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First off, an apology. Yesterday we were calling the @Pfizer released study protocol the trial study data paper. Why? Who the fuck even knows at this point. Sorry.
In case you missed it, here is the study protocol: https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-09/C4591001_Clinical_Protocol.pdf
Annnnnd here’s out thoughts on it and the vaccine.
The protocol is very robust. The stop actions alone were over cautious and in point in today’s climate.
What stuck out to us though was the covid 19 end point.
What stuck out to us though was the covid 19 end point.
That is between the 150-300 the FDA wanted for a trial but for participants, it also low. So low, we need to see the stat model used to get that endpoint.
To that same measure, they called the vaccine ~90% effective at 95 pts with no SAE or AE’s. (Sever adverse effects, adverse effects). That’s just over half the models endpoint status. From there, extrapolation can get sketch fast.
Why we need the study data.
We need to know if the vaccine is more effective in one age group or ethnic race than another. What are the titers in those groups at 7 days and 24? Is one group 12-15yrs 100% protected while 16-55yrs is 80% and that’s the 90% claim?
Having the data will help build trust.
Having the data will help build trust.
Beyond that this vaccine has always been on out top list. For the following reasons.
1:mRNA vaccines, once formulated for mass production scales, can be made anywhere a proper bio-reactor can be had.
1:mRNA vaccines, once formulated for mass production scales, can be made anywhere a proper bio-reactor can be had.
2: @pfizer is one of the few drug producers in conjunction with @Zoetis have a full cold chain for shipping.
3: Pfizer is installing dry ice manufacturing on campus and has designed shipping containers.
4: A program to freeze dry the vaccine is currently in motion...
3: Pfizer is installing dry ice manufacturing on campus and has designed shipping containers.
4: A program to freeze dry the vaccine is currently in motion...
... this will aid in shipping all over the US and the world.
The moral of this @TEDTalks, we need the data. And calm the fuck down. We won’t see this at any level till Late December. So, wear a mask, social distance and wash your hands.
The moral of this @TEDTalks, we need the data. And calm the fuck down. We won’t see this at any level till Late December. So, wear a mask, social distance and wash your hands.
