(Reuters) – AstraZeneca Plc said on Sunday that an analysis of the safety data of people vaccinated with COVID-19 vaccine showed no evidence of an increased risk of blood clots.
The review of AstraZeneca, which covered more than 17 million vaccinated people in the United Kingdom and the European Union, comes after health authorities in some countries suspended the use of its vaccine due to clotting problems.
“A careful analysis of all available safety data of more than 17 million people vaccinated in the European Union and the UK with the COVID-19 AstraZeneca vaccine did not reveal an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia at any defined age. group, gender, lot or in a particular country, “the company said.
Authorities in Ireland, Denmark, Norway and Iceland suspended the use of the vaccine due to clotting problems, while Austria stopped using a batch of AstraZeneca photos last week while investigating a death due to clotting disorders.
The European Medicines Agency said there was no indication that the events were caused by vaccination, an opinion that was repeated on Friday by the World Health Organization.
The drug manufacturer said that so far 15 events of deep vein thrombosis and 22 events of pulmonary embolism have been reported, which is similar to other authorized COVID-19 vaccines.
The company said the additional testing was and is being performed by the company and European health authorities and none of the re-tests showed any cause for concern. The monthly safety report will be made public on the EMA website next week, AstraZeneca said.
The AstraZeneca vaccine, developed in collaboration with Oxford University, has been licensed for use in the European Union and many countries, but not yet by US regulators.
The company is preparing to submit the US Emergency Use Authorization and expects data from its US Phase III study to be available in the coming weeks.
Reporting by Radhika Anilkumar and Aakriti Bhalla in Bengaluru, edited by Jane Merriman