The Russians publish the results of the early coronavirus vaccine

Friday, a team of Russian scientists Published The first report on their Kovid-19 vaccine was severely criticized last month by President Vladimir Putin for approving it before clinical trials could be proven safe and effective.

Among a small group of volunteers, scientists have found that this vaccine produces modest antibodies against coronavirus, while causing only mild side effects. Research has not yet shown whether vaccinated individuals are more likely to become infected than those who are not.

In August, Mr. Putin Announced Vaccine – with great affection for the so-called Sputnik v – To be approved “works efficiently enough”. He declared its approval “a very important step for our country, and for the whole world in general.”

But vaccine developers Denied Observed decision that no data were published on the vaccine. In addition, critics point out that Russian scientists have not yet conducted a large trial on tens of thousands of people, who need to prove that the vaccine works.

The new paper, published in The Lancet, contains the first batch of public data from Sputnik V’s clinical trials. Independent scientists were impressed by the rigor of this work.

Nour Bar-Jeev of the Johns Hopkins Bloomberg School of Public Health said: “Science seems to have done it honestly. Commentary On new paper. However, he warned that no one would know if Sputnik V was safe and effective until the big trials were over.

“If the Russian vaccine is successful we should welcome it, and if other vaccines are successful we should welcome them,” Dr. Bar-Jeev said. “But all must be assessed equally rigorously.”

Researchers at the Gamaleya Research Institute in Moscow used a design for a vaccine they had previously developed and tested for another coronavirus-causing disease called MERS.

The Sputnik V vaccine stimulates the immune system to attach to a person’s cells to make the protein commonly found in the coronavirus that causes Kovid-19. The researchers transmitted the gene for this viral protein to a second virus called adenovirus.

When injected into the hand, the adenovirus slips into the muscle cells. It is genetically engineered so that it does not make copies of itself or cause illness. But once it sends the coronavirus gene into a cell, the cell begins to make protein.

Similar adenovirus-based vaccines Are also being tested By AstraZeneca, Consinobio and many other teams including Johnson & Johnson.

Each team is testing a different strain of adenovirus. Unlike everything else, the Russian team is combining two adenoviruses into one vaccine. For their initial clinical trial, Gamaliya researchers gave volunteers an initial shot of an adenovirus called Ad26, and then, three weeks later, a shot called Ad5.

In the Lancet paper, the researchers said they tested the vaccine on hamsters and monkeys. They claim to have protected animals from coronavirus without any harmful side effects, but have not submitted any data about these studies in their new paper.

The trial phase they conducted on human volunteers is called the 1/2 trial. This is small: only 40 volunteers with both types of adenovirus received the full vaccine. No one got a placebo.

In comparison, the Chinese company Consinobio a Step 1/2 Trial Of these, 382 were vaccinated and another 126 were given placebo.

The Russian vaccine has produced mild symptoms in many cases, the most common of which are fevers and headaches. Other adenovirus-based vaccines have produced similar side effects.

“I hope you have some symptoms – it’s normal,” Dr. Bar-Jeev said.

Researchers have found that volunteers who receive the full vaccine produce antibodies that can prevent the virus from replicating in cells.

To assess the effectiveness of their vaccine, Russian researchers compared the level of antibodies with samples taken from people recovering from Kovid-19’s natural infections. Convalescent plasma, as these models are known, contains antibodies to the virus that people make themselves.

In the paper, researchers said that vaccinated people had levels of antibodies found in circulating plasma.

The vaccine produces “good antibody levels in all volunteers,” said Akiko Ivasaki, an immunologist at Yale University who did not participate in the study.

But one News release, The Gamalaya Institute suggests that its vaccine is superior to estrogenica. The level of antibodies from vaccinated volunteers was “1.4-1.5 times higher than the level of antibodies in patients recovering from Kovid-19”.

AstraZeneca, however, produced only antibody levels similar to those in plasma.

It is not clear why the paper presents a different picture. The authors of the study did not respond to a request for comment.

John Moore, a virologist at Veil Cornell Medicine in New York, who did not participate in the study, said it was too early to make any meaningful comparisons between the various Kovid-19 vaccines. Each team uses different tests to measure antibody levels. And in each group of recovered patients they are studied for recovered plasma.

“We’ve been suffering from the apple-versus-orange scene for a long time, but now we’re in the fruit salad territory, and it tries to figure out all of the bananas,” he said.

One thing is clear: however, the Phase 1/2 trial does not demonstrate protection from Kovid-19.

This requires a so-called Phase 3 trial, in which a large number of volunteers are vaccinated or placebo. Stage 3 trials also reveal harmful side effects that small preliminary studies have missed.

Russian scientists wrote in their paper that they had received permission on August 26 to conduct a third phase trial on 40,000 people. There are Seven Other vaccines currently in the final stages of trials. Johnson & Johnson is set to launch its own Phase 3 trial later this month, with Novavox expected to launch on its own in October, reaching a total of 10.

Stage 3 trials can take months to give clear results, Dr. Bar-Jeev said, adding that they should be carefully considered before making any decision about the widespread use of the vaccine.

“Yes, we all want the vaccine, but we don’t want to go wrong,” he said. “So stay there and wait, so we know what we’re doing.”

Andrew Kramer contributed to the reporting from Moscow.