EMA Says AstraZeneca’s COVID-19 Vaccine Is Safe

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 blood clotting concerns.

However, the agency said it couldn’t rule out a link to two rare blood clotting conditions in 25 people who were given the vaccine. It added that warnings should be included with information about the vaccine that will be provided to doctors and patients. Nine of these people died.

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

Emer Cooke, EMA Executive Director, told a news conference that the committee found that nearly 20 million people who have received the vaccine around the world have lower incidences of blood clots compared to the general population.

“The committee came to a clear scientific conclusion,” she said. “This is a safe and effective vaccine.”

However, Sabine Straus, chair of the PRAC, said experts could not rule out an association with 18 cases of a condition known as cerebral venous sinus thrombosis (CVST) and seven cases of disseminated intravascular coagulation (DIC), both along with reduced blood platelet counts. In CVST, clots can prevent blood from draining out of the brain, causing bleeding. DIC is a condition in which clots form in many tiny blood vessels throughout the body, which can lead to serious 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 currently kills thousands of Europeans every week, far outweigh the risk of clotting.

“The committee therefore recommended raising awareness,” she said.

Some experts had speculated that the coagulation incidents were related to certain lots of the vaccine, but Straus said the EMA did not support that theory. “PRAC found no evidence of a quality or batch problem,” she said.

On Thursday, the White House confirmed reports that the Biden government will ship 2.5 million doses of the AstraZeneca vaccine to Mexico and 1.5 million to Canada. These shots are from existing domestic shipments pending FDA approval. These could be done as early as next month after a large US study of the vaccine is completed.

The move follows a request for the cans from Mexico earlier this week. Biden told reporters on Thursday that the US is discussing shipping excess doses overseas once domestic vaccination is complete. A senior FDA official, Peter Marks, testified in Congress Wednesday that his agency has concerns about exporting too many excess doses just in case vaccine immunity is found to be short-lived and booster vaccinations are required for the U.S. population .

Others have speculated that AstraZeneca’s vaccine will cause more problems in the US, as Anti-Vaxxers picked up on the problems when it was launched.

“Does it really have a niche to fill? Would it be trustworthy enough? Or will it 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.

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