Polina Nikolskaya, Polina Ivanova
MOSCOW (Reuters) – Russia will announce the interim results of the third and final phase of the coronavirus vaccine research after the first six weeks of testing, the head of the drug development institute told Reuters.
Alexander Gintsburg, director of the Gamaleya Research Center, whose Sputnik V vaccine was registered on August 11, said that an “intermediate frame” of 42 days from the start of research on September 9 was set by a scientist from the Russian Ministry of Health.
That is, the interim results may be announced after October 21.
“Why not enough? First, we need to inform you, inform the public. For me, for example, it is not enough, but for people who are interested in how things are going, there are already a lot. But the trend will already be visible,” he said, adding, that observations will be carried out for another 180 days from the date of vaccination of the last volunteer.
Interim results are expected in October or November, said the Russian Direct Investment Fund (RDIF), which has invested in the vaccine. The plan to publish interim results means that Russia has a great chance of becoming the first country in the world to announce any data obtained during the final phase of the test.
Several Western developers are also currently running final tests, which have been going on for over 42 days, but do not publish intermediate results.
Since the beginning of September, about 5,000 volunteers have already received the first vaccination against coronavirus in Russia. Of these, more than 1,000 are people over 50, Gunzburg says. 14-15% had the side effects indicated in the instructions.
“This means that the remaining 85% did not feel at all that they were vaccinated. No fever, no redness in the shoulder, no aches in the back, arm and no headache,” he said.
Also, the day before the start of the third phase of research, the first batch of Sputnik V was released into civilian circulation – for voluntary vaccination of people at risk. First of all, medical workers and teachers, said earlier Minister of Health Mikhail Murashko. At the moment, about 400 people from risk groups have been vaccinated, according to the Ministry of Health. They undergo less rigorous medical examinations than volunteers.
A government source told Reuters that after the interim results have been summed up, a decision may also be made to extend the age range for vaccination to include risk groups over 60.
There are age groups in the post-registration studies of Sputnik V.
“A certain number of 60-year-olds should be recruited, plus 70-year-olds and even 80-year-olds,” Gunzburg said.
But “nobody else forms any groups on purpose,” he said, answering a question whether, for example, there are groups of ethnic origin among the volunteers.
Vaccine manufacturers from other countries have promised to include volunteers of different races, ethnicity, gender, age and other factors in the studies.
A total of 40,000 volunteers are participating in the study, 10,000 of whom will receive a placebo.
“You can imagine, the cost, if we are talking about 40,000, is significant. Therefore, such an experience could only be pulled by the Moscow government in terms of the scale of the organization, with the support of the Russian Ministry of Health.”
WITHOUT SPECIAL INFECTION
Vaccine companies in several other countries began mass trials in Brazil, South Africa and the United States, as the epidemic had already peaked in European cities at that time and the transmission rate of coronavirus had decreased.
On September 9, when the post-registration tests of the Sputnik V vaccine began, 642 new cases of coronavirus infection were registered in Moscow; on September 28, this figure increased to 2,217. For comparison, at its peak in May, Moscow recorded 6,169 new infections.
Studies in which volunteers are specially infected with COVID-19 are not possible in Russia, Gunzburg said. Earlier, the Financial Times, citing sources, reported that such studies are planned to be carried out in the UK.
“Although I have nothing to do with official documents, orders, permits, I am more than sure that it is not in the tradition of Russian medicine to infect people. Ethically. The news also surprised us.”
Russian scientists, according to Gunzburg, are guided that the Sputnik V vaccine will be 75% more effective than a placebo, which is higher than the 50% threshold for the coronavirus vaccine set by the US Food and Drug Administration.
Chief Scientist of the World Health Organization Sumya Swaminatan said earlier that vaccines against coronavirus developed by different countries should show an efficiency of at least 50%.
After the end of the third phase, scientists plan to publish an article on the research results “in a highly rated English-language journal,” Gunzburg said.
The Gamaleya Center also plans to conduct a “complex experiment”, examining not only the level of antibodies, but also memory cells in military personnel who were vaccinated in the second phase of research.
“Among any organized collectives, it does not matter, military or non-military, it is very interesting to see what they will have with the intensity of immunity in six months, a year or two.”
“LIKE IN WAR”
Scientists at the Gamaleya Institute began developing a Russian vaccine at the end of February, when they received a government order from the Ministry of Health. The time frame was short: in five months, scientists completed the entire set of studies, Gunzburg said. They managed to meet them, since the center had already worked for many years with a platform that became the basis for a new vaccine, he added.
In April, the Russian government issued a decree authorizing fast-track drug registration in an emergency. In August, President Vladimir Putin announced that Russia was the first in the world to register a coronavirus vaccine.
International observers have publicly questioned whether the speed with which Russia is introducing the vaccine into circulation means that Moscow is prioritizing national prestige over safety.
“The accelerated procedure is not the same as that we, as it appeared in some publications, cut corners. In no case, no one cancels any procedures aimed at proving the safety and efficacy of the drug with this decree,” said Gunzburg.
The scientist who has headed the Gamaleya Institute for 23 years said that the speed with which Russia is introducing the coronavirus vaccine is justified “on the basis of moral, ethical considerations.”
“A pandemic is an extreme condition, namely, how people die in a war,” says Gunzburg. “If the relatives of those who died are offered to be vaccinated with a vaccine that had no comments on the first and second phases, or to wait for the results of the third phase, as do you think we would have heard the answer? ”
According to him, now “there is no indication that the developed vaccine differs in its side effects from those vaccines that are in the national vaccination schedules of many hundreds of countries.”
“As for those people who already serve commercial interests related to making money, very big money, very big money, problems begin here for obvious reasons. Nobody expected Russia with their drug on this supposedly free market, where, as we understand, every vial and every ampoule (vaccine) is divided 10 years ahead, “said Gunzburg, sitting in his office under the lifetime portrait of the famous Russian biologist Ilya Mechnikov.
After the publication in the international scientific journal Lancet of articles by the staff of the Gamaleya center on the first and second phases of research, Western scientists published an open letter. In it, they drew attention to some statistical anomalies.
“I got the impression that none of the people who signed this letter have ever created a single vaccine in their life,” Gunzburg said.
But when Lancet himself asked to explain the data, the developers sent a letter there with explanations. The Gamaleya Center will publish the original research data only at the request of the journal.
“But the Lancet, as far as I know, said that they were completely satisfied with our answer, and put an end to that.”
In April, the 68-year-old Gunzburg promised Putin via videoconference that, with additional funding, the institute could increase the production of vaccines to 4-5 million doses a year if the entire cycle, including packaging, remains in the center of Gamalea.
“In November, we will reach, in October, the level of production that was discussed at that meeting,” Gunzburg said, refusing to specify exactly what volumes are being discussed.
Now trial batches have arrived in all regions of the country, and not a single temperature violation sensor has worked, Gunzburg said. So far, the vaccine is administered only in the form of a solution, which requires storage in frozen form with a strict temperature regime. In the future, it is planned to establish the production of a powder form – a lyophilisate, the production of which is longer and technologically more expensive.
The capacity to start mass vaccination when anyone can get the vaccine is not enough for the Gamaleya center alone.
“Now other, more powerful sites are connected. And when they are connected, I think, within a year (from the moment the vaccine was introduced into civilian circulation), accordingly, we can carry out mass vaccination of the population,” Gunzburg said. “I will allow myself one figure from the textbooks. , we must strive for 70-75-80% coverage of the population with this vaccine in order to stop the circulation of this virus at the population level. ”
(Editor Anton Zverev)