About the vaccine to prevent the novel coronavirus infection COVID-19, Gam-COVID-Vac, developed by the National Research Centre for Epidemiology and Microbiology named after academician N.F. Gamalei
About the vaccine to prevent the novel coronavirus infection COVID-19, «Gam-COVID-Vac», 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» vaccine, 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, has shown its efficacy and safety in human use based on the results of preclinical and clinical trials. It was proved that the vaccine forms SARS-CoV-2 as an antibody and cellular immune response, that will put a barrier on the spread of dangerous infection and save people's lives and health. There were no serious adverse reactions detected when conducting clinical trials in few sites.
National Research Centre for Epidemiology and Microbiology named after academician N.F. Gamalei of the Russian Ministry of Health has experience in developing and manufacturing of recombinant adenovirus vector-based, for example creation and manufacture of vaccines for the prevention of Ebola.
The state registration of the vaccine is carried out by the Ministry of Healthcare in line with current Russian legislation, with post-marketing measures according to the decree of the Government of the Russian Federation No. 441 of 03.04.2020. It should be noted that procedure of marketing authorization "on conditions" exists in other countries.
It is unacceptable for organizations that do not have complete information on these issues to distort the terms of pre-marketing and marketing procedures for medicinal products in the Russian Federation.
Post-marketing measures to control vacine efficacy and safety include clinical trial with a total coverage of 2000 people. At the same time, the quality and safety of the vaccine will be monitored at all stages of its life cycle.
The pharmacovigilance system was established and operates effectively in the Russian Federation, it allows to track all serious adverse reactions when using any medicine registered in the Russian Federation and take the necessary response measures.
The system of admission to civil circulation of immunobiological medicines, primarily vaccines, requires mandatory quality control of each batch for all quality indicators in laboratory complexes and permission from Roszdravnadzor to enter into civil circulation. The existing system of admission to civil circulation in conjunction with the system of state quality control of medicines guarantees the receipt of vaccines of the established quality.
