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Post by newlife on May 16, 2021 16:25:29 GMT 1
URGENT. New legal advice from lawyer Dimitris Daskalakis. OUT OF STATE DECLARATION DENY SARS – CoV-2 DETECTION DETERMINATION WITH RESERVATION OF RIGHTSDimitris Daskalakis: Those of parents with minor children attending kindergartens, primary schools, high schools and in high schools of our country and are possessed by the same concern and anxiety about the future of their children and refuse to consent to conduct biomedical operations conducted under conditions of mental coercion and overt social blackmail , may at their discretion use exactly the same extrajudicial statement (certainly writing their personal details) to provoke their opposition to the regime of health tyranny that is formed and established in our country . (This extrajudicial statement is enriched and updated in relation to the previous one that was posted and concerned exclusively the opening of high schools (here the previous post) . New elements have been included, such as that the JMC violates, among other things, the International Convention on the Rights of the Child, reference is made to the 26-5-2015 Recommendation of the National Bioethics Committee, while an explicit reference is made to a provision of the law according to which the A self-test characterized as a self-diagnostic test for rapid antigen detection of the SARS-CoV-2 virus should be used in the presence of medical staff and parallel questions are addressed to the teaching community). After the newest and most enriched statement of students' refusal for the tests of the respected lawyer Mr. Dimitris Daskalakis, I believe that the time has come for the GENERAL RESISTANCE DEFENSE OF OUR CHILDREN. The basic condition for victory is to banish FEAR AND DO THE SACRED DUTY TO YOUR CHILDREN, IF YOU WANT TO BE CALLED PARENTS… Kalliopi Soufli Writes Dimitrios Nick. Daskalakis, Lawyer of Athens The following statement is made public, which I addressed together with my wife, in our capacity, as exercisers of parental responsibility, to the principal of our minor child's high school, while communicating the contents of the document to Mrs. Minister of National Education and Religions and in the Regional Directorate of Secondary Education of Athens. Those parents who have minor children who attend kindergartens, elementary schools, high schools and high schools in our country and are possessed by the same concern and anxiety for the future of their children and refuse to consent to the performance of biomedical operations performed under conditions of mental illness. and overt social blackmail , may at their discretion use exactly the same extrajudicial statement (certainly writing their personal details) in order to provoke their opposition to the regime of health tyranny that is being formed and established in our country . This extrajudicial statement is enriched and renewed in relation to the previous one that was posted and concerned exclusively the opening of high schools. from 26-5-2015 Establishment of the National Bioethics Committee, while an explicit reference is made to a provision of the law according to which the self test characterized as a self-diagnostic test for rapid detection of SARS-CoV-2 virus must be used in the presence of medical staff and parallel questions are addressed to the teaching community). To avoid the cost of performance with a bailiff, they can send by e-mail the out-of-court statement to the e-mail address of the Ministry of National Education and Religions as well as to the relevant Directorate of Secondary Education of the parents' place of residence. It is emphasized that the present statement is primarily aimed at safeguarding the integrity of the personal conscience of each person from any illegal, unconstitutional, unlawful state and medical intervention in his life and health, which is carried out without his explicit and unconditional consent and free consent. . The principal of the school unit is considered very likely after receiving the statement to remove the student from school and record his absences. Any future recourse to justice implies for the parents of the students the prior acceptance of the applied health protocols (compulsory use of a mask, negative result of a mandatory diagnostic test for coronavirus disease, proof of vaccination) and the judge who will be summoned litigation will be fully harmonized with compliance with sanitary measures. In my personal opinion, major social issues affecting the lives of millions of people cannot be resolved through legal aid and in the cold frame of a courtroom, but require massive peaceful social struggles and collective awakening and awareness. of an entire people. If every Greek citizen and every Greek woman individually shakes off the fear of state propaganda and stands up by saying " NO, I DO NOT SUBMIT MY CHILD TO SELF TEST " personal objection and disagreement will be the collective expression of the whole Greek will. I express the following opinion : Citizens who disagree and refuse to comply with the orders of the health authorities (mandatory use of a mask, preventive diagnostic disease, vaccination) will be equated with the Jewish citizens of Hitler Germany , to work, move, study, access public services and health facilities. The Historian of the Future will record whether the coronavirus posed a virtual threat to public health or a real (but covert) terrifying threat to democracy and the constitutional freedoms of citizens . My reference to the history of the future clearly indicates my inward wish but also the certainty for the collapse of the divine tyranny of God, because if it finally prevails, the future that will emerge from the present will be so nightmarish that it has devoured freedom of thought and expression and therefore the "historian" in the future dystopian society will be an anachronistic caricature of a forgotten period of Human History. The following is the statement: IN FRONT OF EVERY COMPETENT COURT AND PRINCIPLE OUT OF STATE DECLARATION DENY SARS – CoV-2 DETECTION DETERMINATION WITH RESERVATION OF RIGHTS 1) Dimitriou Daskalakis, son of Nikolaos, Lawyer of Athens, (ID / DSA 19368), resident of Athens, 2 Alexandrou Ragavi Street, Gyzi, for myself individually and in the capacity of legal representative, as a practitioner the parental care of my minor child, ………………… .. Daskalaki of Dimitriou and Styliani, student of the 3rd High School . 2) Stylianis ……………… of Dimitriou, wife of Dimitrios Daskalakis, private employee, resident ……………………………………, for myself individually and in the capacity of legal representative, as an practitioner the parental care of my minor child, ασ Daskalaki of Dimitriou and Styliani, a student of GY Gymnasium. TO The ………. Day High School τικής Attica located on the street …………………… and legally represented by its Principal, ……………………… Notified to : 1) The Minister of National Education and Religions who resides in Maroussi, Attica, at 37 Andrea Papandreou Street and 2) The Regional Directorate of Primary and Secondary Education of Attica, Directorate of Public Works. NW of Athens , located on Mesogeion Avenue no. 324, in Agia Paraskevi which is legally represented by the Director of Secondary Education of Athens II, ……………………… .. First of all, we feel obliged to thank you for your sincere interest and tireless care for the safety and health of students and teachers. From the combination of the provisions of art. 1510 and 1518 of the Civil Code, it is concluded that the parental care of the minor child includes the custody of his / her person (which includes the upbringing, supervision, education and training of the child, as well as the determination of the place of residence), in addition and the administration of his property and the representation of the child in any case or legal act or trial that concerns the person or his property. The right of parental responsibility is recognized by the legal order as an absolute, obligatory and personal right which highlights the crucial role of parents in shaping political, social and moral conscience in their children in order to form free and integrated personalities that will be nurtured by healthy principles and values, so that as citizens of tomorrow they can fight for democratic and social ideals. Listening to the recent government announcements that have already been implemented with the issuance of No. Δ1α / Γ.Π.οικ. 27707 K.Y.A. (Government Gazette II Sheet No. 1825 / 5-5-2021), the citizens (parents, students and teachers) realize that the resumption of school life (but also of economic and social activity in general in our country ) is necessarily associated with the mass use of rapid test which is already distributed free of charge by pharmacies. According to the publications of the electronic press but also the statements of government officials (You see an interview of the Minister of State and Digital Government Mr. Kyriakos Pierrakakis on the TV station SKAI www.pentapostagma.gr/politiki/kiber_kik -ta-thetika-kroysmata-apo-ta-self-test and interview of the General Secretary of Coordination of the Government Mr. Athanasios Kontogeorgis on the television station OPEN here: www.ethnos.gr/ellada/150417_self-testing-me-nea -tehnologia-test-covid-sto-spiti-dorean-4-ana-atomo-mina ) the government decided to start (and is already implementing) the free administration to the citizens of the self test pharmacies (SARS-CoV-2 virus rapid antigen self-diagnostic test) which is characterized by the competent bodies as the new "tool" for the treatment of the pandemic of the aforementioned coronavirus . The Minister of State and Digital Government in his interview stated among other things about the self test characteristics and the following: "The system for reporting cases from citizens who will do a self test will interact with that of the intangible prescription, to which everyone has access the pharmacists. In fact, there should be a platform mainly for statistical reasons , to have a first record and for EODY to have an idea of the citizens who took the test. In addition, there will be a platform to declare those who have a positive result, if they wish. It will not be entirely equivalent to the citizen going to a diagnostic center or being registered centrally in the Covid register, but it will be useful». Mr. Kontogeorgis in his interview, among other things, also stated about the self tests that "these are not the classic rapid tests that we know, but they are a new technology , they are very easy to use, since they are intended for home use". However, the statements of government officials raise the following very critical questions concerning the protection of public health and to which the scientific community must provide valid and substantiated answers. 1) Is the self test reliable and safe ? And if so, why does the Minister state that it is not absolutely equivalent to that carried out in a diagnostic center or other health structure ? The Secretary General of Coordination of the Government clarified that the positive diagnosis of the home test can not be used as a certificate to obtain permission or justification of absences from school but it is required to conduct a re-examination with PCR test (molecular) in the country's health structures, ie in hospitals and Health Centers. From the above statements there is no doubt that self tests are less reliable in relation to the molecular tests performed in health structures. Also according to the instructions of the German Robert Koch Institute , the strips in the self test box contain antigen antibodies that activate a specific enzyme. If the coronavirus test is positive, then it will produce a visible pigment. The diagnostic accuracy of the test reached 71%. The tests were performed on 60 citizens who were diagnosed positive for coronavirus by performing PCR (molecular) tests. (See relevant: www.ethnos.gr/ygeia/150298_self-testing-ti-einai-kai-pos-tha-kanoyme-sto-spiti-ta-yper-kai-ta-kata ) Speaking to OPEN TV and journalist Faye Mavragani, Professor of Epidemiology at the University of Athens, Ms. Athena Linou, commenting on the free rapid coronavirus tests available from pharmacies, said: "They have often been judged to be unreliable . I do not know which one we will have. They lead to erroneous results in the non-symptomatic . And the point is that with them we will not know the tracking. Tracking in Greece is bitter. "Once we make sure they catch asymptomatic, tracking should be organized." (See relevant: www.ethnos.gr/ellada/150291_koronoios-linoy-na-epitrapei-i-metakinisi-apo-dimo-se-dimo-mi-axiopista-ta-rapid-test ) Because the self test is characterized as a self-diagnostic test for rapid detection of antigen of the SARS-CoV-2 virus which according to article 31 par. 1 and 2 of Law 4737/2020, as it was replaced by article 1 of Law 4790/31 -3-2021 (Government Gazette 48A) and is in force today, it is explicitly defined in paragraph 3 that the medical devices of rapid antigen tests SARS-CoV-2 (rapid test), for the performance of disease controls by the coronavirus of natural persons, are used under condition of the presence of medical staff responsible for the correct use of the product and the appropriate information of the natural person regarding the exported result . In fact, the need for the presence of medical staff to perform a diagnostic test for rapid detection of antigen of the SARS-CoV-2 virus is confirmed by the English version of the instructions according to which the rapid diagnostic test for rapid antigen of the virus SARS-CoV for use in the laboratory and under the supervision of health professionals. Therefore, the obligatory, illegal and tyrannical coercion of students and teachers in the diagnostic procedure for the detection of SARS – CoV-2 coronavirus , which is carried out without the presence of specialized nursing staff and under the threat of expelling students from school if they do not attend. the school negative effect card, pose serious and immediate danger to health protection (nosebleeds, possible contamination, causing inflammation or injury to the nasal septum) and hence the respective Director or Head school unit may not be rendered aboulia body execution and implementation of a obviously unjust, illegal and unconstitutional decision of the State. In any case, the requirement of the State for students and teachers to conduct a rapid SARS-CoV-2 antigen self-diagnosis test, without the required presence of medical staff , violates the fundamental constitutional right to the protection of personal health in the provision of paragraph 5 of article 5 of the Constitution , according to which "Everyone has the right to the protection of his health and genetic identity " for the exercise of which is not meant to be imposed any legal sanction that leads to his appeal. The government is therefore asking : Why is it calling on students and teachers to self-test on questionable scientific validity and reliability? In conclusion, the above statements of government officials and experts, reduce the credibility and validity of the much-publicized self- test and cause justified suspicion among students and teachers about the real purpose and expediency of the mass use of self- tests . 