European regulators say blood clots are “very rare side effects” of the AstraZeneca vaccine

April 07, 2021

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The European Medicines Agency said on Wednesday that “unusual blood clots with low platelets should be listed as [a] very rare side effect ‘of AstraZeneca’s COVID-19 vaccine.

“The reported combination of blood clots and low platelets is very rare, and the vaccine’s general benefits in preventing COVID-19 outweigh the risk of side effects,” the agency said in a press release.

The European Medicines Agency said blood clots should be listed as a “very rare side effect” of AstraZeneca’s COVID-19 vaccine.
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Last month, some European countries temporarily stopped giving the vaccine due to reports of blood clots in people who received it. The European Medicines Agency (EMA) later declared the vaccine safe and said research found no link between the vaccine and thromboembolism or blood clots.

In its latest conclusion, the EMA’s Security Committee took into account “all evidence currently available, including advice from an ad hoc group of experts,” the agency said.

“EMA is reminding health professionals and those receiving the vaccine to be aware of the possibility of very rare cases of blood clots combined with low platelet levels within two weeks of vaccination. So far, most reported cases in women under 60 have occurred within two weeks of being vaccinated, ”the agency said. “Based on currently available data, specific risk factors have not been confirmed.”

The safety committee said clots appeared in veins in the brain and abdomen, as well as in arteries. The committee considered 62 cases of cerebral vein sinus thrombosis and 24 cases of splanchnic vein thrombosis that occurred in the European Union on March 22, of which 18 were fatal.

According to the EMA, around 34 million people in the UK and the European Economic Area have received the AstraZeneca vaccine.

A possible explanation for the clotting and low platelets could be an immune response leading to a condition similar to heparin-induced thrombocytopenia, the EMA said. The safety committee has requested more research to better understand the coagulation cases.

perspective

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Amesh A. Adalja, MD

Every vaccine has a risk-benefit calculation, and there are no vaccines without side effects. All in all, the AstraZeneca vaccine is a life saving, safe and effective vaccine. Even with the possible association of an identifiable and treatable rare blood clotting and platelet disorder with the vaccine in some individuals, the risk-benefit ratio greatly favors the vaccine.

However, I fear that the negative headlines that have plagued this vaccine for months will deter many in the public from taking it. Very differentiated and transparent communication will be required, but it is achievable. The more this vaccine is accepted, the better we can control the pandemic.

Amesh A. Adalja, MD

Senior Scholar

Johns Hopkins Center for Health Safety

Disclosure: Adalja does not report any relevant financial information.

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