EMA Says AstraZeneca’s COVID-19 Vaccine Is Safe
The AstraZeneca COVID-19 vaccine is “safe and effective” and should continue to be used, the European Medicines Agency said today following a review of blood clotting concerns.
However, the agency said it could not rule out a link to two rare blood clotting conditions seen in 25 people who received the vaccine. He added that warnings should be included with information about the vaccine provided to doctors and patients. Nine of them have died.
The EU 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 – stopped vaccinations after
EMA Executive Director Emer Cooke told a news conference that the commission found a reduced overall incidence of blood clots, compared to the general population, to nearly 20 million people who have been vaccinated so far worldwide.
“The commission has reached a clear scientific conclusion,” he said. “This is a safe and effective vaccine.”
However, Sabine Straus, president of PRAC, said experts could not rule out an association with 18 cases of a condition called cerebral venous thrombosis (CVST) and seven cases of diffuse intravascular coagulation (DIC), both of which occur together with Decreased blood counts platelets. In CVST, clots can prevent blood from draining from the brain, leading to bleeding. DIC is a condition in which clots form in many tiny blood vessels throughout the body, which could lead to severe organ damage.
The EMA will continue to investigate these incidents and possible links to the vaccine. However, Cooke stressed that the benefits of the AstraZeneca vaccine in protecting people from COVID-19, which now kills thousands of Europeans every week, far outweigh the risk of coagulation.
“What the commission has recommended is to raise awareness,” he said.
Some experts had suggested that coagulation cases were related to specific batches of the vaccine, but Straus said the EMA did not support this theory. “PRAC found no evidence of batch quality or problem,” he 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 downloads will come from existing domestic supplies awaiting FDA approval, which could come as early as next month after a major US vaccine test is completed.
The move follows a request for installments from Mexico earlier this week. Biden told reporters Thursday that the United States is considering sending overdoses abroad as soon as the domestic vaccination is completed. A senior FDA official, Peter Marks, testified in Congress on Wednesday that his agency was concerned about overdosing if the vaccine immunity proves to be short-lived and needed boosting for the U.S. population.
Others have speculated that the AstraZeneca vaccine will cause more problems in the US, as anti-altar makers have figured out the problems during its release.
“Does he really have a place to fill? Would it be reliable enough? Or will it just be 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.