4 yıl önce

AstraZeneca data review finds no increased blood clot risk from vaccine

AstraZeneca says it has found no evidence indicating its vaccine caused sporadic blood clots after reviewing safety data of more than 17 million people vaccinated in UK and EU.

AFP

European Medicines Agency says there is no indication blood clot events were caused by AstraZeneca vaccination, a view echoed by World Health Organisation.

AstraZeneca Plc has said a review of safety data of people vaccinated with its Covid-19 vaccine showed no evidence of an increased risk of blood clots.

"A careful review of all available safety data of more than 17 million people vaccinated in the European Union and UK with Covid-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia, in any defined age group, gender, batch or in any particular country," the company said on Sunday.

AstraZeneca's review comes after health authorities in some countries suspended the use of its vaccine over clotting issues.

Risks of 'real harm'

Authorities in Ireland, Denmark, Norway, Iceland and the Netherlands have suspended the use of the vaccine over clotting issues, while Austria stopped using a batch of AstraZeneca shots last week while investigating a death from coagulation disorders.

"It is most regrettable that countries have stopped vaccination on such 'precautionary' grounds: it risks doing real harm to the goal of vaccinating enough people to slow the spread of the virus, and to end the pandemic," Peter English, a retired British government consultant in communicable disease control, told Reuters news agency.

No indication of a cause

European Medicines Agency has said there is no indication that the events were caused by the vaccination, a view that was echoed by the World Health Organisation 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 across other licensed Covid-19 vaccines.

Preparing for US emergency use approval

The company said additional testing has and is being conducted by the company and the European health authorities and none of the re-tests have shown cause for concern.

The monthly safety report will be made public on the EMA website in the following week, AstraZeneca said.

The AstraZeneca vaccine, developed in collaboration with Oxford University, has been authorised for use in the European Union and many countries but not yet by US regulators.

The company is preparing to file for US emergency use authorisation and is expecting data from its US Phase III trial to be available in the coming weeks.

SOURCE: Reuters