2) The Minister in the above interview stated: "In addition, there will be a platform to declare those who have a positive result, if they wish ." Asked: Why is the student or teacher who will be diagnosed positive, not obliged to declare the positive report of the test on the relevant platform, in order to follow the relevant procedure of isolating the case? With the process of self-regulation proposed by the Minister, there is an immediate and serious risk of passing on the responsibility of recording and isolating the confirmed positive case from the competent health bodies to individuals with the obvious conclusion of the impossibility of timely identification of cases. In this case, ie the optional positive case report, the government appears to be uninterested in protecting public health, as in each case the student or teacher, in order not to be restricted, will continue to move freely and instead of self test to be used as a useful and valuable tool to combat the spread of the virus due to deliberate (?) government incompetence, will potentially cause its uncontrolled transmission. 3) Does the home environment provide the necessary and safe biosafety guarantees or is there a serious and immediate risk of transmission of the virus from the incorrect and inappropriate use of the self test ? In the English version of the instruction manual referred for literally the following : «This product is intended for professional use in laboratory and Point of Care environments, or self-collection under the supervision of a healthcare worker». Has care also been taken for the safe collection and collection of sanitary waste that has been classified as special medical waste collected by a certified body and incinerated or has everything been left to its own devices? 4) Have clinical studies and researches by independent scientists and health experts been published in reputable medical scientific journals to confirm and verify the high degree of sensitivity and validity of the self test ? Is it enough just to "barrage" the statements by the managers of the health crisis "about the reliability of the self test " but without presenting sound medical studies of known scientific validity to prove their claims? 5) Does the self-examination that will be performed at home have the ability to detect mutations in the virus? To date, the most common infectious diseases have not been ruled out. It may be a minor issue in relation to the tedious daily monitoring of cases. However, the US Centers for Disease Control and Prevention (CDC) suggests that these tests be used in targeted populations that benefit from the test, with careful parallel examination of epidemiological data. Following the above findings, which substantially shakes and weakens the safety and effectiveness of the SARS – CoV-2 coronavirus self-diagnosis procedure , we summarize our justified and reasonable objections and reservations to the following stated reasons and causes. For reasons mainly related to the protection of the individual health of the above mentioned minor child as well as for reasons of personal and social conscience in combination with what is recognized by the current legislation, we do not consent individually but as co-exercisers of parental responsibility of our minor child , neither now nor in the future to submit our underage daughter - whose opinion has been taken into account, at an appropriate age with appropriate intellectual development, in order to be able to realize her real interest - in any SARS – CoV-2 coronavirus screening test (either in a molecular PCR test , or in a rapid test - antigen test - or in a self test (self-diagnostic test for rapid antigen detection of the virus) administered by pharmacies or in any other, as a preventive measure for COVID-19 disease , for the following correct, legal and well-founded reasons and causes as well as for those others we reserve the right to report in the future. 1) The confidentiality of the results of the diagnostic test is not guaranteed , which as a personal health issue is a sensitive personal data, which is explicitly recognized and protected by the current legislation. According to the provision of article 7 of the number D1a / G.P.oik. 27707 K.Y.A. (Government Gazette II Sheet No. 1825 / 5-5-2021) to the personal data of our minor child (but also of our own personal data, as parents) that will be collected and processed by the anonymous non-profit company with the name "ELECTRONIC GOVERNANCE OF SOCIAL INSURANCE Societe Anonyme" and the distinctive title "IDI.KA. Α.Ε. » include a) name, b) father's name, c) mother's name, d) date of birth, e) AMKA, f) date of the self-diagnostic test, g) result of the self-diagnostic test, h) date of declaration and in fact the processing will take place for an impermissibly long period of time until at least the end of the school year , (see article 96 of Law 4790 / 31-3-2021) will be systematic and generalized, since these data will be constantly updated and will be subject in processing and registration during the continuous and constantly repeated self-diagnostic examination that has been decided to be performed at least once a week. 2) According to information and news that have been published in printed and electronic form, there is intense doubt and disagreement in scientific circles about the scientific validity and technical completeness of the commercially available SARS – CoV-2 coronavirus detection tests , as they have been reported. cases where healthy people are recorded as false positives in the tests performed and this is because commercial manufacturers and laboratories set their own limits on control when processing samples. According to the recent instructions issued by the World Health Organization, on January 20, 2021, it emphasizes that it is necessary to carefully interpret the "weak" positive results . The number of magnification cycles required to detect the virus is inversely proportional to the patient's viral load. When the test results do not correspond to the clinical picture , a new sample should be taken and re-examined using the same or different test method. (See connection: www.who.int/news/item/20-01-2021-who-information-notice-for-ivd-users-2020-05?fbclid=IwAR3oTJjzLfwUru4v3WXSDo7yE3rDtSxb3hqO_hq6lwYkFkgxadJMPYmDzHU ) Especially in the PCR test, the reliability diagrams must necessarily be accompanied by the number of amplification cycles , because as is well known, as the amplification cycles increase, the percentage of false positive tests increases accordingly. For example, in the State of Kansas, USA. In early January 2021, the state health authorities decided to reduce the number of PCR test multiplication cycles from 42 to 35, automatically finding a significant reduction in recorded cases. (See: sentinelksmo.org/kdhe-quietly-reduced-cycle-threshold-on-covid-tests/ ) Therefore, care is not taken and the process of verifying and confirming the results of the first test is not defined and on the other hand the limit of the cycles used in the control and processing of the sample is not stated, since each test for detection of SARS – CoV-2 coronavirus with a cycle limit above 30-33, has the consequence that its result becomes false positive. In addition, the WHO points out that the antigen test should not be used in people without symptoms , ie. In asymptomatic, unless contact history, and a low incidence of the disease, because in this case it is not reliable . See in this regard: www.ethnos.gr/ellada/132437_koronoios-kathigitria-apth-pote-einai-anaxiopista-ta-rapid-test as well as here: www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwj59pOe_8jvAhWHy4UKHal2CqgQFjAAegQIARFF 25CE% 25BF-% 25CF% 2584% 25CE% 25B5% 25CF% 2583% 25CF% 2584-% 25CF% 2583% 25CE% 25B1% 25CF% 2582-% 25CE% 25B3% 25CE% 25B9% 25CE% 25B1-% 25CE% 25BA% 25CE% 25BF% 25CF% 2581% 25CE% 25BF% 25CE% 25BD% 25CF% 2589% 25CF% 258A% 25CF% 258C-% 25CE% 25B5% 25CE% 25AF% 25CE% 25BD% 25CE% 25B1% 25CE% 25B9 -% 25CE% 25B8% 25CE% 25B5% 25CF% 2584% 25CE% 25B9% 25CE% 25BA% 25CF% 258C-% 25CE% 25AF% 2F & usg = AOvVaw0YOhyrjgnu_l4yi8hHaAwt and here: www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd= 25BA% 25CE% 25AC% 25CE% 25BD% 25CE% 25B4% 25CE% 25B1% 25CE% 25BB% 25CE% 25BF-% 25CF% 2583% 25CF% 2584% 25CE% 25B7-% 25CE% 25B3% 25CE% 25B5% 25CF% 2581% 25CE% 25BC% 25CE% 25B1% 25CE% 25BD% 25CE% 25AF% 25CE% 25B1-% 25CF% 2584% 25CE% 25B5% 25CF% 2583% 25CF% 2584-pcr-% 25CE% 25AD% 25CE% 25BD% 25CE% 25B1-% 25CE% 25B1% 25CE% 25BA% 25CF% 2581% 25CE% 25B9% 25CE% 25B2% 2F & usg = AOvVaw2WgdpwAnxv_0foRQ3j6hH6 ) 3) Today, in order to perform in the medical practice any kind of diagnostic, preventive or therapeutic intervention, the interested person should be free to consent to the medical act in question or on the contrary to refuse it , provided that the necessary information is provided. Consequently, the SARS – CoV-2 coronavirus test cannot be performed without the consent of the person , which is interrelated with his or her free will. In this context, there is talk of "informed patient consent" ( fundamental consent) as a fundamental principle of Law and Medical Ethics. To date, the OVIEDO Convention - Convention on Human Rights and Biomedicine - is the only legally binding text of international law in relation to the applications of Biology and Medicine. In particular, the OVIEDOU Convention was ratified by the Greek State with Law 2619/1998 (Government Gazette A '132) and has the force defined by article 28 par. 1 of the Constitution, ie the Council of Europe Convention for the protection of of human rights and the dignity of the individual in relation to the applications of biology and medicine: Convention on Human Rights and Biomedicine. Specifically, Article 5 thereof provides that: " Intervention in matters of health can take place only after the interested person gives his free consent , after prior relevant information." In addition, the provision of article 12 § 1 of the Code of Medical Ethics ( Law 3418/2005) moves in the same direction where it is defined that: "The doctor is not allowed to perform any medical operation without the prior consent of the patient. 2 . Conditions of valid patient consent are the following : a) To be provided after complete, clear and understandable information , according to the previous article. b) The patient has the capacity for consent. aa) If the patient is a minor, the consent is given by those who exercise parental care or custody . However, his opinion is also taken into account, if the minor, in the opinion of the doctor, has the age, mental and emotional maturity to understand his state of health, the content of the medical act and its consequences or results or risks. act of it. In the case of paragraph 3 of Article 11, the consent of the persons exercising parental care of the minor is always required. bb) If the patient does not have the ability to consent, the consent for the execution of a medical operation is given by the legal assistant, if he has been appointed. If there is no legal aid, the consent is given by the patient's relatives. In any case, the doctor must try to ensure the voluntary participation, partnership and cooperation of the patient, and especially that of the patient who understands his state of health, the content of the medical operation, the risks, the consequences and the results of the operation. her. c) Consent should not be the result of error, fraud or threat and should not conflict with good morals. d) The consent to fully cover the medical act both according to its specific content and at the time of its execution ". It follows from the above legal provisions that the principle of the patient's free consent is reduced to a key and decisive point for the performance of any medical operation, and therefore of the test for the detection of the SARS-CoV-2 coronavirus. It is also clear from the above provisions that the consent given in order to be valid, must be free from any external pressure, threat or coercion. However, under the erasing social conditions of intense psychological terrorism, constant television propaganda and brainwashing, misinformation as well as the lack of objective and polyphonic information, in relation to the reliability or not of the covid tests, the intimidation of students with social and their exclusion from school life , in case they refuse to undergo a coronavirus detection test, undermines the effort to fully, clearly, comprehensibly and objectively inform people about the benefits of covid tests in epidemiological research, consequently the consent of the citizens, as parents of the students, suffers from invalidity, since it can be characterized as a product of mental coercion, deliberate deception and overt social blackmail, since the non-display of the school card automatically entails the expulsion and expulsion of the student. the cessation of his participation in the educational process. We therefore rightly and justifiably argue that the exercise of constant psychological pressure, the constantly intolerable and unacceptable dilemma that is summed up in the phrase: either you undergo a self test or you are expelled from school and the systematic cultivation of an atmosphere of insecurity is aimed at of the human will and the leveling of his personal resistances, in order to undergo a constantly repeated process of detection of the coronavirus SARS – CoV-2, without his consent and against his will . Therefore, the systematic and methodical violation of the legal and dominant in the field of medical science, as well as in the Code of Medical Ethics, principle of the patient's free consent before performing any medical procedure , finds us completely opposed and separates us. declaring openly to any competent Authority that we, in our capacity as caregivers of our above-mentioned minor child, refuse to undergo a diagnostic procedure for the detection of SARS – CoV-2 coronavirus, which massifies and depersonalizes the human being, human dignity and abolishes his free will. According to article 1 paragraph 1 of the Code of Medical Ethics (Law 3418 / 28-11-2005), a medical act is defined as "one that aims at the prevention , diagnosis, treatment and restoration of human health by any scientific method ". Therefore, the mandatory submission of a person to the diagnostic procedure for the detection of SARS – CoV-2 coronavirus , as a preventive medical procedure, for the treatment of COVID-19 disease, is clearly a biomedical intervention for which the explicit and unconditional consent must be sought. , free from all mental coercion and social blackmail. This is clearly based on the provision of article 12 § 1 of the Code of Medical Ethics (Law 3418/2005) which stipulates that: "The doctor is not allowed to perform any medical procedure without the prior consent of the patient." Because according to Article 338 of Law. 4512/2018 stipulates that ' any decision contrary to the provisions of N . 3418/2005 is invalid . If doctors have participated in the making of these decisions, they are subject to disciplinary responsibilities ". 4) It is also worth emphasizing that the self-diagnostic tests for SARS-COV-2 coronavirus disease administered by pharmacies have not received quality and safety certification from the competent European or national auditing bodies and are available in accordance with the individual use instructions. to students and teachers under a special permit of the competent Authority, ( but without mentioning the body that issued the special permit or the decision authorizing the special use ) and bear the special mark for exceptional self-diagnostic use. It is therefore clear that these medicinal products have not been legally authorized by the drug regulatory authorities, only an exceptional use license, which means that medical research is ongoing and their safety and efficacy have not been adequately established. . Also according to the instructions for personal use the self-diagnostic test is used to detect antigens of the SARS-COV-2 virus in people for whom covid -19 is suspected , ie it is indicated for people who have come into contact with a confirmed case and therefore can not to be applied indiscriminately to the general population. 