Convacell® is a first vaccine in the world on the nucleocapsid (N) protein basis of the SARS-CoV-2 virus.
First-generation vaccines are aimed at the production of neutralizing antibodies to the surface S protein of the original coronavirus strain, which was appropriate only at the beginning of the pandemic, before the emergence of new coronavirus strains due to S protein mutations. The action of Convacell® is directed to another, nucleocapsid N protein of the SARS-CoV-2 virus, which is identical in all virus strains.
Thus, we can assume that Convacell® is a versatile or pan-COVID vaccine.
Vaccination with Convacell® results in 100% production of high titers of specific IgG antibodies to the nucleocapsid N protein of the SARS-CoV-2 virus, specific cellular immunity with Th1 polarization, which is safe for humans, and generation of specific central memory cells, as well as the development of pronounced antibody-dependent cytotoxicity.
Convacell-induced post-vaccination immunity proved by observations lasts for more than a year.
Other developers have begun to create COVID-19 vaccines with an action directed to the nucleocapsid (N) protein only in 2022.
What does the vaccine name mean?
Co – coronavirus, N – N protein, Va – vaccine, Cell - cell.
Vaccine composition:
Convacell® is an emulsion for intramuscular injection.
1 dose (0.5 mL) contains:
Active substance:
N1New protein – 50.0 µg
Convacell® is a recombinant nucleocapsid protein of the SARS-CoV-2 virus produced in Escherichia coli with a mixture of excipients in the form of emulsion.
Launch of the Research and Development Center (R&D Center) of the Saint Petersburg Institute of Vaccines and Sera of the Federal Medical and Biologic Agency of Russia
April 2020
WHO included the first Russian development – a candidate vaccine of the Saint Petersburg Institute of Vaccines and Sera of the Federal Medical and Biologic Agency of Russia – in the list of candidate vaccines
“We started developing the vaccine when the pre-marketing trials of the first two vaccines, Sputnik and EpiVacCorona, had been completed. And we initially took a different path in order to level out those possible changes that occurred in the structure of the so-called S, or spike, protein – the outer protein of the SARS-CoV-2 virus.
We faced the task of finding such protein structures that, on the one hand, were conservative and minimally variable, and, on the other hand, were immunogenic, i.e. induced immunity, predominantly cellular one. In addition, this vaccine had to be protective, i.e. having a huge defensive potential.”
HEAD OF FMBA OF RUSSIA
VERONIKA SKVORTSOVA
December 2020
The first formula of the candidate vaccine was received
“Preclinical development took almost a year and was finished in June 2021. In our preclinical trials, we confirmed the immunogenicity and revealed the mechanisms of cellular immunity generation. The immunogenicity was confirmed, but we needed to go further – to conduct a number of experiments to study the protective properties of these activated cells of the immune system.
The experiments were carried out on various small animals: mice, rabbits, golden hamsters. It was demonstrated that these activated immune cells really prevented the damage to organs, primarily the bronchopulmonary system, and actually protected the lung tissue in animals, which was very important. This combination of safety, immunogenicity and protectivity allowed us to complete the preclinical trials.”
HEAD OF FMBA OF RUSSIA
VERONIKA SKVORTSOVA
March 2021
A new technological platform - recombinant products - was created
June 2021
Interim report of preclinical trials (PCTs) was received
July 2021
Permission to conduct Phases I and II clinical trials (CTs) was obtained
September 2021
The Recombinant Preparations Production Area of the Saint Petersburg Institute of Vaccines and Sera of the Federal Medical and Biologic Agency of Russia was launched. The new production area was built and launched as part of the Year of Science and Technology events in the Russian Federation
January 2022
A package of documents for the registration of a new generation COVID-19 vaccine was submitted to the Russian Ministry of Health. The product was named Convacell®
“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.”
HEAD OF FMBA OF RUSSIA
VERONIKA SKVORTSOVA
March 2022
On March 18, a marketing authorization for the innovative COVID-19 vaccine Convacell® was obtained
“The subunit recombinant COVID-19 vaccine Convacell® is the world's first vaccine based on components of the nucleocapsid N protein of the SARS-CoV-2 virus instead of the surface spike S protein.
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 practically universal; it is non-allergenic and is well tolerated by humans.”
HEAD OF FMBA OF RUSSIA
VERONIKA SKVORTSOVA
April 2022
Commercial production of Convacell® was launched
“After the transfer of the vaccine production technology from the Research and Development Center of the Saint Petersburg Institute of Vaccines and Sera of the Federal Medical and Biologic Agency of Russia to the Recombinant Preparations Production Area, the production technology optimization process was started to ensure the production of Convacell® in required commercial volumes."
FIRST DEPUTY DIRECTOR OF SPbSRIVS
ANATOLY EVTUSHENKO
