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Wednesday, April 21st, 2021

AstraZeneca defends safety of COVID-19 vaccine after countries suspend use

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Drugmaker AstraZeneca defended the safety of its COVID-19 vaccine after three more European countries said they would suspend the use of the vaccine.

Over the weekend, Germany, Ireland, and The Netherlands announced they would stop using the vaccine temporarily over concerns about the vaccine’s link to blood clots, joining nine other countries that have suspended the use of the vaccine.

AstraZeneca said the science and safety data shows no link between the vaccine and heightened blood clot risks.

“A careful review of all available safety data of more than 17 million people vaccinated in the European Union (EU) and UK with COVID-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country,” the company said in a statement. “So far across the EU and UK, there have been 15 events of DVT, and 22 events of pulmonary embolism reported among those given the vaccine, based on the number of cases the Company has received as of 8 March. This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines.”

The company said that a monthly safety report would be made public on the European Medicines Agency website in the coming week. The European Medicines Agency has said there is no indication that the Oxford-AstraZeneca vaccine causes blood clots, noting that the vaccine’s benefits “continue to outweigh its risks.”

The World Health Organization also reaffirmed the safety of the AstraZeneca vaccine.

The three countries join Denmark, Norway, Thailand, Iceland, Bulgaria, Luxembourg, Estonia, Lithuania, and Latvia in suspending the use of the AstraZeneca vaccine. Additionally, Austria and Italy have said they would stop using certain batches of the vaccine as a precautionary measure.

AstraZeneca said the numbers support the safety of their vaccine, however.

“Around 17 million people in the EU and UK have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population,” AstraZeneca Chief Medical Officer Ann Taylor said. “The nature of the pandemic has led to increased attention in individual cases, and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety.”