5) In the field of medical science, the supreme principle is the non-negotiable and universal axiom according to which "the will of the patient is the supreme law" (" voluntas aegroti suprema lex ") which as a moral imperative characterizes the timeless value and importance of the whole. medical procedures and determines the legitimate limits of medical intervention in human life and health . Because the principle of informed consent of the examined person, as a fundamental principle of Law and Medical Ethics, is reduced to a crucial and decisive point for the performance of any medical and biomedical operation or intervention, therefore the diagnostic test for detection of the SARS – CoV-2 coronavirus and is an internationally guaranteed and explicitly recognized universal right , as this undoubtedly arises through a plethora of legislative texts. The Human in Article 2 of the Universal Declaration of Rights states that " Every human being is the subject of all rights and freedoms set out in this Declaration, without distinction of any kind , such as sex, language, religion, political or other opinion , national or social origin, property, birth or any other situation ". The above-mentioned provision defines the universal framework that binds the UN member states. which prohibits the admission for any reason and cause of discrimination leading to unequal treatment and social exclusion and stigmatization of people in a favored democratic state . In fact, the preamble to the Universal Declaration of Human Rights recognizes that the principle of respect for human dignity and the equal and inalienable rights of all members of the human family is the foundation of freedom, justice and peace in the world. The Charter of Fundamental Rights of the European Union in Article 3 (2) states : " In the field of medicine and biology, the following must be observed in particular: the free and informed consent of the person concerned, in accordance with the most detailed provisions laid down in by the law. Article 7 of the United Nations International Covenant on Civil and Political Rights provides: " In particular, the submission of a person without his free consent to a medical or scientific experiment" which has been ratified by the Greek State with law 2462/1997 , in accordance with the procedure of article 28 par. 1 of the Constitution and has acquired supra-legislative force. The patient's human rights were formulated in rules accepted by modern states in the Lisbon Declaration issued by the World Medical Association. The declaration states that the patient, after being informed of his state of health, has the right to agree with the proposed treatment or to disagree with it and not to accept it and therefore the patient's right to self-determination is explicitly guaranteed , as a result of his human condition, according to which he can decide exclusively for his own health. According to the OVIEDO Convention ratified by the Greek State with Law 2619/1998 (Government Gazette A '132) and has the supra-legislative force defined by article 28 par. 1 of the Constitution, ie the Council of Europe Convention on the protection of human rights and the dignity of the individual in relation to the applications of biology and medicine: Convention on Human Rights and Biomedicine, Article 5 thereof provides : "Intervention in health matters may take place only after the person concerned give his free consent , after prior relevant information ". In the current context of the spread of coronavirus disease, the Bioethics Committee of the Council of Europe, in a statement issued on 14 April 2020 , recalled the fundamental principles of respect for human dignity and human rights , which must be govern medical decisions and practices to deal with the current health crisis. The committee emphasizes that the Oviedo Convention is the only legally binding tool at international level in the field of biomedicine and provides a unique human rights framework, including an emergency health crisis management framework, to guide decisions and practices in clinical and research areas. (See: www.coe.int/en/web/bioethics/-/covid-19-human-rights-principles-must-guide-health-decisio-10 ) According to the Nuremberg Code, which contains a set of principles and rules of ethical medical ethics (including the principle of informed consent of the patient, the absence of coercion), it is explicitly recognized as the first rule, that "voluntary informed consent of the human subject is essential " (" Ôhe voluntary informed consent of the Human Subject is absolutely essential ») has now become universally accepted and incorporated in Article 7 of the International Covenant of the United Nations on Civil and Political Rights (" in particular, the person submitting prohibited , without his free consent to a medical or scientific experiment "). Therefore, the published JMC, which is already defined as a condition for attending school, the previous submission to a negative diagnostic test for coronavirus SARS-COV-2, which reflects the state will and aspiration for direct or indirect enforcement the compulsory compulsion of students and teachers in diagnostic tests and later in vaccination, is clearly outside our legal culture , as it blatantly violates the principles and framework of European Law, Medical Ethics, International Conventions and Covenants ratified by laws by the Greek State in accordance with the procedure of article 28 par. 1 of the Constitution and therefore constitute an integral part of the internal legal order and therefore prevail over any other contrary provision of law, with the consequence that the above joint ministerial decision cannot be applied as contrary to provisions of supra-legislative force. Therefore, for these reasons and causes for those other reserve to expose in the future, we expressly declare that you do not consent and refuse to bear above our minor daughter in diagnostic screening coronavirus SARS-CoV-2 for the treatment of disease COVID -19. The Hellenic State ratified by law 2101 / 2-12-1992 (Government Gazette 192 A / 2-12-1992) with the procedure of article 28 par. 1 of the Constitution the international convention on the rights of the child according to which the parties States expressly undertake to guarantee the rights of the child without any discrimination as to the race, color, sex, language, religion, political or other beliefs of the child or his or her parents or legal representatives or in any other situation. During the combined application and interpretation of articles 28 and 29 of Law 2101/1992, it appears that elementary education becomes compulsory and free for all students while the Contracting States must ensure and encourage the development of various forms of secondary education , both general as well as professional and make them open and accessible to every child and therefore the establishment by the provision of article 96 of Law 4790 / 31-3-2021, as a prerequisite for the participation of students in the educational process, the previous finding after coronary heart disease diagnosis, contravenes the supra-legislative provisions of the International Convention on the Rights of the Child which recognizes children the right to demand from the state to provide them with education and schooling . According to Articles 16 & 2 and 3 of the Constitution, it is explicitly stated that "Education is a basic mission of the State and aims at the moral, spiritual, professional and physical education of Greeks, the development of national and religious consciousness and their transformation into free and responsible citizens, while it is also clearly stated that the years of compulsory education cannot be less than nine . It is clear from this constitutional provision that the prohibition of a student refusing to undergo a SARS – CoV-2 coronavirus detection test runs counter to the fundamental constitutional right to education , the exercise of which is not subject to any law. According to the 26-5-2015 recommendation of the National Bioethics Committee, it is considered that the attendance of the compulsory education program can not depend on the condition of the vaccination and by analogy can not depend on the condition of the previous submission to a self-diagnostic screening test. of the SARS – CoV-2 coronavirus, since then compliance with a public obligation would presuppose the waiver of the exercise of the fundamental right, ie the right to health of art. 5 par. 5 of the Constitution, which includes the principle of consensus . According to No. Φ.353.1 / 324/105657 / Δ1 published in the Government Gazette 1340 / 16-10-2002, the specific duties and responsibilities of the heads of the regional services of primary and secondary education, the principals and deputy principals of the school units and SEC and teachers' associations. Article 36 defines it verbatim: “ Teachers carry out a work of high social responsibility. Their work includes teaching, educating and educating students . The progress, economic development, culture and cohesion of society depend to a large extent on the quality of education and consequently on the contribution and effort of teachers. The duties and responsibilities of teachers must be harmonized with these objectives ". We therefore emphasize with all possible clarity that your duties do not include the exercise of control over students, if they carry the school card, nor much more of course their removal from the school premises for reasons that are detrimental to your educational role and are foreign to your constitutional mission, as teachers who perform the highest social function . In any case, it is emphasized that the transfer of responsibility for the health of students to school principals, in no case should replace the constitutional obligation to take responsibility for the cultivation of education, for the purpose of moral, spiritual and vocational education and transformation of students into free, responsible and sane citizens. It is a heartbreaking finding to observe the change of schools, from educational institutions to sanitary cleaners, a fact that causes great concern and reflection regarding the purpose and mission of the modern school and the educational function . According to the provision of article 25 par. 3 of Law 3528/2007 (Government Gazette 26 / Α / 9-2-2007) with which the Ratification of the Code of Status of Public Civil Servants and Employees of N.P. Δ.Δ. are worded as follows: " If the order is manifestly unconstitutional or illegal, the official must not enforce it and report it without delay.. When an order, which is manifestly contrary to the provisions of laws or regulations, expresses urgent and exceptional reasons of general interest or , the official must execute the order and at the same time report to the superior authority of the person who ordered it. The teaching community is therefore asked : Why are school principals and heads in a hurry to comply with an unjust, illegal and unconstitutional ministerial decision ? When there is a conflict between the law of the state on the one hand and the "law" of personal-educational conscience on the other, in this case, the "law" of conscience is superior and stronger and people must obey it. Laws and ministerial decisions come and go, situations change, and interpersonal teacher-parent and student relationships are maintained and do not fray over time. The good testimony of the personal conscience of the teacher, the after years sweet embrace and the "thank you" of the adult student and the tear of emotion of both, will constitute the unshakable proof that he has fulfilled his moral duty, which can not be balanced by his commitment to a "lifeless" and illegal JMA that denervates and degrades the school and mocks the teacher, after turning him into a "sergeant of the sanitary" in charge of obeying sanitary orders. Because, for all the above reasons, with our present statement, WE INVITE YOU not to block the attendance of the student ασ Daskalaki tou Dimitriou, a student of the High School, at the school and at the same time to contribute to within your duties for its smooth and smooth participation in the educational process, otherwise we DECLARE YOU that any ban on the entry of the above student to school will entail your civil, criminal and disciplinary control and that of any other third party and we expressly reserve the right to sue any third party involved. exercise all our legal rights in order to defend before the competent courts the individual rights of our minor child, as a member of society, for her participation in the educational process from any unjust, illegal and unconstitutional decision. With the express reservation of any other lawful our right, Responsible bailiff ordered to legally deliver this, to that to which is addressed to the attention of and to bring about the legal consequences, copying the whole the performance report, while not , ordered the the same Judge Bailiff, to legally disclose the content of this extrajudicial statement and to 1) The Minister of National Education and Religions who resides in Maroussi, Attica, at 37 Andrea Papandreou Street and 2) The Regional Address and Secondary Education of Attica, Directorate of Public Administration NW Athens located on Mesogeion Avenue no. 324, Agia Paraskevi, which is legally represented by the Director of Secondary Education B Athens ..................... .. to the attention of each to which notifications are made and to the legal consequences made by copying the whole of the performance report . …………………………… Attica 10-5-2021 The Out-of-Court Declarators. Source in Greek: thesecretrealtruth.blogspot.com/2021/05/sarscov-2.html
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Post by newlife on May 18, 2021 10:04:59 GMT 1
GLOBAL EARTHQUAKE AND OVERTURN CAUSE DOCTOR'S DISCOVERIES ABOUT SARS-COV-2! S.OS. and by the research team of Professor of Medicine Mr. I. Kountouras.
Kalliopi Soufli writes
The news that recently reached ATTICA NEWS, is already causing a GLOBAL EARTHQUAKE as it exposes and subverts the fact that until today the majority of the world medical community of Rockefeller medicine believed in SARS-COV-2 (KORONAIOU-2).
The most important but also the most tragic of all is that through the INDEPENDENT SCIENTIFIC RESEARCH, IT CHARACTERIZES ALL VACCINES, DESTRUCTION FOR THE HUMAN ORGANISM.
It all started when a team of Doctors in America, decided to examine and analyze with medical clarity, respect for man, INDEPENDENT Medicine and faithful to the OATH OF HIPPOCRATES, the famous SARS-COV-2 and the panic it has caused for more than a year, doing a simple but difficult and laborious experiment.
They isolated all spike proteins from the SARS-COV-2 virus and placed them in an experimental model system, both in animals and in a high-tech biological system that mimics the human vascular system.
The team of American medical researchers, proved that the SARS-COV-2 VIRUS WITHOUT THE PROTEIN SPIN, CAUSES NO DAMAGE.
