An initiative group of Russian citizens sent a letter to the Ministry of Health of the Russian Federation, Rospotrebnadzor, Roszdravnadzor, FBSI GNTs VB "Vector", to the Office of the President and President of the Russian Federation Vladimir Vladimirovich Putin, which says:
Independent experts have many reasonable doubts about the effectiveness of the EpiVacCorona vaccine, and the publication of data on its protective properties is delayed. Therefore, we ask the departments to coordinate and accelerate work on the early publication of interim data on the III phase of trials of this vaccine. Continuation of vaccination of the population with this vaccine without taking into account its proven effectiveness, we believe, may pose a threat to the life and health of citizens.
Our volunteers have been working since the beginning of the COVID-19 pandemic, taking part in vaccinations in the early stages of trials of vaccines for civilian circulation. These include citizens, healthcare professionals, scientists, and vaccine volunteers. There are over 170,000 people in our chat network on the Telegram social network https://t.me/sputnik_is_starting. We are also engaged in active educational activities - we dispel myths about vaccination, we are promoting vaccination against COVID-19 among users of social networks and the population.
Earlier, we sent an open letter to the Ministry of Health of the Russian Federation with a request to conduct an independent verification of the effectiveness of the EpiVacCorona vaccine, since information about this vaccine has not yet been published and is of a closed nature, in connection with which there are reasonable doubts about its effectiveness among representatives the scientific community, medical professionals and independent experts. The Ministry of Health of Russia (letter number 30-4 / 3039671-10904 of 04/20/2021) indicated: the EpiVacCorona vaccine was registered in accordance with the Federal Law of 04/12/2010 No. 61-FZ “On the Circulation of Medicines”, thus its effectiveness and safety confirmed. However, the current instruction for the EpiVacCorona vaccine (Date of approval of the instruction by the Ministry of Health on October 13, 2020 (No. LP-006504-131020) indicates that the protective antibody titer is currently unknown. The duration of immunity is unknown. Clinical studies to study the epidemiological efficacy have not been conducted. Independent experiments to evaluate the virus neutralization showed that antibodies produced after vaccination with the EpiVacCorona vaccine are not able to neutralize the SARS-CoV-2 virus, which causes COVID-19.
According to the available information, the developer of the EpiVacCorona vaccine, FBSI SSC VB Vector, of Rospotrebnadzor, was supposed to submit to the Ministry of Health of Russia the interim results of the III phase of vaccine trials. At the moment, there is no publicly available information about these results. Without the publication of this information, it is not possible to assess the effectiveness of the vaccine.
Please note that it is possible to assess the presence of immunity after EpiVacCorona only using the SARS-CoV-2-IgG-Vector test system, TU 21.20.23-093-05664012-2020, RD 32336/24402 (entered in the register No. RZN 2020 / 10017 dated 10.04.2020, Roszdravnadzor), the developer and manufacturer of which is the FBSI SSC VB "Vector". The documentation for the set of antigens, which would allow independent testing, is also non-public, representatives of the FBSI SSC VB "Vector" refuse to disclose it. Currently, there is no other test system in the world that is capable of detecting antibodies after EpiVacCorona. The developer proposes to check the effectiveness of the vaccine with a test system, the composition of which is unknown (there is no publicly available information that would allow to recreate the test system for independent verification). No other test system detects antibodies after EpiVacCorona vaccination. The vaccine manufacturer's explanation for this fact does not hold up to scientific scrutiny. This also causes distrust of the EpiVacCorona vaccine and the State Research Center Vector.
The current situation raises concerns about the protection of our citizens who have been vaccinated with EpiVacCorona. According to the postulate of evidence-based medicine, until the effectiveness of a drug has been proven experimentally, the scientific community and doctors have the right to consider the drug inoperative and have doubts about the appropriateness of its use. This means that citizens vaccinated with the EpiVacCorona vaccine most likely do not have effective protection against COVID-19. The developer of "EpiVacCorona" FBUN SSC VB "Vector" promises to publish the results of vaccine trials in the fall of 2021, but earlier he repeatedly broke his own promises regarding the timing and method of publishing the data.
Since the Russian Ministry of Health did not support our initiative to conduct an independent experiment on virus neutralization, we ask that the materials of the interim results of Phase III trials of the EpiVacCorona vaccine, sent by Vector, be published in the public domain as soon as possible. The statement of the Minister of Health M. Murashko of 23.07.2021 on the postponement of the publication of the results of the III phase of the EpiVacCorona trials to the end of 2021 - the beginning of 2022 is very worrying and even alarming. The very fact of such a delay in the publication of research results reduces the level of public confidence in vaccines against COVID-19 and does not contribute to an increase in the rate of vaccination of the population. At the same time, we are asking Rospotrebnadzor and the Ministry of Health to develop and publish a form for recording statistics on the number of cases and hospitalized with COVID-19, including those vaccinated by Sputnik V, EpiVacCorona and KoviVak in absolute and percentage terms, taking into account the severity of the disease to increase citizens' confidence in civil vaccination, including protection from severe disease, and to counter the anti-vaccine movement, open data on the number of vaccinated in the country.
We ask Rospotrebnadzor to openly and publicly make a request to the subordinate organization SSC "Vector" for the early publication of the interim results of the III phase of trials of the "EpiVacCorona" vaccine.
If for some reason it turns out to be impossible to do, then we ask you to suspend the vaccination of the population with the EpiVacCorona vaccine, and recommend that those who received it earlier be revaccinated with a drug with proven efficacy.
We ask Roszdravnadzor to support our appeal and make a public call to open interim test data, or to pause vaccination with a drug with unproven efficacy, while the country already has a reliable and proven vaccine.
We ask independent scientists to support our appeal and speak in the media to support our position on the issue of civil vaccination.
We are ready to provide any assistance and support we can to increase confidence in civil vaccination in our country against COVID-19. We ask you to consider our appeal and send a response to email@example.com, as much as possible to shorten the response time to our letter in comparison with the time limits established by law.
Thank you for your cooperation and your fight against the COVID-19 pandemic and hope for an early resolution.
Respectfully yours, Andrey Krinitskiy, head of the independent initiative group for civil vaccination and verification of vaccines for civil circulation of the vaccine "EpiVacCorona".
1. Our previous open letter to the Ministry of Health and their response
2. Description of our experiments and tests of the "EpiVacCorona" vaccine
3. Criticism of the EpiVacCorona vaccine by the scientific community:
https://epivakorona.com/scientistsspeak.html and many media reports
4. Official instructions for the vaccine "EpiVacCorona"
https://www.rospotrebnadzor.ru/files/news/%D0%9B%D0%9F-006504 [2020 ]_0%20(1).pdf
5. Statement by the Minister of Health Murashko on the timing of the publication of the results of the two vaccines trial