The AstraZeneca Covid-19 vaccine is “safe and effective”, the European Medicines Agency (EMA) has concluded, leading France and Italy to announce they would resume using the jab.
French Prime Minister Jean Castex said the country will begin vaccinating people again with the Oxford/AstraZeneca vaccine from Friday, while Italy expects to start on the same day.
The European regulator has said it “cannot rule out definitively” a link between “a small number of cases of rare and unusual but very serious blood clotting disorders” and the vaccine, though investigations were ongoing.
Emer Cooke, EMA executive director, said this situation was not unexpected, adding that “when you vaccinate millions of people” such reports of rare events will occur.
But the EMA has concluded there is no overall increase in the risk of blood clots with the vaccine, and in fact it is likely to reduce the overall risk of clots.
Ms Cooke, who said she would personally take the vaccine, told a press briefing: “The committee has come to a clear scientific conclusion.
“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.”
It comes after it emerged five men in the UK have suffered an “extremely rare” blood clot problem after having the AstraZeneca coronavirus vaccine, though no causal link with the jab has been established.
The men, aged 19 to 59, have experienced a specific type of blood clot in the brain together with low blood platelet count. One of the five has since died.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said it was looking at the reports but stressed the events were “extremely rare” and there was a possibility they could have been caused by Covid itself.
It said the cases represented a less than one-in-a-million chance of suffering this type of clot among those who have been vaccinated, while the risk of dying from Covid aged 40 to 49 is one in 1,000.
The MHRA concluded that any link between the jab and clots is unproven and the benefits of the AstraZeneca vaccine outweigh any risks.
The type of clot – cerebral venous sinus thrombosis (CVST) – prevents blood from draining out of the brain.
It is this type of clot that led Germany to halt its rollout of the AstraZeneca vaccine, prompting other countries across Europe, including Italy and France, to follow.
Officials in Germany received six reports of CVST associated with low blood platelets – all in younger to middle-age women.
The EMA said the committee had recommended “raising awareness” of possible risks associated with the AstraZeneca vaccine and ensuring they are included in the product information for the vaccine.
Around 20 million people in the UK and Europe had received the vaccine as of March 16 and the EMA had received reports of just seven cases of blood clots in multiple blood vessels and 18 cases of CVST, it said.
Ms Cooke told the briefing: “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.
“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.”
Ms Cooke said the AstraZeneca vaccine “demonstrated at least 60% efficacy in clinical trials in preventing coronavirus disease and, in fact, the real world evidence suggests that the effectiveness could be even higher than that”.
She added: “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 (from Covid) – 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.
“The scientific conclusions adopted today provide member states with the information they need to take an informed decision regarding the use of the AstraZeneca vaccine in their vaccination campaigns.”
Later, she told the briefing: “If it were me, I would be vaccinated tomorrow.”
Urging countries to use the jabs available, she added: “We just have to continually remind ourselves of what a difficult situation we are in.
“This pandemic is costing lives.
“We have vaccines that are safe and effective, that can help prevent death and hospitalisation. We need to use those vaccines within the environment that we have them.”
The EMA said the CVST cases it had seen appeared to occur in more women than men.
It is looking into whether oral contraceptives or prior Covid infection could be a factor in increasing risk.
The EMA said there was also no evidence of a problem related to specific batches of the vaccine or manufacturing sites.
Dr June Raine, MHRA chief executive, said CVST “can occur naturally in people who have not been vaccinated, as well as in those suffering from Covid-19.”
She added: “Given the extremely rare rate of occurrence of these events among the 11 million people vaccinated (in the UK), and as a link to the vaccine is unproven, the benefits of the vaccine in preventing Covid-19, with its associated risk of hospitalisation and death, continue to outweigh the risks of potential side effects.”
Dr Raine later told the Downing Street press conference that, as a precautionary measure, the MHRA advised “anyone with a headache that lasts more than four days after vaccination or bruising beyond the site of vaccination after a few days to seek medical attention”.
England’s chief medical officer Professor Chris Whitty said Covid-19 was still a “common disease” that was “dangerous” for many people.
He said there were “anecdotal reports” of small numbers of people not turning up for vaccine appointments following the controversy, but he expected many of those would decide to get the jab after “a pause for thought”.