When the scientists took the needles and placed them in synthetic capsules, they found that the protein - the needle, is the one that causes the disease and not the SARS-COV-2 virus.
This is the protein produced by the virus.
This means that any vaccine causes the production of the SARS-COV-2 virus spike protein, and is poisonous to the human body.
This research is a huge scientific achievement, as it overturns all the "scientific" data and MAKES ALL VACCINES USED FOR SARS-COV-2 DANGEROUS.
And any scientific authority that has been defined, CANNOT OVERTURN THE COMPLETELY DOCUMENTED RESEARCH OF AMERICAN DOCTORS AND PUT HIS HAND ON THE FIRE IN ORDER TO LIGHT UP.
You can refer to the following links to read the relevant scientific achievement, which demolishes the story about the coronavirus SARS-COV-2 ..
The novel coronavirus' spike protein plays additional key roles in illness
As well as in this link here
I also quote the following links
SARS-CoV-2 Spike Protein Impairs Endothelial Function via Downregulation of ACE 2 The Salk Institute for Biological Studies Finally, I quote the Research of GREEK RESEARCHERS on this major issue, which is the work of the research team of Om. Professor of Medicine Mr. I. Kountouras, a well-known scientist with international prestige and recognition, who honors both himself and his team, the FUNCTION OF THE DOCTOR, THE GREEK ORTHODOX, THE SCIENTIST.
COVID -19: Does vaccination guarantee Hippocrates' fundamental principle of "benefit or non-harm"?
PROLOGUE
The following study is the work of Om. Professor of Medicine Mr. I. Kountouras, where data from the international literature on vaccines were developed and recorded, based on the research methodology, which were developed in extremely compressed time for the treatment of coronavirus ( Covid- 19 or SARS - CoV -2), including t s new technology vaccines mRNA .
But what is the purpose of this study? According to the seven scientists, " this review , based on current scientific data and emerging questions about COVID- 19 vaccines , aims to stimulate the interest of clinical and laboratory scientists in finding the best possible strategy." individual and wider approach to this new pandemic ".
The said study has been published in English-language medical journal « Medicina » Swiss Publishing House MDPI (PubMed indexed) with the participation of 21 authors (attached text as Doulberis M, et al 2021; 57,253 ) and the Greek version, enriched with new data , was submitted to a Greek medical journal for notification to the domestic scientific and non-public.
Main conclusions of the review on coronavirus vaccines.
As a basic principle of the present study , vaccines are not generally rejected, because in the past , they have saved humanity from various diseases. However, despite actually put questions based methodology and arguments, on vaccines developed in compressed short time, especially on the mRNA vaccine .
The reading of this study reveals the absence of scientific documentation of certain positions about the vaccine expressed by incompetent bodies (eg Media, Social Media, Internet) and by some proponents of vaccination.
What are the potential risks of shortening vaccine growth time?
The authors point out that the urgency of the implementation of vaccination, because of the morbidity COVID -19 ' was essential limitation, the non-application of rigorous scientific statutory procedures required for the primary control SAFETY each vaccine "ignoring the" value of the necessary pre- clinical trials highlighting medium and long term potential positive or harmful effects on man ... rapid vaccine development process involves the risk of escape adverse reactions that would otherwise be detected by long-term studies " .
It is noted that the approval studies show "the absence of a sufficient number of specific population groups , such as high-risk patients with autoimmune diseases, malignancies, diabetes, obesity or the elderly ", which " may overlook serious short-term and long-term " . For example, " in Norway, 26 elderly people died shortly after receiving the Pfizer - BioNTech vaccine , which raises serious concerns . "
The institutionalized vaccine production process provides for at least a decade of preclinical studies
An interesting note from this article states that " all stakeholders need to approach scientifically a careful, strictly standardized and qualitatively objective approach that sheds light on the potential benefits or potential side effects of these vaccines ." A related impermissible ascertained, scientific « bias » involves responsibilities .
Therefore, a safe time to ensure reliable results requires at least 9-10 years of preclinical studies before the vaccine is administered to humans " .
The authors of the present study also note " the urgent need for an effective and safe vaccination side effect with reduced COVID- 19 infectivity, morbidity and mortality ".
The available vaccines have not received final approval
but "Emergency Authorization".
In addition, the study emphasizes that " the high trend of mutation in the genetic mechanism of SARS - CoV -2 and the already existing accumulated genetic variations of its genome, create uncertainties and raise relative uncertainty as to whether these vaccines are effective and have an effective response. against the predominant strains of coronaviruses .
That's why the FDA ( Food and Drug Administration) NOT concessions final approval for the two vaccines mRNA ( Pfizer and Moderna ) but provide " Emergency authorization ( Emergency Use Authorization - EUA ) applying a strict and long-term monitoring program for control of possible side effects and further investigation of the duration of protection . The study notes that "the authorization was given to prevent SARS - CoV- 2 disease ( Covid-19), for use in people 16 years and older . This indicates, among other parameters, the ambiguity of controlling their potential security ".
In the same direction, " the EMEA ( European Medicines Agency - EMA ) issued a conditional license administration for the vaccine Pfizer-BioNTech. This type of license is also granted for medicines for emergency health needs , despite the incomplete clinical data " .
Three necessary successive stages (phases) of vaccine preparation.
What (did not) happen during the preparation of the vaccines
The study states that the required sequential steps for vaccine preparation are three . " They necessarily include the pre-clinical in vitro and in vivo studies , the 1.2 phase clinical trials and finally the phase 3 phase , so that the final conclusions on efficacy or not can be drawn in full transparency. of each vaccine or drug being tested ".
To initiate each subsequent phase in the vaccine development sequence, it is important that " the results of all previous phases are scientifically sound to justify the next stage of research. On the contrary, this necessary scientific process for the development of vaccines against COVID- 19 was carried out in a significantly shorter period of time, because the development phases overlapped .
Finally, before the collection and extraction of the necessary conclusions regarding the safety and efficacy of the candidate vaccines was completed , their widespread industrial production and distribution to the general population began . "These data give rise to a variety of scientific ' bias ' that have potentially serious consequences . "
Rapid production of vaccines inevitably led to an outbreak of reactions and refusals to vaccinate , which could have been avoided if vaccines had been prepared at a time that would provide greater safety.
Side effects from vaccinations. To what the aggressive
"Immunity passport" campaign.
One of the issues, inter alia, relates to the study and a ytoanosia probably caused by cross-reactivity of the vaccine, which is involved in the development of several pathologies such as Guillain-Barré syndrome, multiple sclerosis, other apomyeloinotikes neuropathies or systemic lupus erythematosus . Therefore, an essential side effect of mass vaccination is the induction of autoimmune diseases , especially in people with a genetic predisposition.
On the other hand, the promotion and implementation of such an aggressive "passport immunity" campaign, through vaccination on a global scale, without the knowledge of studies that accurately clarify the health safety of vaccines , can cause an also high cost an outbreak in the global community in the form of an additional epidemic involving the rise of autoimmune disease syndromes in the immediate or delayed period after vaccination .
The Disease Control Center and the US Prevention (Centr ers for Disease Control and Prevention - CDC), underlines the safety data are ignored for this patient population, concluding that: " ... no information available at this stage to safety of mRNA vaccines for these patients ” .
The long-term safety of vaccines is a prerequisite for approval for widespread use.
According to the Brighton Conference , the list of " adverse events of special interest ( AESI )" vaccines includes side effects such as anaphylaxis, myocarditis, meningoencephalitis, vasculitis and generalized seizures .
The most common side effects are mild and include swelling, redness and pain at the injection site, fatigue and transient pyrexia. However, serious adverse events, such as allergic rash reactions, are associated with a potentially fatal type of allergic shock requiring immediate treatment .
Therefore, " the long-term safety of vaccines is a key pre-approval control parameter for widespread use . "
Finding suitable guinea pig patterns is a cornerstone of making a vaccine.
The importance of finding appropriate standards of laboratory animals, for proper study of a vaccine candidate, stressing that " the experimental models studied, including rodents and other mammals Mr. century nonhuman primates, especially monkeys Rhesus , initially produced promising results for the simulation immune response and adverse outcomes after vaccination. However, all animal models tested, lacked to provide the ideal substrate for in v ivo clinical study is needed to develop a vaccine against the virus SARS - CoV -2 ».
In addition, " common and serious complications, including acute respiratory distress syndrome and blood clotting disorders, were not recorded in animal models , indicating additional limitations in their clinical assessment ."
In addition, relevant experience with other viruses suggests that antibodies may promote rather than reduce inflammatory responses . This phenomenon, called antibody-dependent enhancement (ADE), is due to the presence of cross-reactive antibodies with a neutralizing ability, which instead of neutralizing the virus, instead attach to the virus and allow it to enter the cell. This mechanism is an inhibitory factor for the development of a vaccine for SARS - CoV -2 , because the host response to the virus may be harmful after vaccination.. Therefore, more relevant studies are needed to determine if the host's reactions to the vaccine are protective or harmful. "
Potential exacerbation of the disease after vaccination?
The design of relevant clinical trials and surveillance - even after formal licensing - may provide a more reliable strategy for identifying contraindications, including the potential increase in the severity of COVID- 19 disease after vaccination .
Therefore, bypassing the established process of animal studies has raised some critical questions and raised questions about the long-term safety and efficacy of newer vaccination methods and their preparations against the SARS-CoV-2 virus.
Start-up safety questions
mass vaccinations in the elderly.
Questions for pregnant women and newborns.
The study notes that " the SARS - CoV -2 vaccine- induced humoral immune response may induce viral infectivity or even lead to a more severe onset of the disease ."
In an estimated minority of patients, the induction of natural immune responses may contribute to the over-induction of the inflammatory process with concomitant histotoxicity . This is especially true in the elderly who have an underlying condition of mild chronic inflammation, internationally referred to as " inflammaging ". This type of chronic inflammatory process is associated, in part, with aging, and with changes in the gut microbiome. The latter raises questions about the safety of starting vaccination programs for the elderly against SARS -CoV -2 ».
In addition, “ the normal completion of pregnancy is highly dependent on the increased activity of Th 2 lymphocytes and regulatory cells, with a concomitant reduced response of said Th 1 lymphocytes. In contrast, the potentially vaccine-related " diverging Th 1 ( CD 4+ T cellular ) immune response may cause distant neonatal disorders . Consequently, pregnant women and their gynecologists are required in the future to take into account the available data to weigh the benefits and potential risks of vaccines against of COVID -19 .
The duration of the protection provided is unknown
from the vaccine. Long-term studies are required
for accurate evaluation of effectiveness
and for potential risks of vaccine administration .
In addition, " the duration of the protection provided by the vaccine remains unknown, as no data from long-term results are available to date. Therefore, long-term relevant studies (2. Years) are required for a more accurate assessment of the efficacy and potential risks of vaccine administration. "Another essential problem is the heterogeneity between the data on the vaccine dosage regimen required for optimal efficacy . "
Uncertainty as to whether vaccination
protects or not from contagion
Another interesting issue is that “there is ambiguity about potential transmissibility after vaccination. While these vaccines are indicated to prevent or reduce the symptoms of the disease, there is no clear indication to prevent clinical infection or transmission . "Therefore, because there is a scientific ambiguity as to whether or not the vaccine protects against infectivity, further thorough screening is required for relevant in-depth clarification ."
The uncertain role of mutations
Regarding the mutations of the virus, it is pointed out that " the dynamics of the mutations of SARS - CoV -2, as RNA virus , in combination with the urgent process of development of vaccines based on the primary strain (wild-type), carries the risk of achieving lower than expected results mass vaccination and survival of resistant strains " .
Vaccine mRNA technology and the dangers.
Regarding mRNA vaccine technology, the study states, among other things, that "most available vaccines against SARS-CoV-2 (Covid-19) are based on mRNA technology, expressing the surface antigen of the virus spike. While initial studies have shown encouraging results, scientific concerns about the long-term safety of vaccines have gradually emerged .
Therefore, it is considered necessary to further evaluate at least the subpopulations at risk for autoimmune diseases and to give alternative approaches .
In addition, " the presence of RNA in the extracellular space appears to predispose to endothelial damage, rupture of intermediate cell connections and edema, increased viscosity, hypercoagulability and increased incidence of thromboembolic events ."
Vaccination guarantees the saying of Hippocrates
about "benefit or not harm"?
