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* Russia has licensed potential coronavirus vaccine
* The Lancet has published results of early-stage trials
* Russian wealth fund chief says results answer critics
(Adds comments by Dmitriev, expert, institute director)
By Polina Ivanova and Andrew Osborn
MOSCOW, Sept 4 (Reuters) - Russia's "Sputnik-V" COVID-19
vaccine produced an antibody response in all participants in
early-stage trials, according to results published on Friday by
The Lancet medical journal that were hailed by Moscow as an
answer to its critics.
The results of the two trials, conducted in June-July this
year and involving 76 participants, showed 100% of participants
developing antibodies to the new coronavirus and no serious side
effects, The Lancet said.
Russia licensed the two-shot jab for domestic use in August,
the first country to do so and before any data had been
published or a large-scale trial begun.
"The two 42-day trials – including 38 healthy adults each –
did not find any serious adverse effects among participants, and
confirmed that the vaccine candidates elicit an antibody
response," The Lancet said.
"Large, long-term trials including a placebo comparison, and
further monitoring are needed to establish the long-term safety
and effectiveness of the vaccine for preventing COVID-19
infection," it said.
The vaccine is named Sputnik-V in homage to the world's
first satellite, launched by the Soviet Union. Some Western
experts have warned against its use until all internationally
approved testing and regulatory steps have been taken.
But with the results now published for the first time in an
international peer-reviewed journal, and with a 40,000-strong
later-stage trial launched last week, a senior Russian official
said Moscow had faced down its critics abroad.
"With this (publication) we answer all of the questions of
the West that were diligently asked over the past three weeks,
frankly with the clear goal of tarnishing the Russian vaccine,"
said Kirill Dmitriev, the head of the Russian Direct Investment
Fund (RDIF), Russia's sovereign wealth fund, which has backed
the vaccine.
"All of the boxes are checked," he told Reuters. "Now... we
will start asking questions of some of the Western vaccines."
Commenting on the results of the early-stage trials, lead
author Dr Naor Bar-Zeev of the International Vaccine Access
Center, Johns Hopkins Bloomberg School of Public Health, USA
said the studies were "encouraging but small".
Bar-Zeev, who was not involved in the study, said "clinical
efficacy for any COVID-19 vaccine has not yet been shown."
"The report is a case of 'so far, so good'," Brendan Wren,
Professor of Microbial Pathogenesis at London's School of
Hygiene and Tropical Medicine said.
RACE TO DEVELOP VACCINE
Dmitriev said at least 3,000 people had already been
recruited for the large-scale trial of the Sputnik-V vaccine
launched last week, and initial results were expected in October
or November this year.
Health minister Mikhail Murashko has said Russia will start
mass inoculation from November or December, with a focus on
high-risk groups. It will take nine to 12 months to vaccinate
the majority of the population, said Alexander Gintsburg,
director of the Gamaleya Institute which developed the vaccine.
Governments and big pharmaceutical firms are racing to
develop a vaccine to end the COVID-19 pandemic, which has killed
more than 850,000 people globally and infected around 26
million.
Over half a dozen drugmakers are already conducting advanced
clinical trials, each with tens of thousands of participants.
Several, including Britain’s AstraZeneca and U.S.
drugmakers Moderna and Pfizer expect to know if
their COVID-19 vaccines work and are safe by the end of 2020.
The Lancet said the early-stage trials suggested the
Sputnik-V vaccine produced a response in a component of the
immune system known as T cells.
Scientists have been scrutinising the role played by T cells
in battling coronavirus infection, with recent findings showing
these cells may provide longer-term protection than antibodies.
The Sputnik-V vaccine is administered in two doses, with
each based on a different vector that normally causes the common
cold: human adenoviruses Ad5 and Ad26.
Some experts have said using this delivery mechanism could
make a COVID-19 vaccine less effective, as many people have
already been exposed to the Ad5 adenovirus and developed
immunity to it.
Russia has said it expects to produce between 1.5 million
and 2 million doses per month of its potential vaccine by the
end of the year, gradually increasing production to 6 million
doses a month.
(Reporting by Andrew Osborn and Polina Ivanova; Writing by
Polina Ivanova, Editing by Timothy Heritage)
