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UPDATE 6-Putin hails new Sputnik moment as Russia is first to approve a COVID-19 vaccine

Published 08/12/2020, 11:47 AM
Updated 08/12/2020, 11:50 AM

* Russia approves a vaccine before other countries
* Experts have raised safety concerns
* Putin says own daughter was vaccinated
* Says he hopes mass production will start soon
* Vaccine to be called "Sputnik V"

(Adds Azar quote, detail in pars 25, 26)
By Gabrielle Tétrault-Farber and Vladimir Soldatkin
MOSCOW, Aug 11 (Reuters) - President Vladimir Putin said on
Tuesday that Russia had become the first country to grant
regulatory approval to a COVID-19 vaccine after less than two
months of human testing, a move Moscow likened to its success in
the Cold War-era space race.
The vaccine, which will be called "Sputnik V" in homage to
the world's first satellite launched by the Soviet Union, has
however not yet completed its final trials.
Moscow's decision to grant approval before then has raised
concerns among some experts. Only about 10% of clinical trials
are successful and some scientists fear Moscow may be putting
national prestige before safety.
Putin and other officials have said it is completely safe.
The president said one of his daughters had taken it as a
volunteer and felt good afterwards.
"I know that it works quite effectively, forms strong
immunity, and I repeat, it has passed all the necessary checks,"
Putin told a government meeting.
The Russian business conglomerate Sistema has said it
expects to put the vaccine, developed by Moscow's Gamaleya
Institute, into mass production by the end of the year.
Government officials have said it will be administered to
medical personnel, and then to teachers, on a voluntary basis at
the end of this month or in early September. Mass roll-out in
Russia is expected to start in October.
The vaccine is administered in two doses and consists of two
serotypes of a human adenovirus, each carrying an S-antigen of
the new coronavirus, which enter human cells and produce an
immune response.
The platform used for the vaccine was developed by Russian
scientists over two decades and had formed the basis for several
vaccines in the past, including those against Ebola.
Authorities hope it will allow the Russian economy, which
has been battered by fallout from the virus, to return to full
capacity.
Kirill Dmitriev, head of Russia's sovereign wealth fund,
said Russia had already received foreign requests for 1 billion
doses. He said the vaccine was also expected to be produced in
Brazil.
Dmitriev said clinical trials were expected to start soon in
the United Arab Emirates and the Philippines. Philippine
President Rodrigo Duterte has said he is willing to participate
personally. III TRIAL
The approval by the health ministry comes before the start
of a larger trial involving thousands of participants, commonly
known as a Phase III trial.
Such trials, which require a certain proportion of
participants to catch the virus to observe the vaccine's effect,
are normally considered essential precursors for a vaccine to
receive regulatory approval.
The Moscow-based Association of Clinical Trials
Organizations (ACTO), a trade body representing the world's top
drugmakers in Russia, this week urged the ministry to postpone
approval until that final trial had been successfully completed.
In a letter to the ministry, it said there were high risks
associated with registering a drug before that happened.
"It is during this phase that the main evidence of a
vaccine's efficacy is collected, as well as information on
adverse reactions that could appear in certain groups of
patients: people with weakened immunity, people with concomitant
diseases and so forth," it said.
Some international experts have also questioned the speed at
which Russia approved its vaccine.
"Normally you need a large number of people to be tested
before you approve a vaccine," said Peter Kremsner from the
University Hospital in Tuebingen, Germany, currently testing
CureVac's COVID-19 vaccine in clinical trials.
"In that respect, I think it's reckless to do that (approve
it) if lots of people haven't already been tested."
Top U.S. infectious disease official Dr. Anthony Fauci said
he had not heard any evidence that the vaccine was ready for
widespread use.
"I hope that the Russians have actually definitively proven
that the vaccine is safe and effective. I seriously doubt that
they've done that," Fauci, who is a member of the White House
coronavirus task force, told National Geographic at an event to
air on Thursday.
U.S. Health Secretary Alex Azar, asked about Russia's
announcement, said safety was paramount and late-stage trials
were key. He said the United States was on track for an
effective vaccine by the end of the year, with six candidates
under development.
"The point is not to be first with a vaccine. The point is
to have a vaccine that is safe and effective," Azar said on ABC
News' "Good Morning America" programme.
Azar later told reporters in Taiwan he was confident the
United States would soon develop its own vaccine.
"We believe that it is highly credible that we will have in
the high tens of millions of doses of gold standard safe and
effective vaccine by the end of this year, and many hundreds of
millions of doses as we go into the beginning of next year."
More than 100 possible COVID-19 vaccines are being developed
around the world. At least four are in final Phase III human
trials, according to WHO data. <^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
Scientists ask: Without trial data, how can we trust Russia's
COVID vaccine? scramble for a vaccine will a coronavirus vaccine be ready?
The race for a coronavirus vaccine vaccine candidates with early human-trial data
ask: Without trial data, how can we trust Russia's
COVID vaccine?
^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^>
(Additonal reporting by Maxim Rodionov, Polina Ivanova and
Alexander Marrow in Moscow and by Caroline Copley in Berlin,
Josephine Mason and Kate Kelland in London, Susan Heavey and
Eric Beech in Washington; Writing by Gabrielle
Tétrault-Farber/Andrew Osborn; Editing by Giles Elgood, Tom
Brown and Kim Coghill)

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