However, the agency said that it cannot be ruled out that it is related to two rare blood clotting diseases in 25 vaccinated people.It added that the warning should be included in the information about the vaccine Provided to the doctor And patients. Nine of them have died.
After the EU Pharmacovigilance Risk Assessment Committee (PRAC) was asked to review the safety of AstraZeneca vaccines Over 20 European countries-including Germany, France, Italy and Spain- Stop vaccination Rare coagulation disorders are reported below.
After the EMA announcement, Germany, France, Italy and Spain all stated Will continue Use AstraZeneca’s vaccine.
On Thursday, EMA executive director Emer Cooke said at a press conference that the committee found that compared with the general population, the overall incidence of blood clots among nearly 20 million people vaccinated around the world has so far been reduced.
“The committee has reached clear scientific conclusions,” she said. “This is a safe and effective vaccine.”
However, PRAC Chairman Sabine Straus said that experts cannot rule out the 18 cases Cerebral Venous Sinus Thrombosis (CVST) and seven cases Disseminated intravascular coagulation (DIC), both appear with a decrease in platelet count. In CVST, clots prevent blood from draining from the brain, which can cause bleeding. DIC is a disease in which clots form in many tiny blood vessels throughout the body, which can cause serious organ damage.
EMA will continue to investigate these incidents and possible links to vaccines. But Cook emphasized that the benefits of the AstraZeneca vaccine in protecting people from COVID-19 infection far outweigh the risk of clotting.
“So what the committee recommends is to raise awareness,” she said.
Some experts speculate that the coagulation event is related to a particular batch of vaccine, but Straus said that EMA does not support this theory. “PRAC found no evidence of quality or batch issues,” she said.
On Thursday, the White House confirmed reports that the Biden administration will ship 2.5 million doses of AstraZeneca vaccine to Mexico and 1.5 million doses to Canada. These vaccines will come from existing domestic supplies that are awaiting FDA authorization, which may take place next month after the main U.S. trial of the vaccine is over.
The action is as follows Dosage requirements From Mexico earlier this week. Biden told reporters on Thursday that once domestic vaccination is completed, the United States is discussing shipping any excess dose overseas. Senior FDA official Peter Marks testified before Congress on Wednesday that his agency is concerned about exporting excessive doses in case the vaccine immunity proves to be short-lived and the US population needs booster injections.
Others speculated whether AstraZeneca’s vaccine would cause more problems in the United States because anti-vaccineists caught these problems when it was launched.
“Does it really have a niche to fill? Will it be trusted enough? Or is it just another headache?” John Moore, a virologist at Weill Cornell Medical College in New York who is engaged in vaccine development, told BuzzFeed earlier this week news.