" The scientific community is required to remain impartial and objective in the processes of relevant research, production and approval, efficacy and safety of available vaccine formulations .
The officials of Medicine, in order to responsibly manage the strong sense of duty and to successfully cope with the present challenge, are required to have an uninterrupted conscious reference and as a guide to the timeless demise of Hippocrates "to benefit " harms me .
The full text of the study follows.
COVID -19: Guarantees vaccination t not fundamental principle "ofeleein or no harm"?
M. Doulberis, 1,2 A. Papaefthymiou, 2,3 A. Kyriakopoulos, 4 K. Karafyllidou, 5 G. Kotronis, 2,6 Ch. Liatsos, 7 I Kountouras 2 .
Gastroenterology and Hepatology Clinic, University Pathology Wing, Aarau Canton Hospital, Aarau 5001, Switzerland.
B 'Pathology Clinic, Aristotle University of Thessaloniki, Hippocratic Hospital, Thessaloniki 54642.
Gastroenterology Clinic, University Hospital of Larissa, Larissa 41110.
Department of Research and Development, Nasco AD Biotechnology Laboratory, Piraeus 18535.
Department of Pediatrics, University Pediatric Hospital Zurich, Zurich 8032, Switzerland.
Pathology Clinic, General Hospital of Thessaloniki "Agios Pavlos", Thessaloniki 55134.
Gastroenterology Clinic, 401 Athens General Military Hospital, Athens 11525.
SUMMARY.
The current pandemic with the international term Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), implies the urgent need to implement an effective and safe vaccination side effects with reduced infectivity, morbidity and mortality from the disease 2019 Cor onavirus disease 2019- COVID -19). To achieve this, the intensive research in the fields of biology and medical sciences combined with the extremely urgent need worldwide reduction of the reported pandemic and its consequences in multiple areas of human life and global prosperity, led to the rapid development of a vaccine arsenal. However, the urgency of implementing a relevant vaccine had, as a substantial limitation, the non- application of the strictly scientifically established procedures required for the primary safety control of each vaccine . The consequent scientific gap created by COVID- 19, has led to reasonable intense concern and concern mainly in the global medical community. The relevant scientific inconsistency and the ensuing concerns in the medical and wider community have been pointed out in the international contemporary literature. In particular, the accelerated development of vaccines has degraded, ignoring the value of the necessary pre-clinical studies to highlight the medium and long-term potential positive or even harmful effects on humans . Previous scientific experience and knowledge of the background of the pathophysiology of coronavirus infections and the development technologies of the relevant vaccines, combined with the need for their global implementation, leads to the following strict adherence to the current protocol: All stakeholders must scientifically approach a careful, strictly standardized and quality objective approach that sheds light on the potential benefits or potential side effects of these vaccines . A relevant inadmissible scientific " bias " entails responsibilities. Additionally, the mutation great tendency of the genetic mechanism of SARS - CoV -2 and existing accumulated genetic variations of the genome, create ambiguities and raise relative uncertainty as to whether these vaccines are effective and elicit a strong immune response against predominant coronavirus strains .
The present review, based on current scientific data and emerging questions about vaccines against COVID-19, aims to stimulate the interest of clinical and laboratory scientists in finding the best possible strategic approach to an individual and broader level. of this new pandemic.
ABSTRACT
Does COVID-19 vaccination warrant the fundamental principle “ ofelein i mi vlaptin” ?
The current pandemic, widely known under the international term Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), imposes the urgent necessity to implement an effective and safe vaccination, in terms of side effects with accompanied reduced virus' infectivity, morbidity and mortality by Coronavirus disease 2019 (COVID-19). To achieve this, enormous research in the biomedical world, combined with the extremely urgent need to reduce, worldwide, the reported pandemic and its consequences in multiple areas of human life and global prosperity, led to the rapid development of a vaccine arsenal. However, the urgency of implementing a relevant vaccine had, as a substantial limitation, the non-application of the strictly scientifically established procedures warranted for the primary safety control of each vaccine.The ensuing scientific gap emerged by COVID-19 has led to reasonable concern and skepticism, especially in the global medical community. The relevant scientific inconsistency and the ensuing concerns in the medical and wider community have been pointed out in the international up-to-date literature. In particular, the accelerated development of vaccines has degraded, ignoring the value of the necessary pre-clinical studies to highlight medium- and long-term positive or potentially harmful effects on humans. Previous scientific evidence and knowledge of the background of the pathophysiology of coronavirus infections and the development technologies of the relevant vaccines, combined with the necessity for their global implementation, leads to the following strict scientific observance of the current protocol:All stakeholders scientifically a careful, strictly standardized and qualitative way of approaching that in depth elucidates the possible benefits or possible side effects of these vaccines. A relevant unacceptable scientific bias entails responsibilities. In addition, the high mutation tendency of the SARS-CoV-2 genetic mechanism and the already existing accumulated genetic variations in its genome give birth to uncertainty and raise relative doubt as to whether these vaccines are effective and elicit a strong immune response against the dominant strains.the high mutation tendency of the SARS-CoV-2 genetic mechanism and the already existing accumulated genetic variations in its genome give birth to uncertainty and raise relative doubt as to whether these vaccines are effective and elicit a strong immune response against the dominant strains.the high mutation tendency of the SARS-CoV-2 genetic mechanism and the already existing accumulated genetic variations in its genome give birth to uncertainty and raise relative doubt as to whether these vaccines are effective and elicit a strong immune response against the dominant strains.
The present review, based on current scientific evidence and emerging questions about vaccines against COVID-19, aims at triggering the interest of clinical and basic research scientists in finding, as far as possible, an optimal strategic approach on an individual and general level of this new pandemic.
Keywords: COVID -19, SARS - CoV -2, vaccines, Hippocrates, restrictions
INTRODUCTION.
COVID-19 is an emerging infectious disease that was first described in Wuhan, China in December 2019 and was classified as a pandemic in March 2020. 1 It is caused by severe coronavirus-2 respiratory syndrome or internationally Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). This particular virus is a novel genetic gene of coronaviruses with ribosonucleic acid (RNA) genome size 27-34 kb and characteristic membrane proteins - spikes, which act as the main pathogenetic elements. 1 According to the World Health Organization (March 7, 2021), the total number of confirmed cases of COVID-19 was 116,135,492 with a concomitant mortality of 2,581,976 (2.2%). In Greece, the corresponding incidents for the same date amount to 273,908 and 6,705 (mortality rate 2.4%). 2
Given that there is currently no scientifically established treatment for SARS-CoV-2 for humans, among other approaches, the urgent need to develop an appropriate vaccine to combat this pandemic becomes urgent. By the entire biomedical scientific community operated in a constant and novel exertion rapid development and application : a) an effective and safe in terms of side effects of vaccination with concomitant reduced virulence, morbidity and mortality from the disease COVID -19 and b) of suitable antiviral agents and approved treatment protocols. 1
However, the urgency of the relevant vaccine application was, as a substantial limitation, the non-application of the strictly scientifically established procedures required for the primary safety control of each vaccine . The ensuing scientific vacuum created by COVID- 19 has led to intense concern and concern in the global medical community . The relevant scientific inconsistency and the ensuing concerns have been pointed out in the international contemporary literature. In particular, the accelerated development of vaccines has bypassed the value of the necessary pre-clinical studies to look for medium- and long-term positive or potentially harmful effects on humans.. All stakeholders must scientifically approach a careful, strictly standardized and qualitative pathway of objective approach, which sheds light on the potential benefits or potential side effects of these vaccines. A relevant inadmissible scientific " bias " entails responsibilities.
In addition, the high mutation tendency of the SARS - CoV -2 genetic mechanism and the already existing accumulated genetic variations in its genome create uncertainties and raise relative uncertainty as to whether these vaccines are effective in the long run and if they produce a potent immune response. of the predominant strains of coronaviruses .
In this context, the contribution of the eminent physician of classical antiquity, the Greek Hippocrates (460-370 BC) makes him the father of Western Medicine. 3 In his book entitled 'On Epidemics' (Book 1, field 11), among other parameters, the following diachronic phrase is mentioned: " ἀσκεῖν περὶ τὰ νοσήματα δύο, ὠφελέειν ἢ μὴ βλάπτειν ". 3 Based on this fundamental principle of " benefit ἢ harm" and existing current scientific data in conjunction with the emerging questions about vaccines against COVID-19, The purpose of this review is to stimulate relevant research by clinical and laboratory scientists in search of an optimal strategic approach to this new pandemic.
BRIEF HISTORICAL RETROSPECT OF VACCINES.
The first development of vaccine against the smallpox virus is attributed to Benjamin Jesty and Eduard Jenner in the 18 the century. 4 This vaccine was based on a simple but effective technique for controlling pathogenic microorganisms by inoculation with zoonotic smallpox viruses in sick people. This technique causes mild disease while providing immunity to future virus infections. 4 Etymologically, the word "vaccine" comes from the Latin word "vacca", which translates as cow.
This was followed by the application of a wide variety of attenuated vaccines . Pasteur and his colleagues developed the attenuation method and investigated the use of many vaccines, including those against the bacterium Pasteurella multocida , charcoal and rabies. This category includes the TB vaccine, also known as BCG (Bacillus Calmette Guérin). 4 An alternative method of vaccination was to inactivate using killed microorganisms from diseases such as rickettsia, pertussis and polio. Innovative in vaccine production methodology was the development of in vitro vaccines , using cell cultures in a test tube. 4 In addition, vaccines with purified proteins or microbial cell membrane polysaccharides have been used, such as vaccines against diphtheria, released tetanus toxin-secreting proteins, secreted carbonic or bacilli, or polycarbonate-secreting proteins. 4 Hepatitis B vaccination was pioneered , using virus surface antigen. In the last decade, additional innovative scientific developments have led to the production of messenger RNA ( mRNA ) vaccines for use against both infectious and neoplastic diseases. 4
The engineering of mRNA vaccine technology aims to rapidly express certain proteins through a specific mRNA molecule that is delivered to the body by the ribosomes of the vaccinated organism itself. Advantages of mRNA vaccines include potentially eliminating the infection, safety / efficacy, stability, low cost and large scale production. 5
The reported advantages have led to the design of SARS-CoV-2 vaccines with the expectation of their high efficacy and potential medium- to long - term safety.
VACCINES AGAINST COVID -19.
The need to develop effective and safe vaccines against the existing pandemic is a major challenge and subject to ongoing intensive study by the global community of scientists. To this end, deciphering and understanding the complex molecular and cellular mechanisms of the host's SARS-CoV-2-induced immune response is a major research goal for the development of vaccines and related therapeutic strategies with the ultimate goal of limiting milder clinical course of patients.
While the long pre-scientific process is necessary for the development of safe vaccines , the experience of the existing SARS - CoV- 2 pandemic surprised and accelerated the process in this case . 6
In this regard, it should be noted that the Pfizer vaccine - BioNTech Covid -19 has not been approved or licensed by the FDA (US Food and Drug Administration), but has only been authorized for emergency use under the SAR-Emergency Prevention Co-inhibition 2 disease, for use in people 16 years and older . This suggests, among other parameters, ambiguity in controlling their potential safety.
The first vaccines were clinically available just 15-18 months after the onset of the pandemic. 7 63 candidate vaccines in human clinical trials and more than 172 candidates in preclinical development worldwide9. Among the 60 clinically evaluated vaccines we find 13 leading candidates who are already carrying out or entering Phase 3 clinical trials. phase 3 clinical studies 8
Briefly, the vaccine development process generally involves two main steps:
the identification of a target antigen, and the development of the optimal method of administration to the body to achieve a strong humoral and cellular immune response of the host. Candidate vaccines are categorized into four groups based on:
virus carriers, RNA matrix, DNA matrix, and virus antigen protein. 9 It is noted that vaccines require at least 10-15 years of scientific process to be safe for clinical use .
In particular, the required sequential steps necessarily include: the preclinical study stage in the laboratory and in the experimental animals , the phase 1.2 phase of clinical trials and finally the phase 3 phase , in order to draw the final conclusions on the effectiveness or not of each vaccine test.
To initiate each subsequent phase in the vaccine development sequence, it is important that the results of all previous phases are scientifically sound to justify the next stage of research. On the contrary, this necessary scientific process for the development of vaccines against COVID- 19 was carried out in a significantly shorter period of time, because the development phases overlapped . Within a few months, more than 30 candidate vaccines were introduced in the clinical trial phase and several of them (12) are already in the 2/3 phase.
