London: Europe’s drug regulator has urged coronavirus-ravaged countries to resume their rollout of the AstraZeneca vaccine after a review detected no link between the jab and a higher risk of developing blood clots.

In a highly anticipated verdict delivered in Amsterdam, the European Medicines Agency said the benefits of the vaccine in combating COVID-19 far outweighed the risk of side effects.

“This is a safe and effective vaccine,” said Emer Cooke, the regulator’s chief executive.

The AstraZeneca vaccine will be manufactured for Australian citizens in Melbourne. Credit:PA

However, the EMA conceded it could not rule out a link between the vaccine and 25 combined cases of two very rare blood disorders and vowed to keep investigating.

Germany, France, Italy, Bulgaria, the Netherlands, Spain, Sweden, Denmark, Norway, Iceland and Ireland had paused the AstraZeneca rollout while EMA experts examined reports of blood clots in some recently inoculated people.

The suspensions – taken against the advice of the regulator and World Health Organisation – triggered a backlash from experts who warned the action was unnecessary and would cost lives as a deadly third wave sweeps across Europe.

“We just have to continually remind ourselves of what a difficult situation we are in,” Cooke said.

“This pandemic is costing lives. We have vaccines that are safe and effective and can prevent deaths and hospitalisations. We need to use those vaccines.”

The countries are now under pressure to urgently restart the AstraZeneca rollout following the EMA’s conclusions.

Working with data from other agencies around the world, the EMA found the number of thromboembolic events reported during trials and the broader rollout was 469 – lower than what would normally be expected in the general population.

Sabine Straus, the chair of the EMA’s pharmacovigilance risk assessment committee, noted about 100,000 people develop blood clots each month in the European Union.

However, the EMA said more work was still needed to determine whether the vaccine may be connected to two rare but “very serious” clotting disorders.

The first, disseminated intravascular coagulation, is a disorder that involves tiny blood clots in multiple blood vessels. There have been seven reported cases of this condition.

The second, cerebral venous sinus thrombosis, creates clots that draw blood from the brain. There have been 18 cases of this disorder, some of which had caused deaths.

“Based on the evidence available and after days of in-depth analysis of lab results, clinical reports, autopsy reports and further information from the clinical trials, we still cannot rule out definitively a link between these cases and the vaccine,” Straus said.

However, she and Cooke stressed the cases were rare.

“About seven million people have now been vaccinated in the EU with the AstraZeneca vaccine and 11 million have been vaccinated in the UK and there is increasing use of this vaccine in other countries,” Cooke said.

The two rare disorders will be added to the list of product risks so doctors and patients in Europe are aware of any potential risk.

Straus said the two rare conditions had been most prominent in women and young women but said it was too early to say whether that was simply because more people have been vaccinated in this group.

The EMA released its findings amid major tension between AstraZeneca and the European Commission over slow deliveries. Europe on Wednesday threatened to take over the company’s factories unless more doses were given to EU members over the coming months.

Britain’s Medicines and Healthcare products Regulatory Agency on Thursday reported five cases of cerebral venous sinus thrombosis among 11 million people given the AstraZeneca vaccine but said the rollout should proceed.

“There is no evidence that blood clots in veins are occurring more than would be expected in the absence of vaccination,” said MHRA chief executive June Raine.

Munir Pirmohamed, the chair of Britain’s Commission on Human Medicines, suggested that even if a link between the clots and the vaccine was eventually established it wouldn’t halt Britain’s rollout.

“If we feel that there’s a causal link then we may need to update the product information, but overall, I don’t think that would necessitate a pause to any kind of vaccination program,” he said.

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