The European Medicines Agency (EMA), a regulatory body of the European Union, said that the vaccine producer AstraZeneca should make mention of rare blood clots as a possible side effect.
Emer Cooke, the executive director of the EMA, said in a media briefing on Wednesday that after an in-depth examination of the vaccine, they arrived at the conclusion “that the reported cases of unusual blood clotting following vaccination with the AstraZeneca vaccine should be listed as possible side effects of the vaccine.”
The EMA and UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) also said that despite the potential side effects, the benefits are greater than the risks.
“The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects,” the EMA said in a statement.
“COVID-19 is a very serious disease with high hospitalization and death rates and every day COVID is still causing thousands of deaths across the EU,” Cooke said. “This vaccine has proven to be highly effective—it prevents severe disease and hospitalization, and it is saving lives.”
The European Union’s drug regulation agency on Wednesday said there is a “possible link” between the AstraZeneca CCP virus vaccine and “very rare” blood clots but recommended that vaccinations continue and stressed the benefits outweigh the risks.
EMA “is reminding healthcare professionals and people receiving the vaccine to remain aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within 2 weeks of vaccination,” the agency said in a statement Wednesday.
The statement continued: “So far, most of the cases reported have occurred in women under 60 years of age within 2 weeks of vaccination. Based on the currently available evidence, specific risk factors have not been confirmed.”
The Epoch Times has contacted AstraZeneca for comment. The pharmaceutical giant and the World Health Organization (WHO) have previously stated that its studies have found no higher risk of clots due to the vaccine.
EMA officials reviewed several dozen cases that came mainly from Europe and the United Kingdom, where around 25 million people have received the AstraZeneca vaccine, according to EMA’s statement.
Last month, more than a dozen European countries—including France, Germany, Italy, and Spain—suspended usage of the AstraZeneca vaccine following reports of blood clots as well as several deaths in people who had received the shot. Most countries have resumed using the vaccine but some have suspended inoculations in older individuals.
Jack Phillips contributed to this report.