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After granting approval last week for a COVID-19 vaccine that has not yet undergone rigorous clinical trials, Russia has announced its goal of donating the vaccine to more than 40,000 volunteers in a trial that will begin next week.
Planned “post-registration” injections in the past are part of a “randomized, double-blind, placebo-controlled multicenter clinical study” of the vaccine, called Sputnik V, according to an August 20 press release from the Russian Direct Investment Fund., which financially supported the development of the vaccine. The more than 40,000 people who will participate in the trial will be recruited to more than forty-five medical centers, the press release added.
On August 11, Russian President Vladimir Putin announced that Sputnik V had received regulatory approval, which made it the world’s first COVID-19 vaccine in national approval.Putin praised Sputnik V as a breakthrough and even announced that one of his daughters had already won a dose of the two-dose vaccine.
“I know it has demonstrated effective and solid immunity to bureaucracy,” Putin said, noting that Sputnik V had passed the tests.Officials are said to have committed to vaccinating millions of others in the coming months.
But researchers and public fitness experts are deeply skeptical about the vaccine and Putin’s claims.To date, Sputnik V has only been tested in a total of 76 people in two small clinical trials, neither of whom has been designed or able to assess whether the vaccine can oppose pandemic coronavirus, SARS-CoV-2, which causes COVID-19.Data from these early small trials are not published in a clinical journal and have not been made public.
Russia ignores the COVID-19 vaccine trial, says millions of others will be vaccinated within a few months Vaccines sometimes get approved after passing 3 stages of trials, which gradually have larger teams of participants.In other words, trials regularly begin with only dozens of others to check protection (phase I), then move on to a lot of other people to continue verifying protection and immune responses (phase II), and then tens of thousands to see if the vaccine is protective (phase III).
Sputnik V appears to have passed only the early stages of Phase I and II tests, the effects of which are still unknown.In addition, the Certificate of Approval granted through the Russian government only allows Sputnik V to be handed over to “a small number of citizens of vulnerable groups,” according to a spokesman for the Ministry of Fitness who spoke to ScienceInsider.The certificate also states that the vaccine will be widely used until January 1, 2021, probably after the final touch of larger trials.
The World Health Organization has reportedly engaged in talks with Russia to see what knowledge it has so far about the vaccine and what it needs to gather to prove its effectiveness.A senior WHO official under pressure from the AP that when it comes to a COVID-19 vaccine, “it is imperative not to take shortcuts in terms of protection or efficacy”.
The recently announced trial may provide protective and effective responses in the coming months, but for now there is little information.The new trial is recorded in Clinicaltrials.gov, a database of clinical trials conducted worldwide (the first two clinical trials have been recorded with Sputnik V).
In addition to Sputnik V, 129 vaccines are in clinical trials, adding six in phase III trials, according to who’s most recent whodest count.There are also 139 candidate vaccines in preclinical development.
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