MOSCOW (Sputnik) – Russia’s health ministry has approved changing the format of post-registration clinical trials of the Sputnik V vaccine against COVID: volunteers will no longer get a placebo, only the real vaccine since it has already proven safe, Alexander Gintsburg, the head of the Gamaleya research institute, said.
“The ministry of health has allowed to stop [registration of volunteers for injecting placebo] as of yesterday or today, as everything has been confirmed, the pandemic is ongoing, and placebo is not fine at all,” Gintsburg said.
Gintsburg specified that the trials would continue but volunteers would no longer get a placebo.
“I would try to identify those who received placebo to vaccinate them, but it is unclear yet if this can be allowed,” Gintsburg added.
The trials of the Sputnik V vaccine saw a total of 40,000 volunteers participating in them and as many as 10,000 of them were to receive a placebo since randomised, placebo-controlled trials are considered nowadays the most efficient way to obtain reliable results.
The head of the Gamaleya research institute previously suggested that up to 80 percent of the Russian population may be inoculated against COVID-19 by autumn 2021.
“If we produce five to six million doses of the vaccine per month, which is quite realistic for our domestic consumption, then by the end of fall 2021 we should have vaccinated 70 to 80 percent of our population. That is to say, this disease will be vaccine-controlled”, Gintsburg told Rossiya-1 broadcaster.
According to the developer of the vaccine, Sputnik V is capable of building up immunity for more than two years.
Throughout clinical trials, Sputnik V — the first-ever COVID-19 vaccine registered in the world — has shown to be more than 90 percent effective at preventing COVID-19 after three control points.