Russia halts new volunteers in Sputnik vaccine trial now it is increasingly available

By Polina Ivanova, Rinat Sagdiev and Anton Zverev
MOSCOW (Reuters) - Russia on Wednesday stopped accepting new volunteers into the trial of its first vaccine against COVID-19. Developers said it was unethical to give participants a placebo as the shot was increasingly open to the public.
Russia began introducing the Sputnik V vaccine as part of a national vaccination program in early December, as the last Phase III trial in the capital continued at the same time.
Now the process is canceled and only 31,000 volunteers are taking part instead of the planned 40,000, the Ministry of Health said in a statement.
Alexander Gintsburg, director of the Gamaleya Institute that developed the vaccine, was quoted by the RIA as saying the decision was based on previous test results that showed the vaccine was safe.
"While the pandemic continues, everything is now proven," said Gintsburg. "So a placebo is not good at all."
People who are already participating in the study will continue to be monitored for six months, the ministry said. It added that there would be no "unblinding" - if the quarter of participants who received a placebo were informed.
Russia is in a unique position as it approved Sputnik V very early in August after Phase I and II human studies showed it is safe and produces the antibodies necessary for a protective immune response.
Soon after, it began vaccinating a small number of people in risk groups, while also launching a large-scale process in the final stages in the capital. The rollout was sped up this month and more than 200,000 Russians got the shot.
The decision to abandon the study underscores the problems facing drug manufacturers around the world as the pressures of the pandemic are forcing regulators to approve new vaccines and administer them faster than usual.
It also means that Russia will likely base its final assessment of Sputnik V's effectiveness on fewer cases of infection among participants than other vaccine manufacturers.
Russia's latest data, collected after including around 23,000 people in the study, showed that the shot was 91.4% effective at protecting people from COVID-19 compared to a placebo. The analysis, published December 14, was based on 78 cases of infection, including 62 in the placebo group.
However, the Ministry of Health said the current scope of the experiment was sufficient to assess the safety and effectiveness of the shot. Data from the study will be published in an international medical journal, developers have said.
With the Sputnik V-shot, which is increasingly available to Muscovites as part of the national vaccination program, officials have been discussing ethical concerns about placebo registration for at least two weeks.
At the same time, some volunteers who suspected they had been given a placebo started voting with their feet: they stopped the process to try to get vaccinated elsewhere.
Reuters spoke to six volunteers who did just that. The Ministry of Health did not respond to a request for comment on how many people have officially left the process.
US-based Pfizer Inc and Germany’s BioNTech SE, whose vaccine will be launched in Europe and the US, plan to notify participants in the US Phase III trial as soon as they are eligible to take shots. They could then choose to find out whether or not they received a placebo.
American drug maker Moderna suggested last week that all volunteers be blinded at the same time and that the vaccine be offered to those who received a placebo.
(Writing by Polina Ivanova; additional reporting by Polina Nikolskaya, Gabrielle Tetrault-Farber and Mike Erman; editing by Nick Macfie)

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