The European Medicines Agency has concluded that AstraZeneca’s COVID vaccine is “safe and effective”.
EMA’s safety committee, the Pharmacovigilance Risk Assessment Committee, concluded its preliminary safety review of AstraZeneca’s COVID-19 vaccine.
Several European countries had temporarily suspended AstraZeneca’s COVID-19 vaccine AZD1222 due to reports of blood clots in people receiving that jab. This prompted the EMA to launch a safety review to see if there was a link between the vaccine and the blood clots.
Emer Cooke, the agency’s executive director, told a news conference: “This is a safe and effective vaccine. Its benefits in protecting people from Covid-19 with the associated risks of death and hospitalization outweigh the possible risks.”
EMA also said that the vaccine is not associated with an increase in the overall risk of blood clots in those who receive it and there is no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites.
However, the EMA added that they could not rule out definitively a link between the vaccine and a “small number of cases of rare and unusual but very serious clotting disorders”.
So far across the EU and UK, there have been 15 events of deep vein thrombosis and 22 events of pulmonary embolism reported among those given the vaccine.
Following the EMA’s announcement, Italy said it would restart its rollout of AstraZeneca vaccinations on Friday.
AZD1222, now referred to as COVID-19 Vaccine AstraZeneca, was authorized for emergency use in the UK on December30, 2020.
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