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April 23 (Reuters) - Europe's drug regulator reiterated on
Friday the benefits of AstraZeneca's COVID-19 vaccine
outweigh any risks, delivering an assessment based on continuing
reviews into rare blood clots to help countries determine the
shot's use.
The renewed backing comes after several countries in the
European Union and worldwide have limited the use of the
vaccine, known as Vaxzevria. Denmark has stopped its use
altogether, after possible links to clotting issues in
combination with low platelet levels were confirmed.
The interim analysis by a committee of the European
Medicines Agency (EMA) determined that serious side effects of
rare blood clots are likely to occur in 1 out of 100,000
vaccinated people, the regulator said in a statement.
EMA officials said in a briefing the update on Friday was
aimed at putting into context the data it has collected and
analysed to help 27 EU member states work out how to use the
shot based on their local situations.
The advantages of getting the vaccine increase with age and
with any rise in infections rates, but the benefits were for now
evident across all scenarios and ages, the officials said.
They said the recommendation may be subject to change
because more data is being collected, and for instance not all
EU member states had included the sex of the vaccine recipients
in their data.
But Peter Arlett, head of EMA's data analytics and methods
task force, said: "The benefit risk balance of the AstraZeneca
vaccine is positive. It's preventing serious disease and saving
lives."
Earlier this month, the EMA said it had found a possible
link between AstraZeneca's coronavirus vaccine and a similar,
rare blood clotting problem connected to the one from Johnson &
Johnson which led to a small number of deaths.
There was not enough data on Vaxzevria from Europe to
determine if blood clot risks with low blood platelets would
differ with each dose of the vaccine, or to provide context on
its benefits and risks with regards to gender, the EMA said.
Countries are also in the midst of determining whether to
use J&J's vaccine over concerns about blood clots and U.S.
regulators were meeting on Friday to consider whether it is safe
to resume J&J injections.
Regulators have found these events occurred mostly in the
brain and abdomen.
(Reporting by Pushkala Aripaka in Bengaluru, Ludwig Burger in
Frankfurt, Alistair Smout and Keith Weir in London; Writing by
Josephine Mason; Editing by Saumyadeb Chakrabarty and Sriraj
Kalluvila, William Maclean)
