gerade habe ich dazu in den USA gelesen:
Today, most educated people in the media, government and financial services, et al. (who know nothing about the drug development process OR the FDA process) think it is likely that an approved vaccine will be widely available sometime between September 2020 and March 2021.
That has a ZERO chance of happening.
I know, Dr. Fauci himself said last Friday that he was ?cautiously optimistic? we would have a safe effective vaccine within 3-8 months.
All that proves is that super-research scientist and physician, Dr. Fauci, is definitely not a drug development expert. No one should expect him to know anything about it.
Please see my disclosures to the side to understand my bonafides and limitations in this area, but you will NEVER hear Fauci, Dr. Gottlieb, or the head of any major biopharma company answer the question, ?Will we have a vaccine before year end? Or early in 2021?? with anything other than something like ?That would be great!?
There are four vaccine candidates in the clear lead now, and two are going into 30,000 person Phase III studies.
This, in itself, is extraordinary beyond words.
Don?t laugh, but any safe, working vaccine, ever, is not guaranteed. Not even in 10 years.
Drug development is hard. These 4 drugs have had a GREAT start, but that?s all it is. Literally the end of the 1st inning for all these drugs.
Imagine your team is up 3-1 at the end of the first inning. How positive are you that they?ll win the game? That?s a pretty accurate approximation of what?s happening now.
The RNA vaccine (one of the 4) being developed uses a technology that has never, in over 30 years, produced a single vaccine that successfully made it through Phase III. And it?s been tried MANY times. There have been, ALWAYS, in Phase III, very serious side-effects.
Until now, not one of these four (or 130, take your pick) vaccine candidates has proven to provide ANY protection against this coronavirus in humans, EVER.
They make antibodies, and in some cases, even the appropriate T-Cells appear, but that?s not the same as proving they provide protection against this coronavirus infection.
Let?s look at somewhat extreme ?best cases?, based on FDA process and experience:
No more than one of the four will be approved (usually about 1 in 10)
30,000 appropriate subjects in multiple international institutes will take 3 months to enroll (can take a year or more).
It will take 1-2 months to ?immunize? the groups with two ?doses? each and provide the appropriate initial data (can take 6 months).
The subjects must go through at least one seasonal cycle before analysis can begin; let?s end March 15th (can take a year or more from the first dose).
Early data analysis to report to FDA at end of Phase III trial. Another two months (can take a year).
Analyze whether the vaccine candidate significantly beat the placebo with good tolerance and low side effects. Another two months (can add 6+ months to the early data in #5 above).
Side effects one year after first dose? and analysis? (can take 2 - 3 years).
So, we haven?t even talked about testing over 55 year olds with co-morbidities, so no doc will approve the vaccine for them, but we?re fast-tracking, BEYOND fast-tracking, above, and the earliest approval by the FDA looks like around October/November of 2021.
Even with the advance manufacture of hundreds of millions of doses, now underway, it will border on a miracle to have a safe, working vaccine available to the healthy, under 55 American public in February 2022.
Am I saying all four lead vaccine candidates might fail in Phase III?
That is what I?m saying.
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