The EU’s drugs regulator said there was a “clear scientific conclusion” that the Oxford/AstraZeneca coronavirus vaccine was “safe and effective”, days after more than a dozen European countries halted use of the jab.
Emer Cooke, head of the European Medicines Agency, said its investigation had concluded that the vaccine was “not associated” with a raised risk of blood clots noted recently by some scientists, adding that the benefits of the shot outweighed possible risks.
“If it were me, I would be vaccinated tomorrow,” Cooke told a press briefing on Thursday.
Mario Draghi, prime minister of Italy, which was one of those to suspend use of the AstraZeneca vaccine, responded to the EMA briefing by saying the country would restart use of the shot on Friday.
EMA officials said that, based on the evidence available, they could not “definitively” rule out a link between rare and serious side effects that include clots to the brain. “A causal link with the vaccine is not proven, but is possible and deserves further analysis,” the EMA said.
Cooke recommended an awareness campaign that would aim to “spot and mitigate any possible side effects” of the vaccine.
The EMA decision comes days after some European nations suspended or limited use of the shot, dealing a fresh blow to the continent’s ailing vaccination campaign and further denting confidence in the AstraZeneca jab.
While countries including Austria and Italy had already suspended batches of the vaccine, this week’s wider suspension came after German researchers noted an apparent raised incidence of rare blood clots that led Berlin to halt the AstraZeneca element of its inoculation programme. The serious and rare side effects alleged include cerebral thrombosis coupled with a lowered count of the particles that help blood to clot.
The UK drugs regulator on Thursday said five such clots had been recorded in Britain in those administered with the vaccine, but also stressed that no link had been established. It also urged people to continue to take the vaccine.
The AstraZeneca jab has faced multiple challenges since it came on to the market. Early data generated by clinical trials were criticised by some experts as being inconsistent. Some European nations also limited use of the vaccine in some age groups, citing a lack of population-specific data.
Those fears had appeared to be easing in recent weeks as evidence emerged from the UK, where it has been administered to millions of people, that the jab was effective, until this week’s blood clot-related suspensions.
Some have decried this week’s vaccine suspensions as political, citing the fact that several European capitals co-ordinated their suspensions. But politicians in France and elsewhere have also signalled a readiness to resume using the AstraZeneca jab as soon as possible if it is given the green light by the EMA.
The EMA’s endorsement comes as the UK’s National Health Service warned that supplies of the AstraZeneca vaccine would be squeezed in the next month, potentially complicating what has been a highly successful campaign that has rolled out shots to nearly 22m people.
The UK is far ahead of its European peers in vaccinating its population, with the FT’s vaccination tracker showing that, as of Monday, it had administered 40.5 doses per 100 individuals, versus the EU’s 11.8.
European countries have struggled to secure vaccine supplies, with AstraZeneca disclosing recently that it is aiming to deliver less than half of its agreed doses in the second quarter of the year. Most of that reduction stems from supply issues, though evidence also points to single nations not deploying doses already available quickly enough.
Sabine Straus, chair of the EMA’s pharmacovigilance risk assessment committee, said on Thursday that its investigation had found nothing to link the side effects to manufacturing issues.
The EMA had previously said it was considering manufacturing issues as a potential cause for the side effects. “The possible link is not there,” she said.