Germany, France, Spain and Italy reverse course after drugs regulator finds jab ‘safe and effective’
Germany, France, Italy and Spain said they would resume using the Oxford/AstraZeneca coronavirus vaccine after the EU drugs regulator said there was a “clear scientific conclusion” that the jab was “safe and effective”. Emer Cooke, head of the European Medicines Agency, on Thursday said its investigation had concluded that the AstraZeneca vaccine was “not associated” with a potential 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,” said Cooke. EMA officials said they could not “definitively” rule out a link between the vaccine and a rarer, and more serious, type of blood clot associated with a low platelet count. “A causal link with the vaccine is not proven, but is possible and deserves further analysis,” the agency said. Cooke recommended an awareness campaign that aimed to “spot and mitigate any possible side effects” of the vaccine.
Mario Draghi, prime minister of Italy, which was among the countries to suspend use of the AstraZeneca vaccine, said it would resume using the shot on Friday.
Jean Castex, prime minister of France, said his country would do the same, adding he would also receive the jab “to show that we can all have total confidence”. Germany’s health minister Jens Spahn announced AstraZeneca vaccinations would restart on Friday. He said it was good news the jab had been cleared but stood by the decision to suspend its use. “EMA’s analysis confirmed our approach. It was important to suspend vaccinations with [AstraZeneca] as a precaution until the conspicuous cluster of cases of this very rare thrombosis had been analysed,” he said. “It would have been irresponsible to let doctors continue to vaccinate people without this information in our view.”
Spain said it would resume administering Oxford/AstraZeneca vaccines as of Wednesday next week. Carolina Darias, health minister, said this timing would allow the country’s health authorities to reconsider who should receive the vaccine. Madrid previously banned the use of the vaccine for over-55s — a decision it had been due to review when the controversy about thrombosis began. Irish health authorities welcomed the EMA decision and said they would be “deliberating” the findings on Thursday night and Friday morning.
The suspensions this week by more than a dozen European countries including Germany and Spain dealt a fresh blow to the continent’s ailing vaccination campaign. While countries including Austria had put their programmes on hold, the 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 UK drugs regulator on Thursday said five such clots had been recorded in Britain in those administered with the vaccine, but stressed that no link had been established. It also urged people to continue to take the vaccine. The AstraZeneca jab has faced multiple challenges. 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 eased in recent weeks thanks to the successful rollout of the jab to 25m people. AstraZeneca welcomed the result of the assessment. Its chief medical officer, Ann Taylor, said: “We trust that, after the regulators’ careful decisions, vaccinations can once again resume across Europe.” The EMA’s endorsement comes as the UK’s NHS warned that supplies of the AstraZeneca jab would be squeezed in the next month. 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, on Thursday said its investigation had found nothing to link the side effects to manufacturing issues.