Did Russian COVID-19 vaccine complete clinical trials or phase I trials?

WHO report lists Russian COVID-19 vaccine study as a phase-I trial

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Numerous reports on Sunday claimed that Russia's Sechenov University had completed clinical trials of a vaccine for the novel coronavirus, touting the same as the first vaccine in the world to complete human trials.

According to Russian news agency TASS, "clinical trials" of a COVID-19 vaccine being tested by Sechenov University had been completed: The first stage of research on the vaccine started on June 18 when a group of 18 volunteers were vaccinated, and the second stage on June 23 with a group of 20 volunteers being vaccinated.

A much-cited report published in Sputnik News stated that clinical trials of the "world's first coronavirus vaccine" had been completed. The report said the vaccine was produced by the Gamalei Institute of Epidemiology and Microbiology and that its safety had been confirmed. "It corresponds to the safety of those vaccines that are currently on the market," Alexander Lukashev, the director of the Institute of Medical Parasitology, Tropical, and Vector-Borne Diseases at Sechenov University, was quoted as saying.

While many news reports claimed this woul be the first vaccine to complete human trials, the time-frame and objective of the research suggest that it has only cleared—or is still ongoing—phase 1 of trials.

In vaccine trials, the first phase usually involves a small group of people with the goal of testing the vaccine's safety for humans. Subsequent phases expand testing exponentially and can run into years before determining a vaccine is safe for mass production. Vaccines typically take 10-15 years to reach market as a result.

For Phase I, the US Department of Health and Human Services says this phase "tests an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage."

The Sechenov study is listed in ClinicalTrials.gov—a registry of ongoing clinical studies run by the US National Library of Medicine—as a two-stage Phase I trial of the drug Gam-COVID-Vac Lyo".

Specifically, the registry lists the trial as "an open two stage non-randomized Phase 1 study with the participation of healthy volunteers. This clinical trial is an open study of safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac Lyo", lyophilisate for the preparation of a solution for intramuscular administration, with the participation of healthy volunteers.

Similarly, a World Health Organisation document on 'Draft landscape of COVID-19 candidate vaccines' lists two trials by the Gamaleya Research Institute as being Phase-I trials.

Russia has been working on 17 vaccines for the coronavirus, as the country’s health minister stated on July 8. In June, Deputy Prime Minister Dmitry Chernyshenko said that mass vaccinations could begin in the fall, although these would be voluntary.

According to Sechenov University’s website, the volunteers, male and female and aged 18-65, received a lyophilised vaccine—a powder from which a solution is prepared for intramuscular injection—for a vaccine developed by Gamaleya Institute.

The Sputnik report quotes Alexander Lukashev, director of the Institute of Medical Parasitology, Tropical, and Vector-Borne Diseases at Sechenov University, as saying that the objective of this stage of the study was to show the vaccine's safety on humans, "which was successfully done".

The report also quotes Vadim Tarasov, director of the Institute for Translational Medicine and Biotechnology, as saying that clinical trials for the vaccine are currently underway. 

Smolyarchuk, who heads the Center for Clinical Research on Medications at Sechenov University, said the volunteers would remain under medical supervision as out-patients after being discharged.

Earlier, on June 30, researchers said they had not observed any adverse side effects of the vaccine on volunteers.

"The trials are being conducted routinely without any serious adverse reactions. There are a few predictable side effects related directly to the vaccine's inoculation. This is a so-called systemic and local post-vaccine reaction which is mild and disappears on its own without any additional measures. The volunteers are in good health," Smolyarchuk told TASS at the time.

Earlier, on July 10, the Russian Defence Ministry said the volunteers being given the vaccine felt well, had no complaints, experienced no side-effects and were developing immunity to the coronavirus, as reported by TASS. Both the first and second groups were forming an immune response after injections of the vaccine, the defence ministry was quoted as saying.

The July 10 report stated that the trials would end on July 15, with the second group of volunteers to receive the second component of the vaccine as part of a “booster scheme” to “strengthen the immune system and...prolong its endurance” the report said.

In addition, a June 22 report published by Sputnik News quoted Gamaleya’s director, Alexander Gintsburg, as saying that the vaccine would protect people against the virus for a period of over two years.

“The vaccine is given twice with the same gene injected using different carriers, which allows to not just get protective immunity, but to acquire it for a longer period of time," Gintsburg told Krasnaya Zvezda, official newspaper of the Russian Defence Ministry, adding that this approach "guarantees with great probability that a person getting this vaccine in the booster form will be protected from the coronavirus infection for at least two years, maybe even for a longer period of time."

Russia is the fourth-worst affected country by the novel coronavirus, having over 727,000 cases and over 11,000 deaths. With the number of new daily cases showing a decrease since their peak in May, the country has started easing up restrictions, with Moscow to drop the requirement for mandatory mask use from July 14, except in stores, public transport, medical facilities and other public places.

At present, according to the WHO list, the only vaccines to reach Phase 3 trials as of July 7 were those by China's Sinovac and the University of Oxford/AstraZeneca. The Serum Institute of India, the world's largest vaccine manufacturer, which partnered with Oxford University to produce its vaccine candidate, recently said that a safe vaccine was at least six months away.