Quote:
Originally Posted by Trapper John
There are a couple of questions embedded in that response so my apology in advance for a lengthy reply:
3. "Operation Warp Speed" accelerated manufacturing by removing the financial risk associated with scale-up of manufacturing processes and therefore the time required for the vaccine being ready for distribution. I am getting outside of my wheelhouse at this stage. SurfnTurf can probably more adequately respond here.
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Operation Warp Speed
A preface…I believe that the Covid 19 was presented to the NCA as a potential worldwide pandemic, with potential high mortality. That would explain the sometimes outrageous response we are experiencing.
First, let me take a shot at explaining “Warp Speed” accelerated manufacturing, as I understand it.
1. The Federal government pre-purchased several BILLION dollars of vaccine and multi BILLION dose orders for “
discovery or early- clinical testing ”medicines from the
Pharma industry (many companies, not just Moderna, J&J, Janssen, or Pfizer). This allowed the companies to laser focus on common clinicals, Manufacturing and distribution, and to not worry about marketing, selling, or profits for their effort. They were guaranteed sales, profit and liability protection from the Federal Government. This process also allowed many different types and variants of vaccine to be tested and manufactured. (Salk / Sabin polio vaccine comes to mind, (though years apart).
This was a radical change to the business model, and to my knowledge had never been attempted before. There are now
several HUNDRED companies that have Covid treatments in development / phased testing for a Covid remedy.
2. To shorten the time-to-market, “Warp speed” allowed IND, Phase 1, 2 and 3 clinical trials, “quantifiable” manufacturing, and distribution to
all happen in parallel. (i.e.)The companies did not have to wait on Phase 3 approval before beginning production (Labs, equipment, staffing), Manufacturing (Plant, scheduling, procurement) and distribution to warehouses. Because of this compression
several vaccines were “available” within WEEKS of the “Experiential Use Authorization” approval.
NOTE: by way of comparison, it normally takes 3 to 10 years to bring a new vaccine to market / distribution.
3.
OPINION..This new method of responding to what was called a PANDEMIC may be useful in the future if we are “
hit” with a real superbug, with high mortality. The major problems with the current vaccines are:
a. We don’t have reliable data on the true outcomes of the various vaccines (mortality, heart problems, neurological disorders, etc.) .
b. We don’t have any history of a vaccine that was just released, and is still labeled as experimental. (ed. This probably requires a trust between Government and the citizens that has not happened)
c. The threatening compulsory mandates for an injection of an experimental Covid-19 vaccine and the coercion with potential punishments, including loss of employment (Take the jab or lose your job) suspension, not honoring religious objection, discharge from the Armed Forces, and other major threats. Threatening the entire populating is not a good way to build confidence in the Covid treatments and the “science” behind it.
https://media.defense.gov/2020/Aug/1...E-TIMELINE.PDF
SnT