AstraZeneca’s COVID-19 vaccine is “safe and effective” and should continue to be used, the European Medicines Agency announced today after a review of concerns about blood clotting.
But the agency said it could not rule out a link with two rare blood clotting diseases seen in 25 people who received the vaccine. He added that warnings should be included with the vaccine information provided to doctors and patients. Nine of these people died.
The EU’s Pharmacovigilance Risk Assessment Committee (PRAC) has been asked to review the safety of the AstraZeneca vaccine after more than 20 European countries – including Germany, France, Italy and Spain – discontinued vaccinations following reports of rare bleeding disorders.
After the EMA announcement, Germany, France, Italy and Spain all said they would start using AstraZeneca’s vaccine again.
EMA Executive Director Emer Cooke told a press briefing on Thursday that the committee had seen a reduced overall incidence of blood clots, compared to the general population, in nearly 20 million people with received the vaccine so far in the world.
“The committee came to a clear scientific conclusion,” she said. “It is a safe and effective vaccine.”
But PRAC chairperson Sabine Straus said experts were unable to rule out a link with 18 cases of a condition called cerebral venous sinus thrombosis (CVST) and seven cases of disseminated intravascular coagulation (CID ), both observed with reduced blood. platelet count. In CVST, clots can prevent blood from flowing from the brain, causing bleeding. DIC is a condition in which clots form in many small blood vessels throughout the body, which could lead to serious organ damage.
The EMA will continue to investigate these incidents and possible links to the vaccine. But Cooke stressed that the benefits of the AstraZeneca vaccine in protecting people from COVID-19, which currently kills thousands of Europeans every week, far outweigh any risk of clotting.
“So what the committee recommended is to educate the public,” she said.
Some experts had speculated that the clotting incidents were linked to particular batches of the vaccine, but Straus said the EMA did not support this theory. “The PRAC found no evidence of a quality or batch problem,” she said.
On Thursday, the White House confirmed reports that the Biden administration would ship 2.5 million doses of the AstraZeneca vaccine to Mexico and 1.5 million to Canada. These injections will come from existing national supplies awaiting FDA clearance, which could come as early as next month after the end of a major trial of the vaccine in the United States.
The move follows a request for doses from Mexico earlier this week. Biden had told reporters on Thursday that the United States was considering shipping excess doses overseas once the national vaccination was completed. Senior FDA official Peter Marks testified in Congress on Wednesday that his agency was concerned about exporting too many excess doses in case vaccine immunity was short-lived and the population needed booster shots. American.
Others have speculated whether AstraZeneca’s vaccine will create more problems in the United States, as anti-vaxxers grabbed hold of the problems when it was rolled out.
“Does he really have a niche to fill? Would it be reliable enough? Or is it going to be just another headache? John Moore, a virologist at Weill Cornell Medical College in New York who works on vaccine development, told BuzzFeed News earlier this week.