Sputnik V vaccine testers will no longer be given a placebo. “The study has failed,” experts say

Volunteers participating in tests of the Russian Sputnik V coronavirus vaccine will no longer be injected with placebos, said Alexander Gintsburg, director of the Gamaleya National Research Center.

“The Ministry of Health has allowed to stop, it seems, on yesterday or today, the recruitment [of volunteers for the introduction of placebo] due to the fact that everything is proven there, and the pandemic is coming, and the placebo is not good at all,” Gunzburg said.

As Gunzburg explained to RIA Novosti, many of those who received a placebo learned about it from the test results and were vaccinated with the vaccine itself in order to be protected from infection.

According to a Meduza source close to the vaccine developers, “with the start of mass vaccination, the volunteers began to withdraw from the trials.” The placebo group shrank, he explained.

At this stage, it is not clear how the data for people who received the vaccine and received a placebo would be compared. This could jeopardize the research.

The director of the Research Institute of Gamaleya also told RIA Novosti that he would like to disclose those test participants who received a placebo and give them vaccinations, “but whether this will allow the regulation is still unclear.” According to Meduza’s source, in mid-December, the developers of the vaccine already approached the Ministry of Health with a request to disclose the placebo group, without disclosing those who received the vaccine, but were refused. The press service of the Ministry of Health confirmed to Interfax that disclosure of data on which of the participants received the vaccine and who received the placebo is “not planned at the current stage.”

“In fact, the research has failed, its goal has not been achieved. There was a change in the rules of the game during the game. The study will not have correct efficacy results because the placebo group is lost, ”Svetlana Zavidova, executive director of the Association of Clinical Research Organizations (ACOI), told Meduza.

Meduza asked the Ministry of Health for comments on how the change in the Sputnik V study format will affect the course of clinical trials and how the drug’s efficacy will be tested without a placebo group. At the time of this writing, no response has been received from the Ministry of Health.

The Sputnik V developers reported on the results of clinical trials of the vaccine on December 14. The third phase of research has not been completed, but a large-scale vaccination with “Sputnik V” has already started on December 5. The vaccination rules specifically stipulate that volunteers participating in the Sputnik V trials and receiving a placebo should not yet apply for vaccination.

(c)MEDUZA 2020

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