Coronavirus: EU medical regulator says AstraZeneca COVID vaccine does not cause blood clots

The EU regulatory body is "fully convinced" that the vaccine's benefits outweigh possible risks. Global health experts have been under growing pressure to answer questions over the safety of AstraZeneca's COVID-19 shot.

Millions of doses of the vaccine has been administered in the UK alone

There is "no indication'' that AstraZeneca vaccines are the cause of blood clots reported in some shot recipients, the European Medicines Agency's (EMA) chief said on Tuesday.

The regulatory agency responded after more than a dozen EU countries suspended the Oxford-AstraZeneca coronavirus vaccine amid health concerns.

The agency is "still firmly convinced that the benefits of the AstraZeneca vaccine in preventing COVID-19 with its associated risk of hospitalization and death outweigh the risk of these side effects," Executive Director Emer Cooke added.

Cooke said that an EMA evaluation of individual incidents is ongoing. It is expected to complete a full review on Thursday.

What are the concerns about the vaccine?

There are fears about the safety of the vaccine in some countries after several cases of blood clots or brain hemorrhages in people after receiving the inoculation. A small number of deaths have been reported.

 Germany, Italy and France became the lastest countries to stop the use of the AstraZeneca vaccine on Monday, saying it was a precautionary measure. Iceland, Ireland and Bulgaria have also suspended use.

Estonia, Lithuania, Luxembourg, Latvia and Romania suspended use of AstraZeneca vaccine batch ABV5300 following Austria's decision to suspend the batch after one person died from multiple thrombosis 10 days after vaccination and another was hospitalized with pulmonary embolism after getting the shot.

Batch ABV5300 was delivered to 17 European Union countries and comprises 1 million doses of the vaccine.

The European Medicines Agency (EMA) has said there is currently no indication that vaccination has caused these conditions, which are not listed as side effects of the AstraZeneca vaccine.

In early March, the Danish Health Ministry announced that it would stop using the AstraZeneca vaccine for the time being. This comes after "reports of severe blood clots in people vaccinated with the AstraZeneca COVID-19 vaccine," the ministry said in a statement. "We need clarification before we can continue to use the vaccine from AstraZeneca," said Soren Brostrom, Director General of the Danish Health Authority, which advises and works with the Health Ministry.

The WHO, AstraZeneca, and the EMA have all insisted the AstraZeneca shot is safe, and that there is no link between the vaccine and reported blood clots. They say clots are not occurring in greater numbers or frequency than normally in the general population.

The EU's largest three nations — Germany, Italy, and France — joined others in suspending the use of the vaccine on Monday. Sweden and Latvia followed suit on Tuesday.

The news has dealt something of a blow to the global immunization campaign against coronavirus, which has now killed more than 2.6 million people.

The vaccine was developed by British-Swedish firm AstraZeneca and the University of Oxford in England. More than 11 million doses have been administered in the UK, without any major problems reported.

Rebuilding trust
Emer stressed that "trust in the safety and efficacy of these vaccines is paramount for us."

She added it was the job of the agency to ensure the vaccines were safe.

EMA, WHO reviews continue
On speculation that incidents of blood clots were related to a specific vaccine batch, Cooke said it was "unlikely" but the EMA was not ruling it out.

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"We are looking at adverse events associated with all vaccines," Cooke said when asked if it was probing the Pfizer-BioNTech and Moderna vaccines as well, following reports of clotting with those jabs in the United States.

A World Health Organization (WHO) committee of experts is also reviewing isolated cases of blood clots and low platelet counts in vaccinated individuals.