Phase 1
Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.
Length of Study: Several months
Approximately 70% of drugs move to the next phase
Posted on 08/09/2021 6:51:08 PM PDT by DoodleBob
...Researchers design clinical trials to answer specific research questions related to a medical product. These trials follow a specific study plan, called a protocol, that is developed by the researcher or manufacturer.
...
Phase 1
Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.
Length of Study: Several months
Approximately 70% of drugs move to the next phase
Phase 2
Study Participants: Up to several hundred people with the disease/condition.
Length of Study: Several months to 2 years
Purpose: Efficacy and side effects
Approximately 33% of drugs move to the next phase
Phase 3
Study Participants: 300 to 3,000 volunteers who have the disease or condition
Length of Study: 1 to 4 years
Approximately 25-30% of drugs move to the next phase
Phase 4
Study Participants: Several thousand volunteers who have the disease/condition
(Excerpt) Read more at fda.gov ...
"It's the clinical trials that take so long--usually several years," says Sandra Kweder, M.D., deputy director of the Office of New Drugs in the CDER.
So....why in the Wide World of Sports, with a shot that uses a heretofore never-released platform (messenger RNA), is Fauci Hopeful COVID Vaccines Get Full OK by FDA Within Weeks/after about nine months of trials?
That'd be like fast-tracking autonomous navigation systems.
What could POSSIBLY go wrong?
Its the old adage “Fast, Cheap or Good? Pick Two.”
In this case they went for Fast and Good. Throw billions of dollars at a problem and you can solve anything quickly.
General timeline is 10-15 years
Sounds like we still have a few boosters to go before testing winds down later this decade.
With the reported Adverse Effects including multiple deaths and long-term injury this trial phase would have been shut down long ago. If it is cleared by Labor Day, something is obviously WRONG! Stated by a freeper who spent his whole career in Medical Devices and mitigating FDA warning letters.
The NIH and CDC are just garbage, politically and monetary driven. If they cared about Americans everyone should have been taking Hydroxychloroquine in an emergency type fashion before and while the vaccines were being developed and tested. Ivermectin too as I think India has done with its citizens with some good results. Instead they politicized it and let Big Pharma in on the cash cow resulting in needless deaths and significant illness for many. Exploitative pieces of garbage and pond scums unworthy of their callings.
That’s a very good summary.
We are lucky we had someone with business experience like Trump in charge. He could slice through the red tap and build an efficient system.
If Biden was in charge last year we would still be at the stage of experimenting on mice.
That’s one way to look at it.
The same is true of clinical trials and vaccine approvals. I don't mind that these shots were made available through EUA. Some day, after years of trials, maybe they'll become fully-approved vaccines following the proper protocols.
But let's not confuse mash with Jack. These shots are mash. Maybe, some day, they can age and become Jack. But without years of trials, they'll be mash, even if someone calls them approved.
So, let's not follow the political science. This is a shot released to the public under EUA:
....and this is an approved vaccine subjected to years of clinical trials and not approved by following the political science:
The USAF rolled out an Adenovirus vaccine in late 1973/early 1974 and used USAF recruits for the initial part of the trial while simultaneously testing the vaccine in lab animals to expedite the approval. Unfortunately the researchers found a cancer gene embedded within the vaccine’s attenuated virus that caused tumors in guinea pigs and hamsters. The USAF abruptly stopped the trial and never told the recipients of the vaccination they were part of a trial.
Warp speed is something from science fiction.
Everyone wanted to get back to normal and wouldn’t wait. The real question is...why pick unused platform?
I think there are few reasons.
1) it would be novel and patentable. No one is going to commit 0.5 to greater than 1 billion dollars and not have long term monetary return possibilities.
2) No benchmark to compare with...so if it works...one cannot say old school vaccine is better. Everyone knew vaccines have to be tested long time. For a novel approach ...no one knows how long to test.
3) Giving an attenuated virus could lead to infection(if attenuation did not render virus harmless)
It doesnt matter...one cannot force a medicine on anyone. Especially if it is not 100% effective...and long and short tsrm sife effects are not completely known.
Public is panicking cause it expects a succesful end to the disease..but this is no hollywood movie. Mankind may NOT always prevail. Estimated that 30 to 60 percent of europe died in the black death. I hope I am proved wrong.
All I can say is that one year from now you’ll see Merck start selling an anti-thrombosis drug from Ono Pharmaceuticals.
FYI
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