A staff member at the Gamaleya Scientific Research Institute of Epidemiology and Microbiology of the Russian Ministry of Health, which produces a COVID-19 vaccine. The vaccine is produced at the institute and other Russian pharmaceutical plants. It will be available to the public on January 1, 2021.
Vyacheslav Prokofyev | TASS via Getty Images
Russia claims its coronavirus vaccine, the first to be registered worldwide, will soon be tested on 40,000 people to test its reliability.
The vaccine, called “Sputnik V,” has been considered safe and effective by Russian authorities after receiving domestic regulatory approval earlier this month. Full-scale production will begin in September.
However, health experts and public officials have expressed concern about the proposed vaccine, with the speed of its approval and the lack of available data. The results of two months of small-scale human trials in Russia have not yet been made available to the public.
“The so-called certificate for registered enrollment means we are required to conduct an additional extensive clinical trial,” Denis Logunov, deputy director of scientific work at Gamaleya Research Institute of Epidemiology and Microbiology, said in an online briefing on Thursday, according to a translation. .
“And at the moment we have agreed on an enormous protocol for 40,000 participants. The purpose of this protocol is not so much to study the immunogenicity and safety of the vaccine, that speaks for itself … But beyond that we will increase the effectiveness of the epidemic should assess this vaccine, “Logunov said.
Russia’s vaccine is being developed at the Gamaleya Research Institute in Moscow.
To date, more than 22.4 million people have contracted Covid-19 infection, with 788,356 related deaths, according to data compiled by Johns Hopkins University.
WHO in talks with Russia over vaccine
Concerns about the safety and reliability of Sputnik V stem from the fact that it has undergone only rapid Phase 1 and Phase 2 clinical trials on a relatively small number of people.
Phase 3 trials are set to begin shortly, but Russia has said it expects to begin production of the next vaccine.
When asked about the Russian coronavirus vaccine during a separate online press release on Thursday, Hans Kluge, Regional Director for Europe at the WHO, replied: “Let me say in general that any progress in vaccine development is very encouraging. is news. “
The country has a “long tradition” of fax development and recording, he added. “But … every vaccine must meet the same strict standards of efficacy and safety. And, finally, knowing that there is only one way to do this are clinical trials: Phase 1, Phase 2 and Phase 3 – inclusive Phase 3, “said Kluge.
A handout photo provided by the Russian Direct Investment Fund (RDIF) shows examples of a coronavirus (COVID-19) vaccine developed by the Gamaleya Research Institute of Epidemiology and Microbiology, in Moscow, Russia on August 6, 2020.
The Russian Fund for Direct Investment Reuters
Catherine Smallwood, senior emergency officer at WHO Europe, also confirmed that the United Nations health agency has been in direct talks with Russia recently about the potential development of Sputnik V, with updates to follow in due course.
“These concerns we have about safety and effectiveness are not specific to the Russian vaccine, it is for all vaccines that are under development,” Smallwood said. “It’s absolutely essential that we do not cut corners in security or efficiency, so it is a central concern for all faxes.”
“We are not going through a quick task here to try to jump to conclusions here. We want to take our time to really understand where the fax is and to get as complete information as possible about the steps that have already been taken , “Smallwood said.
– Holly Ellyatt of CNBC contributed to this report.
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