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PARIS, March 19 (Reuters) - France's medical regulator
approved the resumed use of AstraZeneca's COVID-19
vaccine on Friday, but said it should be given only to people
aged 55 and older.
The restriction breaks with the European watchdog's guidance
that the shot is safe for all age groups, and comes just weeks
after Paris initially said the Anglo-Swedish vaccine should be
used only on people under 65.
The European Medicines Agency said on Thursday it was
convinced the benefits of the AstraZeneca vaccine outweighed the
risks after reports of rare instances of blood clotting.
The recommendation from the National Authority for Health
(HAS) reflected signs that the clotting affected younger people
mostly, whose risk of dying from COVID-19 was lower than the
elderly.
"Given the data provided by the EMA, it is the HAS's belief
that vaccination with the AstraZeneca vaccine can resume
immediately," the French regulator said in a statement.
"However, the EMA has identified a possible increased risk
of (thrombosis) in people under 55 years old. The HAS recommends
using the AstraZeneca vaccine at this stage only for people aged
55 and over, who represent the majority of priority people."
An EMA review covering 20 million people in the UK and the
European Economic Area, which links 30 European countries,
included seven cases of blood clots in multiple blood vessels
and 18 cases of a rare condition that is difficult to treat
called cerebral venous sinus thrombosis (CVST).
France was one of more than a dozen European Union states
that suspended use of the Anglo-Swedish vaccine this week.
The HAS said it would review its opinion soon as new data
came in. Guidance would also be given soon to those under 55 who
have already received a first dose of AstraZeneca, it added.
The new restrictions add yet another complication to
France's troubled vaccination rollout, which has been beset by
onerous red tape, supply difficulties and a high level of public
mistrust.
France has so far delivered 5.7 million first doses -
roughly 8% of the population - compared with more than 25
million in Britain and more than 100 million in the United
States.
When France first approved use of the AstraZeneca shot in
early February, it said it should be only for under 65s, with
President Emmanuel Macron calling it "quasi-ineffective" for
anyone beyond their mid-60s.
France only removed that restriction this month.
(Reporting by Benoit Van Overstraeten; Writing by Richard
Lough; Editing by John Stonestreet, Alex Richardson and Nick
Macfie)