Sputnik V vaccine 91.6% effective in late trial: The Lancet

The Russian Sputnik V vaccine was 91.6% effective in preventing people from developing Covid-19, according to peer-reviewed results from the clinical trial published late in the day in the international medical journal The Lancet.

Scientists say the Phase III trial results mean the world has another effective weapon to fight the deadly pandemic, and that Moscow justified the decision to carry out the vaccine to some extent before final data was released. is.

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

“The development of the Sputnik V vaccine has been criticized for improper haste, cutting corners and the absence of transparency,” said Professor Ian Jones of the University of Reading and Professor Polly Roy of the London School of Hygiene & Tropical Medicine. said in a comment shared by The Lancet.

“But the outcomes reported here are clear and the scientific principle of vaccination is shown,” said the scientists, who were not involved in the study. “Another vaccine may now be involved in the fight to reduce the incidence of Covid-19.”

The results are based on data from 19,866 volunteers, a quarter of whom received a placebo, researchers led by Denis Logunov, Gamaleya Institute, told The Lancet.

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

It showed that a two-dose regimen of the vaccine – two shots based on two different adenovirus vectors, administered 21 days apart – was 91.6% effective against the 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 shot. It calls it Sputnik V, in honor of the world’s first satellite launched by the Soviet Union.

Small numbers of health workers at the front began receiving it shortly thereafter, and a large-scale rollout began in December, although access was limited to those in specific occupations, such as teachers, medical workers and journalists.

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

He said they supported Russia’s decision to start administering Sputnik V to frontline workers while the trial was still ongoing, and suggested that skepticism about such steps was politically motivated.

“The Lancet did a lot of unbiased work despite some political pressure that was possible there,” he said.

The number of people vaccinated in Russia has remained low so far. Authorities pointed to earlier problems with scaling up production, while polls showed low demand among the Russians for the vaccine.

Russia has already shared data from its Phase III trial 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 of information comes as Europe scrambles to secure enough shots for its 450 million citizens as a result of production cuts by AstraZeneca and Pfizer, while US implementation is hampered by the need to store shots in ultra-cold freezers and uneven planning in countries.

There were 2,144 volunteers older than 60 in the trial, and the shot was shown to be 91.8% effective when tested on this older group, without serious side effects that could be associated with Sputnik V, the Lancet- summary said.

The vaccine is also 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 were associated with vaccination, The Lancet said.

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

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

Sputnik V has been approved by 15 countries, including Argentina, Hungary and the United Arab Emirates, and it will rise to 25 by next week, Dmitriev, RDIF, said.

The sovereign wealth fund has 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 shot have so far been sent only to Argentina, which has received enough doses to vaccinate about 500,000 people, and Bolivia, which has received 20,000 shots.

The fund says the production for export will be done mainly by RDIF’s manufacturing partners abroad.

Dmitriev said on Tuesday that production had begun in India and South Korea and that month would begin in China. Trial doses were also manufactured 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 effectiveness of 73% to 85%.