July 7, 2022

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EMA: AstraZeneca COVID-19 vaccine has nothing to do with thrombotic events

EMA: AstraZeneca COVID-19 vaccine has nothing to do with thrombotic events

 

EMA: AstraZeneca COVID-19 vaccine has nothing to do with thrombotic events, but the connection between the two cannot be clearly ruled out.

On March 18, the European Medicines Agency (EMA) announced the conclusion of the investigation into “AstraZeneca vaccine causes thrombosis”: AstraZeneca vaccine is safe and effective in preventing new coronavirus pneumonia, and its benefits still far outweigh its risks.

Dr. Sabine Straus, chairman of EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), said the committee found no evidence of batch quality problems.

EMA Executive Director Emer Cooke said: “We have concluded that the AstraZeneca vaccine is not associated with a thrombotic event or an increased overall risk of thrombosis.”

EMA reviewed a total of 25 reported cases of thrombosis. The research team said that the results of data analysis showed that the overall number of thromboembolic events among the approximately 20 million AstraZeneca vaccinators in the United Kingdom and the European Economic Area was lower than expected for the general population. Therefore, experts believe that the AstraZeneca vaccine did not increase the overall risk of thrombosis.

Cooke reiterated that the benefits of vaccination outweigh the risks. “I want to reiterate that our scientific position is that AstraZeneca’s vaccine is a safe and effective option to protect citizens from the new coronavirus. Data in clinical trials and prevention of new coronavirus disease show its effectiveness. At least 60%. Real-world evidence suggests that the effectiveness may be even higher.”

EMA: AstraZeneca COVID-19 vaccine has nothing to do with thrombotic events
Cook announced at a press conference that the AstraZeneca vaccine is “safe and effective”

However, the study also failed to rule out the possibility of a connection between the AstraZeneca vaccine and individual thrombotic events. EMA expert Sabine Straus pointed out that in several cases, thrombosis occurred in multiple blood vessels or cerebral veins within 7 to 14 days after vaccination. These cases usually occur in young women, but it is not yet certain whether these problems are related to the AstraZeneca vaccine.

EMA recommends raising awareness of these potential risks and ensuring that they are included in product information. Reminding people of these possible rare diseases and providing information to medical staff and vaccinated people will help to detect and mitigate any potential side effects.

Subsequently, Spain, Italy, Cyprus and France announced that they would fully resume AstraZeneca’s vaccination work from the 19th.

According to Xinhua News Agency citing US media reports, French Prime Minister Jean Castel said that he will be vaccinated with AstraZeneca on the 19th, “to show that we can be completely at ease with it.” Italian Prime Minister Mario Draghi said that the government’s first priority is to vaccinate as many people as possible as soon as possible.

Spain, Portugal and the Netherlands announced that they will resume AstraZeneca vaccination next week. However, Spain said that certain groups may be excluded from the scope of vaccination to minimize risks. Cyprus, Latvia and Lithuania will also start using this vaccine again.

Countries such as Sweden and Norway stated that they still need time to conduct scientific assessments. Swedish TV said that on the 18th, Skåne University Hospital in Sweden reported a suspected death of AstraZeneca vaccine side effects, and the Swedish Medical Products Agency is investigating the matter. Sweden will not announce whether to resume AstraZeneca vaccine until at least next week.

The UK has always insisted that the AstraZeneca vaccine is safe and has never stopped the vaccination work of the vaccine. British Prime Minister Johnson also announced on the 17th that he will be vaccinated with AstraZeneca soon. At present, more than 11 million people in the UK have been vaccinated with AstraZeneca.

“We believe that after a careful decision by the regulatory agencies, vaccination in various parts of Europe can be resumed again.” AstraZeneca Chief Medical Officer Ann Taylor said in a statement on the 18th.

(source:internet, reference only)


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