On Friday, a team of Russian scientists published their first report on the Covid-19 vaccine, which was criticized by President Vladimir Putin for his decision last month before it proved safe and effective through clinical trials.
In a small group of volunteers, the scientists found that the vaccine produced normal levels of antibodies to the coronavirus, with only mild side effects. Research has not yet shown, however, whether people who are vaccinated are less likely to become infected than those who are not.
In August Gust, Mr. Putin announced with great fanfare that the vaccine known as Sputnik V – “works effectively according to belief”. He described the approval as “a very important step for our country and for the world in general.”
But vaccine developers condemned the decision, and observed that no data had been published on the vaccine. In addition, critics say, Russian scientists still conducted large trials of thousands of people, which is necessary to show that the vaccine works.
The new paper, published in the Lancet, contains the first batch of public data from Sputnik VN clinical trials. Independent scientists were impressed by the rigor of the work.
“Science looks like it was done flawlessly,” said Naor Bar-Zive of the Johns Hopkins Bloomberg School of Public Health, who co-authored the commentary on the new paper. However, he warned that no one would know that Sputnik V was safe and effective until the big trial was over.
“If the Russian vaccine is successful, it should be welcomed, and if the other vaccine is successful, it should be welcomed,” said Dr. Said Bar-Zive. “But it should all be evaluated equally strictly.”
Researchers at the Gamalea Research Institute in Moscow used the design for the vaccine, which they first developed and tested for the virus, MERS.
The Sputnik VN vaccine, which causes covid-19, stimulates the immune system by coaxing individual cells to make proteins commonly found on the coronavirus. The researchers passed the gene for this viral protein to another virus, called adenovirus.
When injected into the hand, the adenovirus goes into the muscle cells. It has been genetically engineered so that it cannot replicate itself or cause disease. But once it delivers the coronavirus gene to the cell, the cell begins to make proteins.
Similar adenovirus-based vaccines are also being tested by Strazeneca, 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 in one vaccine. For their initial medical trial, the Gamalea researchers gave the volunteers an initial shot of an adenovirus called ad26, and then, three weeks later, a shot of a shot called ad5.
In the Lancet paper, the researchers said they tested the vaccine on hamsters and monkeys. They claimed that the animals were protected against coronavirus without any harmful side effects, but their new paper did not present any data about this study.
The same trial they conducted on human volunteers is known as the 1/2 phase. It was small: only 40 volunteers were fully vaccinated against both types of adenovirus. No one found a placebo.
By comparison, the Chinese company Cancinobio conducted a 1/2 phase trial involving 382 people who received the vaccine and 126 others who were given a placebo.
The Russian vaccine produced mild symptoms in many subjects, including general fever and headache. Other adenovirus-based vaccines have produced similar side effects.
“You have to expect that there are some symptoms – it’s normal,” Dr. Bar-Zive said.
The researchers found that volunteers who received the full vaccine produced antibodies that could prevent the virus from copying into cells.
To estimate the effectiveness of their vaccine, Russian researchers compared the levels of antibodies with samples taken from people who had recovered from a natural infection with Covid-19. Convexant plasma, as these specimens are known, contains antibodies to the virus that people make themselves.
In the paper, the researchers said that vaccinated people had the same levels of antibodies as those found in convulsant plasma.
Akiko Iwasaki, an immunologist at Yale University who was not involved in the study, said the vaccine “produces good antibody levels in all volunteers.”
But in a news release, the Gamalea organization suggested that its vaccine is better than AstraZeneca. It states that the level of antibodies of vaccinated volunteers is “1.4-1.5 times higher than the level of antibodies of patients who have recovered from Covid-19.”
AstraZeneca, they claimed, produced only antibody levels similar to those of nonvalent plasma.
It is not clear why the paper presents a different picture. The study authors did not respond to a request for comment.
Outbreak of Corona virus>
Frequently Asked Questions
Updated September 4, 2020
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What are the symptoms of coronavirus?
- At first, the coronavirus seemed to be primarily a respiratory illness – many patients had fevers and colds, were weak and tired, and breathed a lot, although some did not show many symptoms. Those who looked sick had pneumonia or acute respiratory distress syndrome and received supplemental oxygen. So far, doctors have identified many more symptoms and syndromes. In April, the CDC added to the list of signs of the onset of sore throats, fevers, colds and muscle aches. Gastrointestinal discomfort such as diarrhea and ause baka have also been observed. Another telling sign of infection is that a sudden, profound decrease in one’s sense of smell and taste can occur. In some cases, adolescents and young adults have developed painful red and purple lesions on their fingers and toes, called “covid toes” – but some other serious symptoms.
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Why is it safe to spend time outside together?
- The risk of outdoor gatherings is low because the wind spreads viral drops, and sunlight can kill some viruses. University of Leicester virologist Dr. Julian W. Tang said that open spaces prevent the virus from infecting and inhaling concentrated amounts, while infected people can breathe in confined spaces for longer periods of time. Julian W. Tang said.
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Why does it help to stand six feet away from the other?
- Coronavirus is mainly spread through your mouth and nasal drops, especially when you cough or sneeze. The CDC, one of the organizations using the measure, supports the six-foot recommendation on its feet that when coughing or sneezing, most of the large drops that people emit will fall to the ground within six feet. But six feet has never been a magic number that guarantees complete protection. For example, sneezing can drop as much as six feet, according to a recent study. That’s the rule of thumb: You should be safe outside six feet, especially when the wind is blowing. But always keep the mask on whenever you think you are too far away.
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I have antibodies. Am I immune now?
- For now, that seems likely, at least for a few months. The second quarrel of Kovid-19 seems to have been a terrible reckoning of the people. But experts say that while these patients may have a course of pulling the infection, the virus takes a slow week to months after initial exposure. People infected with the coronavirus usually produce immune molecules called antibodies, which are protective proteins made in response to infection. Harvard University immunologist Dr. “These antibodies can only last two to three months in the body, which is worrying, but they are completely normal once the acute infection subsides,” said Michael Meena. It is possible to get coronavirus again, but early infection will make it possible in a short time or make people sick a second time.
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What are my rights if I am worried about returning to work?
John Moore, a virologist at Will Cornell Medicine in New York, who was not involved in the study, said it was too early to make any meaningful comparison between the various Covid-19 vaccines. Each team uses different tests to measure antibody levels. And in each group of recovered patients they study for convulsive plasma, they may have different levels of antibodies.
“We’ve been suffering from an apple-to-orange situation for a long time, but now we’re in the realm of fruit salad, and that banana is trying to get me out of all this.”
One thing is clear though: no phase 1/2 trial will be able to demonstrate protection against Covid-19.
That 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 a small initial study.
In his paper, Russian scientists wrote that they had received approval on August 26 to conduct a Phase 3 trial on 40,000 people. There are currently seven other vaccines in this late phased trial. Johnson and Johnson are expected to begin their Phase 3 trial later this month, and Novavax will make its own debut in October, reaching a total of 10.
D Bar. Bar-Zive said it could take months to get clear results in phase tri tests, and even then, they would have to be carefully reviewed before a decision could be made to use the vaccine widely.
“Yes, we all want a vaccine, but we don’t want to make a mistake,” he said. “So stop there and wait, so we know what we’re doing.”
Andrew Kramer contributed to the report from Moscow.
