While the “Sputnik-V” coronavirus vaccine developed by Russia is expanding overseas markets, the Russian government announced that the validity rate of the country’s second coronavirus vaccine “EpiVacCorona” has reached 100% and will begin mass production in February.
According to the Russian Satellite News Agency on January 19, the Russian Federal Ministry of Consumer Rights Supervision and Human Welfare Service (Rospotrebnadzor) announced that the results of phase I and phase II clinical trials showed that the “immunization efficiency” of the “EpiVacCorona” vaccine reached 10 0%.
“The overall effect of a vaccine, including immune and preventive effects,” the Russian news department said in a statement.
According to a report on the same day, Russian Deputy Prime Minister Tatyana Golikova said that mass production of the “EpiVacCorona” vaccine will begin in February.
However, Reuters checked the Russian vaccine clinical trial registration system and found that 100 volunteers between the ages of 18 and 60 participated in the phase I and II clinical trials of the vaccine, and the research and development team tested the safety, side effects and immunogenicity of the vaccine.
“Generally speaking, phase III clinical trials require thousands of subjects and placebo groups,” Reuters said.
“In general, the results of early trials of vaccines are based on blood analysis of subjects who have not been exposed to the virus to assess the immune response of the human after vaccination. Larger late clinical trials are based on the actual infection of the subjects in their daily life.
The “EpiVacCorona” vaccine was developed by the Russian “Vector” National Center for Virology and Biotechnology Research (hereinafter referred to as Vector Institute).
The vector is located in Koltsovo in Novosibirsk region.
According to the satellite society, unlike the “satellite-V” vaccine with adenovirus as the vector, the “EpiVacCorona” vaccine is a synthetic peptide vaccine. It is composed of artificially synthesized viral protein fragments, that is, peptides.
The human immune system learns how to recognize and neutralize viruses by synthesizing peptides.
According to Ota, on July 24 last year, Vector obtained the approval of the Russian health department to carry out clinical trials of vaccines on volunteers.
The first volunteer received an injection on July 27.
EpiVacCorona October 14 last year, Russian President Putin announced that the “EpiVacCorona” vaccine was approved and registered in China.
Russian Deputy Prime Minister Tatiana Glikova also said in October that “I have to say that the vaccine (EpiVacCorona) is characterized by no antigenicity and sufficient safety.” At that time, post-registration clinical trials were launched across Russia.
On November 16 last year, the Russian health department approved the vaccine for post-registered clinical trials for people over 60 years old.
Two days later (18th), 3,000 volunteers between the ages of 18 and 60 were approved for the trial.
The document related to “EpiVacCorona” was submitted to the World Health Organization on 8 December, and “we are waiting for the WHO decision”, said Anna Popova, Russia’s chief public health officer.
According to the vaccine registration certificate issued by the Russian State Drug Registry, “EpiVacCorona” is expected to enter the civil circulation field in January 2021.