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March 15
AstraZeneca Plc said on Sunday that a review of safety data from people vaccinated with its COVID-19 vaccine showed no evidence of an increased risk of blood clots.
AstraZeneca’s review, which has covered more than 17 million people vaccinated in the UK and EU, comes after health authorities in some countries suspended use of its vaccine for clotting problems .
“A careful examination of all available safety data from the more than 17 million people vaccinated in the European Union and the United Kingdom with the COVID-19 vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia, regardless of age group, sex, lot or in a particular country, ”the company said.
Authorities in Ireland, Denmark, Norway, Iceland and the Netherlands suspended use of the vaccine for clotting problems, while Austria stopped using a batch of AstraZeneca doses last week while investigating a death from bleeding disorders.
“It is very unfortunate that countries have stopped vaccination for ‘precautionary’ reasons: this could seriously undermine the goal of vaccinating enough people to slow the spread of the virus and end the pandemic”, Peter Français , a retired Briton government consultant for the fight against communicable diseases, told Reuters.
The European Medicines Agency said there was no indication the events were caused by the vaccination, a view that was echoed by the World Health Organization on Friday.
The drugmaker said 15 deep vein thrombosis events and 22 pulmonary embolism events have been reported to date, which is similar for other licensed COVID-19 vaccines.
The company said additional testing has been and is being conducted by the company and European health authorities and that none of the new tests have shown cause for concern. The monthly safety report will be made public on the EMA website the following week, AstraZeneca said.
The AstraZeneca vaccine, developed in collaboration with the University of Oxford, has been cleared for use in the European Union and in many countries, but not yet by US regulators.
The company is preparing to file an emergency use authorization application in the United States and expects data from its US phase III trial to be available in the coming weeks. – Reuters
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