On Friday, a team of Russian scientists published the first report on their Covid-19 vaccine, which had been roundly criticized because of President Vladimir Putin’s decision last month to approve it before clinical trials had proved it safe and effective.
In a small group of volunteers, the scientists found that the vaccine produced a modest level of antibodies against the coronavirus, while causing only mild side effects. The research has not yet shown, however, whether people who are vaccinated are less likely to become infected than those who are not.
In August, Mr. Putin announced with great fanfare that the vaccine — called Sputnik V — “works effectively enough” to be approved. He declared its approval to be a “very important step for our country, and generally for the whole world.”
But vaccine developers denounced the decision, observing that no data had been published on the vaccine. In addition, the critics pointed out, the Russian scientists had yet to run a large trial of tens of thousands of people, which is required to demonstrate that a 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 the work.
“The science looks like it was done impeccably well,” said Naor Bar-Zeev of the Johns Hopkins Bloomberg School of Public Health, who is the co-author of a commentary on the new paper. Still, he cautioned that no one will know if Sputnik V is safe and effective until the larger trials are completed.
“We should welcome a Russian vaccine if it’s successful, and we should welcome other vaccines if they’re successful,” Dr. Bar-Zeev said. “But they should all be equally rigorously evaluated.”
Researchers at the Gamaleya Research Institute in Moscow used a design for the vaccine that they had previously developed and tested for MERS, a disease caused by another coronavirus.
The Sputnik V vaccine stimulates the immune system by coaxing a person’s cells to make a protein normally found on the coronavirus that causes Covid-19. The researchers loaded the gene for this viral protein into a second virus, called an adenovirus.
When injected into the arm, the adenovirus slips into muscle cells. It has been genetically engineered so that it cannot make copies of itself or cause illness. But once it delivers the coronavirus gene into a cell, the cell starts making the protein.
Similar adenovirus-based vaccines are also being tested by several other teams, including AstraZeneca, CanSinoBio and Johnson & Johnson.
Each team is testing a different strain of adenovirus. Unlike the rest, the Russian team is combining two adenoviruses into one vaccine. For their initial clinical trial, the Gamaleya researchers gave volunteers an initial shot of an adenovirus called Ad26, and then, three weeks later, a shot of one known as Ad5.
In the Lancet paper, the researchers said that they tested the vaccine on hamsters and monkeys. They claimed the animals were protected against the coronavirus without any harmful side effects but did not present any data about these studies in their new paper.
The trial they ran on…
Read More News: Russians Publish Early Coronavirus Vaccine Results