The experience of AstraZeneca shows that our pharmacovigilance system works. However, it is very important that we have a harmonized approach across the EU, ”she wrote on Twitter after the European Medicines Agency (EMA) announced that the formation of abnormal blood clots should be labeled as a ‘very rare’ side effect of AstraZeneca’s pandemic coronavirus vaccine. .
“We need to speak with one voice across the EU to increase public confidence in vaccines,” Kiriakides wrote just before a video conference of EU health ministers.
The Amsterdam-based EVA report states that “abnormal blood clots with a low platelet count should be identified as a very rare side effect” and notes that the benefits of AstraZeneca vaccines continue to outweigh the potential risks.
READ ALSO: European Medicines Agency: The benefits of AstraZeneca outweigh the risks, with extremely rare side effects – blood clots
The EEA also emphasized that no specific risk factors for abnormal blood clots had been identified with AstraZeneca.
“Specific risk factors such as age, gender or medical history have not been validated because rare cases are seen in all age groups,” EVA chief Emer Cooke told a news conference.
“The likely explanation for these rare side effects is the immune response to the vaccine,” she added.
In a statement issued on Wednesday, the EEA did not impose new restrictions on the use of the vaccine in individuals over 18 years of age.
Experts reviewed several dozen cases registered in Europe and the United Kingdom, where about 25 million people have been vaccinated with AstraZeneca. people.
If you have any questions about the COVID-19 vaccine, please send them to our editorial staff by e-mail. email address [email protected]