According to an interim result, the Russian Sputnik V vaccine was 91.6% effective against COVID-19 disease. The results come in stark contrast to the messages of U.S. health officials, including Dr. Anthony Fauci, who sowed serious doubts about the sting after being rolled out in Russia ahead of advanced studies on safety and effectiveness.
The findings, published in The Lancet on Tuesday, resulted from a double-blind trial at 25 locations in Moscow, which had an efficacy of 91.6% against COVID-19 disease 21 days after the first dose, and 100 % efficacy against moderate to severe COVID-19 disease among approximately 19,800 adult participants.
“Our interim analysis of this Phase 3 trial with Gam-COVID-Vac has shown promising results,” study authors wrote, and later wrote: “Our interim analysis of the randomized, controlled Phase 3 trial of Gam-COVID-Vac Vac in Russia showed a high efficiency, immunogenicity and a good tolerance profile in participants aged 18 or older. ‘
Supervisors led Denis Logunov and dr. Including Inna Dolzhikova, who is attached to the Gamaleya Center in Moscow.
The team of Russian researchers obtained the results of vaccine efficacy from 78 cases of COVID-19 that appeared among all participants in the trial three weeks after the first dose.
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“From 21 days after the first vaccine dose (the day of dose 2) it was confirmed that 16 (0.1%) of 14 964 participants in the vaccine group and 62 (1.3%) of 4 902 in the placebo group had COVID-19 “Vaccine effectiveness was 91.6%,” the authors write.
After at least 21 days from the initial dose, there were no cases of moderate to severe COVID-19 in the vaccine group, but 20 cases occurred in the placebo group, which translated the 100% efficacy against the severe disease states.
Researchers have suggested that the two-dose recombinant adenovirus vaccine elicits an immune response, among older adults, and that it is well tolerated; 45 (0.3%) of 16,427 vaccinated participants and 23 (0.4%) of 5,435 people who received the placebo had serious adverse events, but these serious side effects were not considered vaccine-related.
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The most common side effects, according to the study, were ‘flu-like illness, injection site reactions, headache’ and weakness.
Four deaths were also reported among participants in the trial, (three in the vaccine group), but no one was found to be associated with the vaccine. Among the vaccine group, two deaths were linked to COVID-19; “These two participants were probably already infected with SARS-CoV-2 at the time of randomization and vaccination,” the study authors wrote. The other death involved a spinal fracture. The death in the placebo group involved a hemorrhagic stroke.
Several unknowns remain, such as the duration of protection, and how well the vaccine works in teens, children and pregnant women.
The vast majority of participants in the trial were white, and Russian researchers said they “welcomed further investigation into a more diverse group.”
Finally, the team noted that as of January 23, more than 2 million doses of Sputnik V vaccine have already been administered to the public in Russia, mostly in high-risk populations, and essential workers such as health care workers and educators.
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“Phase 1/2 clinical trials of the vaccine were completed in August 2020,” authors of the study wrote. “The results showed that the vaccine is well tolerated and highly immunogenic in healthy participants. Consequently, the vaccine candidate has been provisionally approved in Russia under national law.”
Researchers are also investigating a single-dose regimen of the vaccine.
The results of the vaccine efficacy are higher than those recently announced by Johnson & Johnson. According to the single-shot coronavirus vaccine, it is 66% effective in preventing COVID-19 in a global trial. However, MRNA vaccines developed by Pfizer-BioNTech and Moderna are 95% and 94.5% effective against COVID-19 disease, respectively.