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[quote=Anonymous]Let’s END the nonsensical arguments about vaccine approval here is the procedures that all vaccines must go through:

In the United States, vaccines must go through a rigorous process of development, testing, and review before they can be approved or authorized by the Food and Drug Administration (FDA). The standard procedure includes the following steps:

1. Preclinical Research

•	Laboratory and Animal Testing: Researchers test the vaccine candidate in cells and animals to evaluate its safety and potential efficacy.
	•	Objective: Determine whether the vaccine triggers an immune response and whether it is safe enough for human trials.

2. Investigational New Drug (IND) Application

•	Before starting clinical trials in humans, vaccine developers submit an IND application to the FDA.
	•	The application includes preclinical data, manufacturing details, and the proposed clinical trial plan.
	•	FDA reviews the IND to ensure the vaccine is safe to test in humans.

3. Clinical Trials

Phase 1: Safety and Dosage

•	Participants: A small group (20–100) of healthy volunteers.
	•	Focus: Assess the safety of the vaccine, determine appropriate dosage, and evaluate the immune response.

Phase 2: Expanded Safety and Immunogenicity

•	Participants: Hundreds of people, including those from groups intended to receive the vaccine.
	•	Focus: Refine the dosage, continue safety monitoring, and further assess the immune response.

Phase 3: Efficacy and Safety in Large Populations

•	Participants: Thousands to tens of thousands of volunteers.
	•	Focus: Determine the vaccine’s effectiveness in preventing the targeted disease and continue safety monitoring.

4. Biologics License Application (BLA)

•	After successful clinical trials, the developer submits a BLA to the FDA.
	•	The BLA includes all data from preclinical and clinical studies, along with manufacturing and labeling information.
	•	FDA experts review the BLA to determine if the vaccine is safe, effective, and produced to high-quality standards.

5. Advisory Committee Review

•	The FDA often convenes the Vaccines and Related Biological Products Advisory Committee (VRBPAC), a panel of independent experts, to review the data and provide recommendations.

6. FDA Decision

•	Approval: If the vaccine meets all safety, efficacy, and quality standards, the FDA approves it.
	•	Emergency Use Authorization (EUA): In urgent public health situations, the FDA may issue an EUA to allow temporary use of a vaccine based on preliminary data.

7. Post-Market Surveillance

•	Phase 4 Studies: Additional studies to monitor long-term safety and efficacy.
	•	VAERS: The Vaccine Adverse Event Reporting System collects and analyzes reports of side effects.
	•	Continuous Monitoring: Ongoing reviews of manufacturing processes and adverse event data.

This process ensures vaccines are both safe and effective for public use.[/quote]

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