The Gamaleya National Research Center for Epidemiology and Microbiology has announced the completion of clinical trials for a new rotavirus vaccine aimed at children aged 9 months to 6 years. The trials confirmed the vaccine’s effectiveness and safety. According to Izvestia, the vaccine is expected to be introduced into civil circulation in 2026.
The center plans to submit an application for the vaccine’s registration for use in this age group in June. Researchers have now initiated the next stage of clinical trials, testing the vaccine on patients aged 8 to 32 weeks, which is the primary target group for vaccination.
Tatiana Grebennikova, the head of the center’s laboratory of molecular diagnostics, stated in her conversation with the journalists, «For older children, we are applying for registration in June. Once we complete the clinical trial in the target group, we will apply in September. We hope to receive registration of the vaccine for children of all ages. However, when this happens does not solely depend on us, as the Center of Expertise will review the application. I hope the vaccine will be introduced into civil circulation in 2026» .
The center explained that the vaccine is hexavalent, containing six genotypes of the pathogen, while also providing protection against two additional genotypes through cross-immunity. This makes it effective against all eight genotypes of rotavirus infection common in Russia.
Grebennikova noted that the new vaccine is planned to be included in the national vaccination calendar for children aged 8 to 32 weeks, and a special version for adult patients may also be released.
Andrey Prodeus, Chief Children’s Allergist and Immunologist at the Moscow Region Ministry of Health, emphasized the need for a modern and safe rotavirus vaccine. He pointed out that current vaccines are administered to children at 2,5–3 months and again at 6–8 months to achieve the desired effect. The new drug’s broader age range is particularly important.
Mikhail Bolkov, a researcher at the Institute for the Study of Aging at the Russian State Scientific and Clinical Center of the Russian National Research Medical University, highlighted the absence of a modern Russian rotavirus vaccine as a significant technological gap. He noted that virus-like particles can enter a cell without causing harm, making them suitable for a vaccine.
Gamaleya National Research Center for Epidemiology and Microbiology received an approval from the Russian Ministry of Health for the trials of Gam-VLP-rota vaccine for preventing rotavirus infection in 2023. It was reported that the new vaccine, based on virus-like particles, is administered intramuscularly, contrasting with existing oral vaccines (administered as drops) available in Russia.
