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March 14 (Reuters) - AstraZeneca Plc said on Sunday
a review of safety data of people vaccinated with its COVID-19
vaccine has shown no evidence of an increased risk of blood
clots.
AstraZeneca's review, which covered more than 17 million
people vaccinated in the United Kingdom and European Union,
comes after health authorities in some countries suspended the
use of its vaccine over clotting issues.
"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.
Authorities in Ireland, Denmark, Norway and Iceland 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.
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.
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 U.S. regulators.
The company is preparing to file for U.S. emergency use
authorisation and is expecting data from its U.S. Phase III
trial to be available in the coming weeks.
(Reporting by Radhika Anilkumar and Aakriti Bhalla in
Bengaluru, Editing by Jane Merriman)
