Russia Plans 40,000 Patient Study for Approved Coronavirus Vaccine
Following approval of its coronavirus vaccine, the first in the world, Russia plans to initiate a new study involving 40,000 people as the country looks to boost production and distribute the drug to patients in that country, as well as to patients in countries it has struck deals with.
Russia approved its vaccine against the novel coronavirus earlier this month after the government assured the medication is safe and effective. The vaccine, dubbed Sputnik V, is an adenoviral vector vaccine developed by Moscow’s Gamaleya Institute. The two-vector vaccine has been genetically modified to infect cells than make those cells manufacture spike proteins of SARS-CoV-2, the novel virus that causes COVID-19.
Russia had its vaccine in clinical testing for about two months before it approved the medication. The little data that is available, two Phase I/II studies posted to clinicaltrials.gov, show a total of 38 patients treated with the experimental vaccine. There is a question as to whether or not that is 38 per study for a total of 76, or 38 studied twice. Since its hasty approval, the vaccine has been viewed with skepticism from researchers over its potential as a long-term solution against the global pandemic, largely due to the speed with which it was approved and the small number of patients involved in the studies.
The Russian Direct Investment Fund established a vaccine website to provide details of its clinical programs for Sputnik V.
“The vaccine induced strong antibody and cellular immune response. Not a single participant of the current clinical trials got infected with COVID-19 after being administered with the vaccine,” according to the Russian website.
Russia initially said it intended to launch a larger, post-approval Phase III study involving about 2,000 patients. But now that number of patients has grown.
“Next week a previously planned post-registration, randomized, double-blind, placebo-controlled multicenter clinical study of the efficacy, immunogenicity and safety of the Sputnik V vaccine will begin in Russia, simultaneously with the vaccination of volunteers from risk groups. More than 40,000 people will take part in the study in more than 45 medical centers,” the Russian Direct Investment Fund, which worked alongside Moscow’s Gamaleya Institute to develop the vaccine, said in a statement.
Denis Logunov, deputy director for scientific work of Gamaleya Research Institute of Epidemiology and Microbiology, told CNBC that the institute has agreed to a “huge protocol for 40,000 participants” as a sort of Phase III/ confirmatory trial for Sputnik V.
“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 CNBC’s report.
More than 22 million people have been infected with the novel coronavirus, according to the Johns Hopkins COVID-19 dashboard. Russia has reported 944,671 cases, with more than 16,000 related deaths.