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MHRA and EMA have confirmed that the benefits of the AstraZeneca COVID-19 vaccine continue to outweigh the risk of side effects.
The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom and the European Medicines Agency (EMA) have confirmed that the benefits of the AstraZeneca COVID-19 vaccine continue to outweigh the risk of side effects.
After a scientific review, MHRA concluded that there was no evidence of blood clots in veins occurring more than would be expected in the absence of vaccination. EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has also concluded that there is no increased overall risk of blood clots with the AstraZeneca COVID-19 vaccine. A causal link between thromboembolic events and the vaccine has not been established and is not proven.
In a March 18, 2021 press release, AstraZeneca confirmed that it will continue to work closely with regulators to ensure the COVID-19 vaccine is used appropriately and will implement the recommendations of PRAC, which include updated product information. Additionally, the company has stated it will continue to work on the understanding behind the nature and relevance of the thromboembolic events to ensure the safe delivery of the vaccine continues.
“Vaccine safety is paramount and we welcome the regulators’ decisions which affirm the overwhelming benefit of our vaccine in stopping the pandemic,” said Ann Taylor, chief medical officer, in the press release. “We trust that, after the regulators’ careful decisions, vaccinations can once again resume across Europe.”