An employee of the Gamaleya Scientific Research Institute of Epidemiology and Microbiology at the Russian Ministry of Health, which makes a COVID-19 vaccine. The vaccine is to be manufactured in the institute and in other Russian pharmaceutical factories. It will be open to the public on January 1, 2021.
Vyacheslav Prokofyev | TASS via Getty Images
Russia claimed its coronavirus vaccine, which was the first to be registered in the world, will soon be tested on 40,000 people to test its reliability.
Named "Sputnik V", the vaccine was deemed safe and effective by Russian authorities after it received national regulatory approval earlier this month. Series production is scheduled to begin in September.
However, health experts and officials expressed concern about the proposed vaccine, citing the speed of its approval and the lack of data available. The results of two months of small human experiments in Russia have not yet been made available to the public.
"The so-called conditioned certificate of registration means that we are required to conduct an additional expanded clinical study," said Denis Logunov, deputy director of scientific work at the Gamaleya Research Institute of Epidemiology and Microbiology, in an online briefing on Thursday.
"And now we have agreed on a huge protocol for 40,000 participants. The purpose of this protocol is not to study the immunogenicity and safety of the vaccine, it goes without saying … But, in addition, we need to evaluate the epidemic effectiveness of this Vaccine, "said Logunov.
Russia's vaccine is being developed at the Gamaleya Research Institute in Moscow.
To date, according to the Johns Hopkins University, more than 22.4 million people have become infected with the Covid-19 infection, with 788,356 deaths.
WHO in conversation with Russia about vaccine
Concerns about the safety and reliability of Sputnik V arise from the fact that it has only undergone rapid Phase 1 and 2 clinical trials on a relatively small number of people.
Phase 3 trials are slated to begin shortly, but Russia has announced that it will produce the vaccine as early as next month.
When asked about the Russian coronavirus vaccine during a separate online press conference on Thursday, Hans Kluge, WHO Regional Director for Europe, replied, "Overall, let me say that advances in vaccine development are very encouraging news."
The country has a "long history" of vaccine development and uptake, he added. "But … every vaccine has to go through the same rigorous standards of effectiveness and safety. And ultimately, there is only one way to know that clinical trials are in place: Phase 1, Phase 2, and Phase 3 – including Phase 3," said Smart.
A handout photo from the Russian Direct Investment Fund (RDIF) shows samples of a coronavirus disease (COVID-19) vaccine developed by the Gamaleya Research Institute of Epidemiology and Microbiology on Aug 6, 2020 in Moscow, Russia.
The Russian direct investment fund Reuters
Catherine Smallwood, WHO Europe Senior Emergency Officer, also confirmed that the United Nations Health Department had recently started direct discussions with Russia on the possible development of Sputnik V. Updates will follow in due course.
"These concerns about safety and effectiveness are not specific to the Russian vaccine, but to all vaccines currently in development," Smallwood said. "It is imperative that we do not compromise safety or effectiveness, so this is a key concern of all vaccines."
"We are in no hurry to reach conclusions here. We want to take the time to really understand where the vaccine is and to get as full information as possible about the steps that have already been taken," said Smallwood.
– CNBC's Holly Ellyatt contributed to this report.