Germany, France and Italy resume AstraZeneca rollout from Friday after vaccine ruled ‘safe’

Video report by ITV News Science Editor Tom Clarke

Germany, France and Italy will all resume their AstraZeneca Covid vaccination programmes from Friday, after the jab was ruled safe to use by both the UK and EU's regulators.

The European Medicines Agency (EMA) said the Oxford/AstraZeneca jab was a “safe and effective vaccine” and said there is no proven link between the jab and blood clots.

Countries across Europe put their rollout of the vaccine on hold amid concerns about blood clots.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said on Thursday there was "no proven causal association" between five reports in the UK of a "unique" blood clot and the Covid Oxford/AstraZeneca jab.

  • ITV News Europe Editor James Mates speaks about the impact of European countries suspending the AstraZeneca vaccine:

France's Prime Minister Jean Castex said the country will begin vaccinating people again with the vaccine from Friday, while Italy, Germany and Lithuania expect to start on the same day.

French TV station BFM TV had reported Mr Castex would also get the AstraZeneca jab on Friday.

Spain, Portugal and the Netherlands said they will follow suit next week, although Spain said it could exclude certain groups.

Ireland’s deputy chief medical officer Dr Ronan Glynn welcomed the ruling and said he will consider it further on Thursday and engage in discussions before issuing an update on Friday.

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Emer Cooke, the EMA executive director, said the benefits of the AstraZeneca coronavirus vaccine “outweigh the possible risks”.

She added: “This is a safe and effective vaccine. Its benefits in protecting people from Covid-19, with the associated risks of death and hospitalisation, outweigh the possible risks.

“The committee also concluded that the vaccine is not associated with an increase in the overall risk of thromboembolic events, or blood clots.”

The UK's regulator, the MHRA, echoed the findings of its European equivalent.

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The group said on balance the benefits of the vaccine outweighed any risks, but added it was continuing to investigate any link between a "very rare and specific type of blood clot in the cerebral veins".

The clot – cerebral venous sinus thrombosis (CVST) – prevents blood from draining out of the brain.

One of these cases was fatal, experts from the regulator told a press briefing.

As a precaution, anyone with a headache that lasts for more than four days after vaccination, or bruising beyond the site of vaccination after a few days, is advised to seek medical attention the group said.

Earlier this week the health secretary urged people to 'listen to the regulators'

Dr June Raine, MHRA chief executive said: “Please remember that mild flu-like symptoms remain one of the most common side effects of any Covid-19 vaccine, including headache, chills and fever,” Dr Raine said.

“These generally appear within a few hours and resolve within a day or two, but not everyone gets them.”

Phil Bryan, MHRA vaccine safety lead, said: “Where we are now is that no proven causal association with what is still an extremely rare medical event has been proven for the AZ vaccine.

“But we do know that these are highly effective vaccines. We still have a huge burden of Covid disease in the population.“So, right now, the balance of benefits and known risks of the vaccine are favourable.”

Members of the Italian military receive their AstraZeneca Covid jab. Credit: AP

Announcing its findings on Thursday, EMA chief Emer Cooke said: “We are very much aware that some (EU) member states have paused vaccinations, waiting for EMA’s outcome of a review.

“Given that thousands of people in the EU die every day – in fact over 2,500 were reported one day last week – it really was crucial for EMA to review rapidly and thoroughly all the available evidence, so we made this review our highest priority.”

Ms Cooke added: “During the investigation and review, we began to see a small number of cases of rare and unusual, but very serious, clotting disorders, and this then triggered a more focused review.

Chief executive of the National Health Service Sir Simon Stevens getting his vaccination at Westminster Abbey, London Credit: Aaron Chown/PA

“Based on the evidence available, and after days of in-depth analysis of lab results, clinical reports, autopsy reports and further information from the clinical trials, we still cannot rule out definitively a link between these cases and the vaccine.

“What the committee has therefore recommended is to raise awareness of these possible risks, making sure that they are included in the product information.

“Drawing attention to these possible rare conditions and providing information to health care professionals and vaccinated people will help to spot and mitigate any possible side effects.”