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(Adds comments by WHO regulatory director, background)
GENEVA, April 6 (Reuters) - The World Health Organization
expects there will be no reason to change its assessment that
the benefits of the AstraZeneca vaccine against COVID-19
outweigh any risks, its regulatory director said on Tuesday.
The WHO is closely studying the latest data alongside
European and other regulators, in light of reports of blood
clots among people who have been vaccinated, said Rogerio
Gaspar, WHO director of regulation and prequalification.
A senior official at Europe's medicines regulator has said
there is a clear "association" between AstraZeneca's COVID-19
vaccine and very rare blood clots in the brain, though the
direct cause of the clots is still unknown.
The European Medical Agency (EMA) said in a statement after
the comments by Marco Cavaleri, chair of its vaccine evaluation
team, that it was still conducting a review of the vaccine and
expected to announce its findings on Wednesday or Thursday.
Gaspar said the WHO expects to reach a fresh assessment on
Wednesday or Thursday, after its own vaccine safety advisory
group meets, but does not believe there will be a reason to
change its advice that the benefits outweigh any risks.
"What we can say is that the appraisal that we have for the
moment - and this is under consideration by the experts - is
that the benefits-risk assessment for the vaccine is still
largely positive," he told a Geneva news conference.
"We continue to see a number of events that are rare events
linking thrombocytopenia to thromboembolic events and those rare
events are now being categorised in terms of the diagnostics, in
terms of the population, in terms of the distribution within the
population," he said.
WHO was in touch with various national and regional expert
committees that will decide on the vaccine's regulatory status,
Gaspar said.
"For the time being there is no evidence that the
benefit-risk assessment for the vaccine needs to be changed," he
added.
(Reporting by John Miller and Stephanie Nebehay in Geneva
Writing by Peter Graff
Editing by Kevin Liffey and Matthew Lewis)
