Moscow outpatient clinics No. 2, No. 220, and No. 62 have received the first batch of a vaccine against the coronavirus, Deputy Moscow Mayor Anastasia Rakova told reporters.
“Today Moscow medical institutions received the first batch of a vaccine against the coronavirus for post-registration trials. Municipal outpatient clinics No.2, No. 220, and No. 62 became pioneers. The medical institutions are completely ready for the study launch which will begin next week,” she said.
The deputy mayor noted that the vaccine is stored under certain conditions, due to which special freezers capable of maintaining a temperature as low as minus 40 degrees centigrade were purchased for the clinics.
As early as today Moscow residents can apply to participate in the study and be the first to obtain the vaccine.
The clinics conducting the study are accredited by Russia’s Healthcare Ministry to hold clinical trials. The specialists will conduct screenings to determine possible contraindications. During six months the participants of the study will be under constant medical observation, including through the use of telemedicine technologies.
“The Moscow government and the Gamaleya National Research Institute of Epidemiology and Microbiology of the Russian Healthcare Ministry invite the residents of the capital to take part in post-registration clinical trials of the vaccine against COVID-19. 40,000 people are invited. The vaccination is free of charge,” the deputy mayor added.
Adult citizens of the Russian Federation with the Moscow health insurance policy may participate provided they didn’t have an acute respiratory infection two weeks before the study, are not sick at the moment of inoculation, did not have the COVID-19 infection (with negative results of the PCR test and a negative test for IgМ and IgG antibodies) and did not contact with COVID-19 cases for at least two weeks prior to the study. Women need to produce a negative pregnancy test. Another must for both women and men is that they should not be trying to conceive within the next three months. The study is to help obtain a permanent registration certificate for the vaccine and expand the circle of its potential recipients, including the age group of over 60 years. The study will last for 180 days.
The Gamaleya Research Institute of Epidemiology and Microbiology under the Russian Health Ministry may be granted permission to release a batch of the newly-developed vaccine Sputnik V against the novel coronavirus for civilian use next week, the institute’s deputy director for research, associate member of the Russian Academy of Sciences, Denis Logunov, said on Friday.
“Its examination is to begin within days. Also, within days we are to obtain permission. There is a certain procedure of authorizing a batch for civilian use. It must pass the quality check of the medical watchdog Roszdravnadzor. Within days, between September 10 and 13, we are to obtain permission to release a batch of the vaccine for civilian use. Respectively, from that moment on the population will begin to be vaccinated,” he said on the Rossiya-24 round-the-clock television news channel.
The vaccine’s distribution will be under the Health Ministry’s purview. Earlier, Health Minister Mikhail Murashko said that at the current stage the term civilian use implied vaccination of people from the risk groups, such as medics and teachers. This procedure will take place alongside post-registration clinical research.
“The vaccine’s registration allows for vaccinating the whole population, but the high-risk groups will come first. There are no restrictions as far as others are concerned, but the Health Ministry has set a task of protecting the risk groups in the first place,” Logunov said.
“The platform [on which the vaccine against the coronavirus has been developed] had been well studied not only by us, but globally, too. It is registered in China, the EU and the United States. The vast evidential base the vaccine is safe was the main pre-requisite for its conditional registration. What does conditional registration allow for? It allows for protecting the risk groups right away without spending two, three, four or five years testing the vaccine on volunteers, during which many people in the high-risk groups may die or be harmed. This resolution allows for starting the protection of the population. That’s what it means,” Logunov said.
Russia on August 11 was the first country in the world to have registered a vaccine against the coronavirus – Sputnik V. The vaccine was created at the Gamaleya Institute and underwent clinical tests in June-July. It is based on a platform that had already been used to create a number of other vaccines. On August 15, the Health Ministry said the vaccine’s production had been launched.
Later, the director of the Gamaleya Institute of Epidemiology and Microbiology, Alexander Gintsburg, told TASS that the vaccination of volunteers as part of post-registration tests would commence at the beginning of September. A total of 40,000 people will be involved. Ten thousand of them will be injected with a placebo substance.
Header: In this handout photo taken on Thursday, Aug. 6, 2020, and provided by Russian Direct Investment Fund, an employee shows a new vaccine at the Nikolai Gamaleya National Center of Epidemiology and Microbiology in Moscow, Russia. Russia on Tuesday, Aug. 11 became the first country to approve a coronavirus vaccine for use in tens of thousands of its citizens despite international skepticism about injections that have not completed clinical trials and were studied in only dozens of people for less than two months. (Alexander Zemlianichenko Jr/ Russian Direct Investment Fund via AP)