Finally, before the collection and extraction of the necessary conclusions regarding the safety and efficacy of the candidate vaccines was completed, their widespread industrial production and distribution to the general population began . These data give rise to a variety of scientific " biases " that have potentially serious consequences .
Candidate vaccines tested against COVID-19 include the following categories: 6
(non) replicating carrier viruses virus-like particles DNA template live - inactivated viruses inactivated viruses recombinant proteins-antigens of the virus plant-derived antigens RNA template. At the beginning of 2021, at least five candidate vaccines have been authorized for emergency use in various countries for clinical application . 8 The mRNA-based BNT162b2 vaccine, developed by Pfizer-BioNTech, was the first to receive the reported emergency authorization for SARS-CoV-2 in the United States. 10 The mRNA-1273 the company Moderna vaccine, also received authorization for emergency supply. 11 To Sputnik V vaccine Gamaleya company, based in the use of viral vector for the transfer of antigen administration was authorized initially in Russia. 7 The fourth licensed vaccine COVID-19, developed by Astrazeneca Vaccitech companies and the University of Oxford and is based on the same technology as the V. Sputnik 8 The interim analysis of the ongoing clinical trials for the four vaccines 12 describes a short-term safe and beneficial result for all formulations . In addition, the vaccine, which originated in the People's Republic of China and was developed by Sinopharm, contains the inactivated SARS-CoV-2 virus. 8 An interim analysis of the phase data 1, yielded comparable results in the aforementioned vaccines. 13
CONCERNS THAT ARE RAISED
FROM VACCINES AGAINST COVID -19.
The FDA's use of Emergency for two COVID- 19 mRNA vaccines and the accompanying expectation of the development of a variety of other vaccines in the near future have sparked multiple questions, concerns and public controversy from the scientific community and the general public about . 14 More than 190 candidate vaccines are already in some stages of development against the SARS-CoV-2 pandemic. 15 The important misleads the scientific community and the recipients of the vaccines, focused on the fact that certain vaccine trials have been withdrawn or blocked for security reasons . Nevertheless, others have declared candidate vaccines as effective and safe , as described by the Russian and Chinese authorities who approved their release. 16 In this context, evaluators and managers must responsibly consider ways to address the challenges that arise . challenges that are not related to vaccines themselves. These challenges are probably combined with the general reluctance of some citizens about all vaccinations, the conspiracy theories that emerge and take over the media at a frenetic pace in anything "innovative" but not fully scientifically substantiated and tested in modern, with the economic and mental fatigue and the serious consequences of the current and proposed measures of health restriction worldwide, but also the dizzying speed of vaccination efforts of the world population . All this raises logical "conflicts" essential for human life, elements that need in-depth clarification for reasons of legitimacy.
The rapid global pace of development and early implementation of new vaccines that have not been adequately tested is fueling existing concerns and phobias about imminent vaccination and a priori jeopardizing SARS-CoV-2 vaccination programs, as noted by some . 17 Vaccination hesitation, especially in the context of vaccination against COVID- 19, is a global reality and anti-vaccination movements are progressively increasing, 18 especially in the growing number of adults questioning the validity of preventive vaccination programs. 19 It is important to note that the autonomy of each individual is an inviolable fundamental principle and this does not justify, for example, compulsory vaccination . The imposition of compulsory vaccination is condemnable . According to a commonly accepted example, the world community prohibits voluntary slavery and duel because the expulsion or murder of capable individuals , even if they consent , is incompatible with the conditions of autonomy necessary for people to continue to enjoy a dignified life. and healthy living of their choice. For example, John Stuart Mill was placed in n principle that does not justify all voluntary acts autonomy. "Άτομο The person selling himself a slave at the same time gives up freedom… Freedom that takes him away from freedom is impermissible, irrational ". 20 In the same way, human rights allow for the refusal of vaccination, and therefore compulsory vaccination by any body that attempts it is unacceptable, has legal and judicial consequences and has not been properly enforced worldwide.
VACCINES AGAINST CROWNS AND AUTO IMMUNITY.
Autoimmune and inflammatory pathologies occur in patients with COVID-19, such as autoimmune cytopenia, anti-phospholipid syndrome, Guillain-Barré syndrome or Kawasaki disease, and require special care and treatment of such potentially life-threatening patients. 21 It is noted that a wealth of scientific evidence correlates COVID-19 with the development of autonomy. 21 Autoimmunity induced cross reactivity of the vaccine, is implicated in the development of several pathological conditions include, apart from said Guillain-Barré syndrome, multiple sclerosis, other apomyeloinotikes neuropathies, systemic lupus erythematosus, narcolepsy syndromes or orthostatic tachycardia in susceptible populations.22 Consequently, an essential side effect that mass vaccination can cause is the induction of autoimmune diseases , especially in individuals with a genetic predisposition to autoimmunity. 23 The existence of homology between SARS-CoV-2 virus epitope proteins and human protein epitopes leads to cross-reactivity and the induction of autoimmune diseases that reflect the adverse effects of vaccination. 24 Because -schetizomena the crossreactivity proteins of SARS-CoV-2 to TF epitopes of human-diseases may seriously worsen subjects of patients diseases or lead to unforeseen reactions that threaten the lives of patients undergoing vaccination A thorough investigation of the potential for induction of an autoimmune reaction by SARS-CoV-2 antigens is required . 25
The promotion and implementation of such an aggressive "passport immunity" campaign, through vaccination worldwide, without the knowledge of studies that accurately clarify the health safety of vaccines , can cause another costly explosion in the global community with form of an additional epidemic involving the increase of autoimmune disease syndromes in the immediate or delayed period after vaccination . 25
Studies in one-year-old and one-year-old experimental animals vaccinated with SARS-CoV virus double-inactivated vaccines (DIVs) have shown that adult mice vaccinated with the immunized and aluminum peroxide) showed high levels of eosinophils in the lung . Pulmonary eosinophilic infiltrations were confirmed by histological examination and flow cytometry. 26 Pulmonary eosinophilic and Th2 lymphocyte infiltrates were observed in mice inoculated with SARS vaccines (enriched or not with aluminum hydroxide as adjuvant). 24 It is noted that autoimmunity is characterized by Th2-mediated eosinophilic clinical entities. 27 Indeed, eosinophilia is associated with many autoimmune and rheumatological disease or connective tissue disease such as vasculitis, Churg-Strauss, Wegener's syndrome, dermatomyositis, severe rheumatoid arthritis, sarcoidosis, progressive systemic sclerosis, systemic lupus erythematosus, I gG 4-associated disease and idiopathic inflammatory bowel disease . 28
Molecular mimicry between virus and host epitopes also leads to cross-reactions with consequent production of toxic autoantibodies . The cytokine profile seen in patients with COVID-19 and lung damage is similar to that seen in patients with autoimmune diseases . lesions compatible with those observed in necropsies of COVID-19 patients in China. 29 Furthermore, the existence of a common heptapeptidic chain between the viral glycoprotein akidikis and human proteome (proteon) has been reported. 30 In the same context, a common sequence has been identified between the soluble receptor of the angiotensin 2 converting enzyme (ACE-2) and the SARS-CoV-2 virus proteins, which cross-reacts to produce autoantibodies. The type of lesions caused by these autoantibodies in the lungs of patients with COVID-19 is similar to that of the lungs caused by autoantibodies to angiotensin 2 in patients with scleroderma. 31
The Centers for Disease Control and the US Prevention (Centr ers for Disease Control and Prevention - CDC), emphasize safety data are ignored for this patient population, concluding that: " ... no information available at this stage on safety mRNA vaccines for these patients ” . 28
COVID- 19 vaccines and their progress towards final approval: pre-clinical animal STANDARDS.
There is an urgent need to find suitable experimental animal models for proper pre-clinical evaluation of a vaccine candidate and a novel treatment strategy. Preclinical experimental studies are prerequisites during the development of vaccines to determine the route of administration, the interfering immune mechanisms and the duration of the acquired protection, in order to achieve an optimal balance between immunity and side effects . 31 Animal models provide a means to investigate the pathogenicity and the biological mechanisms of disease COVID-19, illustrate particular features of the pharmacology, toxicology and immune to v developing a therapeutic vaccination strategy. 32 The initial step in this process requires determining the most appropriate experimental model for each specific disease under investigation. Consequently, the route of infection, the receptors, the mechanisms, and the susceptibility to the disease are required to resemble those of humans. When the host is infected, under ideal conditions, it will develop the corresponding clinical symptoms and course of the disease to provide sufficient material for the study of the immune response. 31 Therefore, a safe period of time to ensure reliable results requires at least 9-10 years of preclinical studies before being administered to humans . 31
The current SARS-CoV-2 pandemic has prompted the identification of experimental models as suitable for the study of COVID-19 disease in humans, with the aim of contributing to the treatment and vaccination against the increasing transmission and mortality of the disease. 33 The experimental models studied, including rodents and other mammals and non-human primates, especially Rhesus monkeys , initially produced auspicious results in simulating the immune response and adverse outcomes after vaccination . 34 However, all animal models tested failed to provide the ideal substrate for in v ivo clinical study necessary for the development of a vaccine against the SARS - CoV -2 virus . This is because in none of these experimental models was it possible to reproduce the severe or critical clinical symptoms associated with the death of patients from COVID- 19 . 35
In addition, common and serious complications, including acute respiratory distress syndrome and blood clotting disorders, were not recorded in animal models, indicating additional limitations in their clinical assessment . 36
In particular, at the preclinical level, vaccination of Rhesus monkeys induced the production of neutralizing antibodies, suggesting the development of potential adjuvant activity against the SARS-CoV-2 virus. 37 In this experimental model, the effectiveness of the protection correlated with the titers of neutralizing antibodies against the protein spike and required further analysis of the immune response of T lymphocytes. 32 Infected Monkeys virus SARS - CoV -2, developed mild attack lung, without clinical symptoms of COVID -19 or death. The duration of clinically adequate immunization or the potential adjuvant effect of the vaccine in n metemvoliastiki period does not become possible to estimate, because the direct innate viral clearance, the self-limiting pneumonitis not brought about death and said absence of clinical course . 35 Additionally, the relative experience of other viruses indicates that the antibodies can promote rather than reduce inflammatory responses . This phenomenon, called antibody-dependent amplification (antibody-dependent enhancement - ADE), is due to the presence of cross-reactive antibodies with defective neutralizing ability, which attach to the virus and allow it to enter the cells. 32 This mechanism is inhibiting the development of a vaccine for SARS - CoV -2, because the response of the host against the virus may be harmful after inoculation . 38 Accordingly, necessary additional studies to determine if the host's reactions to the vaccination is protective or deleterious. Considering the viral infection, the reported ACE-2 receptors and the transmembrane protease receptors of serine-2, which are highly related to the proteins found in the virus particles and mediate their intracellular penetration, differ in human tissues compared to Rhesus monkeys . 39 Human lung cell type II with concomitant high ACE- 2 expression are the primary targets of SARS - CoV- 2 virus , leading to infection and respiratory failure. In contrast, the corresponding cells of Rhesus monkeys are characterized by lower receptor expression ACE -2, apparently indicating an endogenous resistance to COVID- 19 infection compared to humans . 40
Accordingly, a detailed assessment of experimental models for the n disease COVID -19 and compliance with a set time frame, can ensure that any possible differences of opinion and deviations from the scientific accuracy of premature delivery in humans .
