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16 Mar, 2021 14:13

AstraZeneca Covid-19 vaccine review an ‘ongoing process,’ says EU drugs regulator, but ‘no indication’ jab caused blood clots

AstraZeneca Covid-19 vaccine review an ‘ongoing process,’ says EU drugs regulator, but ‘no indication’ jab caused blood clots

The European Medicines Agency (EMA) has said initial data suggest there is “no indication” the AstraZeneca jab caused blood clots after a number of thromboembolic events were recorded in people who had been inoculated.

Speaking on Tuesday, EMA executive director Emer Cooke said the regulator was still continuing its research into the jab’s safety profile, but as yet had not found a link between the vaccine and the alleged fatal side effects. Cooke said the incidents would be “rapidly evaluated” by the agency’s safety review team, but added that adverse reactions were “not unexpected” in a large-scale vaccine rollout program. 

The EMA chief said that thousands of blood clots develop in people every year and that, so far, there was nothing to suggest there was a higher occurrence of thromboembolic events in people that had been vaccinated with the AstraZeneca jab than in the population normally.

Cooke also pointed to AstraZeneca’s trial data, which suggested there was no greater likelihood of blood clotting in the group that received the jab versus those in the placebo group.

The regulator said they would not comment on the decision of individual nations to suspend the vaccines’ use, noting these actions are “taken at national level and it is the country’s prerogative to do so.” 

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Last week, the EMA said that its Pharmacovigilance Risk Assessment Committee was already reviewing all cases of thromboembolic events, and other conditions related to blood clots, following around 40 reports around Europe of adverse side effects after the administration of the AstraZeneca Covid jab.

The body stated that it was aware that Denmark, as well as other European nations, had suspended the vaccines’ administration but contended there was no indication that vaccinations had caused these conditions, “which are not listed as side effects with the jab.” 

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Latvia and Sweden are the latest countries to suspend the jab’s use, with France, Germany, Italy, Denmark and Norway temporarily halting their administration of the vaccine in recent days.

Meanwhile, other states and health experts have dismissed any purported causal link with the blood clots, and echoed the EMA and World Health Organization’s position in saying the benefits of the vaccine outweigh the risks. On Tuesday, Canada updated its Covid vaccine guidance to recommend using the AstraZeneca jab among people aged 65 and above.

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