Vaccine Convacell® received the registration in Russia

21 March 2022

   The Saint Petersburg Scientific Research Institute of Vaccines and Sera of the FMBA of Russia received the marketing authorization for the innovative vaccine for COVID-19 prevention - Convacell®. The vaccine has been developed by the group of scientists and tecnologists of the institute by order of the head of FMBA of Russia, Veronika Skvortsova.  The certificate № LP-007967 was issued by the Ministry of Health on March 18, 2022.   

    «The recombinant subunit vaccine against COVID-19, Convacell®, is the first vaccine in the world based on the application of the components of a nucleocapsid N protein of the SARS-CoV-2 virus, and not of a surface spike protein S. The nucleocapside N protein of the SARS-CoV-2 has the highest immunogenicity in respect to cellular and humoral immunity beginning from the early stages of contagion and is characterized by high conservatism having not only high identity between the lines of the SARS-CoV-2 virus but more than 90 % of the homology with other betacoronavirus. The vaccine has been developed on a new technological platform of high capacity. The results of clinical studies have demonstrated that the vaccination with Convacell® in humans leads to 100% production of high titers of specific IgG class antibodies to the N protein, specific cellular immunity polarized according to a Th1 profile safe for humans, formation of specific central memory cells and to the development of pronounced antibody-dependent cytotoxicity. Thus, the Convacell vaccine includes different mechanisms of immune defense and prevents the development of coronavirus infection», - Veronika Skvortsova mentioned.  

   The vaccine Convacell® is characterized by high immunogenicity and protective properties, regardless of mutations in the surface proteins of the virus, including the spike S protein, being almost universal, it is deprived of allergenicity and is well tolerated by humans. 

   Earlier on March 15 during the meeting with the President of the Russian Federation the head of FMBA of Russia reported on the main areas of the Agency’s work, including the ongoing efforts to combat the spread of COVID-19, in particular, the development of the preventive vaccine Convacell®.

 We recall that in June 2021, preclinical trials of the vaccine formulation were successfully completed, proving safety, immunogenicity, and protective capacity of vaccine.

   On July 19, 2021, the Federal Medical and Biologic Agency obtained an official approval from the Ministry of Health of the Russian Federation to conduct Phase I and Phase II clinical trials of a sub-unit recombinant vaccine for the prevention of the coronavirus infection caused by SARS-CoV-2.

   We consider it important to note that vaccination remains the most reliable way to protect yourself against COVID