MOSCOW: Scientists have approved Russia’s Sputnik V vaccine saying it was almost 92% effective in fighting COVID-19, according to peer-reviewed late-stage trial of an advanced study published in The Lancet international medical journal.
Experts said the Phase III trial results meant the world had another effective weapon to fight the deadly pandemic and justified to some extent Moscow’s decision to roll out the vaccine before final data had been released.
The results, collated by the Gamaleya Institute in Moscow that developed and tested the vaccine, were in line with efficacy data reported at earlier stages of the trial, which has been running in Moscow since September.
The results were based on data from 19,866 volunteers of whom a quarter received a placebo, the researchers. Since the trial began in Moscow, there were 16 recorded cases of symptomatic COVID-19 among people who received the vaccine, and 62 among the placebo group, the scientists said.
This showed that a two-dose regimen of the vaccine – two shots based on two different viral vectors, administered 21 days apart – was 91.6% effective against symptomatic COVID-19.
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The Sputnik V vaccine is the fourth worldwide to have Phase III results published in leading peer-reviewed medical journals following the shots developed by Pfizer and BioNTech, Moderna and AstraZeneca. Pfizer’s shot had the highest efficacy rate at 95%, closely followed by Moderna’s vaccine and Sputnik V while AstraZeneca’s vaccine had an average efficacy of 70%.
Sputnik V has also now been approved for storage in normal fridges, as opposed to freezers, making transportation and distribution easier, Gamaleya scientists said. Russia approved the vaccine in August, before the large-scale trial had begun, saying it was the first country to do so for a COVID-19 shot. It named it Sputnik V, in homage to the world’s first satellite, launched by the Soviet Union.
Small numbers of frontline health workers began receiving it soon after and a large-scale roll out started in December, though access was limited to those in specific professions, such as teachers, medical workers and journalists.
“Russia was right all along,” Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF), which is responsible for marketing the vaccine abroad, told reporters on Tuesday.
He said the results supported Russia’s decision to begin administering Sputnik V to frontline workers while the trial was still underway, and scepticism of such moves was politically motivated. “The Lancet did very unbiased work despite some of the political pressures that may have been out there,” he said.
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In January, the vaccine was offered to all Russians. The number of people vaccinated in Russia has remained low so far as authorities have pointed to some early issues with scaling up production.
The vaccine was also found to be 100% effective against moderate or severe COVID-19, as there were no such cases among the group of 78 participants who were infected and symptomatic 21 days after the first shot was administered.
Four deaths of participants occurred but none was considered associated with vaccination, The Lancet said. The authors of the study noted that because COVID-19 cases were only detected when trial participants reported symptoms, further research was needed to understand Sputnik V’s efficacy on asymptomatic cases and transmission.
Sputnik V has been approved by 15 countries, including Argentina, Hungary and the United Arab Emirates. Hungary was the first member of the European Union to break ranks and unilaterally approve the vaccine last month.
