After hastily granting approval last week for a COVID-19 vaccine that has yet to undergo rigorous clinical trials, Russia has now announced plans to give the vaccine to more than 40,000 volunteers in a trial which will start next week.
The previously planned “post-registration” injections are part of a “multicenter, randomized, double-blind, placebo-controlled clinical study” of the vaccine, dubbed Sputnik V, according to an Aug. 20 press release from the Russian Direct Investment Fund, which financially supported the development of the vaccine. The more than 40,000 people participating in the trial will be recruited from more than 45 medical centers, the press release added.
On August 11, Russian President Vladimir Putin announced that Sputnik V had obtained regulatory approval, making it the world’s first COVID-19 vaccine to gain national approval. Putin hailed Sputnik V as a breakthrough and even announced that one of his daughters had already received a dose of the two-dose vaccine.
“I know it has been shown to be effective and forms stable immunity,” Putin said, noting that Sputnik V had passed the necessary tests. Officials have reportedly pledged to vaccinate millions of people in the coming months.
But researchers and public health experts are deeply skeptical of the vaccine and Putin’s claims. To date, Sputnik V is only known to have been tested on a total of 76 people in two small clinical trials – neither of which have been designed or able to assess whether the vaccine can protect against the pandemic coronavirus, SARS-CoV-2, which causes COVID-19. The data from these small preliminary trials are not published in a scientific journal and have not been made public.
Typically, vaccines gain approval after successfully completing three phases of testing, which gradually have larger groups of participants. That is, trials typically start with just dozens of people to test for safety (phase I), then move on to hundreds to continue testing for safety and immune responses (phase II), then move to tens of thousands. to see if the vaccine is really protective. (phase III).
Sputnik V appears to have only passed through the early stages of Phase I and II trials, the results of which are still unknown. In addition, the certificate of approval that the Russian government has granted only allows Sputnik V to be given to “a small number of citizens from vulnerable groups,” according to a spokesperson for the health ministry who said. ‘is interviewed with ScienceInsider. The certificate further states that the vaccine cannot be widely used until January 1, 2021, possibly after larger trials have ended.
The World Health Organization has reportedly entered into discussions with Russia to try to determine what data it has so far on the vaccine and what it has yet to collect to demonstrate its effectiveness. A senior WHO official stressed to the AP that when it comes to a COVID-19 vaccine, “it is essential not to cut corners in terms of safety or efficacy.”
The recently announced trial may provide some answers on safety and efficacy in the months to come. But for now, there is little information. The new trial is not registered on Clinicaltrials.gov, a database of clinical trials conducted around the world. (The first two clinical trials with Sputnik V have been registered).
Beyond Sputnik V, 129 other vaccines are in clinical trials, including six in phase III trials, according to the latest WHO count. There are also 139 other vaccine candidates in preclinical development.