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