EUROPE’s medical regulator, European Medicines Agency (EMA), concluded Thursday that AstraZeneca’s coronavirus vaccine is “safe and effective,” but it could not rule out a link to a small number of rare and unusual blood clot cases, reports the Washington Post.
The regulator on Monday paused the administration of the vaccine following complaints from a number of European countries, including Germany, France and Italy.
EMA’s current declaration following an assessment will open the way for European countries to restart paused inoculation programs, while not fully allaying fears surrounding side effects.
EMA said it investigated 25 cases, including nine deaths, that involved particularly rare blood clots: one type of brain clot and another condition that clogs multiple veins in the body. The agency noted that was out of the 20 million people in Europe and Britain who have received the vaccine developed by AstraZeneca and the University of Oxford.
“A causal link with the vaccine is not proven, but is possible and deserves further analysis,” the agency concluded, adding that a warning would be added to the product to highlight the clotting risk and that it would conduct outreach about concerning symptoms to watch for after vaccinations, especially easy bruising or bleeding and severe headaches.
“If it was me, I would be vaccinated tomorrow,” said Emer Cooke, the head of the agency. “But I would want to know if anything happened to me after vaccination, what I should do about it, and that’s what we’re saying today.”
Most of the countries that had suspended AstraZeneca shots — including Germany, France, Italy and Spain — were quick to say they would resume on Friday or next week. Though some countries, including Sweden and Norway, said they would need time to make their own scientific evaluations.
A team in Norway said earlier in the day that it had concluded that the hospitalizations of three medical workers there, including one who died, were probably caused by an immune response to the vaccine.
The decisions to pause use of the AstraZeneca vaccine had divided both the scientific community and Europe. Some experts have argued that the extremely unusual and deadly nature of blood clots detected, even if in tiny numbers, warrant caution. Others said hasty decisions will have an irreparable effect on confidence in the vaccine.
How the assurance – with caveats – from the European regulator will affect uptake remains to be seen. The director of one vaccine center in Germany said the task of rebuilding trust would be “herculean.”
