(Reuters) – AstraZeneca Plc said on Sunday that a review of the safety data of people vaccinated with its COVID-19 vaccine shows no evidence of an increased risk of blood clots.
The review of 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 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 AstraZeneca vaccine has not shown any increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia, at any defined age group, gender, batch or in any particular country, ”the company said.
Authorities in Ireland, Denmark, Norway, Iceland and the Netherlands have suspended the use of the vaccine due to clotting problems, while Austria stopped using a batch of AstraZeneca shots last week while investigating the death. for coagulation disorders.
“It is very unfortunate that countries have stopped vaccination for such ‘preventive’ reasons: there is a risk of doing real harm to the goal of vaccinating enough people to curb the spread of the virus and end the pandemic,” Peter said English, a retired British government consultant on communicable disease control, told Reuters.
The European Medicines Agency has said there is no indication that the events were caused by vaccination, an opinion echoed by the World Health Organization on Friday.
The drug maker said so far 15 events of deep vein thrombosis and 22 events of pulmonary embolism have been reported, which is similar in other licensed COVID-19 vaccines.
The company said the company and European health authorities are conducting and are conducting additional tests and that none of the tests performed have shown 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 authorized for use in the European Union and many countries, but has not yet been regulated by U.S. regulators.
The company is preparing to file an emergency use authorization in the U.S. and expects U.S. Phase III test data to be available in the coming weeks.
Reports by Radhika Anilkumar and Aakriti Bhalla in Bengaluru, Additional Reports by Kate Kelland in London; Edited by Jane Merriman and Daniel Wallis