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Experts and international organizations received the news with skepticism. Scientists have already written an open letter asking for more data.
The first batch of the Russian coronavirus vaccine entered civil circulation, the Russian Health Ministry said. Deliveries to Russian regions are expected in the near future. The start of mass vaccination is scheduled for October. At the same time, the third phase of clinical trials will take place.
Last week, the developers of the Russian coronavirus vaccine published the results of their initial trials for the first time in the authoritative scientific journal Lancet. It says that the Russian vaccine induces an immune response. Correspondent.net says the details.
Russians are in no rush to queue
On the night of September 8, the Russian Ministry of Health announced that the first batch of the coronavirus vaccine, Sputnik V, developed by the Gamaleya Institute, had been put into civil circulation.
As explained in the department, the vaccine has passed the necessary quality tests in the Roszdravnadzor laboratories. In the near future, delivery of the first batches of vaccine to the Russian regions is expected.
It is reported that this week the first volunteers will receive the COVID-19 vaccine; This will be the third phase of drug testing. And next week, Sputnik V will receive limited quantities from some clinics, said the head of the Russian Ministry of Health, Mikhail Murashko.
In total, in the third test stage, it is planned to vaccinate 40 thousand people. As Deputy Mayor Anastasia Rakova said yesterday, 25,000 Muscovites have signed up as volunteers and are now undergoing medical examinations.
30 thousand volunteers will receive the real medicine, for the remaining ten thousand a placebo was prepared. What exactly is in the vial will not even be known to the vaccinating physician: the so-called double-blind test.
Even before the completion of the third phase, Sputnik V will be able to receive risk groups; this will also be voluntary, said Anatoly Altstein, Doctor of Medical Sciences, employee of the Gamaleya Center for Epidemiology and Microbiology. We talk about doctors and teachers.
According to a VTsIOM poll, more than half of the Russians surveyed still fear being vaccinated against coronavirus domestically. Among the doubts: its effectiveness and side effects. While fever, headache, muscle and joint discomfort have been described.
Sputnik-V is the first registered coronavirus vaccine in the world. It received the registration in Russia on August 11. Since this happened before the third phase of the trial, which involves testing the drug on several thousand volunteers, it was criticized.
This decision was met with skepticism by many experts and organizations, in particular the Association of Clinical Research Organizations, which unites pharmaceutical companies and participants in the Russian clinical research market.
German Health Minister Jens Spahn also warned of the danger of premature vaccination of millions of people.
The World Health Organization has spoken sparingly about the Russian vaccine, urging careful verification of the drug’s safety and efficacy.
Vaccine criticized for small samples and abnormal numbers
On September 4, one of the most prestigious medical scientific publications, the Lancet, published an article by the developers of the Russian vaccine. This is an important step, as peer review by other scientists helps ensure that the conclusions are correct and that the experiments are complete.
The study involved 76 adult volunteers. No unexpected or serious side effects were reported in this small sample.
The authors write that administration of the vaccine elicited an immune response in all volunteers at least 28 days after immunization. Those who received two components of the vaccine, and not just one, the brightness of the immune response is greater.
We are talking about antibodies and the reaction of the cells of the immune system. Not only do vaccinates form antibodies against the “thorn” of the coronavirus, but also the population of so-called T cells – lymphocytes that fight the virus – begins to increase.
A group of Russian scientists also demonstrated that the stable formulation of the lyophilized vaccine they developed works in the same way as its frozen liquid formulation. This is important in the delivery and administration of the vaccine.
The Conversation portal, writing about the research, points out that the most important indicator is not the level of antibody production, but its ability to prevent or neutralize the infection of the cell with the virus.
The levels of neutralizing antibodies in this study are quite low compared to data from other published vaccine trials, the newspaper notes. The same is true of the T cell response.
However, in the absence of international reference standards, it cannot be said how much better or worse this vaccine performs compared to other formulas, notes Conversation.
Furthermore, the authors themselves admit that one of the most important limitations of their work is the very young age of the volunteers, an average of 25 years.
Lancet Editor-in-Chief Richard Horton notes that it would be too premature to talk about the emergence of a working coronavirus vaccine for mass use.
“So far, only one thing is clear to us: the vaccine actually induces the desired immune response … But only 76 volunteers participated in the trials. So far, we can say that the vaccine appears to be safe and does not cause serious side effects. “he said in an interview with CNN.
However, on September 7, a group of scientists from the United States, Italy and other countries published an open letter announcing the discovery of statistical anomalies in an article about the Russian vaccine against coronavirus.
In fact, the letter authors expressed doubts that the data on successful vaccine trials reported in the article are true.
Scientists pay attention to the fact that the level of antibodies in the blood of volunteers after immunization in different groups is the same, although we are talking about different people who received different components of the vaccine.
The scientists who signed the letter urge the creators of the Russian vaccine to publish the “raw” data from the instruments obtained during the measurements and to clarify some other details of the study.
Denis Logunov, an employee at the Gamaleya Center, who oversaw the creation of the vaccine, told Meduza that he did not intend to respond to the open letter.
“If the Lancet editors ask for clarification, we are ready to respond,” Logunov said, noting that there were no errors in the article.
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