The world’s first COVID-19 vaccine has been registered in the Russian Federation
Ministry of Health of the Russian Federation has issued a registration certification № ЛП-006395 dated August 11, 2020 for a vaccine to prevent the novel coronavirus infection COVID-19, which was developed by the National Research Centre for Epidemiology and Microbiology named after academician N.F. Gamalei of the Ministry of Health of the Russian Federation.
Gam-COVID-Vac is a vector two-component vaccine based on the human adenovirus. The vaccine passed all the necessary safety and efficacy trials on several species of animals (rodents and primates), later the vaccine was tested on two groups of volunteers (38 people in each case). The vaccine does not contain the components of the COVID-19 virus. A two-fold injection scheme allows the formation of long-term immunity. The experience of using vector vaccines (with a two-fold scheme of administration) shows that immunity lasts up to 2 years.
«The Russian Federation has a rich history of vaccines development and manufacture: we have many enterprises and research centers that are successfully engaged in this activity, – said the head of Roszdravnadzor Alla Samoylova. – The system of admission to civil circulation of immunobiological medicines, primarily vaccines, requires mandatory quality control of each batch on each quality indicator at the laboratory complexes as well as permission from Roszdravnadzor to enter the civil circulation. In conjunction with the system of state quality control of medicines, such system of entering the market guarantees quality, efficacy and safety of medicines. I am sure that the vaccine created in our country will be a significant breakthrough in the fight against the spread of a new coronavirus infection around the world».