Clinical Trials for Skolkovo Resident Covid Vaccine Begin in October
The Ministry of Health in Russia approved the first and second phases of clinical trials for the covid-19 vaccine “Betuvaks-CoV-2” (RKI No.581, 27.09.2021).
The drug only contains surface antigens of the coronavirus, which reduce the protein content and, consequently, its allergenic potency. The trials will take place on 170 patients at clinical centers in St. Petersburg and Perm. The vaccine was developed by the Skolkovo (VEB.RF Group) resident company Betuvaks, part of the Human Stem Cells Institute.
Russia's Ministry of Health approved phases 1-2 of clinical trials for the Betuvaks-CoV-2 vaccine against the coronavirus. Photo: Sk.ru
Betuvaks-CoV-2 is a recombinant subunit new generation vaccine based on spherical particles, which contain surface antigens (proteins) of the coronavirus. The vaccine does not carry genetic material, excessive antigen load, additional preservatives, stabilizers, and non-organic adjuvants, minimizing the risks of side effects.
Natalia Polushkina, vice-president, deputy director of the biomedical technologies cluster of the Skolkovo Foundation: “For nearly two years, the world has been directing huge efforts into fighting SARS-CoV-2. During this time, Foundation residents have offered many effective solutions in this direction. Undoubtedly, the next achievement was the approval for clinical trials for a new vaccine by the company Betuvaks, a Skolkovo resident. Many vaccine developments are underway worldwide; however, few are making it to the finish line. We hope that in the course of clinical testing, the Betuvaks-CoV-2 vaccine will prove its high efficacy and improved safety profile, which will make its wide usage possible.”
Subunit vaccines have fewer side effects than others, which is particularly important for risk groups and offers good prospects for repeat booster shots. In addition, the Betuvaks-CoV-2 vaccine design makes it possible to optimize it quickly for new strains of Covid-19.
Artur Isaev, chairman of the board of directors of the Human Stem Cells Institute: “From the moment of filing the dossier, gaining approval from the Ministry of Health for clinical trials took four months. I believe that this is a normal, well-founded timeframe for experts to examine and consider in detail the submitted package of documents – a lot of pre-clinical trials and many dossier materials in general. I am grateful to the Ministry of Health and its experts for their good study of the dossier and recommendations which we have considered. Betuvaks is a recombinant subunit vaccine. That type of vaccine is known to the professional medical community as causing the minimum undesirable side effects. Another side of the coin is that to develop subunit vaccines requires a little more time and effort.”
According to the results of the pre-clinical trials, the Betuvaks-CoV-2 vaccine showed an exemplary safety and efficacy profile, forming high titers of neutralizing antibodies against SARS-CoV-2 in animals. The Moscow Seed Fund supported the development of the vaccine.