The EU’s drug watchdog said on Thursday it is still convinced the benefits of AstraZeneca’s Covid-19 vaccine outweigh the risks following 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 healthcare 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, have stopped administering the shot pending the review.
The suspensions were the latest blow to the European Union’s inoculation campaign, which has lagged the United States and former EU member Britain.
Spain’s government was meeting to discuss whether to resume vaccinations following the EMA’s verdict.
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.
RPS welcomes verdict
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 and the MHRA,” said Royal Pharmaceutical Society chief scientist Professor Gino Martini.
“The vaccine is playing a crucial role in protecting vulnerable groups from hospitalisation and death and helping to decrease infection rates across the UK.
“The MHRA is renowned as a world-class regulator of medicines and vaccines. They are continuing to monitor the Oxford/AstraZeneca vaccine closely as part of a ‘rolling review’ approach to Covid-19 jabs, through rigorous checks and processes, at they would for any other vaccine or medicine.
“As trusted health professionals, pharmacists are playing a key role in administering Covid-19 vaccinations and have contributed enormously to the success of the programme so far. We have full confidence in these vaccines and can confidently state that pharmacists can continue administering them to patients. It is so important that we get all those at risk from the virus vaccinated as soon as possible.”
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.