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.
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.