The Russian Sputnik V vaccine was 91.6% effective against COVID-19 in a final-stage trial, according to new provisional results. The results come in stark contrast to messages from US health officials, including Dr. Anthony Fauci, who sowed serious doubts about the jab after it was launched in Russia before advanced studies on safety and effectiveness.
The findings, published in The Lancet on Tuesday, were extracted from a double-blind study at 25 locations in Moscow and revealed a 91.6% efficacy against COVID-19 disease 21 days after the first dose and 100% of moderate effectiveness against severe COVID-19 disease among approximately 19,800 adult participants.
“Our interim analysis of this Gam-COVID-Vac phase 3 study showed promising results,” wrote the study authors, writing later, “Our interim analysis of the Gam-COVID-Vac randomized controlled phase 3 study in Russia has showed high efficacy, immunogenicity and a good tolerability profile in participants aged 18 or over. ”
Co-leaders of the study included Denis Logunov and Dr. Inna Dolzhikova, who are affiliated with the Gamaleya Center in Moscow.
The team of Russian researchers obtained vaccine efficacy results from 78 cases of COVID-19 that emerged among all trial participants three weeks after the first dose.
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“From 21 days after the first dose of the vaccine (the day of dose 2), 16 (0.1%) of the 14,964 participants in the vaccine group and 62 (1.3%) of the 4,902 in the placebo group were confirmed to have COVID-19; vaccine effectiveness was 91.6% “, wrote the study authors.
After at least 21 days of the initial dose, there were no cases of moderate to severe COVID-19 in the vaccine group, but 20 cases appeared in the placebo group, resulting in 100% effectiveness of the vaccine against more severe courses of the disease.
The researchers suggested that the two-dose recombinant adenovirus vaccine induced an immune response, including among older adults, and was 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 to be related to the vaccine.
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The most common side effects were “flu-like illness, reactions at the injection site, headache” and weakness, according to the study.
There were also four deaths reported among trial participants (three in the vaccine group), but none were found associated with the vaccine. Among the vaccine group, two deaths were related to COVID-19; “These two participants were probably already infected with SARS-CoV-2 at the time of randomization and vaccination,” wrote the study authors. The other death involved a fractured spine. 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 adolescents, children and pregnant women.
Noteworthy, the vast majority of trial participants were white, and Russian researchers said “further investigations in a more diverse cohort are welcome”.
Finally, the team noted that, as of January 23, more than 2 million doses of the Sputnik V vaccine have been administered to the public in Russia, mainly in high-risk populations, and in essential workers such as health professionals and educators. .
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“Phase 1/2 vaccine clinical trials were completed in August 2020,” wrote the study authors. “The results showed that the vaccine was well tolerated and highly immunogenic in healthy participants. As a result, the vaccine candidate was provisionally approved in Russia according to national legislation.”
The researchers are also studying a single-dose vaccine regimen.
The vaccine’s efficacy results exceed those recently announced by Johnson & Johnson, which saw its single-injection coronavirus vaccine reveal 66% effectiveness in preventing moderate to severe COVID-19 in a global trial. However, the mRNA vaccines developed by Pfizer-BioNTech and Moderna are 95% and 94.5% effective against COVID-19 disease, respectively.