EU regulator says Oxford-AstraZeneca vaccine is ‘safe and effective’

The EU’s medicines agency has said the AstraZeneca vaccine is “safe and effective” following an investigation into the reports of blood clots

The decision by the European Medicines Agency (EMA) comes after more than a dozen European countries – including Germany, Italy, Spain, the Netherlands, France and Sweden – halted the vaccine’s rollout over fears regarding the claims.

The EMA said the benefits outweigh the risks – and the vaccine is not linked to an “overall risk” of blood clots.

However, the agency’s safety committee has also said it can’t rule out a potential link with a “small number of cases” of a rare clotting disorder occurring after the vaccination.

It has therefore recommended that governments “raise awareness” of the possible effects by including them in product information.

This comes after the University of Oxford has said that the existing COVID-19 vaccines may protect against the Brazilian variant of the coronavirus as the P1 strain could potentially be less resistant to antibodies than was first thought.

“Drawing attention to these possible rare conditions and providing information to healthcare professionals and vaccinated people will help to spot and mitigate the possible side effects,” said EMA executive director Emer Cooke on Thursday.

“We’re also launching additional investigations to understand more about these rare cases and we’re conducting targeted observational studies.”

Concerns about the vaccine were initially raised after a report from the Norwegian Medicines Agency revealed blood clotting events in four adults who had the COVID jab.

AstraZeneca also said after a thorough review of its COVID-19 immunisation data, that it found no evidence of any increased risk of blood clots in any age group or gender in any country.

The World Health Organization (WHO) added its weight behind the debate ahead of the EMA’s announcement, urging countries to continue using the jab.

“As of now, we do not know whether some or all of the conditions have been caused by the vaccine or by other coincidental factors,” said Hans Kluge, the WHO’s European director.

“At this point in time, however, the benefits of the AstraZeneca vaccine far outweigh its risks – and its use should continue, to save lives.”

This comes after The European Commission and Italy have blocked a shipment of the Oxford-AstraZeneca COVID-19 vaccine that was destined for use in Australia, to prevent a shipment of doses being sent off before they are given to the bloc.

Prime Minister Boris Johnson has said there is “no reason at all” to stop the vaccine’s rollout.

“It will certainly be Oxford-AstraZeneca that I will be having,” he said on Wednesday, after revealing he has been called up to have his COVID jab.

Everyone aged 50 and over in England is now being invited to book a coronavirus vaccination on the NHS website.

The temporary pause in the rollout of the Oxford-AstraZeneca vaccine comes amid an EU exports row and a warning by ministers of a significant slowdown of the vaccination programme in the UK due to international supply issues.