The safety scare is the latest challenge for AstraZeneca and
its ambition to produce a "vaccine for the world", as the global
death toll from the coronavirus passes 2.8 million.
The European Medicines Agency's (EMA) "clear"
conclusion following an investigation into 30 cases of unusual blood disorders
was that the vaccine's benefits in protecting people from coronavirus-related
death or hospitalisation outweighs the possible risks, though a link between
blood clots in the brain and the shot could not be definitively ruled out.
The agency's review covered 20 million people given the
AstraZeneca shot in the UK and the European Economic Area (EEA), which links 30
European countries.
Safety concerns led at least 13 European countries,
including France, Germany and Italy, to stop administering the shot, slowing an
already faltering inoculation campaign in the EU, which lags Britain and the
United States.
Britain's Medicines and Healthcare products Regulatory
Agency (MHRA) said earlier that it was investigating five cases of the rare
brain blood clot that had been reported out of 11 million shots administered in
the UK.
It said it would investigate reports of clots in the
cerebral veins (sinus vein thrombosis, or CSVT) occurring together with lowered
platelets soon after vaccination. But the agency said use of the vaccine should
continue and one official said Britain's rollout would likely continue even if
a link was proved.
The AstraZeneca shot was among the first and cheapest of the
COVID-19 vaccines to be developed and launched at volume and is set to be the
mainstay of vaccination programmes in much of the developing world.
The drugmaker's own review covering more than 17 million
people who have received its shot in the EU and Britain found no evidence of an
increased risk of blood clots.
The World Health Organization has also this week reaffirmed
its support for the shot.
"This is a safe and effective vaccine", however
the agency will give guidance to patients and healthcare professionals about
issues to look out for, said EMA director Emer Cooke.
"If it were me, I would be vaccinated tomorrow,"
Cooke said.
EMA said it is in touch with regulators around the world to
keep tabs on possible side effects of all COVID-19 vaccines.
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