RFKjr Tapped to Head HHS
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Anonymous
Great editorial! Rips that loon to shreds. |
Anonymous
You know ALL medical tests - medicine, procedures, surgeries, vaccines, etc - are compared to the current best practice, not nothing. Do you think when they develop a new antibiotic that they just let a bunch of people die of strep throat to be the control group? And what would be the point of comparing the control to nothing - you want to make sure if it's better (or at least as good, or with fewer side effects, etc, etc) than what we have now. |
Anonymous
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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. |
Anonymous
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Must all vaccines go through the above process?
Yes, all vaccines intended for use in the United States must go through a rigorous FDA process to ensure safety, efficacy, and quality. However, there are some variations depending on the situation: 1. Standard Approval Process • Most vaccines go through the full process, including preclinical research, clinical trials (Phases 1–3), and FDA review. • This applies to vaccines developed for non-urgent public health needs. 2. Emergency Use Authorization (EUA) • In public health emergencies (e.g., pandemics), the FDA may grant an EUA to allow temporary use of a vaccine before full approval. • To receive an EUA, vaccine developers must provide substantial evidence from clinical trials showing that the vaccine is likely effective and that its benefits outweigh potential risks. • Even under an EUA, vaccines must undergo preclinical studies, clinical trials, and FDA review of safety and efficacy data. 3. Accelerated or Priority Review • The FDA can expedite the review process for vaccines addressing critical public health issues (e.g., fast-tracking or priority review). • This doesn’t skip steps but speeds up the timeline by allocating more resources to the review process. 4. Exceptions for Existing Platforms • Vaccines based on well-studied platforms (e.g., those using technologies already approved for other vaccines) may require fewer initial studies, as long as the safety and efficacy of the platform are well-documented. • Even in these cases, clinical trials and a thorough review are still mandatory. 5. Post-Market Requirements • For all vaccines, post-market surveillance is essential, whether the vaccine is fully approved or authorized under an EUA. The FDA requires continued data collection to monitor long-term safety and effectiveness. No vaccine can bypass the core requirements for ensuring safety and efficacy, though the timeline and specific steps may be adjusted in emergencies or for certain situations. |
Anonymous
| ^ Very helpful but sadly won't have any impact on terminally online conspiracy theorists who can't read more than a Tweet. |
Anonymous
I would be more coherent if the overlord hasnt blocked certain words I've used in the past. Its got to be at least 2 dozen words by now. |
Anonymous
What's "lol" about this? The cable news oligarch behind these print outlets is in bed with Big Pharma and the global food/bev megacorps pushing cancer-causing slop on American cattle, I mean consumers. |
Anonymous
Then RFK Jr will just be an acting. |
Anonymous
It will come down to who is up for reelection in 2026. |
Anonymous
Anonymous
| It’s true! We are a disgusting sloppy, crap eating drug using mess of a country. I live RFK’s ideas but no way will he actually be able to change anything if he’s even confirmed. The lobby is too big and the damage is too deep. |
Anonymous
+1 people could stop eating like crap this very second and start doing light exercise but they won’t. Im more concerned about drug abuse and mental health more than anything and I hope he focuses on that more than the food. |
Anonymous
...so why bother trying?  You're blackpilled.
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Anonymous
Sure they could, but most people have never had an independent thought in their lives. So you have to limit their choices between only healthy options. |