Sputnik V vaccine 91.6% effective late stage of study: 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 late-stage clinical trial published Tuesday in the international medical journal The Lancet.

Scientists said the results of the phase III study meant the world had another effective weapon to combat the deadly pandemic and, to some extent, justified Moscow’s decision to roll out the vaccine before the final data was released.

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

“The development of the Sputnik V vaccine has been criticized for its 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 outcome reported here is clear and the scientific principle of vaccination has been demonstrated,” said the scientists, who were not involved in the study. “Another vaccine can 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, said in The Lancet.

Since the trial in Moscow began, 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.

This showed that a regimen of two doses of the vaccine – two injections 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 injection. It called it Sputnik V, in tribute to the world’s first satellite launched by the Soviet Union.

Small numbers of primary health workers got it soon after and a large-scale rollout began in December, although access was limited to people in specific professions, such as teachers, medical staff and journalists.

In January, the vaccine was offered to all Russians. “Russia was always right,” Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF), which is responsible for marketing the vaccine overseas, told reporters ahead of the release 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 underway, and suggested skepticism about such moves was politically motivated.

“The Lancet has done a very unbiased work, despite some of the political pressure that may have been there,” he said.

The number of vaccinated people in Russia has remained low so far. Authorities have pointed to some early problems with scaling up production, while polls have shown that there is little demand for the vaccine among Russians.

Russia has already shared the 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 released as Europe works to get enough footage for its 450 million residents due to production cuts by AstraZeneca and Pfizer, while US rollout is hampered by the need to store footage in ultra-cold freezers and uneven scheduling between states .

There were 2,144 volunteers over 60 in the trial, and the shot was found to be 91.8% effective when tested on this older group, with no reported serious side effects associated with Sputnik V, according to The summary. 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 participants infected 21 days after the first injection and symptomatic.

Four participants’ deaths occurred, but none were considered to be associated with vaccination, The Lancet said.

“The efficacy looks good even in the 1960s,” said Danny Altmann, professor of immunology at Imperial College London. “It’s good to have one more addition to the global arsenal.”

The study authors noted that because Covid-19 cases were only detected 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, Dmitriev of the RDIF said.

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.

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

Production for export will mainly be performed by RDIF’s manufacturing partners abroad, the fund said.

On Tuesday, Dmitriev said production had started in India and South Korea and would start in China this month. Trial doses have also been produced by a manufacturer in Brazil.

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