AstraZeneca finds no evidence of increased blood clot risk from vaccine
AstraZeneca's review
covered more than 17 million people vaccinated in the United Kingdom
and European Union.
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
the 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, 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.
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 has 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.
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