Untested COVID-19 vaccine, Sputnik V, begins 40,000-person trial next week

Russia skipped trials to grant approval and claim breakthrough.

Beth Mole – Aug 21, 2020 3:38 PM | 408

Credit: Aurich Lawson / Getty Images

After hastily granting approval last week for a COVID-19 vaccine that has yet to enter rigorous clinical trials, Russia has now announced plans to give the vaccine to more than 40,000 volunteers in a trial that starts next week.

The “previously planned post-registration” injections are part of a “randomized, double-blind, placebo-controlled multicenter clinical study” of the vaccine, dubbed Sputnik V, according to an August 20 press release from the Russian Direct Investment Fund, which has financially backed the development of the vaccine. The more than 40,000 people for 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 won regulatory approval, making it the first COVID-19 vaccine in the world to achieve domestic approval. Putin hailed Sputnik V as a breakthrough and even announced that one of his daughters had already received one dose of the two-dose vaccine.

“I know it has proven efficient and forms a stable immunity,” Putin said, noting that Sputnik V had passed necessary testing. Officials have reportedly pledged to vaccinate millions in the coming months.

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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 in a total of 76 people in two small clinical trials—neither of which was designed or able to assess if the vaccine can protect against the pandemic coronavirus, SARS-CoV-2, which causes COVID-19. The data for those small, early trials are not published in a scientific journal, nor have they been made public.

Stable breakthrough?

Typically, vaccines earn approval after successfully making it through three phases of trials, which have progressively larger groups of participants. That is, trials usually start with just dozens of people to test safety (phase I), then move to hundreds of people to continue testing safety and immune responses (phase II), then to tens of thousands to see if 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 outcomes of which are still unknown. Moreover, the approval certificate the Russian government granted allows Sputnik V to only be given to “a small number of citizens from vulnerable groups,” according to a Ministry of Health spokesperson who spoke with ScienceInsider. The certificate further stipulates that the vaccine cannot be used widely until January 1, 2021, likely after larger trials are completed.

The World Health Organization has reportedly begun discussions with Russia to try to ascertain what data it has on the vaccine so far—and what it still needs to collect to show efficacy. A senior WHO official emphasized to the AP that when it comes to a COVID-19 vaccine, “it’s essential we don’t cut corners in safety or efficacy.”

The newly announced trial may provide some answers on safety and efficacy in the months to come. But for now, there’s little information. The new trial is not registered on Clinicaltrials.gov, a database of clinical trials conducted around the world. (The earlier two clinical trials on Sputnik V were registered).

Beyond Sputnik V, there are 129 other vaccines in clinical trials, including six in phase III trials, according to the latest tally by the WHO. There are also 139 other vaccine candidates in pre-clinical development.