Betuvax-CoV-2 vaccine to undergo phase 3 clinical trial

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Betuvax a company of the Human Stem Cell Institute group (HSCI, MOEX: ISKJ), plans to conduct phase 3 clinical trials of its Betuvax-Cov-2 vaccine for the prevention of coronavirus infection.

The company entered into an agreement with Autonomous Nonprofit Organization Clinical Research Center for the preparation of a document dossier for submission to the Ministry of Health of the Russian Federation for a permit to conduct a phase 3 trial.

Initially, the company planned fast-track registration of the Betuvax-Cov-2 vaccine to obtain a temporary use authorization (in accordance with Decree of the Government of the Russian Federation No. 441 of April 3, 2020). However, according to Betuvax director Anna Vakhrusheva: “Having completed phase 1 and 2 clinical trials, we decided to focus on preparing and conducting phase 3 and then submit documents for a marketing authorization for the drug, because a permanent authorization is more meaningful and valuable.”

Reports on the phase 1 and 2 clinical trials have already been prepared. To submit a dossier and obtain a permit to conduct a phase 3 clinical trial, a study protocol must be approved and a set of documents for vaccine production must be prepared.

Work is currently underway to prepare the contract production site in the Perm Region for licensing under the new EAEU rules. Obtaining an updated license for vaccine production was planned for the 1st half of 2023, however, the contract site received a number of comments from the licensing authority which it plans to eliminate before the beginning of clinical trials.

Chairman of the HSCI Board of Directors Artur Isaev: “By developing and supporting technological startups, HSCI has created ecosystem elements in many areas. However, our country has hardly any specialized contract production sites with a full cycle of development and marketing of biomedical products that work with biotech startups. To effectively develop our vaccine portfolio, HSCI is working to create this important element of the ecosystem.”

The results of phase 1 and 2 clinical trials of the Betuvax-Cov-2 vaccine confirmed the high immunogenicity, safety and good tolerability of the new recombinant vaccine. Phase 1 and 2 clinical trials took place at three clinical sites in St. Petersburg and Perm with the participation of healthy volunteers who had not had COVID-19 and had not been immunized with anti-COVID vaccines. During the trials, no serious adverse events associated with the vaccine were reported, such as local or systemic post-vaccination reactions that are common with other vaccines. At the same time, the majority of volunteers developed a high level of specific neutralizing antibodies to the SARS-CoV-2 virus RBD protein.

Betuvax-CoV-2 is a new-generation subunit recombinant vaccine based on spherical particles containing recombinant surface antigen (protein) of coronavirus. The vaccine contains only the surface protein of coronavirus, without additives and other antigens, reducing the stress for the immune system and the risk of adverse reactions when administering the drug. The vaccine does not contain preservatives, viruses, viral vectors, or genetic materials in the form of DNA and RNA.