events out of the millions of COVID-19 vaccinations administered does not suggest a direct link between the administration of Astra Zeneca and the occurrence of thrombosis. Also, remember that adverse event reporting systems are only used to identify a signal of risk, not whether one thing causes another.
The International Society for Thrombosis and Haemostasis (ISTH) made the same statement: “Thrombotic events are common in the general population and were not previously associated with vaccination. We currently do not know if the timing of a blood clot formation during vaccination is coincidental or whether vaccination may in rare cases increase the risk of thrombosis. Importantly, well-conducted clinical trials with COVID-19 vaccination have not shown an increased risk of thrombosis ».
A similar position was taken by the European Medicines Agency (EMA), which is investigating the case. «Many thousands of people develop blood clots each year in the EU for a variety of reasons. The overall number of thromboembolic events in vaccinated people does not seem to be higher than that observed in the general population »- states. EMA also said that it is working closely with the company itself, experts in blood diseases and other health authorities on this matter. The head of the EMA Emer Cooke ensures that the agency is investigating all reported cases of thromboembolism and will inform about the results of its research.
– If millions of people are vaccinated, it is inevitable that rare and serious incidents of disease (…) occur after vaccination. Our role is to ensure that suspicious reactions are quickly analyzed to answer the question of whether it is a vaccine side effect or a coincidence, she says.
- There is no reason to stop using the AstraZeneki vaccine, says WHO. There are more and more organizations in the world that are of the same opinion
It is known that EMA is also testing the hypothesis that blood clots may be caused by vaccines from specific lots of AstraZeneki. «We are testing the hypothesis that the blood clots are related to a specific lot of the vaccine. That they are due to differences in the production of different batches, said Cooke. Another hypothesis under test is the negative effect of the vaccine on certain groups of the population.
At the moment, however, EMA does not change its recommendation and recommends continued use of the preparation. The agency emphasizes that the benefits of vaccinating with AstraZeneka far outweigh the risks.
You may be interested in:
- Prof. Gut: If others don’t want AstraZeneki vaccine, let’s buy as much as possible
- Thrombosis – causes, treatment and prevention. The six most common symptoms of thrombosis [EXPLAIN]
- Side effects of COVID-19 vaccines [COMPARISON]
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