EMA: 'No indication' astrazeneca vaccine cause of rare blood clots

European regulator reviewing jab, full update expected on Thursday

Author: Tara MclaughlinPublished 16th Mar 2021
Last updated 16th Mar 2021

The European Medicines Agency (EMA) is conducting a full scientific review of the AstraZeneca Covid-19 jab but has said it currently "remains convinced'' that the "benefits of this vaccine outweigh the risk.''

The regulator, which approved the jab for Europe, is due to offer a further update on Thursday after several European countries halted its use due to reports of some people suffering blood clots following vaccination.

Emer Cooke, the EMA's executive director, told a press briefing on Tuesday there was no current indication that the Oxford/AstraZeneca's coronavirus vaccine was the cause of the "very rare'' reported blood clots.

"I want to stress at present there is no indication that vaccination has caused these conditions,'' she said.

"They have not come up in the clinical trials and they are not listed as known side events with this vaccine.

"In clinical trials both vaccinated people and people who received the placebo have shown some very small number of blood clot developments.

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

Some countries have suspended use of a particular batch of the jab due to concerns, but Ms Cooke said the small number of reports from Europe involved several batches and "therefore it is unlikely to be something related to a specific batch.''

However, she said this would form part of the EMA's ongoing investigation.

Some 30 cases of blood clots had been reported to the EMA by March 10 among almost five million people vaccinated, but additional cases had been reported over the weekend, Ms Cooke said.

She said there would be an increase in the reporting of such cases due to the publicity surrounding the current reports.

The EMA is looking at the incidence of blood clots and some reports of abnormally low levels of blood platelets among some people who have had the jab.

Ms Cooke said: "We have pulled together an ad-hoc meeting again today to help us evaluate these cases with all the surrounding information that the member states will have.

"The experts will then carry on their assessment and again will meet on Thursday to come to a conclusion on the full information that has been gathered, and to advise us as to whether there are any further actions that need to be taken.

"We will inform the public of the outcome immediately after this meeting.

"Our experts are working tirelessly to carry out this assessment as quickly as possible, but it needs a scientific evaluation. We need to have the facts first. We cannot come to a conclusion until we have done a thorough scientific analysis and we owe it to the European citizens to deliver this clear and science-based response.''

She said that "trust in the safety and effectiveness of the vaccines we've authorised is paramount for us,'' adding the EMA was worried "there may be an effect on the trust of the vaccines.''

But she said the priority was to ensure that vaccines "can be used safely.''

The World Health Organisation's (WHO) global advisory committee on vaccine safety is also meeting on Tuesday to discuss the jab but has urged countries to continue using it.

A small number of cases of blood clots in people having the jab have been reported in Europe, prompting several European countries including Germany, France, Italy, Spain, Ireland, Denmark and Norway to halt rollout of the vaccine.

Sweden added itself to the list on Tuesday, saying the move was precautionary.