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 The first human trial of the vaccine, a month-long test on 38
people, ended this week. Researchers concluded that it is safe for
use and induces an immune response, though the strength of that
response is as yet unclear.
A larger Phase III trial involving several thousand people is
expected to begin in August, said Russian Direct Investment Fund (RDIF)
head Kirill Dmitriev.
"We believe that based on the current results it will be approved in
Russia in August and in some other countries in September..., making
it possibly the first vaccine to be approved in the world," he said
in an interview.
More than 100 possible vaccines are being developed to try to stop
the pandemic. At least two are in final Phase III human trials,
according to World Health Organization data - one being developed by
China's Sinopharm and the other by AstraZeneca and the University of
Oxford.
Producers are also grappling with the question of how to massively
scale up production to meet global needs.
HERD IMMUNITY
Dmitriev said the Russian Phase III trial will be conducted at home
and in two Middle Eastern countries, and will begin after a
100-person Phase II trial wraps up on Aug. 3.
Russia was in talks with Saudi Arabia on being a trial site as well
as a manufacturing partner, he told a separate news conference.
Moscow's Gamaleya Institute, which developed the Russian candidate
vaccine, is producing doses for clinical trials, while private
pharmaceutical firms Alium - part of the Sistema conglomerate- R-Pharm
and are handling bottling.
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Both are updating their lab setup to be able to take over production
within the next couple of months, Dmitriev said.
"There's a general sense that for so-called herd immunity in Russia
you need to vaccinate between 40 million and 50 million people," he
told Reuters.
"So we believe we will be in good shape producing around 30 million (doses
domestically) this year and then we can finalise vaccination next year."
Russia had also struck manufacturing deals with five other countries and could
be producing up to 170 million doses abroad this year, Dmitriev said.
He declined to say where or give any details on pricing, but said countries in
Latin America, the Middle East and elsewhere had expressed interest in importing
the vaccine.
Russia has also reached a deal with drugmaker AstraZeneca on its potential
COVID-19 vaccine, called AZD1222. "We expect one of our portfolio companies to
also be working ...on producing the AstraZeneca vaccine in Russia," Dmitriev
said.
(Writing by Polina Ivanova, editing by Kate Kelland and John Stonestreet)
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