In addition to selecting the appropriate experimental animal, the duration of preclinical studies is the cornerstone for the correct assessment of mid- and long-term outcomes . 31 While the current pandemic does not allow for delay, prolonged in vivo assessment may provide more essential information on the duration of antiviral protection. Especially for RNA viruses, including SARS - CoV -2, the repair mechanisms do not recognize and do not repair their mutations, thus leading to their accumulation in the viral genome. Mutant viral RNA is transcribed into various protein structural antigens, a process called antigenic drift. The new antigens predispose to viral escape from immune system surveillance with the main example being the influenza virus. Annual vaccination against this virus is therefore recommended, and recent scientific data necessitate a similar timing of vaccination against SARS-CoV-2, even at more regular intervals. 31
In addition to the therapeutic benefits, preclinical experimental studies may elucidate potential vaccine safety concerns from data from previous coronavirus outbreaks . In particular, studies of SARS-CoV and MERS-CoV infections have revealed an adverse immune-mediated disease that manifests itself in two ways: antibody-mediated lung disease, or the defective protection of anti-SARS-CoV antibodies, which may to facilitate possible SARS-CoV infection in target cells. 41 Based on data from previous studies, said ADE was considered to be mediated in the Th2 cell activation cases after inoculation, and thus, the estimate of the potential in in vivo , was a prerequisite for studies of the SARS-CoV-2 vaccine in humans. 42 H prevalence of T h 1 immune response to vaccination against SARS - CoV -2, it was considered initially as a safe condition for blocking potential reaction q ADE in the vaccinated organism. 41 However, other quality characteristics, the quantitatively excessive reaction of the immune system can result in the development of the disease leading to immune Th 2 dysfunctional reaction . 43
In addition, the aforementioned viral RNA instability and consequent mutations may trigger an unpredictable ADE or insufficient antiviral protection, predisposing to a strong immune response to a possible SARS - CoV- 2 infection after vaccination . Therefore, a careful approach to the vaccine development process is required to avoid the reported potential adverse events that create safety problems for vaccinated populations.
To date, most available vaccines against SARS - CoV -2 are based on mRNA technology , expressing the surface antigen of the virus spike. 44 While initial studies showed encouraging results, however gradually emerged scientific concerns about the long term safety of vaccines . 5 In addition to the local and / or systemic immune response, which were partially met by the initial studies, persistent expression of vaccine-associated mRNA antigen, foreign nucleotide toxicity in the host genome, and induction of antibodies the host, they demand in vivo long-term assessment before vaccines are made available to the global community, at least to identify subpopulations at risk for autoimmune diseases and to provide alternative approaches .
In addition, the presence of RNA in the extracellular space appears to predispose to endothelial damage, loosening of intermediate cell connections and edema, increased viscosity, hypercoagulability and increased incidence of thromboembolic events . 5
At present, there is no evidence that in vitro or experimental animal models of SARS-CoV-2 infection consistently predict similar experience in humans. While animal models of SARS-CoV-2 infection are likely to elucidate the immune defense mechanisms, future scientific approaches to elevated disease in people receiving COVID- 19 vaccine vaccines are considered urgently needed to identify the disease response . The design of relevant clinical studies and surveillance even after formal licensing may provide a more reliable strategy for identifying contraindications, including the potential increase in severity of COVID- 19 disease after vaccination . 45
In conclusion, bypassing the standard process of animal studies has raised some critical questions and raised questions about the long-term safety and efficacy of newer SARS-CoV-2 vaccine methods and preparations. Therefore, the availability of vaccines to the global population requires the institutionalized pre-vaccination development approach, based on well-designed scientific studies to produce optimal prevention results without the risk of complications .
vaccination efficacy / side effects against COVID-19.
There is no vaccine or medicine that is completely free of side effects or potential complications. Based on the B righton Conference , the list of " adverse events of special interest ( AESI )" vaccines includes side effects such as anaphylaxis, myocarditis, meningoencephalitis, vasculitis and generalized seizures . 46,47
The most common side effects are mild and include swelling, redness and pain at the injection site, fatigue and transient pyrexia. 48 , however, undesirably serious events, including allergic anaphylaxis reactions, related to allergic shock formula (shock) potentially lethal course requiring immediate treatment . 49 In particular, about immunization against COVID-19, have been reported after vaccination allergic reactions, including severe anaphylactic (after the first dose of Pfizer-BioNTech anti-COVID-19 vaccine in December 2020), mobilizing stakeholders to issue targeted and up-to-date guidelines for therapeutic approaches. 49 For this purpose, the sites conducting vaccinations required to have the necessary means and trained personnel for the treatment of anaphylaxis and to ensure adequate time monitoring after the vaccination . In addition, Allergic patients are required to be trained and supplied with adrenaline injections for immediate administration in case of rash outside the hospital . 49
In addition, the long-term safety of vaccines is a key pre-approval control parameter for widespread use . Exacerbation of clinical infectious disease has been observed following vaccinations against respiratory syncytial virus ( RSV , FIRSV vaccine ) . In particular, there was a significant increase in hospitalization rates due to RSV in children vaccinated with FIRSV aged 6-11 months, causing two deaths, and the FIRSV vaccine-related exacerbation of the disease led to the cessation of the clinical trial. Also, studies in experimental animals for the development of vaccines against MERS and SARS - CoV-1 cases of clinical exacerbation of the disease have emerged . 50
It is noted that the SARS - CoV -2 vaccine- induced humoral immune response may induce viral infectivity or even lead to a more severe onset of the disease 45 . Antibody-mediated immunoassay (ADE) or Enhanced Respiratory Disease (ERD) are typical examples of an overexposure to the virus. 51 The risk of such side effects also exists in the case of SARS - CoV -2 vaccines , a finding that may be underestimated by the fact that very recent clinical trials are short-term . 45 In a minority of patients estimator, induction of innate immune responses may contribute to excessive induction of the inflammatory process with concomitant histotoxicity . This is especially true in the elderly who have an underlying condition of mild chronic inflammation, internationally referred to as " inflammaging ". 52 This type of chronic inflammatory process is associated, in part, with aging, and with changes in the gut microbiome. The latter raises questions regarding the safety of initiating vaccination programs in the elderly against SARS - CoV -2. 53
Regarding the SARS-CoV-2 vaccine, in September 2020, safety issues were raised following a case of transverse myelitis in a participant in clinical phase 3 of the AstraZeneca vaccine and the University of Oxford (AZD 1222). This side effect led to the temporary cessation of the clinical study . 7
Regarding the safety of the Moderna mRNA-1273 vaccine, the frequency of adverse events in participants did not differ statistically significantly from the control group for the short 28-day observation period. 11 However, reported cases of patients show palsy Bell ( Bell ' s palsy ) after administration of the vaccine which require further investigation and evaluation . 11
An additional serious concern concerns the effectiveness of vaccination in patients receiving immunosuppressive therapy, as no phase 3 vaccine trial was performed in this category of patients . In particular, treatment with anti-CD20 monoclonal antibodies, mainly Rituximab, causes a rapid and prolonged decline in the B-cells responsible for antibody production, which lasts at least 9-12 months. 54 Based on this impact deduction of acquired humoral immune response, current recommendations suggest the vaccine against COVID -19 at least six months following administration of Rituximab . 55 Similar data apply to Ocrelizumab therapy. 56 Results of studies in patients using formulations Ocrelizumab or Rituximab ( NCT 02,545,868, NCT 00,676,715) suggest that the development of protective antibodies, and more generally the response to vaccination disadvantage to the production of new B lymphocytes. 56 For example, in a study of patients with optic neuromyelitis (NMOSD) treated with Rituximab, the defective immune response to the H1N1 influenza virus was associated with a decreased antibody titer and seroconversion (37.5% of healthy witnesses). 57 In that context, the Helicobacter pylori ( Hp ) infection, by inducing multiple mediators or by molecular mimicry (homology of Hp epitopes with host neuronal elements), is implicated in the pathophysiology of reported optic neuromyelitis. 58 Furthermore, the Hp increases expression of ACE-2 receptors in the gastrointestinal tract, and the symptoms of gastrointestinal tract significantly associated with the presence of Hp in patients with COVID-19. 59
The inclusion of pregnant women in clinical trials for the development of vaccines has been widely discussed in recent years in the light of Bioethics and in the case of vaccines against COVID -19, pregnancy was one of the exclusion criteria . 60 While pregnant patients are more likely to need mechanical ventilation in case of COVID-19 disease and a higher risk of miscarriage, 61 There are some issues that need to be documented in relation to vaccination in this population group. Results of studies using the Pfizer-BioNtech mRNA (BNT162b2) vaccine show a broad immune response by induction of neutralizing antibodies, and activation of Th1 helper (CD4 +) and cytotoxic (CD8 +) lymphocytes in non-male and female lymphocytes. 62 whether there is a similar immunophenotypic response to pregnant unclear . However, it is known that the normal completion of pregnancy depends to a large extent on the increased activity of Th 2 lymphocytes and regulatory cells, accompanied by a reduced response of the reported Th 1 lymphocytes .63 The disturbance in the balance of CD4 + T lymphocyte immune response during pregnancy is associated with perinatal adverse events, including loss of the fetus and premature labor. In addition, the divergent CD 4+ T cellular immune response may cause distant disturbances in the newborn . 64 Consequently, pregnant women and their gynecologists are required in the future to take into account the available data to weigh the benefits and potential risks of COVID- 19 vaccines. . Specific issues to consider include the results of animal studies, the potential risks of pregnancy from the reactogenicity of vaccines in this population, and the coexisting risk factors for pregnancy. 60
An additional high-risk group includes patients with liver disease. Patients with liver cirrhosis have a higher risk of developing COVID-19 and more severe liver complications than those without cirrhosis. Therefore, patients with advanced fibrosis and / or concomitant liver transplantation are considered to be the primary targets of COVID-19 prophylaxis as extremely vulnerable groups. 65 However, in clinical practice, including the number of patients with liver diseases were extremely limited , despite the fact that the three major clinical phase 3 trials with vaccines of Pfizer / BioNTech companies, Moderna and AstraZeneca, have incorporated almost 100,000 people. For example, in her clinical trial Pfizer included 217 participants of whom only three (0.6%) had a history of moderate to severe liver disease . 66
In addition, no scientific impact data vaccines mRNA in the COVID -19 in neurological patients with severe headaches, such as migraine with or without aura and cluster headaches . Given the increased incidence of headaches reported in both cases of mRNA vaccines , caution should be exercised in patients with chronic and severe headaches . These patients may be at greater risk for recurrence of the disease and modification of symptom onset thresholds, promoting a potentially vicious cycle of relapses. In addition, Any interaction of vaccines with new anti - CGRP antibodies (calcitonin gene-related peptide) such as Erenumab is still under investigation .
In addition, the duration of the protection provided by the vaccine remains unknown, as no data from long-term results are available to date. Preliminary studies on the Moderna mRNA-1273 vaccine have shown that a dose of 100 mg may provide an increased titer of neutralizing antibodies for 3 months . 67 The Lumley al , 68 controlling 12,541 workers in the health sector, reported that the presence of antibodies against nucleoside capsid ( anti - nucleocapsid - IgG ) or protein S virus ( anti -IgG - spike ), was associated with a significantly reduced risk of recurrence of SARS - CoV -2 at six months. 68 Consequently, long-term relevant studies (2) years) are required for a more accurate assessment of the efficacy and potential risks of vaccine administration .
Note that the FDA has issued the Emergency Authorization (Emergency Use Authorization - EUA) for both mRNA vaccines for SARS-CoV-2, applying a rigorous and long-term monitoring program to detect possible side effects and further exploration of term . 69 Similarly, the EMEA ( European Medicines Agency - EMA ) issued a conditional license administration for the vaccine Pfizer-BioNTech. This type of license is also granted for medicines for emergency health needs , despite incomplete clinical data . 70
Another essential problem concerns the heterogeneity between vaccine dosing data required for optimal efficacy . Oxford's AstraZeneca analysis showed a significant difference in efficacy, depending on the amount of vaccine administered. The dosing regimen of two (2) full doses over a period of one month was effective in only 62% of cases , while participants who received less vaccine in the first dose and full dose in the second dose had 90% more protection than COVID- 19 in relation to the control group . 71 These ambiguous findings require further clarification.
Another major disadvantage of the emergency procedure followed in SARS-CoV-2 vaccines is the pressure to immunize participants who initially received a placebo vaccine (placebo group). However, the vaccination of the control group alters the statistics on the medium and long term effects of the safety or not of the vaccines and the clinical impact of the immune stimulation between the two groups. The latter critical aspect is of great scientific importance because it creates ambiguity about potential transmissibility after vaccination. 72 While these vaccines suggest to prevent or reduce symptoms of the disease, there are no clear indications prevention of clinical infection or transmission . 72 A similar issue was raised with regard to the results of studies on the 1273 mRNA vaccine. The data collected were considered insufficient to estimate the rates of asymptomatic infection. 11 Accordingly, because no scientific ambiguity if vaccination protects or not infectiousness 11 , further scrutiny for relative depth elucidation.
