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* Third vaccine over 90% effective in Phase III trial
* Sputnik V equally effective for over 60s
* Vaccine rolled out in Russia ahead of trial results
(Adds comment on storage temperature and variants)
By Polina Ivanova
MOSCOW, Feb 2 (Reuters) - Scientists gave Russia's Sputnik V
vaccine the green light on Tuesday saying it was almost 92%
effective in fighting COVID-19 based on peer-reviewed late-stage
trial results published in The Lancet international medical
journal.
Experts said the Phase III trial results meant the world had
another effective weapon to fight the deadly pandemic and
justified to some extent Moscow's decision to roll out the
vaccine before final data had been released.
The results, collated by the Gamaleya Institute in Moscow
that developed and tested the vaccine, were in line with
efficacy data reported at earlier stages of the trial, which has
been running in Moscow since September.
"The development of the Sputnik V vaccine has been
criticised for unseemly haste, corner cutting, and an absence of
transparency," said Ian Jones, professor at the University of
Reading, and Polly Roy, professor at the London School of
Hygiene & Tropical Medicine.
"But the outcome reported here is clear and the scientific
principle of vaccination is demonstrated," the scientists, who
were not involved in the study, said in a comment shared by The
Lancet. "Another vaccine can now join the fight to reduce the
incidence of COVID-19."
The results were based on data from 19,866 volunteers, of
whom a quarter received a placebo, the researchers, led by the
Gamaleya Institute's Denis Logunov, said in The Lancet.
Since the trial began in Moscow, there were 16 recorded
cases of symptomatic COVID-19 among people who received the
vaccine, and 62 among the placebo group, the scientists said.
This showed that a two-dose regimen of the vaccine - two
shots based on two different viral vectors, administered 21 days
apart - was 91.6% effective against symptomatic COVID-19.
'RUSSIA WAS RIGHT'
The Sputnik V vaccine is the fourth worldwide to have Phase
III results published in leading peer-reviewed medical journals
following the shots developed by Pfizer and BioNTech
, Moderna and AstraZeneca.
Pfizer's shot had the highest efficacy rate at 95%, closely
followed by Moderna's vaccine and Sputnik V while AstraZeneca's
vaccine had an average efficacy of 70%.
Sputnik V has also now been approved for storage in normal
fridges, as opposed to freezers, making transportation and
distribution easier, Gamaleya scientists said on Tuesday.
Russia approved the vaccine in August, before the
large-scale trial had begun, saying it was the first country to
do so for a COVID-19 shot. It named it Sputnik V, in homage to
the world's first satellite, launched by the Soviet Union.
Small numbers of frontline health workers began receiving it
soon after and a large-scale roll out started in December,
though access was limited to those in specific professions, such
as teachers, medical workers and journalists.
In January, the vaccine was offered to all Russians.
"Russia was right all along," Kirill Dmitriev, head of the
Russian Direct Investment Fund (RDIF), which is responsible for
marketing the vaccine abroad, told reporters on Tuesday.
He said the results supported Russia's decision to begin
administering Sputnik V to frontline workers while the trial was
still underway, and suggested scepticism of such moves was
politically motivated.
"The Lancet did very unbiased work despite some of the
political pressures that may have been out there," he said.
EFFECTIVE IN ELDERLY
The number of people vaccinated in Russia has remained low
so far. Authorities have pointed to some early issues with
scaling up production while polls have shown low demand among
Russians for the vaccine.
Russia has already shared data from its Phase III trial with
regulators in several countries and has begun the process of
submitting it to the European Medicines Agency (EMA) for
approval in the European Union, Dmitriev said.
The data release comes as Europe scrambles to secure enough
shots for its 450 million citizens due to production cuts by
AstraZeneca and Pfizer. The U.S. roll-out, meanwhile, has been
hampered by the need to store shots in ultra-cold freezers and
uneven planning across states.
There were 2,144 volunteers over 60 in the Sputnik V trial
and the shot was shown to be 91.8% effective when tested on this
older group, with no serious side-effects reported that could be
associated with the vaccine, The Lancet summary said.
RDIF's Dimitriev also said the Gamaleya Institute was
testing the vaccine against new variants of COVID-19 and the
early signs were positive.
The vaccine was also found to be 100% effective against
moderate or severe COVID-19, as there were no such cases among
the group of 78 participants who were infected and symptomatic
at 21 days after the first shot was administered.
Four deaths of participants occurred, but none was
considered associated with vaccination, The Lancet said.
"The efficacy looks good, including in the over 60s," said
Danny Altmann, a professor of immunology at Imperial College
London. "It's good to have another addition to the global
arsenal."
ONE DOSE VERSION
The authors of the study noted that because COVID-19 cases
were only detected when trial participants reported symptoms,
further research was needed to understand Sputnik V's efficacy
on asymptomatic cases and transmission.
Sputnik V has been approved by 15 countries, including
Argentina, Hungary and the United Arab Emirates and this will
rise to 25 by the end of next week, the RDIF's Dmitriev said.
The sovereign wealth fund also said vaccinations using
Sputnik V will begin in a dozen countries including Bolivia, the
United Arab Emirates, Venezuela and Iran.
Hungary was the first member of the European Union to break
ranks and unilaterally approve the vaccine last month. It is set
to receive a first batch of 40,000 doses on Tuesday.
Germany has said it would use Sputnik V if it is approved by
Europe's drug regulator while France has said it could buy any
efficient vaccine.
However, large shipments of the shot have only been sent so
far to Argentina, which has received enough doses to vaccinate
about 500,000 people. Production for export will primarily be
done by RDIF's manufacturing partners abroad, the fund has said.
On Tuesday, Dmitriev said production had started in India
and South Korea, and would launch in China this month. Trial
doses have also been produced by a manufacturer in Brazil.
Russia is conducting a small-scale clinical trial of a
one-dose version of the vaccine, which developers expect to have
an efficacy rate of 73% to 85%.
(Additional reporting by Kate Kelland in London; Writing by
Polina Ivanova; Editing by Mark Potter and David Clarke)
