In the first week of December, the federal authorities announced the start of large-scale vaccination of the population with “Sputnik V”. It will begin in Moscow on Saturday, December 5, and in the regions the following week. Doctors, teachers and social workers will be the first to receive the vaccine. In Moscow, five thousand people expressed a desire to be vaccinated within the first five hours, according to city officials. Will there be enough vaccine for everyone, and when can others expect it? Can it be trusted?
President Vladimir Putin announced the start of the population vaccination campaign on Wednesday, December 2. “Let’s not report to me next week, but start a large-scale vaccination, okay?” Putin suggested to Deputy Prime Minister Tatyana Golikova. “Okay,” the deputy prime minister replied, laughing.
Prior to Putin’s statement, the authorities’ and scientists’ assessments of the timing of vaccination and vaccine production capacities were constantly changing. In August, Deputy Prime Minister Tatyana Golikova claimed that vaccination of health care workers would begin either this summer or in September, and would be available to the general public on January 1. The head of the RDIF, Kirill Dmitriev, claimed on August 20 that vaccination of doctors and teachers would begin “next week.
Currently, more than 100 thousand people have been vaccinated, said Health Minister Mikhail Murashko at the presentation of the Russian vaccine at a special session of the United Nations General Assembly in early December. According to him, the majority of those vaccinated are people from various risk groups.
In November, the head of the Gamaleya Center, Alexander Gintsburg, announced the start of mass vaccinations against Covid-19 in January-February 2021. “When they stop asking whether you are a doctor, teacher, driver, engineer or someone else, in other words, when vaccination will be based on place of residence – that moment should come for us in January-February, when they will be shipping 5-6 million doses [of the vaccine] every month,” he said.
The Russian service of the BBC tried to answer questions about how the vaccination system will work in Russia during the first stage.
We explain quickly, simply, and clearly what happened, why it matters, and what happens next. Episodes End of story Podcast advertising At this stage in Moscow can be vaccinated employees of medical and educational institutions, as well as social services of the city – both public and private, aged from 18 to 60 years. This is stated on the page of the website Mos.ru dedicated to the current stage of vaccination. They are also vaccinating other health and education workers, such as administrators and cleaners, who are “just as at risk as doctors and teachers because they deal with large numbers of people,” said Moscow Deputy Mayor Anastasia Rakova. Some regions are also vaccinating other categories of citizens, such as police officers.
In Moscow, on Friday, employees of educational and health institutions began to receive SMS messages from the Department of Information Technologies of the City Hall, stating that the recipient has “priority right to free vaccination”. BBC News received the message from one of the employees in the education sector.
Contraindications include pregnancy and breastfeeding, as well as chronic diseases – their list is not specified on the announcement page.
The vaccine consists of two parts that must be injected at specific intervals. During the study of the vaccine “Sputnik V” at the N.F. Gamaleya National Research Center of Epidemiology and Microbiology, it was indicated that the vaccination should not be given to those who have had an acute coronary syndrome or stroke in the past year. Contraindications include chronic systemic infections, tuberculosis, neoplasms, hepatitis B and C, syphilis and HIV. In addition, women and men should not participate if they plan to become pregnant within the next three months. Those who have had an acute respiratory viral infection (ARVI) within two weeks prior to vaccination or are currently ill cannot receive the vaccine. In addition, those who have received other vaccinations within the last month or are currently participating in clinical trials of the Gamaleya Center vaccine cannot participate in the current phase of vaccination. Tatiana Golikova also explained that immunity after vaccination is formed within 42 days: during this period a person is recommended to wear a mask, refrain from visiting crowded places and also limit alcohol consumption.
Vaccination is done in two stages: first an injection is given, and after a few weeks a second injection is given. To start the vaccination process in Moscow, you need to find the vaccination center nearest to your polyclinic. This can be done on the website mos.ru. The BBC correspondent, who is attached to one of the clinics in the north of Moscow, was offered to be vaccinated at another branch of the same institution – a 30-minute walk away. After selecting the vaccination site, you can make an appointment at a convenient time. Appointments are available from Saturday, December 5 to Friday, December 18. Time slot – 10 minutes, a total of 55 patients per day can be scheduled for a doctor in a specific location. As of Friday evening, there are only a few slots available on most days. According to the schedule, 15 people have signed up for the first day of vaccination at this clinic. You can register by providing your individual insurance number (SNILS), but the city’s website warns that you must bring a certificate from your workplace confirming that you are eligible to receive the vaccine. In addition to the certificate, you will need to bring your passport and health insurance policy (OMS). Not all regions have yet clarified what their vaccination registration procedure will be. It is most clearly outlined in Moscow.
Currently, only health care, education, and social service workers can receive the vaccine. It is not known when other professions will be able to receive it. The website of the Moscow Mayor’s Office clarifies that the vaccination requires at least one hour of free time. This includes a 10-minute examination by a doctor before the vaccination and another 15 minutes to prepare the vaccine. “The vaccine is stored in a frozen state, and the dose of the drug is thawed separately for each patient after the examination,” the website says. After vaccination, an additional half hour is required for document processing.” The mayor’s website states that there is no need to worry about the second injection yourself – you will be automatically reminded via SMS.
