European countries to resume use of AstraZeneca vaccine after EU regulator declares it 'safe and effective'

Italy and France among first to react after regulator finds 'benefits outweigh the risks'

Major European countries announce they would resume use of the AstraZeneca vaccine after regulators declared it "safe and effective".

The European Medicines Agency, the EU's medicines regulator, recommended that AstraZeneca's Covid-19 vaccine could be used after completing an investigation into a possible link to blood clots.

France, Italy, Spain and Germany were among the first to announce they would restart the vaccinations

Officials from the EMA said on Thursday they could not definitively rule out a link between blood clot incidents and the vaccine.

But the watchdog said it was clear that the "benefits outweigh the risks" when using the drug, made by AstraZeneca and the University of Oxford.

Italian Prime Minister Mario Draghi was first to react to the decision, announcing Italy would resume administering AztraZeneca vaccines as early as Friday.

“The government's priority remains to vaccinate as many people as possible as quickly as possible," Mr Draghi said.

France soon followed suit. French Prime Minister Jean Castex said he will receive the vaccine on Friday afternoon.

"The AstraZeneca Covid-19 vaccine is effective, as underlined by the European regulator. It only has relatively rare side effects ... it has a positive risk/reward ratio," Mr Castex said.

The German government and regional states aim to restart the vaccinations on Friday, Health Minister Jens Spahn said.

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

Latvia, Lithuania and Cyprus said they, too, would resume AstraZeneca vaccinations.

Ireland said it would make a decision on Friday and Sweden said it would make one next week.

UK Prime Minister Boris Johnson also reaffirmed his faith in the jab and said he would be receiving his on Friday.

The agency will update its guidance to include an explanation about the potential risks of blood clotting on the patient leaflet and in the information for medical workers.

"The committee has come to a clear scientific solution: this is a safe and effective vaccine," agency executive director Emer Cooke said.

"Its benefits of protecting people with Covid-19 outweigh the possible risks. If it were me, I would be vaccinated tomorrow.”

She said that because thousands of people die from Covid-19 each day in Europe, hitting 2,500 on one day last week, the review was given the highest priority.

 

The review covered 30 cases of unusual blood disorders in five million people who received the shot in the EU.

The agency was under pressure to clear up safety concerns after more than a dozen European countries paused their use of the vaccine after fears were raised. They included Austria, Denmark and the EU's four largest members – Germany, France, Italy and Spain.

"A situation like the one we have seen here is not unexpected," Ms Cooke said. "When you vaccinate millions of people ... rare or serious illnesses will occur."

 

While other governments previously said they were ready to resume once they received positive guidance, the suspensions might have caused irreparable damage to the reputation of the vaccine.

Questions were raised about the reliability of AstraZeneca's drug when some European countries chose to deny over-65s access to the shot, citing a lack of safety data, although those decisions were reversed.

Europe is embroiled in a row with the pharmaceutical company over delivery of doses and on Wednesday threatened to block exports to countries with higher inoculation rates, such as Britain.

Scientists said the decision to suspend the shot was "going to kill a lot of people".

With millions of Europeans yet to be vaccinated, new variants of the disease are taking hold, leading to a significant increase in infections.

“It's obviously the case that pausing the vaccination is going to kill a lot of people,” said Dr Ilan Kelman, professor of disasters and health at University College London, speaking before the announcement.

“Right now, there is no evidence of a link to blood clots but no evidence does not mean something may change in the future and the politicians have to make a decision.”

The German government defended its decision to suspend use of the vaccine, saying it was based on expert advice. Government spokeswoman Ulrike Demmer said on Wednesday that the move could “strengthen trust” in the vaccines.

“Concerns are taken seriously and examined. And as soon as these concerns are cleared up, a vaccine can be used again without hesitation,” she said.

Earlier on Thursday, the World Health Organisation said the benefits of the AstraZeneca vaccine “far outweigh the risks”.

"In vaccination campaigns, it is routine to signal potential adverse events. This does not necessarily mean that the events are linked to the vaccination," it said.

Dr Hans Kluge, WHO regional director for Europe, said people should "have confidence" in the protection given by vaccines.

In a separate announcement, the UK medicines regulator said a rigorous scientific review had found no evidence that the AstraZeneca vaccine caused blood clots.

Britain’s Medicines and Healthcare products Regulatory Agency said one man had died and four others suffered dangerous blood clotting but there was not enough evidence to link it to the drug.

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