European Union regulators said Thursday that the Oxford-AstraZeneca COVID-19 vaccine is safe and not linked to an overall increase in the risk of blood clots, an announcement that corroborates safety claims made by the vaccine maker and other health agencies after about a dozen countries halted the vaccine’s administration over blood clot concerns.
The AstraZeneca vaccine, which has not been made available in the U.S., has been administered to 20 million people throughout Europe and has been heralded as an important tool for curbing the pandemic due to its relatively accessible refrigeration requirements. But administration of the vaccine was recently halted in more than a dozen mostly European countries following scattered reports that a small number of people who had received it later experienced blood clots, according to The Associated Press.
“[T]the benefits of the vaccine in combating the still widespread threat of COVID-19 (which itself results in clotting problems and may be fatal) continue to outweigh the risk of side effects,” announced the European Medicines Agency late Thursday after a safety review.
“[T]he vaccine is not associated with an increase in the overall risk of blood clots (thromboembolic events) in those who receive it,” the committee’s announcement said. “[T]here is no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites.”
Countries that halted administration of the vaccine include France, Spain, Italy, and Germany, which purportedly did so as a “precaution” on the advice of the Paul Ehrlich Institute, a German health regulator, according to German news site Deutsche Welle.
“A situation like the one we have seen here is not unexpected,” Emer Cook, head of the EMA, said after Thursday’s safety announcement reports The New York Times. “When you vaccinate millions of people, it’s inevitable that rare or serious instances or illnesses will occur in the time immediately following vaccination.”
Other countries, however, continued to use the Oxford-AstraZeneca vaccine, a position embraced by numerous health experts, including at the World Health Organization and in the United Kingdom, which never stopped administering the vaccine.
“A causal relationship with the vaccine has not yet been established,” June Raine, chief executive of the U.K.’s medicine regulator, said prior to the EMA announcement, reports Reuters. She added that the agency had reviewed and would continue to review the reports of blood clotting and that they had determined the benefits of the vaccine outweigh any potential risks.
Following the EMA announcement, Italian Premier Mario Draghi said that Italy would resume inoculations with the AstraZeneca vaccine, according to The Associated Press.
The European Medicines Agency notes that in extremely rare cases, it remains possible the vaccine “may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e. low levels of blood platelets (elements in the blood that help it to clot) with or without bleeding, including rare cases of clots in the vessels draining blood from the brain (CVST).” The agency emphasizes that no causal link has been proven.
“These are rare cases – around 20 million people in the UK and EEA had received the vaccine as of March 16 and EMA had reviewed only 7 cases of blood clots in multiple blood vessels (disseminated intravascular coagulation, DIC) and 18 cases of CVST.”
Sabine Strauss, who heads the committee at the EMA that reviewed the vaccine, said the committee would continue reviewing reports of rare blood clots to ensure safety, reports AP.
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