FDA plans to abandon clinical trials for future Covid Vaccines… | |
Anonymous Coward (OP) User ID: 23415018 United States 06/26/2022 12:26 PM Report Abusive Post Report Copyright Violation | "Over the last thirty years, the federal government has paid out more compensation for adverse events in connection with the flu shot than any other vaccine — so we know that the shot comes with a high rate of anticipated harms. Given that the flu shot does not stop the overwhelming majority of flu cases, the harms likely outweigh any benefits. In a sane world, the WHO, FDA, and CDC would admit that they made a strategic mistake in their response to SARS-CoV-2 and then change course to find better ways to support the human immune system. But we don’t live in a sane world. Instead, the FDA is proposing to take the failed flu strain selection process and apply it to future Covid-19 shots." [link to brownstone.org (secure)] |
Anonymous Coward (OP) User ID: 23415018 United States 06/26/2022 12:27 PM Report Abusive Post Report Copyright Violation | "The only way out of the pandemic is to withdraw these vaccines from the market and pivot to therapeutics. Instead, the FDA is proposing to abandon clinical trials in connection with these vaccines altogether. The purpose of the “Future Framework” is to rig the Covid-19 vaccine regulatory process in perpetuity in favor of the pharmaceutical industry. If this “Future Framework” is approved, all future Covid-19 shots — regardless of the formulation —will automatically be deemed “safe and effective” without additional clinical trials, because they are considered “biologically similar” to existing shots. If you change a single molecule of mRNA in these shots it will change health outcomes in ways that no one can anticipate. That necessarily requires new clinical trials — which is what the FDA is proposing to skip." [link to brownstone.org (secure)] |
Anonymous Coward User ID: 83297873 Saudi Arabia 06/26/2022 12:31 PM Report Abusive Post Report Copyright Violation | |
Anonymous Coward User ID: 80947353 United States 06/26/2022 12:40 PM Report Abusive Post Report Copyright Violation | |
Anonymous Coward (OP) User ID: 23415018 United States 06/26/2022 12:45 PM Report Abusive Post Report Copyright Violation | |
Anonymous Coward User ID: 80899477 United States 06/26/2022 03:54 PM Report Abusive Post Report Copyright Violation | "Pfizer and Moderna have a problem. Their mRNA Covid-19 shots do not stop infection, transmission, hospitalization, nor death from the SARS-CoV-2 virus. Over half a billion doses have been injected into Americans in the past 17 months and these shots have made no discernible impact on the course of the pandemic. Far more Americans have died of coronavirus since the introduction of the shots than before they were introduced. Quoting: Anonymous Coward 23415018 Pfizer and Moderna are making about $50 billion a year on these shots and they want that to continue. So they need to reformulate. Maybe target a new variant, maybe change some of the ingredients — who knows, these shots have disappointed so it’s not clear what it will take to get them to work. This is a problem because reformulated shots mean new clinical trials and new regulatory review by the FDA. There is a decent chance that any reformulated shot might fail a new clinical trial, and the public is deeply skeptical of these shots already, so the scrutiny would be intense. So Pfizer and Moderna have figured out a way to use regulatory capture to get their reformulated Covid-19 shots approved WITHOUT further clinical trials. Their scheme is called the “Future Framework” and it will be voted on by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 28." [link to brownstone.org (secure)] |