EpiVacCorona Vaccine Description
EpiVacCorona is a COVID-19 preventive vaccine developed by the Vektor State Research Center of Virology and Biotechnology in Russia. EpiVacCorona is an antigens-based vaccine that provokes an immune reaction against COVID-19 and promotes the further development of immunity.
The vaccine relies on chemically synthesized peptide antigens of SARS-CoV-2 proteins, conjugated to a carrier protein and adsorbed on an aluminum-containing adjuvant (aluminum hydroxide). The EpiVacCorona vaccine contributes to developing protective immunity against SARS-CoV-2 coronavirus following two intramuscular administrations spaced 21-28 days apart.
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 based on adenovirus, the new vaccine was created based on one of the promising synthetic platforms, and 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.'
Russian chief public health official Anna Popova stated: "Documents related to EpiVacCorona, were submitted to the World Health Organization on December 8, 2020, and we are awaiting the WHO's decision."
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. Drugbank Accession Number: DB16439.
Federal Budgetary Institution of Science The State Research Center for Virology and Biotechnology "Vector" is one of Russia's largest scientific virological and biotechnological centers. 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, and 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 Federal Service for Surveillance press service on Consumer Rights Protection and Human Wellbeing told TASS on October 2, 2020.
EpiVacCorona Vaccine News
February 3, 2021 - Local media reported Russia delivered the new coronavirus vaccine, EpiVacCorona, to Belarus, Head of the Federal Service for Surveillance on Consumer Rights Protection and Human Well-Being [Rospotrebnadzor] Anna Popova told reporters following her meeting with Belarusian Prime Minister Roman Golovchenko, BelTA has learned. Belarus' Healthcare Minister Dmitry Pinevich spoke highly of the new Russian vaccine. “We certainly hope that this vaccine will be supplied in larger quantities and that it will be highly instrumental in our efforts to combat the coronavirus. It is a very good vaccine, it is rated very highly."
January 22, 2021 - TASS reported the immune response to novel coronavirus is not developed earlier than 32-45 days after the vaccination, or 52 days later maximum, said Alexander Gorelov, the deputy director for science of the Central Research Institute of Epidemiology at the Russian Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing. On January 18th, Russian residents were informed they could receive one of the two registered vaccines Sputnik V or EpiVacCorona, for free.
January 19, 2021 - Russia's Second COVID-19 Vaccine EpiVacCorona '100% Effective' In Early Trials, according to the Russian local media outlet. The data based on Phase I and II trials were released before starting the Phase III trial. "The effectiveness of the vaccine is made up of its immunological effectiveness and preventative effectiveness," the TASS news agency reported, citing Rospotrebnadzor.
January 18, 2021 - TASS reported mass production of the experimental Epivaccorona vaccine would be launched in February 2021, according to comments by Russian Deputy Prime Minister Tatiana Golikova.
January 18, 2021 - TASS reported Russians willing to be vaccinated could choose between two COVID-19 vaccines, Sputnik V and EpiVacCorona, registered in Russia. The Sputnik V vaccine was developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology, and EpiVacCorona was created by the Research Center of Virology and Biotechnology Vector.
December 30, 2020 - EpiVacCorona, Russia's potential COVID-19 vaccine, does not harm the embryo's health, the national consumer rights watchdog, Rospotrebnadzor, based on a pre-clinical, non-human study. "Based on the data obtained, it was concluded that the EpiVacCorona vaccine does not have embryotoxic properties and does not affect the generative function," Rospotrebnadzor said. The vaccine did not affect the offspring's survival rate and did not cause any disturbances in their physical development, the watchdog added.
December 25, 2020 - Media reported Russian regions received over 7,000 doses of the EpiVacCorona vaccine. And by the end of 2020, this amount will rise to over 14,000 doses, and by February, medical organizations should receive over 50,000 doses of the preparation, Russian Prime Minister Mikhail Mishustin said.
December 15, 2020 - Over 1,400 volunteers get Russia's first EpiVacCorona vaccine jab. As many as 1,316 volunteers over the age of 18 and 122 volunteers over the age of 60 have received the first shot of Russia's EpiVacCorona coronavirus vaccine as part of post-registration trials, the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing said in a statement on Tuesday.
December 9, 2020 - Documents related to the EpiVacCorona coronavirus vaccine developed by the Vector Center of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing (Rospotrebnadzor) have been submitted to the World Health Organization, Rospotrebnadzor head, and Russian chief public health official Anna Popova said.
November 24, 2020 - Russia’s EpiVacCorona vaccine developed by the Vector Center has been received by nine medical organizations for post-registration clinical trials. Two clinical trials are scheduled; the first one will involve 150 people aged over 60, the second one will see 3,000 volunteers 18 years and older get the vaccine. Five volunteers over 60 were inoculated on November 23, 2020.
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 Federal Service's press 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 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, a 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 Russian regions with 40,000 volunteers. At the same time, I want to say, "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 COVID-19 (EpiVacCorona). Last Update Posted: September 22, 2020.
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.
The Center received approval to conduct a clinical trial of the EpiVacCorona vaccine candidate on July 27, 2020. Five people aged 18 to 30 participate in the test's first stage. 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 clinical trial's second phase 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.
Study completion date: October 4, 2020.