A medical worker fills a syringe with the Gam-COVID-Vac vaccine (under the brand name Sputnik V) in Butovo, southern Moscow.
Sergei Savostyanov | TASS | Getty Images
The Russian Sputnik V vaccine was 91.6% effective in preventing people from developing Covid-19, according to peer-reviewed results from their final-stage clinical trial published in the international medical journal The Lancet on Tuesday.
The scientists said the results of the Phase III trial mean that the world has another effective weapon to fight the deadly pandemic and justify, to some extent, Moscow’s decision to launch the vaccine before the final data is released.
The results, collected by the Gamaleya Institute in Moscow, which developed and tested the vaccine, were in line with efficacy data reported in earlier stages of the trial, which has been running in Moscow since September.
“The development of the Sputnik V vaccine has been criticized for improper haste, cutting corners and a lack of transparency,” said Professor Ian Jones of the University of Reading and Professor Polly Roy of the London School of Hygiene & Tropical Medicine, in a comment shared by The Lancet.
“But the result reported here is clear and the scientific principle of vaccination is demonstrated,” said the scientists, who did not participate in the study. “Another vaccine may now join the fight to reduce the incidence of Covid-19.”
The results were based on data from 19,866 volunteers, of whom a quarter received a placebo, the researchers, led by Denis Logunov of the Gamaleya Institute, said in The Lancet.
Since the start of the trial in Moscow, there have been 16 reported cases of symptomatic Covid-19 among those who received the vaccine and 62 among the placebo group, the scientists said.
This showed that a two-dose vaccine regimen – two injections based on two different adenovirus vectors, administered 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, saying it was the first country to do so for a Covid-19 vaccine. It was baptized as Sputnik V, in honor of the first satellite in the world, launched by the Soviet Union.
A small number of frontline health professionals began receiving him soon afterwards and a large-scale deployment began in December, although access was limited to those in specific professions, such as teachers, medical workers 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), responsible for marketing the vaccine abroad, told reporters before the results were published on Tuesday.
He said he supported Russia’s decision to start administering Sputnik V to frontline workers while the trial was still underway, and suggested that skepticism about such measures was politically motivated.
“Lancet did a very impartial job, despite some political pressures that may have existed,” he said.
The number of people vaccinated in Russia has remained low so far. Authorities pointed to some initial problems with increased production, while surveys showed low demand among Russians for the vaccine.
Russia has already shared data from its Phase III trial with regulators in several countries and has started the process of submitting them to the European Medicines Agency (EMA) for approval in the European Union, said Dmitriev.
The data release comes at a time when Europe is struggling to ensure enough photos for its 450 million citizens due to production cuts by AstraZeneca and Pfizer, while deployment in the United States has been hampered by the need to store photos in freezers frozen foods and uneven planning across states.
Effective for the elderly
There were 2,144 volunteers over the age of 60 in the trial and the injection proved to be 91.8% effective when tested in this older group, with no reported serious side effects that could be associated with Sputnik V, said the Lancet summary.
The vaccine also proved to be 100% effective against moderate or severe Covid-19, as there were no such cases among the group of 78 infected and symptomatic participants 21 days after the first injection.
Four deaths of participants occurred, but none were found to be associated with vaccination, said The Lancet.
“The effectiveness looks good, even in the 60s,” said Danny Altmann, professor of immunology at Imperial College London. “It is good to have one more addition to the global arsenal.”
The study authors noted that, since Covid-19 cases were only detected when participants reported symptoms, further research is needed to understand the effectiveness of Sputnik V in asymptomatic and transmission cases.
Sputnik V has been approved by 15 countries, including Argentina, Hungary and the United Arab Emirates and will increase to 25 by the end of next week, said RDIF’s Dmitriev.
The sovereign wealth fund also said that vaccination with Sputnik V will begin in a dozen countries, including Hungary, Bolivia, the United Arab Emirates, Venezuela and Iran.
However, large shipments of the vaccine have so far only been sent to Argentina, which has received enough doses to vaccinate about 500,000 people, and to Bolivia, which has received 20,000 vaccines.
Export production will be conducted mainly by RDIF’s manufacturing partners abroad, the fund said.
On Tuesday, Dmitriev said production started in India and South Korea, and will be launched in China this month. Experimental doses were also produced by a manufacturer in Brazil.
Russia is also conducting a small-scale clinical trial of a single-dose version of the vaccine, which developers expect to have an efficacy rate of 73% to 85%.