AstraZeneca vaccine: European medicines watchdog finds ‘no indication’ jab is cause of blood clots

The European Union’s medicines regulator has said there is “no indication” that AstraZeneca’s coronavirus vaccine is the cause of reported blood clots.

The European Medicines Agency (EMA) said the benefits of AstraZeneca's inoculation continue to outweigh the risks after several countries halted its use due to concerns about blood clots.
The EMA's Executive Director Emer Cooke said the agency was carrying out a case-by-case evaluation of incidents and was expected to complete a review on Thursday.

But the watchdog has received more reports of blood clotting events associated with the Oxford AstraZeneca Covid-19 vaccine.

Ms Cookesaid she could not reveal the full extent of reports but the recent highlighting of cases in countries like Austria and Norway has led to more notifications.

Irish-born Ms Cooke said there is still no evidence that there is a causal link between the vaccine and the blood clotting events.

As of now it believes the benefits of the vaccine outweigh any risks, she told a lunchtime press conference.

As of March 10 there were 30 cases reported among 5 million people who received the vaccine.

The association is being investigated and a finding will be released on Thursday afternoon.

Ireland has stalled the roll out of the vaccine here this week pending the evaluation.

Ms Cooke said the regulator initially investigated whether individual batches were possibly causing adverse events, after Austria banned a batch, and that as more events are reported “more batches are involved and therefore it is unlikely it is a batch specific event”.

She said the reports are serious and they need a "serious evaluation."

Questioned on whether states would abide by any EMA recommendation regarding the jab following its review, she said information sharing is a constant process.

Asked if the decision of countries to pause the vaccine could lead to lower trust in the AstraZeneca jabs, she said that trust in the safety of the vaccine was paramount and that scientific evaluations were the best way to maintain this.

"We are worried that there may be an effect on the trust of the vaccines but our job is to make sure the products we authorise are safe."

She said the EMA could take a number of different actions on Thursday at the conclusion of the expert review of the jab but would not be drawn to speculate.

The priority is to ensure that the vaccines can be used safely in the European population, if this means that an additional warning might be necessary we’d look into the that, if we believe there is a problem that can’t be solved we’ll take the necessary action to deal with that. It really depends on the outcome of the expert evaluation.
She said it is is important to reiterate that the EMA believes the benefits continue to outweigh the risks, but there is “serious concern” which demands “serious and detailed” scientific consideration, after she was asked about the conundrum facing states who have paused their rollout –

thus potentially putting people at greater risk of fatal Covid.

Questioned on the different approaches taken by countries she said they are being taken in the context of information available at the national level.

“It is the country’s prerogative to do so,” she adds. “It is our responsibility to focus on the science associated with these risks and whether there is scientific evidence to show if they are causally related to the vaccine.”

She acknowledged that some specific batches have been suspected of being behind adverse health events, and that this forms a plank of the EMA’s expert investigation.

The EMA is receiving more information about German cases including three deaths and that its experts were assessing the details.

Asked about similar reports from the Pfizer and Moderna jab regarding blood clotting, Ms Cooke said the EMA is looking at adverse events associated to all vaccines but that the current focus was on the AstraZeneca vaccine.

“It looks like there’s similar numbers coming in from across the world,” she said.

The EMA remains “firmly convinced” that the benefits of the AstraZeneca vaccine outweighs “the risks of these side effects”.

She urged anyone who suspects they have had a side effect after receiving the jab to contact their relevant health professional.

The EMA’s expert committee is investigating each individual potentially adverse event. It will meet on Thursday to conclude their findings and advise the EMA on whether it needs to take any further action. The EMA will make an announcement immediately, she added.

“We need to have the facts first, we cannot come to a conclusion until we’ve done a thorough scientific analysis.”

“At present, there is no indication that vaccination has caused these conditions. They have not come up in the clinical trials and they are not listed as known or expected side events with this vaccine.

“In clinical trials both the vaccinated people and those who received the placebo have shown very small numbers of blood clot developments.

“The number of thromboembolic events overall in the vaccinated people seems not to be higher than that seen in the general population.”

She said events involving blood clots, “some with very unusual features”, have occurred in “a very small number of people who have received the vaccine”.

Ms Cooke added that many thousands of people develop blood clots annually in the EU for various reasons and that the committee is assessing whether the vaccine “might have caused the adverse events or whether the events are due to be to other causes”.

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