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EU drug regulator investigating AstraZeneca vaccine

16th Mar 2021
EU drug regulator investigating AstraZeneca vaccine

By Gozde Bayar

 

ANKARA (AA): The European Medicines Agency (EMA) on Monday said it was continuing an investigation into possible side effects of the novel coronavirus vaccine developed by AstraZeneca and Oxford University.

With several European countries having recently suspended the vaccine, the EMA said in a statement that the probe was a “precaution” while it investigates reports of people developing blood clots after receiving the jab in recent weeks.

“Events involving blood clots, some with unusual features such as low numbers of platelets, have occurred in a very small number of people who received the vaccine,” it said, adding that thousands of people develop blood clots annually in the EU for different reasons.

“The number of thromboembolic events [blood clots] overall in vaccinated people seems not to be higher than that seen in the general population,” it added.

The body underlined that it is working closely with the company, with experts in blood disorders, and with other health authorities in the investigation, with rigorous analysis of all the data related to thromboembolic events to be carried out in the coming days.

So far, Germany, France, Italy, Ireland, the Netherlands, Denmark, and Norway are among the countries that have suspended the AstraZeneca jab.

Although several more countries have suspended AstraZeneca vaccines’ use as a precautionary measure, it does not necessarily mean these events are linked to vaccination, the World Health Organization (WHO) head said Monday.

“Several more countries have suspended the use of AstraZeneca vaccines as a precautionary measure, after reports of blood clots in people who had received the vaccine from two batches produced in Europe,” said WHO director-general Tedros Gebreyesus.

“This does not necessarily mean these events are linked to vaccination, but it’s routine practice to investigate them, and it shows that the surveillance system works and that effective controls are in place,” he said, speaking at a twice-weekly WHO webinar.

AstraZeneca’s coronavirus vaccine is used to prevent the COVID-19 infection in people aged 18 years and above. It has been designed to prepare the immune system to identify and combat the coronavirus SARS-CoV-2 causing COVID-19.

The viral vector technology used for this vaccine has been successfully tested and employed in the prevention of other diseases in several countries.

[Image of 3D medical animation of Covid-19 structure www.scientificanimations.com/Creative Commons]

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