Thank you for the animal research link...I found where I got the idea that they did not do animal trials...They started human trials without doing animal trials first...Isn’t it great that fake-news AP is now working to support the President on the vaccine rollout? Who knew!
But STATnews reported this in March:
So they did Phase 1 and Phase 2 concurrently instead of sequentially...
So I stand by what the American Frontline Doctors said in a press conference...The EAU makes the drug “experimental” so that is not as you say “normal”...Let’s not forget that it is also a novel therapy.
And an Emergency Use authorization is DEFINITELY different than normal clinical trial timeline...this was shorter...I have a family member (PhD) who actually works with Pharma clinical trials who confirmed this...
You really have a problem with putting words in my mouth...I never made accusations, never used word “rushed.”
It is not an accusation to say trials were “fast-tracked”... It is a fact that they were...Phase 1 and Phase 2 concurrent, and approx. 2-2.5 months for Phase 3.
I did not make an accusation that they were unsafe or untested...Phase 1 and Phase 2 were concurrent...That is not normal...Again, I did not say it is unsafe. I am trying to determine how safe it is to assess risk in taking it... safe...And what is wrong with that? How do I do that? Ask questions, look at different sources, etc.
If you wish to imply that my asking questions, having concerns, and having some skepticism is somehow a lack of support for President Trump or VP Pence and “tarnishing” his achievements, you are barking up the wrong tree, FRiend. As I said, I have been a long-time Trump supporter as many here will attest...I understand the need for the vaccine ASAP, and I certainly commend our President for marshalling the resources to bring it, but that does not mean I can’t have concerns and ask questions.
Frankly, I don’t trust some of the leadership in our health
bureaucracies. They have not always supported the President’s initiatives, nor have they all been honest with the American public. Additionally, there have been pharma drug rollouts that have resulted in unintended side-effects. Ex. H1N1 ...Rise in children developing narcolepsy resulting from 2009 Pandemrix Influenza Vaccination in Europe—Dr. Slaoui and Fauci(?) https://www.cdc.gov/vaccinesafety/concerns/history/narcolepsy-flu.html
As far as being on same page with other Freepers, since when do we all need to be on same page?? This is not Democrat Underground...it is FREE Republic. We can have differing opinions and positions. Though I certainly appreciate and value all the Freeper medical personnel input, I don’t know their experience, field of expertise, etc...I have read CVs of America’s Frontline Doctors and seen them testify before congress. So I am eclectic and looking at what all open-minded reasonable Freepers have to say as well as other sources...
My asking questions or having some reluctance in no way prevents you from being first in your category to get the vaccine. You and yours, and Gas-Doc, Mom MD and anyone else are all welcome to take the vaccine ASAP...Actually, I think it is great because you all can report back to the rest of us who don’t qualify yet about your experiences and impressions.
My questions and comments are not “Democratic talking points” simply because you don’t like them. And actually America’s Frontline doctors have been supporting treatment regimens recommended by the President.
You may not have made the original post about which I wondered, but you certainly seem to want to go after me for asking some honest questions.
Clearly an oversight on their part. No doubt somebody got fired for accidentally posting truthful information.
"So they did Phase 1 and Phase 2 concurrently instead of sequentially..."
That's somewhat misleading. What they got approval to do was to start the Phase 2 clinical trials before full data was available from the Phase 1 trials. The purpose of the Phase 1 clinical trials is entirely safety: "does this thing you want to put into people cause severe problems?" You test this by giving to a very small group (e.g. 100 volunteers) and making sure it isn't killing anyone or causing major problems with any of them. Typically you would wait until all the data has been compiled and submitted to the FDA, let it sit in some bureaucrat's inbox for a few months (or longer) while he finishes up naptime, then you get approval to begin Phase 2. What many of the manufacturers were allowed to do in this case was to begin Phase 2 without waiting on approval. In practice, you give the drug to 100 people, observe them for a period of time in which any serious side effects should present themselves (e.g. if your drug breaks down in hours or a few days, a week or two is likely plenty of time to see if any of the components will cause major problems), then you just move right in to Phase 2.
Admittedly, this is less common. But it's not unheard of when something is in the fast track process. That process is designed to clear a lot of the inefficiencies that exist in the longer, extended process where non-urgent things go.
"an Emergency Use authorization is DEFINITELY different than normal clinical trial timeline...this was shorter."
My point was that there are multiple tracks/processes for drug approvals. There is nothing unusual or special about the process used for testing these vaccines. It's the same process for anything on the FDA fast track program. This process is the same for anything which is authorized for the fast track process. From the FDA site describing the program:
"Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients."
This is a normal thing. It happens for plenty of other drugs in development where there's an urgent need. If you're testing a new diabetes drug and there's 75 other options already available, you don't need to move quickly. If you're testing something that's going to prevent many fatalities, you (we, the American people) can't afford to wait for several years while overpaid, underworked FDA bureaucrats hit the snooze button at their desk.