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By Polina Ivanova
MOSCOW, Feb 2 (Reuters) - Russia's Sputnik V vaccine was
91.6% effective in preventing people from developing COVID-19,
according to peer-reviewed results from its late-stage clinical
trial published in The Lancent international medical journal on
Tuesday.
Scientists 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," Professor Ian Jones of the University of Reading
and Professor Polly Roy, of the London School of Hygiene &
Tropical Medicine, said in a comment shared by The Lancet.
"But the outcome reported here is clear and the scientific
principle of vaccination is demonstrated," said the scientists,
who were not involved in the study. "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 in Moscow began, 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 adenovirus vectors, administered 21
days apart - was 91.6% effective against symptomatic COVID-19.
'RUSSIA WAS RIGHT'
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 ahead of the
publication of the results on Tuesday.
He said they 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.
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 while the U.S. roll-out
has been hampered by the need to store shots in ultra-cold
freezers and uneven planning across states.
EFFECTIVE FOR ELDERLY
There were 2,144 volunteers over 60 in the 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 Sputnik V, The Lancet summary said.
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."
The authors of the study noted that because COVID-19 cases
were only detected when participants reported symptoms, further
research is 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
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 Hungary,
Bolivia, the United Arab Emirates, Venezuela and Iran.
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, and Bolivia, which received 20,000 shots.
Production for export will primarily be conducted by RDIF's
manufacturing partners abroad, the fund has said.
On Tuesday, Dmitriev said that production had begun 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 also 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)
