BFF-51 EU regulator ‘scrutinising’ AstraZeneca jab’s safety

379

ZCZC

BFF-51

HEALTH-VIRUS-EU-VACCINE

EU regulator ‘scrutinising’ AstraZeneca jab’s safety

BRUSSELS, March 15, 2021 (BSS/AFP) – The EU’s medicines regulator is
closely reviewing how safe AstraZeneca’s Covid-19 vaccine is, after reports
of blood-clot deaths led several countries to suspended its use, an official
said Monday.

“We’re scrutinising all the data, particularly the fatal cases that have
been reported,” the head of the European Medicines Agency’s health threats
and vaccines strategy, Marco Cavaleri, told the European Parliament’s health
committee.

Cavaleri was speaking after Germany announced it was suspending the use of
the AstraZeneca vaccine, and just before France and Italy followed suit.

But, while the data is under review, Cavaleri said that the EMA so far
does “not see any problem in continuing with the vaccination campaign using
this vaccine.”

The agency is trying “to understand if there are any specific cluster of
cases around the certain type of pathologies or background stages, medical
stages of the subjects, in order to refine the benefit-risk options.”

The comments came on the same day the EU’s biggest member states joined
other countries, including Norway, Denmark and Thailand, in suspending use of
the AstraZeneca vaccine.

The individual capitals’ decisions were described as “precautionary”,
pending further analysis on whether there was any causal link between the jab
and the deaths and other reported side-effects in people following
injections.

The EMA on January 29 authorised the AstraZeneca vaccine for use against
Covid-19 for all adults, though some EU countries hesitated before allowing
it to be injected in elderly people because of a lack of data on them in
clinical studies.

The vaccine has been massively used in former EU member Britain since
December, starting with the older population.

British officials and AstraZeneca, which is headquartered in Britain, have
said there is no evidence that the vaccine is unsafe.

Cavaleri told the MEPs that “we are receiving the data from the UK” to
weigh the safety of the vaccine and “we are going through a rapid review of
all the evidence around thromboembolic events with this vaccine.”

Initial evidence was not showing an “emerging risk” he said, adding that
“the benefit-risk of the AstraZeneca vaccine is considered positive” —
meaning any adverse side-effects were outweighed by its usefulness in
combating Covid-19. French President Emmanuel Macron said his country’s
officials were hoping to resume AstraZeneca vaccinations “quickly if the
judgement of the EMA allows it”.

BSS/AFP/FI/2250 hrs