Groups of people who will be vaccinated first have been or will be determined in each country of the world. This is the practice not only in Russia. This is due to the fact that nowhere is there enough capacity to produce the vaccine for the entire population at once. The number of offers should remain:
Doctors, teachers and social workers in Russia have started because they communicate with the maximum number of people and are exposed to the maximum risk of infection and further spread of the infection, says the head of scientific expertise at the venture pharmaceutical fund Inbio Ventures, Ilya Yasny. The authorities in each country decide who should be vaccinated first. In the UK, people in care homes are first in line, followed by people aged 80 and over, health and social care workers, people with chronic illnesses, and then in decreasing order of age. “We apparently do not want to close schools and consider it impossible,” explained Yasny, the beginning of vaccinating teachers on an equal basis with medical professionals. All these schemes will work if the vaccine actually interrupts the chains of infection, the expert reminds. So far, there is no data on this parameter for the main vaccines. The data on efficacy published by manufacturers refer to the prevention of infection.
The first and foremost problem is production capacity. President Putin has openly acknowledged this problem. “The only problem Russia needs to solve for mass production of coronavirus vaccines is a lack of equipment,” he said in late October. Preparations for large-scale vaccine production began in September at the latest. Companies were engaged, capacity expanded and equipment procured. “Until now, vaccines of this type have not been produced in millions of doses anywhere in the world,” says Ilya Yasnii. “To produce a new drug, especially a vaccine, on such a large scale, it usually takes at least a year to scale up production and validate it.” He explains that production validation is the process of obtaining evidence that a quality product is being consistently produced. “At this stage, delays are inevitable, things don’t work out, they have to be redone, and that’s why it takes so much time,” says the expert.
It is unclear whether vaccine production is sufficiently established in Russia. According to him, the political pressure is currently so great that if something goes wrong during production, it will be very difficult to say, “Wait, we need another month to redo everything,” he says. “Under these circumstances, it takes a lot of courage to insist on scientific integrity and to follow all the procedures,” Yasny says. To report to the president on the readiness to mass-produce the vaccine “there was a slight rush,” primarily at the Russian Direct Investment Fund, says a source close to Moscow City Hall, as told the BBC, requesting anonymity, as they are not authorized to comment on such matters in the media. In July, RFPI (Russian Direct Investment Fund) talked about the possibility of jointly producing 200 million doses by the end of 2020, in September – 10 million doses, and now we are talking about two million doses. The problem of scaling up production is primarily systemic, as Russia has not specialized in pharmaceutical production since Soviet times – this was done in the Baltic States and Hungary, explains a source close to the mayor. There is another problem in Russia that does not exist in the West – the division of laboratories and production into state and private, he adds. For example, the Gamaleya Center is state-owned, while pharmaceutical companies are private. “[The Gamaleya Center] refuses to certify products produced by private facilities,” the source explains. “Either private developers should be made [state-owned] – like the Gamaleya Center. Or the producers should be transferred to the state category.” “Filling the vaccine shortage is not a matter of weeks, but of months. The biggest problem with the vaccine is not the development, but the industrial scale,” warned a source close to the Ministry of Health and vaccine developers at the Bi-bi-si in mid-autumn. According to him, during the second phase of the trials, the Gamaleya center was producing “50-70 thousand doses of vaccine per month”. Regions are also complaining about the lack of supplies, despite Prime Minister Mikhail Mishustin’s call this week for regional leaders to begin vaccinations immediately. “We have worked out logistics and storage and are ready to receive supplies,” a source close to the leadership of one of the regions in the Northwest Federal District told the BBC.
The main producers of “Sputnik V” are currently the companies “Generium”, “R-Pharm” and “Binnopharm”. Later, “Medsintez”, “Biocad” and “Farmasintez” will also join the production. The production potential of “Binnopharm” is estimated at about 1.5 million vaccine vials per year, Rustem Muratov, the head of Alium pharmaceutical holding, which owns the plant, told RBK in an interview. The R-Pharm plant announced in September that it would be able to produce about 8 million doses of the “Sputnik V” vaccine per month. According to the plant’s director, Vladimir Kolyshkin, there are two reactors at the plant for the production of the Covid-19 vaccine. “Each of the reactors will allow us to produce about 4 million doses of the vaccine in one cycle. Since the technology is new, we estimate the full cycle to be about 35-37 days. This translates into about 8 million doses per month,” Kolyshkin said. R-Pharm estimates the investment in the production of “Sputnik V” at 8 billion rubles ($108 million). “Generium has promised to produce up to 100 million doses of the vaccine when it reaches full capacity, but the company has not provided any projections regarding the timeline.
