The Russian Direct Investment Fund and the Gamaleya National Research Institute of Epidemiology and Microbiology revealed on Thursday, Russia will test the world’s first registered COVID-19 vaccine on more than 40,000 people.
“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,” the agencies said in a statement.
They added, “More than 40,000 people will take part in the study in more than 45 medical centers.”
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, acknowledged there have been several questions surrounding the vaccine “including the platform on which it was developed.”
He explained, “RDIF and the Gamaleya Institute strive for maximum transparency about the details of the vaccine’s development” and noted they would post more information to the website sputnikvaccine.com.
“We would like to thank everyone for their interest in ‘Sputnik V’ both in Russia and abroad – the vaccine website has already been visited by representatives of more than 200 countries,” Dmitriev said.
He added, “We plan to add new content to the site with new details on the vaccine in the future.”
Leading health experts have expressed their concern with Russia’s vaccine, including Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, as IJR previously reported.
Fauci said he “seriously” doubts Russia has “actually, definitively proven that the vaccine is safe and effective.”
Former Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb also admitted he is doubtful about the vaccine.
He claimed the approval of the vaccine could “be another effort to stoke doubts or goad U.S. into forcing early action on our vaccines.”
World Health Organization chief Tedros Adhanom Ghebreyesus on Tuesday called for an end to “vaccine nationalism,” as IJR previously reported.
He suggested countries are making the pandemic worse by putting their own vaccine interests ahead of other countries.