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Phase III clinical trials show Russia’s Sputnik V coronavirus vaccine is 91.6% effective in fighting COVID-19, according to research published in The Lancet.
The trials involved about 20,000 people, with 16 COVID appearing in the 14,964 people who got the vaccine (.1%) and 62 cases in the 4,902 people in the placebo group (1.3%), study authors said.
Russia has been criticized for authorizing use of the vaccine in August, well before clinical trials were finished. The vaccine was given to frontline health care workers and other at-risk groups last in Russia and has been distributed to more than two dozen countries.
The study has limitations, Julian Tang, MD, clinical virologist at University of Leicester said in a statement to the Science Media Center. For example, it only included cases of coronavirus detected once participants had symptoms and were then tested to confirm infection. It did not measure whether any participants had COVID but were asymptomatic.
“The efficacy analysis only includes symptomatic cases of COVID-19, and further research is needed to understand the efficacy of the vaccine on asymptomatic COVID-19, and transmission,” Tang said. “Furthermore, median follow up was 48 days from the first dose, so the study cannot assess the full duration of protection.”
A Lancet news release quoted two scientists who were not involved in the study saying it looked like Russia made the right call, considering the seriousness of the pandemic.
“The development of the Sputnik V vaccine has been criticised for unseemly haste, corner cutting, and an absence of transparency,” said Ian Jones, professor at the University of Reading, and Polly Roy, professor at the London School of Hygiene & Tropical Medicine.
“But the outcome reported here is clear and the scientific principle of vaccination is demonstrated, which means another vaccine can now join the fight to reduce the incidence of COVID-19.”
The study was conducted by the Gamaleya National Research Centre for Epidemiology and Microbiology in Russia, which developed the vaccine, and was paid for by the Moscow City Health Department and Russian Direct Investment Fund (RDIF).
“Stopping the COVID-19 pandemic requires the introduction of different vaccines based on different mechanisms of action to cover diverse global health demands. Our vaccine, along with other SARS-CoV-2 vaccines, helps to diversify the world SARS-CoV-2 vaccine pipeline,” Denis Logunov, MD, of the Gamaleya National Research Centre and the co-lead author of the study said in The Lancet.
The two-shot vaccine was also found to be 100% effective against moderate or severe COVID-19 and highly effective in people over 60.
“The efficacy looks good, including in the over 60s,” Danny Altmann, a professor of immunology at Imperial College London, told Reuters. “It’s good to have another addition to the global arsenal.”
“Russia was right all along,” Kirill Dmitriev, head of the RDIF, told reporters on Tuesday, according to Reuters. “The Lancet did very unbiased work despite some of the political pressures that may have been out there,”
RDIF is responsible for marketing the vaccine. Dimitriev said the vaccine is being tested against new variants of COVID-19 and the early signs were positive.
In late November, the vaccine developers said Sputnik V was 91.4% effective within 28 days of taking the first dose and 95% after 42 days.
The Pfizer/BioNTech and Moderna vaccines now being given to people in the United States proved to be 95% and 94.1% effective, respectively.
The Sputnik vaccine has already been given to more than 2 million people worldwide, including in Russia, some eastern European nations and Latin America, CNN reported.
The Lancet. “Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia”
Reuters. “Russia’s Sputnik V vaccine 92% effective in fighting COVID-19”
CNN. “Russia’s Sputnik V vaccine is 91.6% effective against symptomatic Covid-19, interim trial results suggest”