The Sputnik V trials were conducted in an expedited manner, which is often criticized by scientists. One ampoule is considered one dose, and for vaccination with “Sputnik V” and other vaccines based on adenoviral vectors, two doses are required – i.e. the indicated number of doses should be divided by two. The publication “Meduza” reported on Friday that in Russia a large quantity of the first component of the vaccine has been produced, but problems arose with the stable production of the second component. According to the publication, the second component of the vaccine turned out to be more demanding in production. Production data is confidential, reminds Professor Dmitry Kulish of the Skolkovo Institute of Science and Technology. According to him, manufacturers have the right not to disclose any information about their capacities.
“We will probably never know the truth except for what official sources tell us,” he says. Kulish sees no reason not to believe the official data that 2 million doses will be released in the near future, and later – 12 million doses.
The Sputnik V vaccine is stored at -18 degrees and is thawed immediately prior to vaccination. Vaccine developers consider this storage temperature an advantage over Pfizer’s vaccine, which must be stored at no higher than -70 degrees. Its transportation requires special refrigerators, which are not available everywhere and only in large cities. Experts consider the complexity of transportation as one of the main disadvantages of the vaccine. Once thawed, the vaccine should be used within five days.
The vaccine must be stored and transported in special refrigerators. For comparison, Moderna’s vaccine can be stored in a regular refrigerator for up to one month, and AstraZeneca’s for up to six months. There is no data yet on the stability of the vaccines. These are separate studies being conducted to select the optimal storage and transportation method. “I don’t know how they are conducted here and if they can be trusted, because it’s classified information. In the case of Pfizer or Moderna, you can look at the expert reports once they are registered and find out what studies were conducted to choose this storage method and how they were evaluated by experts,” says Ilya Yasny.
“In Russia there are at least three cold chains [a continuous series of storage and distribution operations that maintain a certain temperature range] that can easily transport drugs at -18. They were built about five years ago and are absolutely reliable, reaching the remotest corners,” Kulysh tells Sputnik about the transportation process in Russia.
Another problem with the “Sputnik V” vaccine is that the mass vaccination began before obtaining full registration, when the data from the third phase of the study were not yet published, as it is still ongoing, says Ilya Yasny. The so-called “post-registration” vaccine trials may end in May or June 2021, as reported by the Gamaleya Center. “Until detailed clinical data are available, it is difficult to say how effective and safe it really is,” he explains. This can affect people’s confidence in the vaccine and their willingness to be vaccinated. “Confidence in the vaccine is an important factor for mass vaccination,” says Yasny. “Many people refuse to be vaccinated because they know little about the vaccine. In Western countries, this problem is solved by openness. We are not used to such openness. The Western scientific community as a whole has criticized the Russian vaccine, demanding more detailed data on the results of clinical trials. “We were not even given access to the original research data. That means they reserve the right to deny access to the data – this is totally unacceptable!” – Enrico Bucci, a biology professor at Temple University and a well-known crusader against pseudoscience, told the BBC. An employee of one of Moscow’s city hall structures told the BBC that when management urged city hall employees to participate in vaccine trials, the majority refused on the pretext of poor health.
During the fall and early winter in Russia, tens of thousands of new cases of coronavirus infection are reported daily. Recently, Pfizer’s vaccine was also deemed safe for mass use in the United Kingdom and licensed before the end of the third phase of trials. Authorities have said they will begin vaccinating people in the coming days, but warned that there should be no relaxation as the pandemic is not over. The company has released preliminary data showing the vaccine to be 95% effective. Another manufacturer, AstraZeneca, filed for approval and published preliminary results on efficacy, with an average rate of 70.4%. The research protocol of the “Sputnik V” vaccine, unlike other vaccine candidates, has not been published.
“In general, the complete lack of transparency in the procedures of the Ministry of Health does not allow experts to understand what is really happening and on what basis the vaccine has been registered,” says Ilya Yasny. According to the law, the Ministry of Health must publish an expert opinion on its website within five days of registration, but it never does, he notes. He points out that Russia has no experience in independently developing world-class drugs from scratch. So far, no drugs from Russia have been registered in the United States or the European Union. The expert notes that Russia’s internal regulations for production and registration are far behind those of other countries.
Most likely it is possible, but there is no hard data yet. There are only statements from officials and press releases that mention the number of cases in the vaccinated group and the placebo group. The position of the Russian authorities is that the vaccine does not protect a person from the penetration of viruses, including Covid-19, but prevents a severe form of the disease and a fatal outcome. However, these statements about the Covid-19 vaccine are not supported by scientific evidence. During the first wave of the pandemic, some scientists doubted that an effective vaccine could be developed because of the variability of the virus. However, vaccine developers are reporting high efficacy. For example, Pfizer reports 95% protection against coronavirus, meaning that out of 100 people, 95 developed immunity. Moderna has similar efficacy. The Gamaleya Center announced that the effectiveness of “Sputnik V” is 92%. However, Russian scientists have not published detailed public information about the studies. “If there really were 95% fewer cases in the vaccine group, that is a very good and surprising result,” says Ilya Yasny. “Because no one expected such brilliant results from novel vaccines.” According to one expert, the vaccine should not only reduce the incidence of the disease. It should also reduce the likelihood of viral transmission, mortality and the likelihood of developing a severe form of the disease. With the participation of Peter Kozlov.