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Developer may disclose data on Sputnik V trials due to infections among volunteers

This requires relevant amendments to the legislation, according to the Gamaleya National Research Center director

MOSCOW, October 28. /TASS/. The developer of the Russian Sputnik V vaccine against the coronavirus, the Gamaleya National Research Center for Epidemiology and Microbiology of the Russian Healthcare Ministry, is considering the possibility of disclosing the data on who of the volunteers was administered the vaccine, and who - a placebo in mid-November, before summing up the results of the study. According to the Center’s Director Alexander Gintsburg, this is due to the instances of infection among volunteers.

Earlier, Deputy Research Director of the Gamaleya National Research Center, Associate Member of the Russian Academy of Sciences Denis Logunov reported that trial participants will find out whether they received the vaccine or the placebo only after the end of tests. The Center’s director reported that the last group of volunteers out of the total of 40,000 may be inoculated by the end of January 2021.

"Everything proceeds as planned, apparently, there are [coronavirus] infections [among the post-registration trials participants]. At some point in mid-November the provisional results will be summed up, then we will find out the difference between the placebo and the test samples," the Center’s director told TASS.

In response to a question on how the results can be obtained before the end of the study if the data can be disclosed only after its completion, the director said that currently the Center is thinking of introducing relevant amendments to the legislation. "Subsequently, we are now thinking, we would like to do this [obtain the results - TASS] earlier in order to get the idea of what is going on. However, if the regulators don’t allow it, then you’re right, we will have to wait until the entire procedure is completed. If an amendment is introduced, then as a certain number of infections emerges in the course of the experiment it will be possible to go public with the results. The amendment hasn’t been introduced yet. We are thinking about it," the scientist explained. "This practice exists abroad - they introduce amendments. Although the final word is with the [Healthcare] Ministry," he added.

The Center’s director also explained that the coronavirus infections among the volunteers may be related to the fact that an individual wasn’t vaccinated, that is, received the placebo. He also suggested that some participants who were administered the Sputnik V vaccine may not have developed immunity for a number of reasons. "Well, that’s why there are 40,000 people involved, in order to see how many people are not susceptible to the preparation because they abuse alcohol during vaccination or due to some other reasons. "Non-responders" [whose immunity does not respond to the vaccine - TASS] may be using some other medicinal preparations or something else. That is why such a large experiment is conducted, in order to understand what percentage in our actual human population won’t be protected as a result of the vaccination. I hope it won’t be high," he concluded.

On August 11, Russia became the first country worldwide to register the vaccine against the coronavirus which was named Sputnik V. The preparation was developed by the Gamaleya National Research Center for Epidemiology and Microbiology of the Russian Healthcare Ministry. It passed clinical trials in June - July. Post-registration trials of the preparation started in Moscow on September 7, with the first volunteers receiving the vaccine on September 9. In all, 40,000 people participate in the program, 10,000 of whom will receive a placebo instead of the vaccine.