Sputnik V 91.6% effective in the late-stage study: The Lancet

Russia’s Sputnik V vaccine has been 91.6% effective in preventing the development of Covid-19 in humans, according to the results of late-stage clinical trials published Tuesday in the international medical journal The Lancet.

The scientists said that the results of the phase III studies mean that the world has another effective weapon to fight the deadly pandemic and justified to some extent Moscow’s decision to launch the vaccine before the final data are published.

The results, collected by the Gamaleya Institute in Moscow, which developed and tested the vaccine, were consistent with the efficacy data reported in previous stages of the study, which takes place in Moscow in September.

“The development of the Sputnik V vaccine has been criticized for inappropriate haste, cutting corners and lack of transparency,” said Professor Ian Jones of the University of Reading and Professor Polly Roy of the London School of Hygiene & Tropical Medicine. 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 were not involved 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, a quarter of whom received a placebo, said researchers led by Denis Logunov of the Gamaleya Institute in The Lancet.

Since the trial began in Moscow, 16 cases of symptomatic Covid-19 have been reported among people who received the vaccine and 62 among the placebo group, the scientists said.

This showed that a two-dose vaccine regimen – two photographs based on two different adenovirus vectors, administered 21 days apart – was 91.6% effective against symptomatic Covid-19.

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 fire. He named it Sputnik V, in honor of the world’s first satellite launched by the Soviet Union.

A small number of front-line health workers began receiving it shortly afterwards, and a large-scale launch began in December, although access was limited to those in specific professions, such as teachers, health workers and journalists. .

In January, the vaccine was offered to all Russians. “Russia has been right all along,” Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF), which is responsible for marketing the vaccine abroad, told reporters before the results were released on Tuesday.

He said they supported Russia’s decision to start administering Sputnik V to front-line workers while the process was still ongoing and suggested that skepticism about such moves was politically motivated.

“The Lancet did a very impartial job, despite political pressures that could have been there,” he said.

The number of people vaccinated in Russia has so far remained low. Authorities showed some early problems with rising production, while polls showed low demand among Russians for the vaccine.

Russia has already shared data from its Phase III study with regulators in several countries and has begun the process of submitting it to the European Medicines Agency (EMA) for approval in the European Union, Dmitriev said.

The release comes as Europe struggles to provide enough photos for its 450 million citizens due to production cuts by AstraZeneca and Pfizer, while the US launch has been hampered by the need to store photos in ultra-cold freezers. cold and uneven planning in all states.

There were 2,144 volunteers over 60 years 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 associated with Sputnik V. in the Lancet summary.

The vaccine was also found to be 100% effective against moderate or severe Covid-19 because there were no such cases in the group of 78 participants who were infected and symptomatic 21 days after the first shot.

There were four deaths of participants, but none were considered associated with vaccination, The Lancet said.

“Efficacy looks good, including in the 1960s,” said Danny Altmann, a professor of immunology at Imperial College London. “It’s good to have another supplement to the global arsenal.”

The study authors noted that because Covid-19 cases were detected only when participants reported symptoms, further research is needed to understand the efficacy of Sputnik V in asymptomatic cases and transmission.

Sputnik V has been approved by 15 countries, including Argentina, Hungary and the United Arab Emirates, and this will increase to 25 by the end of next week, DIFriev of RDIF said.

The sovereign wealth fund also said that vaccinations with Sputnik V will begin in ten countries, including Hungary, Bolivia, the United Arab Emirates, Venezuela and Iran.

However, large shipments of the shot have so far been sent only to Argentina, which has received enough doses to vaccinate about 500,000 people, and to Bolivia, which has received 20,000 shots.

Production for export will be done primarily by RDIF production partners from abroad, the fund said.

On Tuesday, Dmitriev said production began in India and South Korea and will be launched in China this month. The test doses were also produced by a Brazilian manufacturer.

Russia is also conducting a small-scale clinical trial with a single-dose version of the vaccine, which developers expect to have an effectiveness rate of 73% to 85%.