FMBA of Russia files application for marketing authorization for Convacell® vaccine to the Ministry of Health of Russia

26 January 2022

On January 21 the Saint Petersburg Scientific Research Institute of Vaccines and Sera of the FMBA of Russia submitted a package of documents to the Russian Ministry of Health to obtain a marketing authorization of a second-generation COVID-19-vaccine, developed on behalf of Veronika Skvortsova, the head of FMBA of Russia. The product was named Convacell®.

"The COVID-19 vaccine Convacell® is a recombinant nucleocapsid N protein of the SARS-CoV-2 virus, which is highly conservative and does not differ significantly in new strains of the virus, including "omicron," from the original one. The vaccine was developed on a new processing platform and is aimed primarily at the development of specific cellular immunity as well as antibody-dependent cytotoxicity and antibody-dependent virus neutralization, i.e. the vaccine has a complex protective effect, affecting various components of the immune response", said Veronika Skvortsova, Head of FMBA of Russia.

As it is known, the vast majority of epitopes in protein N of different SARS-CoV-2 strains remain identical, therefore, an almost identical immune response is expected when an individual vaccinated with Convacell® vaccine encounters different mutations and variants of the SARS-CoV-2 virus strain. For example, only four mutations were identified for protein N in the B.1.1.529 "omicron" strain, while there are 32 mutations, i.e. eight times as many, for protein S, which is targeted by the first-generation vaccines.

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.

The results of the clinical trial have shown that vaccination with Convacell® results in development of a confirmed immunity in humans preventing the development of coronavirus infection, an increase in titers of specific IgG antibodies against protein N, proliferation of specifically activated CD4+ T-cells and antibody-dependent cytotoxicity and intracellular virus-neutralization. None of the volunteers who received the vaccine fell ill with COVID-19 during the entire observation period.

It is expected that the drug will be produced at the facilities of a new production area for recombinant products opened in 2021, as part of the Year of Science and Technology on the basis of FSUE SPbSRIVS FMBA of Russia in St. Petersburg.