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After Russia rushed to approve a COVID-19 vaccine last week for which rigorous clinical trials have not yet been conducted, Russia has now announced plans to give the vaccine to more than 40,000 volunteers in a trial that begins next week .
The “pre-planned post-registration injections” are part of a “randomized, double-blind, placebo-controlled, multicenter clinical trial” of the vaccine, named Sputnik V, according to a press release by the Russian Direct Investment Fund on August 20 that financially supported the vaccine's development. The more than 40,000 people for the study 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 received regulatory approval. This makes it the first COVID-19 vaccine in the world to receive 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 that it has been shown to be efficient and form stable immunity," Putin said, noting that Sputnik V passed the required tests. Officials have reportedly pledged to vaccinate millions in the coming months.
However, researchers and public health experts are deeply skeptical of the vaccine and Putin's claims. So far it is only known that Sputnik V was tested in two small clinical studies on a total of 76 people. None of these studies have been developed or can assess whether the vaccine can protect against the pandemic coronavirus SARS-CoV-2, which causes COVID-19. The data for these small, early studies have not been published or published in a scientific journal.
As a rule, vaccines are approved after they have successfully completed three test phases with increasingly larger groups of participants. That said, studies usually start with just dozens of people to test for safety (Phase I), then go to hundreds of people to further test safety and immune responses (Phase II), and then tens of thousands to determine whether the vaccine is actually protective (phase III).
Sputnik V appears to have only gone through the early stages of Phase I and II trials, the results of which are still unknown. In addition, the approval certificate issued by the Russian government allows Sputnik V to be awarded to only "a small number of citizens from vulnerable groups," according to a spokesman for the Ministry of Health who spoke to ScienceInsider. The certificate also stipulates that the vaccine cannot become widely available until January 1, 2021, likely after larger studies have been completed.
The World Health Organization has reportedly started talks with Russia to determine what data it has so far on the vaccine – and what remains to be gathered to prove effectiveness. A senior WHO official told the AP that it is "important not to compromise safety or effectiveness" with a COVID-19 vaccine.
The newly announced study could provide some safety and effectiveness answers in the coming months. However, little information is currently available. The new study is not registered on Clinicaltrials.gov, a database of clinical trials conducted worldwide. (The two previous clinical studies on Sputnik V have been registered).
In addition to Sputnik V, 129 other vaccines are in clinical trials, including six in phase III trials. This emerges from the latest WHO assessment. There are also 139 other vaccine candidates in preclinical development.