The world governments have been pushing a false narrative that the COVID-19 vaccines are safe & effective. Does this mean we should be able to charge and prosecute them for fraud and negligent homicide? Since they did perpetrate the biggest genocide on the world population ever.
Process of Approving Drugs Normally
The process of determining if a vaccine or any new drug can be approved for public use involves rigorous testing and evaluation by regulatory authorities. Here’s an overview of the common steps and entities involved in the approval process:
Preclinical Testing:
- Before testing a drug or vaccine in humans, extensive preclinical research is conducted in laboratories and on animals to gather data on its safety and effectiveness.
- Researchers study the drug’s mechanism of action, potential side effects, and dosage levels.
Investigational New Drug (IND) Application:
- After preclinical testing, the drug’s sponsor (typically a pharmaceutical company) submits an IND application to the regulatory authority, such as the Food and Drug Administration (FDA) in the United States.
- The IND application contains data from preclinical studies and outlines plans for clinical trials.
Clinical Trials:
- Clinical trials involve three phases:
- Phase 1: Involves a small number of healthy volunteers to evaluate the drug’s safety, dosage, and potential side effects.
- Phase 2: Involves a larger group of patients to assess effectiveness and monitor side effects in the targeted population.
- Phase 3: Involves a larger and more diverse group of patients to confirm the drug’s effectiveness, monitor side effects, and compare it to existing treatments or a placebo.
New Drug Application (NDA) Submission:
- If the results from the clinical trials are favorable, the drug’s sponsor submits an NDA to the regulatory authority.
- The NDA contains comprehensive data from all preclinical and clinical studies, along with proposed labeling, manufacturing information, and proposed use of the drug.
Regulatory Review:
- Regulatory authorities review the NDA to ensure the drug’s safety, efficacy, and quality.
- Experts within the regulatory agency evaluate the data independently and may consult with external advisory committees.
Approval and Post-Market Surveillance:
- If the drug is deemed safe and effective, it receives regulatory approval for marketing and distribution to the public.
- Post-market surveillance continues to monitor the drug’s safety and effectiveness in a broader population.
The determination of whether a vaccine or drug can go to the public ultimately lies with the regulatory authority in each country. In the United States, the FDA plays a crucial role in the approval process, ensuring that drugs and vaccines meet strict safety and efficacy standards before becoming available to the public. Other countries have their own regulatory agencies, such as the European Medicines Agency (EMA) in Europe and the Therapeutic Goods Administration (TGA) in Australia, which oversee the approval and monitoring of drugs and vaccines within their respective regions.