Sputnik V vaccine with 91.6% efficacy in final phase trials: The Lancet

Russia’s Sputnik V vaccine was 91.6% effective in preventing people from developing Covid-19, according to peer-reviewed results from its final-stage clinical trial published Tuesday in the international medical journal The Lancet.

The scientists said the results of the phase III trial meant the world had another effective weapon to fight the deadly pandemic and that they justified to some extent Moscow’s decision to launch the vaccine before the data were released. finals.

The results, collected by the Moscow Gamaleya Institute that developed and tested the vaccine, matched the efficacy data reported in the earlier phases of the trial, which has been taking place in Moscow since September.

“The development of the Sputnik V vaccine has been criticized for undue rush, cuts 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 presented here is clear and demonstrates the scientific principle of vaccination,” 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, a quarter of whom received a placebo, the researchers, led by Denis Logunov of the Gamaleya Institute, told 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-vaccine vaccine regimen (two shots 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, and said it was the first country to do so by a Covid-19 shot. 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 soon after, and 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 the time,” Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF), which is responsible for marketing the vaccine abroad, told reporters before the results were published.

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 had political motivation.

“The Lancet did a very impartial job despite some of the political pressures that may have been out there,” he said.

The number of people vaccinated in Russia has so far remained low. Authorities have pointed to some initial problems with increased production, while polls have shown low demand among Russians for the vaccine.

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

Data release comes as Europe prepares to secure enough shots for its 450 million citizens due to production cuts by AstraZeneca and Pfizer, while the US launch has been hampered by the need of storing shots in ultra-cold freezers and uneven planning in all states.

There were 2,144 volunteers over the age of 60 at trial and the shot was shown to be 91.8% effective when the test was performed in this older group, with no reported possible serious side effects. with Sputnik V, according to the summary of The Lancet.

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 infected and symptomatic participants at 21 days after the first administration.

Four participant deaths occurred, but none were considered associated with the vaccination, The Lancet said.

“Efficacy looks good, even at over 60,” said Danny Altmann, a professor of immunology at Imperial College London. “It’s good to have another addition to the world arsenal.”

The study authors noted that because Covid-19 cases were only detected when participants reported symptoms, more 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 will increase to 25 by the end of next week, said Dmitriev of the RDIF.

The Sovereign Wealth Fund also said vaccinations with Sputnik V will begin in a dozen countries, including Hungary, Bolivia, the United Arab Emirates, Venezuela and Iran.

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

Production for export will be carried out mainly by RDIF manufacturing partners abroad, the fund said.

On Tuesday, Dmitriev said production had begun in India and South Korea and would be launched in China this month. A Brazilian manufacturer has also produced test doses.

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