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* Tensions with Hungary's Orban rising before EU summit
* Hungary to be first EU country to import, trial Sputnik V
* EU: Move raises concerns for safety, confidence in vaccine
(Adds first imports, comment from Hungarian foreign minister)
By Francesco Guarascio
BRUSSELS, Nov 19 (Reuters) - Hungary's plans to import and
possibly use Russia's touted Sputnik V COVID-19 vaccine raise
safety concerns and could damage trust in potential shots, the
European Commission said, opening a new front in the EU's
fraught relations with Budapest.
Hungarian Prime Minister Viktor Orban's hard line against
migration and what critics say is his increasingly authoritarian
grip on power - an accusation he has repeatedly denied - as well
as his pursuit of close relations with Russia have caused
repeated clashes with the European Union.
A new showdown is expected on Thursday when EU leaders hold
a video conference that may address the bloc's massive COVID
rescue plan and seven-year budget, which Hungary and Poland's
nationalist governments are blocking because they make access to
money conditional on respecting the rule of law.
Hungarian plans to conduct trials of and possibly produce
the Russian vaccine, an unprecedented step for an EU member
state, add to existing frictions with Brussels.
Asked about these plans, a spokesman for the Commission, the
EU's executive, said: "The question arises whether a member
state would want to administer to its citizens a vaccine that
has not been reviewed by EMA."
Under EU rules, Sputnik V must be authorised by the European
Medicines Agency before it can be marketed in any state of the
27-nation bloc, EMA said.
"This is where the authorisation process and vaccine
confidence meet. If our citizens start questioning the safety of
a vaccine, should it not have gone through rigorous scientific
assessment to prove its safety and efficacy, it will be much
harder to vaccinate a sufficient proportion of the population,"
the Commission spokesman added in an emailed statement.
A recent study of 8,000 people in the United States and
Britain found that fewer people would "definitely" take a
COVID-19 vaccine than the 55% of the population which scientists
estimate is needed to provide so-called herd immunity
.
Experts have said that misinformation and perceived weak
safety checks on candidate vaccines play a central role in
reducing confidence in their efficacy.
Hungary on Thursday imported the first doses of Sputnik V as
part of a plan that could lead to larger imports and domestic,
mass production next year if the shot proves safe and effective.
"Hungarian experts will have the opportunity to study the
vaccine in the forthcoming period and make a well-founded
decision on potential usability and approval," Foreign Minister
Peter Szijjarto said in a Facebook video.
The government did not respond to questions on whether it
wanted to licence the Sputnik V vaccine at home or through the
required EU process.
Russia's sovereign wealth fund said last week that interim
trial results showed Sputnik V is 92% effective at protecting
people from the COVID-19 respiratory disease, and the country is
preparing for mass inoculations.
Vaccines being developed by U.S. firms Moderna and
Pfizer - the latter in cooperation with Germany's
BioNTech - have showed slightly better
results on a much larger sample of people exposed to the virus.
"Vaccines should be out of politics and countries should
have a choice how to protect their citizens," said Kirill
Dmitriev, head of the Russian sovereign wealth fund which has
underwritten the development of Sputnik V.
He added that Russia was ready to share data with the
European Medicines Agency and said it aimed to produce the
vaccine in Hungary and in other willing EU nations. A subsidiary
of the wealth fund also requested scientific advice from EMA in
late October but has received no reply so far, the fund said.
EMA said that it had received no data from Russia or Hungary
on Sputnik V or any other COVID-19 vaccine.
Sputnik V is expected to be trialled and produced in other
countries across the world beyond Russia, with Brazil, Mexico,
the Philippines and the United Arab Emirates among those who
have expressed an interest in the shot.
IMPORT DOUBTS
But the EU questions even the import of Sputnik V by one of
its member states.
Temporary import and distribution of unauthorised vaccines
is allowed for emergency use in the EU "in response to the
suspected or confirmed spread of pathogenic agents, toxins,
chemical agents or nuclear radiation, any of which could cause
harm," the relevant EU law reads.
This rare exemption has been subjected to scrutiny in recent
months by EU experts, the Commission said. "The widely supported
view is that it should be considered very carefully," its
spokesman said. Such emergency procedures, he added, would also
conflict with the EU's current vaccine strategy.
Under that strategy, the EU has signed contracts with five
vaccine makers, including Pfizer, for the supply of nearly 2
billion doses of their potential COVID vaccines and is talking
with at least two other manufacturers for additional shots.
That would cover the 450 million combined population of all
EU states, including Hungary, which under those deals also
ordered millions of doses of the Pfizer, AstraZeneca and
Johnson & Johnson vaccines now in development.
(Reporting by Francesco Guarascio @fraguarascio in Brussels
with additional reporting by Marton Dunai in Budapest and Polina
Nikolskaya in Moscow
Editing by Mark Heinrich)
