MOSCOW, January 9. /TASS/. Russian scientists plan to wrap up clinical trials of a domestic polio vaccine by mid-2018. Additionally, they are drawing up the necessary documents for its registration, Director of the Chumakov Federal Scientific Center for Research and Development of Immune and Biological Products at the Russian Academy of Sciences, Aydar Ishmukhametov, told TASS.
"In accordance with the current legislation, we will submit a full package of documents to register the drug with the Ministry of Health after the end of the clinical trials. Clinical research will be conducted in three stages and will involve more than 600 volunteers. We plan to complete clinical trials and evaluate their results by mid-2018," he said.
At present, there are two types of vaccines in the world. One is the live (oral) Sabin strain vaccine and the other, an inactivated poliovirus vaccine, which contains killed (inactivated) polioviruses.
The innovative polio vaccine was developed based on weakened polio strains - the Sabin strains. "The mechanism of its function is standard. The antigen (inactivated virus) introduced into the body stimulates the immune system of a vaccine recipient, which responds by developing the antibodies neutralizing viruses," Ishmukhametov added.
He noted that during the animal testing phase the vaccine had proved to be safe, while having sufficient immunizing power (the ability to create an immune response against three types of polioviruses).
The development of a domestic inactivated vaccine at the Chumakov Federal Scientific Center for Research and Development of Immune and Biological Products has been going on for 10 years now. According to the center’s director, "it is very difficult to calculate the exact amount of funding spent on research and the development of the vaccine." "Nevertheless, the center has invested over $5 mln over the past two years to conduct final laboratory research," he added.
Ishmukhametov also noted that the center would need substantial investment to launch large-scale production. "Of course, we look forward to government support for our project," he added. "We have no intention of stopping here and plan to develop a multicomponent vaccine based on the inactivated polio vaccine," he said.