Information on the production of the Sputnik V vaccine

Today, a press tour to the production site of Karaganda Pharmaceutical Complex LLP took place, during which the General Director of LLP Sergey Baron, as well as the Deputy Chairman of the Medical and Pharmaceutical Control Committee of the Ministry of Health of the Republic of Kazakhstan Nurlybek Asylbekov, introduced the media representatives with the production of the Russian vaccine against corona virus infection Sputnik V “.
On August 26, 2020, SK-Pharmacia and the Russian Direct Investment Fund (RDIF) signed an agreement on mutual understanding and the allocation of a guaranteed volume of Sputnik V corona virus vaccine.
On November 11, 2020, in a telephone conversation, President of the Republic of Kazakhstan Kassym-Jomart Tokayev and President of the Russian Federation Vladimir Putin discussed the intensification of cooperation in the fight against the pandemic, including plans to organize joint production of vaccines in the territory of Kazakhstan.
On December 4, 2020, RDIF entered into a cooperation agreement with the Ministry of Health of the Republic of Kazakhstan, and on December 13, 2020, Karaganda Pharmaceutical Complex LLP received a substance for the production of a pilot batch of the drug in the amount of 6 thousand doses.
“Together with the working group of the Ministry of Health of the Republic of Kazakhstan, partners from RDIF and Generium, a roadmap has been developed, all issues are discussed on a daily basis. We carried out a technology transfer, preparation of production, retrofitting with refrigeration equipment, personnel training and started production a pilot series of vaccines for the study of its quality and registration in Kazakhstan “, – noted S. Baron.
From December 24, 2020 to January 21, 2021, the vaccine will undergo quality control of the experimental series at the N.N. N.F. Gamalei. In case of successful verification from January 26 to February 11, 2021, it is planned to register the drug in the Republic of Kazakhstan.
“We plan to complete the registration of the vaccine produced at our site and transfer the first batch to RDIF by February 12, 2021. The Russian Direct Investment Fund is the owner of the product and the supplier of the vaccine to the United Distributor of SK-Pharmacia LLP,” said Baron.
It is expected that in February 2021, 80 thousand doses of the Sputnik V vaccine will be produced, in March – 150 thousand doses, and from April the volumes will be increased to 600 thousand doses.
“At the initial stage, it is planned to vaccinate medical workers, primarily the staff of infectious diseases hospitals and emergency medical care, as well as teachers who, by the nature of their professional activities, are at high risk of infection, for whom it is difficult or acceptable to work remotely,” N. Asylbekov.
According to the preliminary need, for immunization of 20% of the population, from 6 million doses and up to 20 million doses are needed for 50% of the population, taking into account the two-fold immunization schedule. The final data on the need for the vaccine is being formed. Currently, the Ministry of Health is working to prepare a plan for organizing and conducting vaccination against COVID-19. Vaccination against CVI will be organized on the basis of the existing vaccination rooms of medical organizations conducting routine preventive vaccinations.
During the press tour, journalists were able to get acquainted with the vaccine production process, visit the workshop for injectable and lyophilized drugs, the labeling line, secondary packaging and storage of the vaccine.