(Reuters) – AstraZeneca Plc said on Sunday that a review of safety data from people vaccinated with the COVID-19 vaccine has revealed no evidence of an increased risk of blood clots.
AstraZeneca’s review, which involved more than 17 million vaccinated people in the UK and the European Union, comes after health authorities in some countries have suspended the use of their vaccine due to clotting problems.
“A careful review of all available safety data from more than 17 million people vaccinated in the European Union and the UK with the COVID-19 vaccine AstraZeneca has revealed no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia, in a certain age. group, gender, batch or in a specific country, ”the company said.
Authorities in Ireland, Denmark, Norway and Iceland have suspended use of the vaccine due to clotting problems, while Austria stopped using a batch of AstraZeneca injections last week during the investigation of a death from coagulation disorders.
The European Medicines Agency has said there is no evidence that the events were caused by the vaccination, an opinion echoed by the World Health Organization on Friday.
The drugmaker said 15 cases of deep vein thrombosis and 22 cases of pulmonary embolism have been reported so far, which is comparable to other approved COVID-19 vaccines.
The company said additional tests have been and are being conducted by the company and the European health authorities and none of the new tests have raised any cause for concern. The monthly safety report will be made public on the EMA website the following week, AstraZeneca said.
The AstraZeneca vaccine, co-developed with Oxford University, has been approved for use in the European Union and many countries, but not yet by US regulators.
The company is preparing to apply for a US emergency use permit and expects data from the US Phase III trial to be available in the coming weeks.
Reporting by Radhika Anilkumar and Aakriti Bhalla in Bengaluru, edited by Jane Merriman