Russia coronavirus vaccine will be tested on 40,000 people. It is being developed at the Gamaleya Research Institute in Moscow.
“Sputnik V,” the name for the Russia coronavirus vaccine, has been regarded by authorities as safe and effective after it was granted domestic regulatory approval earlier this month. The full-scale production of the candidate vaccine will begin in September.
Meanwhile, health experts and public officials are worried about the proposed vaccine, particularly the speed of its approval and the lack of relevant data. The findings of two months of small-scale human trials in Russia have not yet been released publicly.
“The so-called conditioned registration certificate means that we are obliged to conduct an additional expanded clinical trial,” Denis Logunov, deputy director for scientific work of Gamaleya Research Institute of Epidemiology and Microbiology, said in an online briefing according to a translation.
“And currently we have agreed on a huge protocol for 40,000 participants. The purpose of this protocol is not that much to study the immunogenicity and safety of the vaccine, that goes without saying … But, additionally, we will have to assess the epidemic efficacy of this vaccine,” Logunov said.
According to data compiled by Johns Hopkins University, there are more than 22.4 million Covid-19 cases worldwide with 788,356 related deaths.
The Sputnik V has only gone through rapid Phase 1 and Phase 2 clinical trials on a small number of people. This spurred concerns over its safety and effectiveness.
Dr. Francis Collins, director of the NIH, said that Russia’s coronavirus vaccine did not go through the “fundamental parts” of the approval process. Because of this, some people have labeled it “Russian roulette.”
“I think virtually every vaccine expert in the world looking at this has been quite concerned whether this was a wise decision. Some have called this Russian roulette,” he said during a conference call with reporters.
Phase 3 trials
Phase 3 trials will start soon, but Russia announced that it expects to begin manufacturing the Covid-19 vaccine as soon as next month.
“Let me say, overall, that any advances in vaccine development is very encouraging news,” Hans Kluge, regional director for Europe at the WHO, said regarding the Russian coronavirus vaccine.
The country has a “long tradition” of vaccine development, he noted. “But … every vaccine has to go (through) the same rigorous standards of efficacy and safety. And, ultimately to know there is only one way to do so is clinical trials: Phase 1, Phase 2 and Phase 3 – including Phase 3,” Kluge said.
Catherine Smallwood, senior emergency officer at WHO Europe, shared that the WHO had recently been in direct talks with Russia over the potential development of Sputnik V.
“This concern that we have around safety and efficacy is not specifically for the Russian vaccine, it is for all of the vaccines that are under development,” Smallwood said. “It is absolutely essential that we don’t cut corners in safety or efficacy, so it is a central concern for all of the vaccines.”
“We are not going through a rush job of trying to jump to conclusions here. We want to take our time to really understand where the vaccine is at and to get as full information as possible on the steps that have already been taken,” Smallwood said.
