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 The initial results are only the second to be published from a
late-stage human trial in the global effort to produce vaccines that
could halt a pandemic that has killed more than 1.2 million people
and ravaged the world economy.
The results are based on data from the first 16,000 trial
participants to receive both shots of the two-dose vaccine, the
Russian Direct Investment Fund (RDIF), which has been backing its
development and marketing it globally, said.
"We are showing, based on the data, that we have a very effective
vaccine," said RDIF head Kirill Dmitriev, adding that it was the
sort of news that the vaccine's developers would talk about one day
with their grandchildren.
The analysis was conducted after 20 participants in the trial
developed COVID-19 and examined how many had received the vaccine
versus a placebo.
That is significantly lower than the 94 infections in the trial of a
vaccine being developed by Pfizer Inc <PFE.N> and BioNTech <BNTX.O>.
To confirm the efficacy rate, Pfizer said it would continue its
trial until there were 164 COVID-19 cases.
RDIF said the Russian trial would continue for six more months and
data from the study will also be published in a leading
international medical journal following a peer review.
European stocks and U.S. stock futures extended their gains slightly
after Russia's announcement.
ANOTHER BOOST
Russia's announcement follows swiftly on from results posted on
Monday by Pfizer and BioNTech, which said their shot was also more
than 90% effective.
The Russian results are another boost to other COVID-19 vaccines
currently in development and are a proof of concept that the disease
can be halted with vaccination.
Experts said knowledge about the trial's design and protocol was
sparse, making it difficult to interpret the figures released on
Wednesday.
Scientists have raised concerns about the speed at which Moscow has
worked, giving regulatory go ahead for the shot and launching a mass
vaccination programme before full trials to test its safety and
efficacy had been completed.
Russia registered its COVID-19 vaccine for public use in August, the
first country to do so, though the approval came before the start of
the large-scale trial in September.
The so-called Phase III trial of the shot developed by the Gamaleya
Institute is taking place in 29 clinics across Moscow and will
involve 40,000 volunteers in total, with a quarter receiving a
placebo shot.
The chances of contracting COVID-19 were 92% lower among people
vaccinated with Sputnik V than those who received the placebo, the
RDIF said.
That's well above the 50% effectiveness threshold for COVID-19
vaccines set by the U.S. Food and Drug Administration.
"I can see no a priori reason to disbelieve these results, but it's
so very hard to comment, because there is so little data there,"
said Danny Altmann, a professor of Immunology at Imperial College
London.
He said that while the Russian release was similar in its level of
detail to the one from Pfizer and BioNTech, the key difference was
that Pfizer's release came against a backdrop of a wealth of
published data on how the trial was designed, its protocol, and what
its endpoints were.
The results of the early-stage trials were peer reviewed and
published in September in The Lancet medical journal.
SPUTNIK V
The Russian drug is named Sputnik V after the Soviet-era satellite
that triggered the space race, a nod to the project's geopolitical
importance for Russian President Vladimir Putin.
The vaccine is designed to trigger a response from two shots
administered 21 days apart, each based on different viral vectors
that normally cause the common cold: human adenoviruses Ad5 and
Ad26.
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The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology and is
designed to trigger an immune response without using pathogens, such as actual
virus particles.
Russia is also testing a different vaccine, produced by the Vector Institute in
Siberia, and is on the cusp of registering a third, Putin said on Tuesday,
adding that all of the country's vaccines were effective.
RDIF said as of Nov. 11 no serious side effects had been reported during the
Sputnik V Phase III trial.
Some volunteers had short-term minor adverse events such as pain at the
injection site, flu-like syndrome including fever, weakness, fatigue, and
headache, it said.
MASS VACCINATIONS
Successful vaccines are seen as a crucial to restoring daily life around the
world by helping end the health crisis that shuttered businesses and put
millions out of work.
Russia registered the vaccine for domestic use in August, and has also
inoculated 10,000 people considered at high risk of COVID-19 outside of the
trial
Putin has said that Russia expects to start mass vaccinations by the end of the
year.
"The publication of the interim results of the post-registration clinical trials
that convincingly demonstrate Sputnik V vaccine’s efficacy gives way to mass
vaccination in Russia against COVID-19 in the coming weeks," Alexander Gintsburg,
director of the Gamaleya Institute, said.
Moscow is rolling out a large network of vaccination rooms and residents who
want the shot may be able to get it as early as next month if large volumes of
doses are supplied by then, Deputy Mayor Anastasia Rakova said on Oct. 30.
However, production challenges remain. Earlier estimates that Russia could
produce 30 million doses of the vaccine this year have since been scaled down.
Moscow aims to produce 800,000 doses this month, industry minister Denis
Manturov has said, followed by 1.5 million in December. But significantly higher
volumes of output per month are expected from early 2021.
Manturov cited issues with scaling up production from small to large-volume
bioreactors, while Putin last month cited issues with the availability of
equipment.
In late October, the vaccination of new volunteers was temporarily paused due to
high demand and a shortage of doses.
Officials have said that domestic production of the vaccine will be used first
to meet Russia's needs.
RDIF, however, has also struck several international supply deals, amounting to
270 million doses in total.
It is expected that these will in large part be produced in other countries and
RDIF has previously announced a deal to manufacture 300 million doses in India
and an undisclosed amount of doses in Brazil, China and South Korea.
Trials have also begun in Belarus, and are on track to begin soon in the United
Arab Emirates, Venezuela and India.
Russia reported 19,851 new coronavirus infections in the past 24 hours and a
record high of 432 deaths. At 1,836,960, its overall case tally is the fifth
largest in the world, behind the United States, India, Brazil and France.
(Reporting by Polina Ivanova; Additional reporting by Kate Kelland, Ludwig
Burger and Josephine Mason and Thyagaraju Adinarayan; Editing by David Clarke)
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