MOSCOW, Aug 20 (Reuters) - Mass testing of Russia's first
potential COVID-19 vaccine to get domestic regulatory approval
will involve more than 40,000 people and will be overseen by a
foreign research body when it starts next week, backers of the
project said on Thursday.
These were the first details on the shape and size of the
upcoming late-stage trial of the vaccine given by its
developers, who are aiming to allay concerns among some
scientists about the lack of data provided by Russia so far.
The vaccine, called "Sputnik V" in homage to the world's
first satellite launched by the Soviet Union, has been hailed as
safe and effective by Russian authorities and scientists
following two months of small-scale human trials, the results of
which have not been made public yet.
But Western experts have been more sceptical, warning
against its use until all internationally approved testing and
regulatory steps have been seen to be taken and proved a
success.
"A range of countries is running an information war against
the Russian vaccine," Kirill Dmitriev, head of the Russian
Direct Investment Fund (RDIF) that is backing the vaccine, told
a briefing.
The vaccine data will be published in an academic journal
later this month, he said.
Russia has received requests for up to a billion doses of
the vaccine from around the world and has capacity to produce
500 million doses per year via manufacturing partnerships, he
said.
A director at Moscow's Gamaleya Institute, which developed
the vaccine, said 40,000 people would be involved in the mass
testing at more than 45 medical centres around Russia.
The data is being provided to the World Health Organization
(WHO), Dmitriev said, and to several countries that are
considering participating in the late-stage trial, including the
United Arab Emirates, India, Brazil, Saudi Arabia and the
Philippines.
Sputnik V has already received approval from domestic
regulators, leading President Vladimir Putin and other officials
to name Russia the first country to license a COVID-19 vaccine.
The registration took place, however, ahead of the start of
the large-scale trial, commonly known as a Phase III trial,
considered by many as a necessary precursor to registration. At
least four other potential COVID-19 vaccines are currently in
Phase III trials globally, according to WHO records.
TWO-SHOT INOCULATION
But Russia's early registration of the vaccine will permit
it to begin administering it to people in high-risk groups, such
as healthcare workers, alongside the late-stage trial, from
October, Dmitriev said.
He said the process would be conducted on a voluntary basis
and participants would have regular medical check-ups.
The trial itself will be supervised by a foreign clinical
research organisation, Dmitriev said, ensuring the data
collection is fully in line with international standards. He did
not give details of the research organisation.
The Sputnik V vaccine will involve a two-shot jab, using two
different vectors of the human adenovirus. As this vector had a
significant track record of use in previous vaccines, it had
more historic data supporting its safety than some other
potential COVID-19 vaccines, Dmitriev said.
This has been echoed by researchers outside Russia. Ian
Jones, a virologist at Britain's Reading University, said of the
Russian vaccine: "I think there is enough general background
data on recombinant adenovirus-based vaccines to assume the
vaccine itself will be safe at the usual doses."
Russian researchers have said that early trials showed the
vaccine eliciting a significant immune response, but how long
protection would last remains unclear.
"Each person may react differently," the head specialist in
infectious diseases at the Russian Health Ministry, Vladimir
Chulanov, was cited as saying in an interview by Gazeta.Ru on
Thursday.
"Some may develop very strong protective immunity, while
others may not. In such cases, (coronavirus) infection may be
possible, but the illness should, theoretically, have light
symptoms. And in general the share of such people will be very
small."
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