The Russian holding company Natsimbio (part of Rostec Group of Companies) has received permission from the Ministry of Health of the Russian Federation to conduct Phase I clinical trials of UltrixCovi, an influenza and COVID vaccine, the press service of the state corporation reported. Research on its safety and efficacy is planned to be completed by the end of 2025.
The new vaccine was developed jointly with specialists from the Polio Institute of the M.P. Chumakov Federal Scientific Center for Research and Development of Immunobiological Drugs. The influenza component is going to be produced at the Fort enterprise (part of Natsibio), and the COVID-19 component at the Polio Institute (a federal institution of the Ministry of Education and Science).
“The UltraCovi vaccine is a completely domestic development, focused on the needs of patients and doctors. It combines protection against influenza and COVID-19, which is especially important during the simultaneous circulation of the viruses,” said Andrei Zagorsky, general director of Natsimbio.
As follows from the State Register of Drugs, the trials will be held on the basis of the Medical and Sanitary Unit No. 163 of the FMBA in the Novosibirsk region and in OOO AIx Clinic in Yaroslavl. 130 patients will take part in the trials.
The influenza component of the new drug is identical to that used in Ultrix Quadri, Russia’s first quadrivalent flu vaccine. The COVID component of coronavirus infection is produced with the CoviVac vaccine manufacturing technology. The manufacturer claims that in addition to maximum technological compatibility with the influenza part there is also a synergy effect in the development of immunity to several pathogens at the same time.
Earlier, Rostec announced the withdrawal of Natsimbio from a joint project with Artgen Biotech, in which they were to develop a combined vaccine against influenza and coronavirus infection. The company said that it will continue to develop a combined vaccine with another partner. Cooperation with Artgen Biotech was suspended due to some objections to the drug development process.