Russia's Sputnik V vaccine is 91.6% efficient within the late-stage
© Reuters. FILE PHOTO: Argentina continues its vaccination process for medical workers with the Sputnik V vaccine
By Polina Ivanova
MOSCOW (Reuters) – Russia's Sputnik-V vaccine prevented 91.6% of people from developing COVID-19. This emerges from peer-reviewed results of its clinical study published Tuesday in The Lancent International Medical Journal.
Scientists said the results of the Phase III study meant the world had yet another powerful weapon to fight the deadly pandemic and to some extent justified Moscow's decision to launch the vaccine before the final data was released.
The results, compiled by the Gamaleya Institute in Moscow, which developed and tested the vaccine, were in line with efficacy data reported in earlier stages of the study, which has been running in Moscow since September.
"The development of the Sputnik V vaccine has been criticized for undue rush, corner trimming and lack of transparency," Professor Ian Jones of the University of Reading and Professor Polly Roy of the London School of Hygiene & Tropical Medicine said in a comment from The Lancet.
"But the result reported here is clear and the scientific principle of vaccination is demonstrated," said the scientists who were not involved in the study. "Another vaccine can now join the fight against the incidence of COVID-19."
The results were based on data from 19,866 volunteers, a quarter of whom received a placebo, the researchers, led by Denis Logunov of the Gamaleya Institute, said in The Lancet.
Since the Moscow study began, 16 cases of symptomatic COVID-19 have been recorded in people who received the vaccine and 62 cases in the placebo group, the scientists said.
This showed that a two-dose regimen of the vaccine – two shots based on two different adenovirus vectors given 21 days apart – was 91.6% effective against symptomatic COVID-19.
"Russia was right"
Russia approved the vaccine in August before the large-scale trial began and said it was the first country to do so for a COVID-19 shot. It called it Sputnik V, in homage to the world's first satellite launched by the Soviet Union.
Small numbers of frontline health workers received it soon after, and a large-scale induction began in December, although access was restricted to those in certain professions such as teachers, medical professionals, and journalists.
In January the vaccine was offered to all Russians.
"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 ahead of the results released on Tuesday.
He said they supported Russia's decision to give Sputnik V to frontline workers while the process was ongoing, and suggested that skepticism about such measures was politically motivated.
"The Lancet has worked very impartially, despite the political pressure that may have been out there," he said.
The number of people vaccinated in Russia has so far remained low. Authorities have pointed out some early problems with increasing production, while surveys have shown Russians' demand for the vaccine is low.
Russia has already shared data from its Phase III study with regulators in several countries and has begun submitting it to the European Medicines Agency (EMA) for approval in the European Union, Dmitriev said.
The data is published because Europe is due to production cuts by AstraZeneca (NASDAQ 🙂 and Pfizer (NYSE :), while the US roll-out was hampered by the need to store recordings in ultra-cold freezers and uneven planning across states.
EFFECTIVE FOR THE ELDERLY
There were 2,144 volunteers over 60 in the study and the shot was found to be 91.8% effective when tested on this older group with no reported serious side effects that could be linked to Sputnik V, the abstract said by The Lancet.
The vaccine was also found to be 100% effective against moderate or severe COVID-19, as there were no such cases in the group of 78 participants who were infected and symptomatic 21 days after the first shot was administered.
Four participant deaths occurred but none were considered related to vaccination, The Lancet said.
"The effectiveness looks good, even in the 1960s," said Danny Altmann, professor of immunology at Imperial College London. "It's good to have another addition to the global arsenal."
The study's authors noted that COVID-19 cases were only detected when participants reported symptoms. Therefore, more research is needed to understand the effectiveness of Sputnik V in asymptomatic cases and in transmission.
Sputnik V has been approved by 15 countries including Argentina, Hungary and the United Arab Emirates. By the end of next week there should be 25, said Dmitriev of the RDIF.
The sovereign wealth fund also said Sputnik V vaccinations will begin in a dozen countries, including Hungary, Bolivia, the United Arab Emirates, Venezuela and Iran.
So far, however, only large shipments of the shot have been sent to Argentina, where enough doses have been given to vaccinate around 500,000 people, and to Bolivia, where 20,000 shots have been fired.
Production for export is primarily done by RDIF's manufacturing partners overseas, the fund said.
On Tuesday, Dmitriev announced that production has started in India and South Korea and will start in China this month. Sample cans were also made by a manufacturer in Brazil.
Russia is also running a small clinical trial of a single-dose version of the vaccine, for which developers expect an efficacy rate of 73% to 85%.