The first Russian HPV vaccine will be tested on children in 2024

0
843
Nanolek, a Russian biopharmaceutical company, will test its human papillomavirus (HPV) vaccine on children aged 9-17 in 2024. The company stated that the drug’s impact has already been investigated in adult patients, yielding promising results.
The start of a project to develop a vaccine under the trade name “Tsegardex” was announced in 2020. It has been confirmed that the entire vaccine production process, including the manufacturing of the active substance, will take place at a plant located in the Kirov region. The drug underwent a thorough evaluation for safety and immunogenicity during the first phase of clinical trials that took place in 2021. The performance of the domestic vaccine turned out to be comparable to those of the American drug produced by MSD.
During the conclusive stage of the clinical trial, which ended in 2023, the development demonstrated a degree of tolerability and safety. The observed side effects were predominantly limited to local reactions at the injection site. These studies were conducted in adult patients. After testing the drug on children and adolescents, the company plans to bring “Tsegardex” to the market.