The pressure to develop vaccines over a period of months , as reported by the previous coordinators of the respective programs, has led to the omission of the mentioned important scientific steps in the pre-clinical study phase , despite the fact that the new laboratory techniques require less time compared to traditional . The rapid development of vaccines carries the risk of avoiding side effects that would otherwise be detected through long-term studies . In addition, the absence of a sufficient number of specific population groups, such as high-risk patients with autoimmune diseases, malignancies, diabetes, obesity, or the elderly, may overlook serious short-term and long-term consequences after vaccination . Therefore, future studies in such groups are required to evaluate the safety of SARS - CoV -2 vaccines . 14.73 Recently, in Norway, 26 elderly people died shortly after receiving the Pfizer vaccine - BioNTech , 74 which raises serious concerns.
In summary, further prospective studies in a large population sample are expected to provide information on the duration of protection or not of each vaccine, prevention or not of severe forms of COVID- 19 after vaccination , their effectiveness or not in immunocompromised patients, children , pregnant or mutant strains and possible transmission protection . 70
Following careful planning and calculation of the benefit-risk balance, it makes sense to conduct some comparative vaccine control studies in order to lay a solid foundation for pandemic management . 75
SARS - CoV -2 gene mutations and effectiveness of COVID- 19 vaccines .
A total of 149 mutations in 103 different strains of SARS-CoV-2 have been identified since the early stages of the pandemic . 76 The largest proportion of induced mutations includes 67.4% synonymous mutations and 84.3% non-synonymous mutations, reflecting new origin or population growth. 77 Among the identified mutations, twenty-three detected in surface glycoprotein (S), one in the envelope protein (E), two in the glycoprotein of the viral membrane (M) and seven in the nucleocapsid protein (N). Among structural proteins, protein s S , M and N exert important role induction of the immune response . 78 Protein S is the major vehicle for virus entry into cells through interaction with the host ACE2 receptor. Several candidate vaccines aim to inhibit S protein by neutralizing antibodies, preventing the virus from entering the cell . 79 In this context, pathogenic viruses, including COVID- 19, are constantly evolving through antigenic conversion and reported shift and drift . This evolutionary trend of the virus leads to the emergence of new serotypes, which prove to be deadly in human influenza pandemics , with SARS -CoV -2 is the most recent example. 80 The rapid shift and drift of viruses cause changes in their antigenic properties, thus making them unrecognizable by the host's immune system . In this way the viruses escape the immune surveillance of the host and are capable of causing additional infections . In particular, antigenic diversion is a key feature of RNA viruses, providing an endogenous mutation potential due to the absence of genome repair mechanisms, and predisposing to changes in virus epitopes with consequent escape of their binding by host-developing antibodies. 31 Environmental conditions, such as transmission from host to host and the immune response, lead to the accumulation of sequence-related nucleotide-amino acid-protein-structural transformations that are reflected in changes in the viral phenotype of the viral phenotype and the allelic phenotype. 81 Unlike typical examples of viruses, such as influenza or acquired immunodeficiency virus (HIV), the SARS-CoV-2 expressing a 3'-5 'exonuclease, which acts as a stabilizer of RNA, reproducibility and homogeneity by monitoring the replication of the virus genome. 79 The existing viral heterogeneity among virus strains HIV -1, influenza or j Procedure dengue fever raises doubts about the effectiveness of vaccines against these viruses , which, however, are a different population from the SARS - CoV -2 virus . In this context, said S protein, which facilitates viral particles to attach to and invade host cells, was initially thought to be relatively unchanged, being a reasonable target for antibodies to achieve host immunity and protection. 82 As a result, the initial isolated genome of SARS-CoV-2 (Wuhan- Hu-1) in December 2019 was evaluated the various vaccine development matrix as mRNA-1273, BNTX BNT162b2 and Ad5-nCoV. 83.84 However, despite the short duration of the pandemic, significant genetic changes are recorded in the gene encoding protein S. 85 The predominant mutation of the S protein involves the replacement of the amino acid aspartate (D) by glycine (G) at position 614, which is the current prevailing form of the virus worldwide, 86 possibly due to its resistance to environmental stressors, as indicated by its higher title in related studies. 85 The mutant model of position 614 follows a geographical distribution, with the G614 prevailing in the West and the D614 in the East. The receptor-binding domain (RBD) region of the S1 segment specifically interacts with ACE-2, in contrast to the rest of the virus S protein. The RBD region is sufficient to bind strongly to the ACE-2 peptidase region. Accordingly, the RBD area appears to be a catalyst for: 1) the N binding of virus to its receptor, 2) the range of interaction between virus and host and 3) the tropism and virulence of. 87 Although site 614 is not included in RBD, its mutation modifies the structure of the S protein in a region that facilitates viral protein binding to host cell receptors and their subsequent fusion, increasing pathogenicity compared to the primary virus. 85 On this link, the mutant strain may virus causing increased severity and mortality of infection related disadvantageous immune response, the modified G614 protein S remaining uncoupled with its associated with immune receptors / antibody system as described in other viral infections, including RSV and HIV. 86 However, studies in experimental animals infected with the mutant strain G 614 showed that administration of serum to individuals infected with the original virus provided adequate neutralization of the mutant epitope . 85 The commercially available vaccine mRNA -1 273, in pre-clinical studies led stimulation CDs 8+ T lymphocytes and the production of antibodies against both virus variants SARS - CoV -2, but the clinical protection that is described in v study does not can be reduced to humans due to the different pathophysiological mechanisms between muscle and humans. In addition, G614 mutant virus-associated infection causes a higher load on the nasopharyngeal smear and concomitant infectivity, expressed in fewer RT-PCR cycles. 85 This indicates that probably require higher titer antibodies to neutralize virus compared to the starting strain D614. An additional condition observed during the SARS - CoV- 2 pandemic was the reported ADE in case of infection with the mutated virus. 85 However, current data do not correlate the specific mutation of the virus by ineffectiveness or side effects of authorized vaccines for emergency use. 88
On the other hand, a number of additional mutations have already been recorded, some of which appear to have a significant clinical and therapeutic impact. The most important region of the S protein is the RBD sequence, due to its proximity to epitope regions, where its possible modifications may affect the immune response and the clinical outcome of the infection. In particular, specific amino acid sequences within the S protein have been described that exert antigenic properties, such as sequences 370–394, 450–469, 480–499 and 818–835, 89, but also related variants thereof. Regarding clinically significant mutations in the virus, viral strains expressing A 475 V , L 452 R , V 483 A , N 439 K , Y 508 H and F 490 L possess endogenous protection against the humoral immunity of the host, 90 and trials investigating the efficacy of therapies with monoclonal antibodies, they recorded the resistance of these strains to the specific treatment q. 90 The recent British mutation is mainly characterized variant N501Y and incorporates additional 23 mutations in protein S, although with unclear effects on the immune response and vaccine efficacy . 89 In addition, the aforementioned G614 mutation is accompanied by additional instability of the virus genome and accumulation of further mutations. 81 In particular, in many areas, particularly in the West, strain G 614 comprises additional mutation ORF 1 ab 4715 L , associated with increased mortality, while the coexistence of I 472 V was associated with enhanced virulence and resistance to immune clearance . 86.90 Based on the above, strains with resistance to the immune response are required be closely monitored for their ability to prevail after eradication of current forms of the virus by vaccination .
In addition to the amino acid chain, glycosylation determines the stereotactic form of protein S and its interaction with protein receptors. Like the previous CoV, the current SARS-CoV-2 virus maintains a significant degree of glycosylation of the S protein in 22 N-glycosylated regions, regulating its relationship to the immune response and host virus interaction. 91 Based on this finding, genetic diversity concerning the glycosylation may affect essential viral functions, including the escape of the virus from host defense mechanisms. 92 In terms of infectivity, deficient glycosylation of N331 and N343 sites reduces the possibility of colonization, while in terms of resistance to neutralizing antibodies, N234Q variants are resistant and N165Q sensitive. 90 As regards the associated immune cells binding RBD, serine 673, threonine 678 and serine 686 are three possible O-glycosylation site, whereas there is uniformity in other positions N- or O-glycosylation. These three sites are thought to protect viral particles against the host's defense mechanisms, creating the mucin-like domain. 93 Glycosylation may vary between host species. Consequently, The development of vaccines in bacteria, mammalian cells and plant expression systems may affect the structure and effectiveness of antibodies in diseased humans . 90
Currently, many databases have been developed to record mutations in the RNA of SARS-CoV-2 for the purpose of scientifically designing technologies for the treatment and reduction of disease. The Global Evaluation of SARS-CoV-2 Sequence (GESS) and GISAID databases consist of up-to-date sources of detectable COVID-19 virus mutations, which can provide detailed information on the stable and conserved epitopes of the S protein chain by guiding the development of global and virus-independent vaccine strains . 84
The dynamics of SARS - CoV -2 mutations , as viral RNA , in combination with the urgent development process of wild - type vaccines , carries the risk of achieving inferior to the expected results of mass vaccination and survival of resistant strains . Therefore, further adequately designed studies, taking into account virus mutations, are necessary to identify lower heterogeneity epitopes for vaccine production with potentially optimal and long-term results . At present, it is unlikely that the virus has mutated into something more dangerous or milder, because mutations can occur in a part of the virus genome . The long-term study of the virus is now expected to provide secure relevant information .
Experts' concerns about the use of mRNA technology for COVID- 19 vaccination .
Sample related questions and concerns of some recognized experts are reported.
According to Professor Anthony Fauci , director of the National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, US, who has already been vaccinated with the Moderna vaccine for SARS - CoV -2, there is still insufficient evidence that vaccines can completely stop the transmission of the virus and replace social measures such as safety distance and mask use . 94 "In the worst of cases, you will have people who will walk around and feel good, but will spread the virus everywhere " , says virologist Stephen Griffin from Leeds University , UK . 72
The professor William Schaffner (Vanderbilt University School of Medicine) commented that : " As we create vaccines we travel more than the usual in uncharted waters ," 95 and the Dr. Amesh Adalja (senior scholar at the Johns Hopkins Center for Health Security a senior scholar at the Johns Hopkins Center for Health Security) commented : " The new technology may be caused some times unforeseen problems or side effects ”. 95 In addition, Norbert Pardi and colleagues 5 also expressed -in a recent review (magazine Nature ) in favor of mRNA emvolion- their concerns as to the effectiveness of vaccines . 5 In particular, they stressed that " the potential of the vaccine to induce a strong response of helper T lymphocytes and B lymphocytes in stem cells " is " an area that remains poorly understood ". 5 The same authors commented that there are no regulatory guidelines, via FD A or EMA (European Medical Agency), to set the standard for the use of mR NA as a vaccine in humans . 5 In addition, the Stanley Plotkin , an expert on vaccines ( vaccinologist ) and former pharmaceutical executive officer, who is still consulted for vaccine makers, reported in November 2020 as follows: " personally, I expect additional data regarding the responses of T- lymphocytes and the lifespan of antibodies ”. 96
Sensation caused by the following statement of Professor of Virology Oveta Fuller of the University of Michigan, one of the four specialists refused to vote for approval of the vaccine mRNA of Pfizer : "The point is that if I say that here is the bar you need to reach the which was 50% of the effectiveness, after two months of administering the vaccine to humans, Pfizer has reached it . It seems that their study was designed to achieve the minimum, but it was not designed to do much more ". 97 Finally, the George Gao Fu (director of the Chinese Center for Disease Control and Prevention), a health official of particular importance in China, stressed that mRNA vaccines were administered to healthy people for the first time and that this "unwinded the thread" of the impending dangers . 98
CONCLUSIONS.
Disease management includes prevention and treatment, with the first option being the most desirable. During the pandemic, the development of vaccines created global optimism, taking into account, among other parameters, the absence of effective and established treatment regimens . However, the scientific community is required to remain impartial and objective in the processes of relevant research, production and approval, efficacy and safety of available vaccine formulations .
Emergencies, such as the COVID-19 pandemic, require rapid reflexes and decisive relevant scientific steps with precision from health scientists. However, given that these decisions and measures concern all of humanity and public health, any complacency and concessions to the quality of the proceedings are not acceptable . The officials of Medicine, in order to responsibly manage the strong sense of duty and to successfully cope with the present challenge, are required to have an uninterrupted conscious mention and as a guide to the timeless demise of Hippocrates "to benefit " does not harm me .
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Does COVID-19 Vaccination Warrant the Classical Principle “ ofelein i mi vlaptin ”?
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