Post by atownbeaver on Jun 24, 2020 12:00:21 GMT -8
Jun 24, 2020 11:44:34 GMT -8 @thickhead said:
Just a recent update by Jake Weber from mauldineconomics.com. Jake writes for Jon Mauldin on his free newsletter concerning up to date news on bio tech. The major news deals with ability of modern technology and artificial intelligence to use virus RNA and DNA instead of using the traditional fore mat. Using the new technology, 2 companies have sequenced vaccines for the corona virus in less than 3 hours. Inovio Pharmaceuticals used a DNA based vaccine that started clinical trials in April. Moderna was actually faster starting clinical trials than INO because they used a RNA based vaccine that started clinical trials in March. MRNA hopes to have phase 3 trials done by late July to mid August and approval immediately. INO hopes to have there approval sometime in late August. The timing on all this is the question mark as the FDA has never even looked at viral DNA or RNA vaccines before. If approval is quick mass production will explode to meet demand. Please be aware there are over 12 bio tech firms working on this issue and they could all potentially be approved. If that happens there will be vaccines galore. Bio tech in the next 10 years will make more progress than in the last 50 years. Hope the update gives you an idea of what some firms are doing. GO BEAVS!!!
Phase Three Trials
Similarly, phase three trials continue to monitor toxicity, immunogenicity, and SAEs on a much larger scale. The vaccine must be shown to be safe and effective in natural disease conditions before being submitted for approval and then general production. In the United States, the Food and Drug Administration (FDA) is responsible for approving vaccines.
Phase Four Trials
Phase four trials are typically monitor stages that collect information continuously on vaccine usage, adverse effects, and long-term immunity.
And this:
Phase IV
A Phase IV trial is also known as postmarketing surveillance trial, or informally as a confirmatory trial. Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold (e.g. after approval under the FDA Accelerated Approval Program). Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive (finding a new market for the drug) or other reasons (for example, the drug may not have been tested for interactions with other drugs, or on certain population groups such as pregnant women, who are unlikely to subject themselves to trials). The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials. Harmful effects discovered by Phase IV trials may result in a drug being no longer sold, or restricted to certain uses; recent examples involve cerivastatin (brand names Baycol and Lipobay), troglitazone (Rezulin) and rofecoxib (Vioxx). The minimum time period mandatory for Phase IV clinical trials is 2 years.
So apparently after Phase 3, it needs FDA approval. I don't know if it can then be immediately distributed for widespread use during "safety surveillance". We can hope that the critical need for a COVID vaccine along with great results from a Phase 3 trial will result in quick FDA approval and allow them to expedite widespread distribution in time for fall sports, but I have no clue.
successful completion of a phase III trial, which for most companies are going to involve a several week study of 30,000+ individuals, is going to be the minimum necessary requirement for SOME level of approval. bare in mind, data may limit the scope of that approval, only allowing the vaccine to be provided to a limited scope of people at first (health adults with no co-morbidities, for example).
Phase III is the big one though. it is what is going to show if the drug A. works, and B. is safe. 30,000+ people in a controlled trial is more than sufficient to determine both factors. That ongoing phase IV monitoring will uncover rare side effects and speak to exactly how long the vaccine protect for and what the actual observed efficacy is.