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