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 disorders that prompted more than a dozen nations to suspend its use.
The news came as the European Medicines Agency (EMA) director Emer Cooke said the agency could not definitively rule out a link to blood clot incidents and the vaccine in its investigation into 30 cases of a rare blood clotting condition.
But she said in a briefing the “clear” conclusion of the review was that the vaccine “benefits in protecting people from COVID-19 with the associated risk of death or hospitalization outweighs the possible risks.”
The agency will however update its guidance to include an explanation about the potential risks on both the patient leaflet and in the information for healthcare professionals, she said.
“This is a safe and effective vaccine,” said Cooke.
But EMA wants “to raise awareness among people who have been vaccinated or are going to be vaccinated about things they should look out for,” she said.
The agency 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.
The agency’s review covering 5 million people, included 30 cases of unusual blood disorders in people in the European Economic Area (EEA), which links 30 European countries.
Cooke said the EMA is in touch with regulators around the world to keep tabs on possible side-effects of all COVID vaccines.
The EMA’s focus and primary concern has been on cases of blood clots in the head, a rare condition that’s difficult to treat called cerebral venous thrombosis (CVT) or a subform known as cerebral venous sinus thrombosis (CVST), it said earlier this week.
More than 45 million of the shots have been administered across the EEA.
At least 13 European countries, including France, Germany and Italy, have stopped administering the shot pending the review, the latest blow to the bloc’s faltering inoculation campaign.
Britain’s medicines regulator said on Thursday it was investigating five cases of CVST among people given AstraZeneca’s vaccine but it also reaffirmed that the benefits of the shot far outweighed any possible risks.
The World Health Organization has also this week reaffirmed its support for the shot.
Health Canada, whose officials attended the EMA meeting, is on the same page. The agency has so far said the vaccine’s benefits are strong and it had not seen evidence to link the vaccine to blood clots.
Deputy chief public health officer Dr. Howard Njoo says Canada is monitoring all the evidence closely.
“The fact is that all four COVID-19 vaccines authorized by Health Canada meet our country’s high standards for safety, and provide a high degree of protection against severe illness and death related to COVID-19,” said Njoo.
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.
Many governments have said the decision to pause inoculations was out of an abundance of caution.
But experts have warned the political interference could undermine public confidence and hobble the bloc’s slow vaccination campaign as governments struggle to tame more infectious variants.
The bloc’s vaccine roll-out has lagged the United States and former EU member Britain.
— with Global News files