After a vaccine developed by Pfizer and BioNTech recently showed that it was over 90 percent effective in preventing the infection, Russia also announced that its NO 1 candidate Sputnik was 92 percent effective. This data comes from the first interim analysis of data from its Phase 3 clinical trial that was conducted in…
There wasn’t a lot of information in the statement released by the RDIF and came out just two days after Pfizer Inc. released its data. According to a report by The Associated Press, some experts suggest that the Russian data may have been rushed out to keep up with the worldwide race for a successful coronavirus vaccine.
“Whilst encouraging, I worry that these data have been rushed out on the back of the Pfizer/BioNtech announcement earlier in the week. The Sputnik data are based on only 20 cases of COVID-19 in the trial participants, compared to more than 90 cases in the earlier trial,” Eleanor Riley, professor of immunology and infectious disease at the University of Edinburgh, told Reuters.
“It is particularly important that the pre-set criteria for unblinding the trial data are adhered to avoid cherry-picking the data. Anything less than this risks a public loss of trust in all vaccines, which would be a disaster,” she added.
Professor Bodo Plachter, Deputy Director of the Institue of Virologie, Mainz University Teaching Hospital, told Reuters, “This looks quite good at first sight, but we certainly need longer-term observations to draw valid conclusions about efficacy and side effects. The same goes for Pfizer’s and BioNTech’s numbers.”
The Sputnik V vaccine, developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology, and the Russian defense ministry, is a two-shot vaccine.
According to the statement, from a total of 40,000 volunteers participating in the Phase 3 trials, more than 20,000 volunteers have been vaccinated with the first dose of the vaccine and more than 16,000 volunteers with the first and second doses of the vaccine.
Out of the 16,000 volunteers, there were only 20 confirmed coronavirus infections 21 days after they were immunized, and hence it is 92 % effective.
It remained unclear from the statement of how coronavirus was diagnosed among the trial participants and whether all of them, including those showing no symptoms, were tested for the virus.
The release of “the interim results of the post-registration clinical trials that convincingly demonstrate Sputnik V vaccine’s efficacy gives way to mass vaccination in Russia against COVID-19 in the coming weeks,” Alexander Gintsburg, director of the Moscow-based Gamaleya Insitute that developed the vaccine, was quoted as saying in the statement.
However, in an interview with The Associated Press, Ilya Yasny, head of scientific research at the Russian investment fund Inbio Ventures, pointed out that the efficacy rates may change once all 40,000 volunteers are given the shots.
“How the numbers will change once all 40,000 people are given shots is unclear,” but “I would say it is premature to conclude the analysis.”