Quote:
Originally Posted by Box
I am ignorant of the inner working of the process - is this a "good" thing for the populace or a "bad" thing for the populace?
It sounds good - since nothing was altered or abbreviated - is there a down side? It certainly seems like using NEW technology would have slowed an otherwise unaltered process down instead of speeding it up.
If nothing was abbreviated or altered to shorten the approval - why does everything else take so long?
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There are a couple of questions embedded in that response so my apology in advance for a lengthy reply:
1. The mRNA technology, although new, was off the shelf and ready to enter clinical safety (Phase 1) and efficacy (Phase 2) trials. The pre-clinical IND enabling studies had already been completed. This saved 1-2 years right off the bat. (Pretty good pun imho.)
2. Conventional vaccine development would have required development of an inactive live virus or validated that a killed virus would induce an appropriate immune response. This would have taken an additional 1-2 years prior to entering the clinical IND phase. So all things being equalized. The mRNA technology shortened the development time 2-4 years.
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.
4. As to your question: "If
nothing was abbreviated or altered to shorten the approval - why does everything else take so long?" I was referring to the pre-clinical and clinical safety studies. Everything else just takes time and therefore $s. I hope that through my and SnT's reesponses in this thread you all can begin to appreciate the huge risks, and costs that the Pharma industry faces in order to bring all of us safe and effective medicines! Can we do better? Yes indeed! I can confidently say that my colleagues with different technologies and new drug candidates all are driving towards a lower cost point for patients as a success metric!