EpiVacCorona Vaccine Description
EpiVacCorona is a coronavirus vaccine developed by the Vektor State Research Center of Virology and Biotechnology in Russia.
The EpiVacCorona vaccine contains fragments extracted from the virus — synthetic peptide antigens. The antigens-based vaccine provokes an immune reaction against COVID-19 and promotes the further development of immunity.
On October 14, 2020, Tatyana Alekseevna Golikova stated 'I want to note that clinical studies were carried out on one hundred volunteers. Unlike the first Russian vaccine "Sputnik V", which is a vector vaccine, that is, produced on the basis of adenovirus, the new vaccine was created on the basis of one of the promising synthetic platforms, it is a peptide vaccine, it consists of artificially synthesized short fragments of viral proteins - peptides, through which the immune system learns and subsequently recognizes and neutralizes the virus. I must say that the vaccine is characterized by the absence of reactogenicity and a sufficiently high level of safety.'
EpiVacCorona is planned to be introduced into civil circulation during January 2021, according to data from the vaccine registration certificate published in the state registry of medicines.
Federal Budgetary Institution of Science The State Research Center for Virology and Biotechnology "Vector" is one of the largest scientific virological and biotechnological centers in Russia. The Center was organized in 1974. It includes a branch - the Institute of Medical Biotechnology, located in Berdsk, Novosibirsk Region.
EpiVacCorona Vaccine Indication
EpiVacCorona Vaccine is indicated to prevent COVID-19 a disease caused by SARS-Cov-2. The composition, dose, method of administration of the future vaccine will be determined.
Pregnant women and children will not participate in post-registration trials of a vaccine against the coronavirus developed by the Vector State Research Center of Virology and Biotechnology, the press service of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing told TASS on October 2, 2020.
EpiVacCorona Vaccine News
October 27, 2020 - Output of the vaccine developed by former biological weapons lab Vector State Virology and Biotechnology Center in Novosibirsk, will ramp up by the end of the year, Anna Popova, the head of Russia’s public-health watchdog, said at a conference.
October 20, 2020 - Director-General Rinat Maksyutov told a virtual conference: “The expected advantage of this vaccine compared to other vaccine platforms is the effectiveness of the vaccine against antigenically evolving strains since the vaccine contains conservative SARS-COV-2 epitopes, the safety of the vaccine, … simplicity of production and stability of the components, as well as the mode of storage and transportation."
October 14, 2020 - The Russian Federation President announced the 'Novosibirsk center "Vector" has registered today the 2nd Russian vaccine against coronavirus "EpiVacCorona.'
October 5, 2020 - Nearly 30,000 volunteers will take part in post-registration trials of the coronavirus vaccine developed by Russia's Vector State Research Center of Virology and Biotechnology, the press service of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing told TASS.
October 2, 2020 - Post-registration trials of a vaccine against the coronavirus developed by the Vector State Research Center of Virology and Biotechnology will begin in November-December 2020.
September 30, 2020 - Experts from the Federal Institute of Industrial Property (FIPS) have completed the second examination phase related to the medicines from coronavirus infection SARS-Cov-2. The State Scientific Center of Virology and Biotechnology "Vector", located in Novosibirsk, has received patents for the vaccine from COVID-19.
August 17, 2020 - The Vector State Research Center of Virology and Biotechnology in Novosibirsk has started the second phase of clinical studies of the vaccine against the novel coronavirus.
August 6, 2020 - Another 86 volunteers will be inoculated with the vaccine against the novel coronavirus developed by the Vektor State Research Center of Virology and Biotechnology during the second stage of clinical trials, the press service of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing told TASS.
August 5, 2020 - EpiVacCorona is being developed by VECTOR, taking into account all mandatory requirements and regulatory recommendations provided for by the Russian Federation's legislation, the watchdog said. According to Rospotrebnadzor, the research protocols that comply with the Russian and world experience and strictly adhere to the research rules indicate the drug's quality.
August 2, 2020 - "All vaccinated volunteers are in good health. No complications after the inoculation with the EpiVacCorona vaccine against the coronavirus have been recorded," the statement said.
July 30, 2020 - The Russian Vektor State Research Center will monitor volunteers testing a vaccine against COVID-19 from three to six weeks, the official government site stop coronavirus.rf's Telegram channel, citing Russia's Rospotrebnadzor consumer watchdog.
July 28, 2020 - Center “Vector” began testing the Russian peptide vaccine against COVID-19 disease.
March 20, 2020 - In Russia, for the prevention and control of the COVID-19 epidemic in the State Research Center of VB "Vector" of Rospotrebnadzor, vaccine prototypes based on six different technological platforms were developed in the shortest possible time.
EpiVacCorona Vaccine Clinical Trials
On October 13, 2020, a government statement indicated 'Vector will begin post-registration clinical trials in various regions of Russia with the participation of 40,000 volunteers. At the same time, I want to say that at the same time "Vector" plans to conduct a clinical study among 150 people over 60 years old.'
Clinical Trial NCT04527575: Study of the Safety, Reactogenicity and Immunogenicity of "EpiVacCorona" Vaccine for the Prevention of COVID-19 (EpiVacCorona)
- According to information in registry Russian clinical trials, the combined first and second phase trials of the EpiVacCorona vaccine were registered on July 24, 2020. Simple-blind, placebo-controlled, randomized trials will involve 100 volunteers aged 18 to 60 years. Last Update Posted: September 22, 2020
- The Center received approval to conduct a clinical trial of the EpiVacCorona vaccine candidate on July 27, 2020. Five people aged 18 to 30 take part in the first stage of the test. They are vaccinated in turn, with an interval of 72 hours.
- The first phase of the clinical trial is an open trial. The study will enroll 14 men and women aged 18 to 30 years, inclusive, who meet the inclusion criteria and have no exclusion criteria, whose data will be used for subsequent analysis of safety and immunogenicity.
- The second phase of the clinical trial is a simple, blind, placebo-controlled, randomized, parallel-group study. The study will enroll 86 men and women aged 18 to 60 years, inclusive, who meet the inclusion criteria and have no exclusion criteria whose, data will be used for subsequent analysis of safety and immunogenicity.
- If volunteers drop out of the study, they will not be replaced.