EU regulator says AstraZeneca vaccine ‘safe and effective’
European Medicines Agency says benefits of AstraZeneca's Covid-19 vaccine far outweighed any possible risks, prompting several states to resume dispensing the shots
Amsterdam — The EU's drug watchdog said on Thursday it is still convinced the benefits of AstraZeneca's Covid-19 vaccine outweigh the risks after an investigation into reports of blood clots that prompted more than a dozen nations to suspend its use.
European Medicines Agency (EMA) director Emer Cooke said the watchdog could not definitively rule out a link between blood clot incidents and the vaccine in its investigation into 30 cases of a rare blood clotting condition.
But she said the “clear” conclusion of the review was that the benefits in protecting people from the risk of death or hospitalisation outweighs the possible risks. The issue deserves further analysis, the EMA said.
“This is a safe and effective vaccine,” Cooke told a briefing.
The agency will, however, update its guidance to include an explanation for the patient about the potential risks and in information for health-care professionals, she said.
“If it were me, I would be vaccinated tomorrow,” Cooke said.
The EMA has been under growing pressure to clear up safety concerns after a small number of reports in recent weeks of bleeding, blood clots and low platelet counts in people who have received the shot.
At least 13 European countries, including France, Germany and Italy, had stopped administering the shot pending the review. Germany, France, Italy, Luxembourg and Slovenia said on Thursday after the EMA report they will all resume dispensing the vaccine, and other countries are expected to follow. Sweden, however, is keeping it on hold as it continues its own review.
Spain's government was meeting to discuss whether to resume vaccinations after the EMA's verdict.
The Dutch health minister also said the Netherlands would resume using the vaccine next week.
The suspensions were the latest blow to the EU's inoculation campaign, which has lagged behind the US and former EU member Britain.
Many governments have said the decision to pause inoculations was out of an abundance of caution. But experts have said political interference could undermine public confidence in vaccinations as governments struggle to tame more infectious variants.
Some scientists said the agency's endorsement should be enough to allay EU governments' concerns.
“I hope that any concerns about potential links between the Oxford-AstraZeneca Covid-19 vaccine can now be discarded given the positive verdicts delivered by the EMA, the WHO [World Health Organization] and the MHRA [Medicines and Healthcare products Regulatory Agency]," said Royal Pharmaceutical Society chief scientist Prof Gino Martini.
The AstraZeneca shot was developed with Oxford University, and Oxford's vaccine trial chief welcomed the statements by European and British medical regulators that the vaccine should continue to be rolled out.
Even before the scare over blood clots a YouGov poll published on March 7 showed perceptions of safety for the AstraZeneca vaccine in France and Germany were lower than for those developed by Pfizer and its partner BioNTech and Moderna.
In Germany and France, the reputation of the AstraZeneca shot was dented by a decision to initially authorise the vaccine only for people aged under 65 due to a lack of data on its efficacy in older people.
News reports of side effects among front-line workers also slowed take-up in Germany, causing doses to go unused.
The EMA's review covering 20-million people in the UK and the European Economic Area (EEA), which links 30 European countries, included seven cases of blood clots in multiple blood vessels and 18 cases of a rare condition that is difficult to treat called cerebral venous sinus thrombosis (CVST), it said.
Overall the number of thromboembolic events reported after vaccination, both in studies before licensing and in reports after rollout, was lower than that expected in the general population, it said.
That means there is no increase in overall risk of blood clots. However, in younger patients there remain some concerns, related in particular to these rare cases, it said.
Britain's medicines regulator said on Thursday it was investigating five cases of CVST among people given AstraZeneca's vaccine but it also reiterated that the benefits far outweighed any possible risks.
The WHO has also this week reaffirmed its support for the shot.
AstraZeneca has said a review covering more than 17-million people who had received its shots in the EU and Britain had found no evidence of an increased risk of blood clots.
The safety scare is the latest challenge for AstraZeneca in its ambition to produce a “vaccine for the world”.
Its shot was among the first and cheapest to be developed and launched at volume since the coronavirus was first identified in central China at the end of 2019, and is set to be the mainstay of vaccination programmes in much of the developing world.
But the vaccine has been dogged by questions since the results of human trials released in December revealed a dosing mishap.
They have continued with concerns about its efficacy in older people and against the variant first identified in SA.
Political drama has also engulfed the Swedish drugmaker after it slashed its deliveries to the EU due to production issues.
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