On Friday, a team of Russian scientists Published His first report on the Covid-19 vaccine, which was criticized last month by President Vladimir Putin for his decision to approve it before clinical trials proved it safe and effective.
In a small group of volunteers, the scientists found that the vaccine produces a mild level of antibodies against the coronavirus, with only minor side effects. Research has not yet shown, however, whether vaccinated people are less likely to become infected.
In August, Mr. Putin Announced With great fanfare what is called vaccination Sputnik also – To be approved “works effectively”. He called the approval “a very important step for our country and for the world in general.”
But vaccine developers Slander Judgment, given that no vaccine data was published. In addition, critics say, Russian scientists still had a large trial of thousands of people who needed to demonstrate that a vaccine works.
The new paper, published in the Lancet, is the first set of public data from the clinical trials of Sputnik V. Independent scientists were impressed by the rigor of the work.
“Science seems to have done an impressive job,” said Knorr Bar-Zeev, co-author of the Johns Hopkins Bloomberg School of Public Health. Comments On new paper. However, he warned that no one knows that Sputnik is safe and effective until the big trials are over.
“We should welcome a Russian vaccine if it is successful, and we should welcome other vaccines if they are successful,” said Dr. Bar-Ziv. “But they should all be evaluated equally.”
Researchers at the Gamalea 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 vaccine also stimulates the immune system by coaxing a person’s cells to produce a protein commonly found on corovids that causes covid-19. The researchers loaded the gene for this viral protein into another virus, called adenovirus.
When injected into the arm, the adenovirus slips into the muscle cells. It is genetically engineered so that it cannot replicate itself or cause disease. But once the coronavirus transmits the gene to a cell, the cell begins to make proteins.
Other similar adenovirus-based vaccines Are also being tested By AstraZeneca, Kansinobio and several other teams, including Johnson and 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, Gamalea researchers gave volunteers an initial shot of an adenovirus called adenovirus 26, and then, three weeks later, a pill known as ad 5.
In the Lancet paper, the researchers said they tested the vaccine on hamsters and monkeys. He claimed that the animals were protected from coronavirus without any harmful side effects but did not provide any data on these studies in his new paper.
The trial they ran on human volunteers was called a stage 1/2 trial. It was small: only 40 volunteers were fully vaccinated with both types of adenoviruses. No one found a placebo.
By comparison, the Chinese firm Cancinobio A. Stage 1/2 trial This included 382 people who had been vaccinated and 126 others who had been given a placebo.
The Russian vaccine produced mild symptoms in many subjects, the most common of which were fever and headache. Other adenovirus-based vaccines have similar side effects.
“You expect some symptoms – that’s normal,” said Dr. Bar-Ziv.
The researchers found that the volunteers who received the full vaccine produced antibodies that could prevent the virus from replicating in the cells.
To determine the effectiveness of their vaccine, Russian researchers compared the levels of antibodies with samples from people who had recovered from natural infections of Kovid-19. Convulsive plasma, as these specimens are known, contains antibodies to the virus that humans make on their own.
In the paper, the researchers said that vaccinated people had the same level of antibodies as those found in plasma.
Akiko Iwasaki, an immunologist at Yale University who was not involved in the study, said the vaccine “produced good levels of antibodies in all volunteers.”
But in one News releasedThe Gamalea Institute indicated that the vaccine was better than AstraZeneca. It states that the level of antibodies from vaccinated volunteers was “1.4-1.5 times higher than the level of antibodies in patients who recovered from Kovid-19.”
AstraZeneca, he claimed, produced antibody levels equivalent to plasma antibiotics only.
It is not clear why the paper presents a different picture. The study authors did not respond to a request for comment.
Outbreaks of coronavirus>
Frequently Asked Questions
Updated September 4, 2020
What are the symptoms of coronavirus?
- Initially, coronavirus It seemed to be primarily a respiratory illness – Many patients had a fever and chills, were weak and tired, and many sniffed, although some people did not show many symptoms at all. The people who appeared to be the sickest had pneumonia or severe respiratory distress syndrome and received supplemental oxygen. So far, doctors have identified many other symptoms and syndromes. In April The CDC joined the list of early signs Sore throat, fever, chills. And muscle pain. Gastrointestinal disorders, such as diarrhea and nausea, have also been reported. Another sign of infection may be a sudden and profound loss Sense of smell and taste. In some cases, adolescents and young adults have developed painful red and purple sores on their fingers and toes – called “covid toe” – but some other serious symptoms.
Why is it safe to spend time together?
- Outdoor assembly Less risk because the air spreads viral drops, and the sun can kill some viruses. Dr Julian W. Tang, a virologist at the University of Leicester, said that open spaces prevent the virus from forming and breathing in even amounts, which can occur when infected people are confined to a confined space for long periods of time.
Why is it helpful to stand six feet away from others?
- Coronavirus is mainly spread through your mouth and nasal drops, especially when you cough or sneeze. The CDC, one of the organizations using this measure, Its recommended base of six feet The idea is that most large drops that people cough out when they cough or sneeze will fall to the ground within six feet. But six feet has never been a magic number that guarantees complete safety. For example, sneakers can carry drops up to six feet deep. According to a recent study. This is the rule of thumb: you should stand six feet apart from the outside, especially when the wind is blowing. But keep a mask on at all times, even if you think you’re far away.
I have antibodies. Am I safe now?
- As of now This seems likely, at least for several months. There have been horrific annihilations of what appears to be the second contest of the Kovid-19. But experts say that while these patients may have a traumatic course of infection, there is a gradual toll in the months following the initial exposure to the virus. People infected with the coronavirus produce Immunomodulatory molecules are called antibodies Protein proteins formed in response to an infection. These can be antibiotics Last in the body Only two to three monthsThat may sound alarming, but it is quite normal after a serious infection, said Dr. Harry, an immunologist at Harvard University. Said Michael Mina. It is possible to get the coronavirus again, but it is very unlikely that it will be possible shortly after the initial infection or that people will get sick a second time.
What are my rights if I am worried about going back to work?
John Moore, a virologist at Well Cornell Medicine in New York, who was not involved in the study, said it was too early to make any meaningful comparisons between the various Covid-19 vaccines. Each team uses different tests to measure antibody levels. And in each group of recovered patients they studied for plasma that may have different levels of antibodies.
“We’ve been saddened by the sight of oranges without apples for a long time, but now we’re in the fruit salad area, and with that, the banana is trying to figure it out for me,” he said.
One thing is clear, though: no stage 1/2 hearing can demonstrate protection against Covid-19.
This requires a so-called Phase 3 trial, in which a large number of volunteers are given either a vaccine or a placebo. A Phase 3 trial may also reveal harmful side effects missed by small liminary studies.
In their paper, the Russian scientists wrote that they had received approval on August 26 for a Phase 3 trial on 40,000 people. there are Seven Other vaccines are currently in late-stage trials. Johnson and Johnson are expected to begin their Phase 3 lawsuit later this month, and Novavax is expected to make its own debut in October, bringing the total to 10.
Dr Bar-Zeev said it could take months for clear results to be obtained in Phase 3 tests, and they should still be carefully reviewed before a decision is made on whether to use the vaccine widely. Let’s go.
“Yes, we all want vaccines, but we don’t want to make a mistake,” he said. “So stay there and wait, so we know where we’re going.”
Andrey K. Kramer contributed to the reporting from Moscow.