'Link between AstraZeneca jab and blood clots' - EMA vaccine chief

Wednesday, 07 Apr, 2021

A pediatric trial of the Oxford-AstraZeneca vaccine has been paused pending a review by the UK's medicines regulator of rare blood clot cases in adults, a University of Oxford spokesperson told CNN Tuesday.

Cavaleri's opinion is therefore not the official position of the EMA, but he added that the agency will be investigating the connection further and an announcement will be made in the coming days. "But we still do not know what causes this reaction".

"Such cases are extremely rare, and the benefits (of the vaccine) still largely outweigh the risks", he stressed.

Regulators in other countries have also reported blood clots among people who have received the vaccine, particularly in Europe, where the AstraZeneca vaccine is widely used.

The EMA has consistently said that "The benefits of the AstraZeneca vaccine in preventing Covid-19, with its associated risk of hospitalisation and death, outweigh the risks of side effects".

The news comes ahead of an updated safety review from EMA-expected Wednesday or Thursday-and after the agency's March 18 decision to continue the shot rollout despite the small number of patients reporting serious, unexpected blood clots.

The EMA said last week that its review had at present not identified any specific risk factors, such as age, gender or a previous medical history of clotting disorders, for these very rare events.

The EMA has previously said that there was "no evidence" to support restricting the use of the Oxford-AstraZeneca vaccine in any population.

A 44-year-old Melbourne man who received the jab on March 22 was found to have abdominal clots and low platelet levels on Friday. "So we need to do very meticulous work to understand if the risk-benefit analysis remains for all ages", he was quoted as saying.

Like other European Union countries, Italy on March 15 issued a "temporary and precautionary" ban on the use of the AstraZeneca vaccine following reports of a small number of clot deaths in the country.

He added: "Just to put this into perspective, it's 0.000016% of people that have clots - there's no proven direct causal link between the two".

"Moderna shot would first be offered in west Wales".

Labour leader Sir Keir Starmer echoed the prime minister's plea for people to continue to receive the AstraZeneca vaccine if invited to get a jab.

Speaking in a personal capacity, she told the Daily Telegraph: "The issue is about safety and public confidence".

The UK has bought 17 million doses of the Moderna vaccine, enough for 8.5 million people.

Boris Johnson said getting vaccinated was "the key thing" and the regulator's advice was to keep giving the jab. If someone has had a vaccine and then develops a blood clot, it doesn't necessarily mean the shot caused the clot.

In total, the United Kingdom has ordered 457 million doses, of which 100 million are from AstraZeneca.