EMA says AstraZeneca’s COVID-19 Vaccine is Safe

AstraZeneca’s Covid-19 vaccine it is “safe and effective” and should continue to be used, the European Medicines Agency said announced today after a review of concerns for blood clotting.

But the agency said it could not rule out a link with two rare situations of blood clotting seen in 25 people who were given the vaccine. He added that warnings should be included with information about the vaccine provided to doctors and patients. Nine of these people died.

The EU Pharmacovigilance Risk Assessment Committee (PRAC) has been asked to review the safety of the AstraZeneca vaccine afterwards. more than 20 European countries – including Germany, France, Italy and Spain – vaccinations stopped following reports of rare coagulation disorders.

Following the EMA announcement, Germany, France, Italy and Spain have said would take over using the AstraZeneca vaccine.

On Thursday, EMA executive director Emer Cooke told a press briefing that the committee found a reduced overall incidence of blood clots, compared to the general population, in nearly 20 million people who gave the vaccine so far. to the world.

“The committee has come to a clear scientific conclusion,” he said. “This is a safe and effective vaccine.”

But Sabine Straus, president of the PRAC, said experts could not rule out a link with 18 cases of a so-called situation. cerebral venous sinus thrombosis (CVST) is seven cases of disseminated intravascular coagulation (DIC), both seen together with reduced platelet counts. In CVST, clots can block blood from the brain, leading to bleeding. DIC is a condition in which clots form in several small blood vessels throughout the body, which could lead to severe organ damage.

EMA will continue to investigate these incidents and possible links to the vaccine. But Cooke pointed out that the benefits of the AstraZeneca vaccine to protect people from COVID-19, which currently kills thousands of Europeans every week, far outweigh any risk of clotting.

“What the committee therefore advised is to raise awareness,” he said.

Some experts have speculated that coagulation incidents were related to particular batches of the vaccine, but Straus said the EMA did not support this theory. “PRAC has found no evidence of a quality or batch problem,” he said.

On Thursday, the White House confirmed that the Biden administration will send 2.5 million doses of the AstraZeneca vaccine to Mexico and 1.5 million to Canada. Those shots will come from existing national suppliers awaiting FDA authorization, which could come just next month after a major U.S. vaccine trial concludes.

The move followed a demand for doses from Mexico earlier this week. Biden had told reporters that the United States is discussing shipping any excess doses abroad once the domestic vaccination is over. A senior FDA official, Peter Marks, told Congress Wednesday that his agency has some concerns about exporting too many overdoses in case the vaccine’s immunity is short-lived and that booster shots are needed to to the population of the United States.

Others have speculated whether the AstraZeneca vaccine will create more problems in the United States, since anti-vaxxers have taken issue with its implementation.

“Does it need a niche to fill?” Would she be trustworthy enough? Or is it just another headache? “John Moore, a virologist at Weill Cornell Medical College in New York who is working on the development of the vaccines, told BuzzFeed News earlier this week.

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