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 vaccine does not contain the live virus and forms immunity due to artificially synthesized peptides.
According to researchers, the peptides and the viral part of the chimeric protein should immunize people who received this vaccine against the SARS-CoV-2 coronavirus and trigger the production of protective antibodies.
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.'
The vaccine was licensed in Russia by State Virology and Biotechnology Center on October 14, 2020, patented on December 7, 2020.
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.
A study published in 2021 stated 'the vaccine (EpiVacCorona) is a suspension for intramuscular administration containing a composition of chemically synthesized peptide immunogens of the S protein of the SARS-CoV-2 coronavirus conjugated to a carrier protein and adsorbed on aluminum hydroxide.'
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
April 28, 2021 - TAS reported 1,833,230 doses of the EpiVacCorona vaccine had been produced, and 1,271,560 doses have gone into civil circulation.
April 9, 2021 - TASS reported the Russian Health Ministry had issued a permit to conduct Phase One and Two clinical trials of the EpiVacCorona-N vaccine against the coronavirus developed by the Vector State Research Center according to the Ministry’s state registry of trial permits. Volunteers aged 18 to 60 will participate in the trials, the entry stated. The trials will involve 300 volunteers and will be conducted at the Federal Medical Biological Agency's medical facility in the Novosibirsk Region, beginning in April 2021, the completion - September 30, 2021.
April 9, 2021 - Science Magazine published an article: Latest Russian vaccine comes with a big dose of mystery.
April 6, 2021 - ScienceMag.org article wrote: 'no peptide-based vaccines have been licensed to date by the United States, Europe, or the World Health Organization (WHO). “There are several in clinical trials. This means we don’t have definitive evidence they are effective, but they do look promising,” says Sarah Caddy of the Cambridge Institute for Therapeutic Immunology and Infectious Disease.'
April 5, 2021 - TASS reported about 230,000 sets of the EpiVacCorona vaccine by the Vector State Research Center of Virology and Biotechnology had been shipped to 40 Russian regions, the press service of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing reported.
March 30, 2021 - Reuters reported Russia supplied Venezuela with 115,000 doses of EpiVacCorona vaccine to be used as part of the Russian coronavirus vaccine candidate's trials.
March 30, 2021 - TASS reported around 200,000 doses of the EpiVacCorona coronavirus vaccine had been made available for general use in Russia, deputy head of the vaccine developer, Vector Center, Tatyana Nepomnyashchikh, confirmed.
March 25, 2021 - TASS reported Russia’s EpiVacCorona coronavirus vaccine is safe and effective, according to the results of clinical trials on volunteers aged between 18 and 60 published in the Infection and Immunity journal, the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing said in a statement.
March 22, 2021 - Meduza journalists Svetlana Reiter and Alexander Ershov asked the main questions about EpiVacCoron to its developer Alexander Ryzhikov and Deputy Director-General of the Vector Center Tatiana Nepomnyashikh.
March 22, 2021 - Reuters reported Russian scientists said the EpiVacCorona vaccine was effective against variants of the coronavirus.
March 12, 2021 - It takes people inoculated with EpiVacCorona vaccine 42 days to develop immunity, according to the head of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing, Dr. Anna Popova, reported TASS. According to Popova, EpiVacCorona produces "quite strong and effective immunity" but works "rather slowly."
March 5, 2021 - TASS reported inoculations with the EpiVacCorona vaccine developed by Russia’s State Research Center of Virology and Biotechnology Vector would begin in the second half of March 2021, the center’s Director-General Rinat Maksyutov told Vesti news.
February 18, 2021 - TASS reported that all volunteers aged 18 to 60 had generated antibodies to COVID-19. However, Ryzhikov noted that the immunological efficacy in the volunteers aged over 60 was slightly lower and amounted to 94%. "It's an excellent result for this age," the expert concluded.
February 16, 2021 - TASS reported experts of the Vector State Research Center of Virology and Biotechnology had confirmed the efficacy of Russian anti-coronavirus vaccines Sputnik V and EpiVacCorona against the virus’ British strain. "The protective effect was demonstrated in neutralization reactions with the use of serum from people inoculated with the Sputnik V and EpiVacCorona vaccines, which contain antibodies to the SARS-CoV-2 virus," it said.
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."
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 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. Study completion date: October 4, 2020.