What is informed consent? What are the consequences of failing to obtain informed consent?
Indian Government holding back on opening jabs for children
Govt. of India held back on injections for children, finally yields
Are children at risk from COVID-19, to warrant experimental “vaccines”? What are the risks from these “vaccines”?
VIOLATION OF FUNDAMENTAL AND HUMAN RIGHTS: Informed Consent, which has been listed as a condition for vaccine administration, has not been fulfilled. This is in contravention of the DCGI’s conditions for restricted use approval of Covaxin as well as a violation of human rights and fundamental rights.
MISREPRESENTATION OF FACTS: The Guidelines issued by the MOHFW blatantly lie that Covaxin has World Health Organisation’s (WHO’s) Emergency Use License (EUL) for use in children ages 15-18 years.
VACCINE SAFETY: Vaccines induce long-term effects on health and well-being, but there is no long-term safety data for Covaxin use in children.
VACCINE EFFICACY: Covaxin DOES NOT induce sterilizing immunity and, therefore, cannot prevent infection transmission. The WHO-specified COVID-19 mortality and morbidity rates in children is 2% and 0.1%, respectively. Therefore, the magnitude of risk justifying the use of this emergency measure needs to be supported by data because the infection is symptomatic or causes only mild disease in most children.
CONDITION OF APPROVAL OF USE IN CHILDREN AGES 15-18 YEARS: Updating of SmPC, PI, Factsheet, informed consent. These were not done prior to the vaccination.
INADEQUACY OF REGULATORY SYSTEM FOR AE, SAE, AEFI REPORTING (article by Priyanka Pulla published by the BMJ https://www.bmj.com/content/376/bmj.n3146 [attached]).
WHO PHSM SEVERITY INDEX on the WHO Dashboard DOES NOT INDICATE HIGH SEVERITY OF THE COVID-19 PROBLEM FOR INDIA (https://covid19.who.int/measures): Therefore, in the absence of relevant COVID-19 data on pediatric deaths and illnesses, the government needs to provide data supporting the use of a vaccine with restricted-use emergency approval in the mass vaccination of children.
NO DISCLAIMER INCLUDED ABOUT THE LACK OF LONG-TERM VACCINE SAFETY DATA IN GOVERNMENT COVID-19 VACCINATION AWARENESS ADVERTISEMENTS/NOTICES IN THE MEDIA
PROMOTION OF COERCIVE MEASURES BY THE DEPARTMENT OF EDUCATION AND OTHER INSTITUTIONS TO MANDATE COVID-19 VACCINATION OF CHILDREN.
WHO HAS NOT ISSUED AN EUL FOR COVAXIN USE IN CHILDREN: “COVAXIN® was also reviewed on 5 October by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which formulates vaccine specific policies and recommendations for vaccines’ use in populations (i.e. recommended age groups, intervals between doses, specific groups such as pregnant and lactating women).
The SAGE recommended use of the vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above.” (Emphasis added) https://www.who.int/news/item/03-11-2021-who-issues-emergency-use-listing-for-eighth-covid-19-vaccine.
WHO Interim Statement on COVID-19 Vaccination in Children and Adolescents: “Countries should consider the individual and population benefits of immunising children and adolescents in their specific epidemiological and social context when developing their COVID-19 immunisation policies and programs. As children and adolescents tend to have milder disease compared to adults, unless they are in a group at higher risk of severe COVID-19, it is less urgent to vaccinate them than older people, those with chronic health conditions and health workers” (Emphasis added) https://www.who.int/news/item/24-11-2021-interim-statement-on-covid-19-vaccination-for-children-and-adolescents
“More evidence is needed on the use of the different COVID-19 vaccines in children to be able to make general recommendations on vaccinating children against COVID-19.”
DCGI approval of Covaxin is for restricted use in emergency situation in clinical trial mode, based on the conditions of permission issues on January 3, 2021 (screenshot attached).
The Subject Expert Committee (SEC) report conferring approval to Covaxin to be used in children is not displayed on the CDSCO website under the notices for vaccines.
Safety and effectiveness of CORBEVAX has not been established in Pediatrics – Corbevax
As per the ‘Summary of Product Characteristics’ (SmPC) document of Corbevax uploaded on CDSCO – https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODI0OA==, on page number 02, section 4.6, it clearly / specifically says that safety and effectiveness of Corbevax have not been established in pediatrics. This means that as per the Indian current definition of pediatrics, age 12 to 14 fall in this category and hence the Corbevax Vaccine safety has not been studied for this age group. So it means it is a pure experiment and the children and their parents are being made subjects for this clinical trial without even informing them. And no informed consent is being taken as per the Indian drugs and cosmetics ACT of 1940.
So this matter should be taken to the Mumbai High Court and the Supreme Court. Legal notices to DCGI, Biological E and its partner Bill Gates, NTAGI, National Covid Task Force on Covid-19, Health Minister Mansukh Mandaviya, Chief Editors of all mainstream media houses for spreading misinformation and disinformation with respect to the safety of the Corbevax.
International Sites on Children around COVID-19
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