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Mahler9th Mahler9th is online now
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Join Date: Oct 2005
Location: Northern California
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FDA has some perspective on EUA on their web site. I have not made any effort to understand details of EUA.

It may help to remember that 21st century molecular biology is probably more advanced than 20th century molecular biology. And that current regulatory systems and processes have likely lagged. So legacy timelines may not be the best comparison.

And then there is all of the big data tech that can help crunch risk-related numbers. Again, century 21 might afford humankind better tools in this regard than those available 10-30 years ago.


I believe that there is a lot at stake, and the key players in industry have already done a lot to ensure transparency. For example several of them have released their protocols, which is not typical. That may be a big deal.

The gubmint has had a big family of challenges on their hands because, because, well the system is complex and while some aspects can be de-risked and priorities elevated, some cannot. It is complex at least in part because... well, it is the gubmint!

Difficult for them to parse through all of that in ways that the public can digest.

Based on my experience, the system is likely to have extreme bias on the safety side of the equation. I think that the stakes are far too high for public companies and gubmint to not have that bias. We have things we can do on the efficacy side.

One question that folks might ask is the role of statistics in all of this. The study sizes used are designed to deliver statistical power. It is possible that under "normal" circumstances, the companies would not invest in the achievement of that level of power so early on and in such a short time window-- due to costs and in general biz risk.

OWS might be translated as "brush clearer/biz de-risker." I heard a director on an OWS company Board say that in a webinar back last Fall.

I hope that in a few years I can have a cocktail with the best experts in my personal network to look back and get into this level of detail. But they are really busy so t I ain't a gonna bother them now!

Meanwhile, perhaps of interest:

https://www.bbc.com/future/article/20210114-covid-19-how-effective-is-a-single-vaccine-dose

ttps://www.reuters.com/article/us-health-coronavirus-vaccine-novavax/novavax-expects-to-produce-150-million-vaccine-doses-per-month-as-early-as-may-ceo-idUSKBN29Y2WP

What would happen in say March , the world's supply of some key ingredient common to all of these vaccines was grabbed up by the North Korean gubmint?

Dang.
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Last edited by Mahler9th; 02-22-2021 at 05:02 PM..
Old 02-22-2021, 04:50 PM
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