Russian vaccine maker Sputnik V reports positive results at the incomplete trial


The makers of the leading Russian vaccine candidate, Sputnik V, said on Tuesday that preliminary results from a clinical trial showed a 95 percent efficacy rate, which is the same or better than the three other vaccines that gave results. results in recent weeks.

However, this data was based on a small group of unspecified volunteers based on an ongoing phase 3 trial of the vaccine, and vaccine manufacturers did not determine how many patients received the vaccine or placebo. When the trial was completed, the company announced that more complete data would be released.

Although the announcement and the fact that the Phase 3 studies were incomplete made it difficult to immediately evaluate the effectiveness of the vaccine, the news promised to increase excitement because of the promise that vaccinations could exacerbate the coronavirus epidemic. is over.

Pfizer’s U.S. and German teams, as well as BioNTech and U.S. Moderna, reported efficiencies of 95 and 94.5 percent, respectively. AstraZeneca and Oxford University said on Monday that their vaccines were 62 and 90 per cent effective, respectively, depending on how the doses were given.

Russia registered the vaccine for emergency use in August before embarking on a clinical trial to measure its effectiveness, shortening the standard procedure, and with international criticism. President Vladimir V. Putin claimed that it was the first vaccine in the world to receive government approval.

Russia’s vaccine was mostly marketed in the former Soviet states and developing economies, saying the cost per dose would be less than $ 10 for international markers. Officials said vaccine producers received orders for 1.2 billion doses from about 50 countries. The Russian direct investment fund said some 10,000 people had been vaccinated with the approval for emergency use.

On November 11, the government-backed Russian Direct Investment Fund announced that its analysis of the top 20 volunteers showed an efficiency rate of 92 percent. On Tuesday, the fund submitted a similar estimate with further details. 18,794 volunteers who received both injections from the two-dose treatment were analyzed; 14,095 received the vaccine and 4,699 received the placebo.

One week after the second dose, 39 cases of Covid-19 were found, with only eight of the affected volunteers receiving the vaccine. Based on the proportion of volunteers receiving the vaccine and placebo, the researchers estimated the effectiveness to be 91.4 percent.

But in their statement, the fund said the researchers also looked at an indefinite number of volunteers three weeks after the second dose. A 95% efficacy rate was calculated in these volunteers.

The researchers will once again examine the results when they reach 78 Covid-19 cases in volunteers.

Some experts were skeptical about the report, which was based on an incomplete data set and was clearly not made during a regular review of test results.

“You don’t have to do this that way,” said Dr. John Moore, a virologist at Weill Cornell Medicine. “It seems to me what they’re doing is slicing, chopping and digging the data to reach 95 percent data.”

In August, the Russian Direct Investment Fund named a vaccine called Sputnik V for the first satellite launched by the Soviet Union, although other vaccines developed further at the time.

Russian scientists have started phase 3 clinical trials with two other vaccines.