4 Sep 2020 17:56

Results of Sputnik V vaccine trials published in The Lancet

MOSCOW. Sept 4 (Interfax) - One of the world's most reputable medical journals, The Lancet, has published the results of the Phase 1 and Phase 2 clinical trials of the Russian coronavirus vaccine Sputnik V, developed by the Gamaleya Institute.

"The research being published in The Lancet proves the high level of safety and efficacy of the Russian vaccine and provides detailed information on the results of the clinical studies," the Gamaleya Research Institute of Epidemiology and Microbiology and the Russian Direct Investment Fund said in a joint statement obtained by Interfax on Friday.

The article authored by a large group of vaccine developers noted that, as a result of Phases 1 and 2 of the clinical trials, 100% of subjects developed strong humoral and cell immunity. Volunteers vaccinated with Sputnik V had 1.4-1.5 times more coronavirus antibodies in their systems than patients who had recovered from Covid-19. The Russian Direct Investment Fund noted that the British pharmaceutical company AstraZeneca has achieved more modest results: the level of antibodies in the systems of recovered patients and vaccinated subjects was approximately the same.

The subjects inoculated with the Russian vaccine did not manifest any undesirable side effects (while the indicator may vary from 1% to 25% in other candidate vaccines), the Russian Direct Investment Fund said.

Gamaleya Institute Director and Academy member Alexander Gintsburg told Interfax that the publication of the materials in The Lancet was prepared for a long time. Consistent with international rules, the article was reviewed by five independent peers. The material was supplemented with comments from the editor, which the institute describes as fair and balanced.

"The scientific community has carried out an absolutely objective review. There's no negativism. Negativism belongs to politics and economics," Gintsburg said.

The Russian Direct Investment Fund has described the article as a response to those who doubt the vaccine.

"Publication in The Lancet shows Russia's openness and preparedness for dialogue; this is also a response to the skeptics who have unfoundedly criticized the Russian vaccine," the statement quoted Russian Direct Investment Fund head Kirill Dmitriev as saying.

According to the statement, this is not the last article: The Lancet plans to continue a series of publications on the Russian vaccine. For instance, it plans to publish the results of the Phase 3 clinical trials, which will begin in Moscow in the coming days and, according to earlier reports, will involve 40,000 volunteers.