Biotech billionaire Winfried Stoecker invented and used his vaccine based on technology that’s easy to scale up in April 2020 for himself because he wanted a vaccine. He waited. Then he vaccinated his family. He waited again and vaccinated a bunch of friends. Then in September he suggest to the RKI in Germany to just vaccinate everybody in Germany by the end of the year. Then the RKI first ignored him and then sued him.
So the timeline for Germany to vaccinate without government interference would be something like end of 2020. However if the government wouldn’t have been in the way of progress Stoecker would likely have been interested earlier into vaccinating people besides himself, family and friends. If that would have happened end of April, German being well vaccinated would be in end of August or September. If you would have wanted to do human challenge trials first maybe + 1⁄2 months.
The vaccine might have be a bit less effective then the one’s we have now but also with less side effects then the one’s we use.
This leaves the question of why those companies are producing vaccine’s with processes that aren’t easily scalled up. This is a similar question as to why Scott Siskind couldn’t get any melatonin in his hospital. It’s the pharma ethos to use technology that can be protected with patents to produce products that can’t simply be copied by their competition.
This means using complicated new technology instead of tried and tested and easy to produce technology.
The main difference is that hamburgers would never be approved by the FDA if the FDA could decide about whether to approve them. Producing hamburgers to the quality standards that are involved isn’t easy either. Just because the batches didn’t meet the high standards that Johnson&Johnson had for them doesn’t mean that they wouldn’t be useful for vaccinating people.
I wouldn’t be surprised if the standards are significantly higher then for the average drug that goes over the counter at our pharmacies and that is produced by an Indian or Chinese generics company which doesn’t care much about quality control.
The burden of proof is still (by the Crawford Standard) on you to demonstrate that Steocker’s vaccine was “easy to scale up.” I agree with you in my OP that regulation and ineffective governance are partly to blame for production delays. What’s in question is the proportion of the blame.
Yes, even small delays are highly consequential in an exponential growth scenario. But determining the proportion of delay due to governance vs. inevitable pratical issues is the question at hand. The point of this post is that to determine the delay due to governance, you need to thoroughly assess the delay due to practicalities, and also investigate that there are other issues beyond these two categories. Simply naming yet more examples of governance failures doesn’t really help address this.
The burden of proof is still (by the Crawford Standard) on you to demonstrate that Steocker’s vaccine was “easy to scale up.”
The argument here is that a biotech billionaire is likely able to know what can be achieved in a 3-month timeframe with his technology.
But lets look at his description:
Man nehme dreimal 15 Mikrogramm rekombinante RBD der S1-Untereinheit (Arg319-Phe541) für eine Person. Als Adiuvans habe ich Alhydrogel von InvivoGen verwendet: Ordentlich durchschütteln und davon 200 Mikroliter mit der Tuberkulinspritze aufziehen. In eine größere Spritze 10 Milliliter Kochsalz aufziehen und die 200 Mikroliter dazugeben, mischen. Davon 500 Mikroliter pro Schuss, mit denen man seine Portion Antigen vermischt. Alles hübsch steril.
Mit einem einzigen 2000-Liter-Reaktor kann man 45 g Antigen pro Tag produzieren, das würde für 1 Million Personen reichen. Mittels eines Hochdichte-Kultursystems schafft man die fünffache Menge. Innerhalb eines halben Jahres könnte man Impfstoff für 80% der Bevölkerung Deutschlands in einem mittelgroßen Laborraum produzieren.
Kochsalz is salt or NaCl which is easily available in very large quantities.
The antigen production seems to require a 2000-liter reactor for producing enough for 1 million people per day and he suggests that more advanced technology can do 5 times as much in a middle sized labatory room, so that doesn’t seem to be a constraint.
That leaves the Alhydrogel of InvivoGen. Current cost seems to be 248,00 € for 250ml which is a bit more then what you need for 1000 dosis. That leaves the question of how fast that can be scaled up. It’s based on Aluminium hydroxide which needs Aluminium is easily available and turning it into Aluminium hydroxide is not very expensive.
In addition to just using Aluminium hydroxide InvivoGen does something they call ultrasonication with it.
I’m not sure how we would go about determining how fast it is to scale up Aluminium hydroxide to 2 million for Germany’s 80 million inhabitants or 200 million worth of it for the world population.
Biotech billionaire Winfried Stoecker invented and used his vaccine based on technology that’s easy to scale up in April 2020 for himself because he wanted a vaccine. He waited. Then he vaccinated his family. He waited again and vaccinated a bunch of friends. Then in September he suggest to the RKI in Germany to just vaccinate everybody in Germany by the end of the year. Then the RKI first ignored him and then sued him.
So the timeline for Germany to vaccinate without government interference would be something like end of 2020. However if the government wouldn’t have been in the way of progress Stoecker would likely have been interested earlier into vaccinating people besides himself, family and friends. If that would have happened end of April, German being well vaccinated would be in end of August or September. If you would have wanted to do human challenge trials first maybe + 1⁄2 months.
The vaccine might have be a bit less effective then the one’s we have now but also with less side effects then the one’s we use.
This leaves the question of why those companies are producing vaccine’s with processes that aren’t easily scalled up. This is a similar question as to why Scott Siskind couldn’t get any melatonin in his hospital. It’s the pharma ethos to use technology that can be protected with patents to produce products that can’t simply be copied by their competition.
This means using complicated new technology instead of tried and tested and easy to produce technology.
The main difference is that hamburgers would never be approved by the FDA if the FDA could decide about whether to approve them. Producing hamburgers to the quality standards that are involved isn’t easy either. Just because the batches didn’t meet the high standards that Johnson&Johnson had for them doesn’t mean that they wouldn’t be useful for vaccinating people.
I wouldn’t be surprised if the standards are significantly higher then for the average drug that goes over the counter at our pharmacies and that is produced by an Indian or Chinese generics company which doesn’t care much about quality control.
The burden of proof is still (by the Crawford Standard) on you to demonstrate that Steocker’s vaccine was “easy to scale up.” I agree with you in my OP that regulation and ineffective governance are partly to blame for production delays. What’s in question is the proportion of the blame.
Yes, even small delays are highly consequential in an exponential growth scenario. But determining the proportion of delay due to governance vs. inevitable pratical issues is the question at hand. The point of this post is that to determine the delay due to governance, you need to thoroughly assess the delay due to practicalities, and also investigate that there are other issues beyond these two categories. Simply naming yet more examples of governance failures doesn’t really help address this.
The argument here is that a biotech billionaire is likely able to know what can be achieved in a 3-month timeframe with his technology.
But lets look at his description:
Kochsalz is salt or NaCl which is easily available in very large quantities.
The antigen production seems to require a 2000-liter reactor for producing enough for 1 million people per day and he suggests that more advanced technology can do 5 times as much in a middle sized labatory room, so that doesn’t seem to be a constraint.
That leaves the Alhydrogel of InvivoGen. Current cost seems to be 248,00 € for 250ml which is a bit more then what you need for 1000 dosis. That leaves the question of how fast that can be scaled up. It’s based on Aluminium hydroxide which needs Aluminium is easily available and turning it into Aluminium hydroxide is not very expensive.
In addition to just using Aluminium hydroxide InvivoGen does something they call ultrasonication with it.
I’m not sure how we would go about determining how fast it is to scale up Aluminium hydroxide to 2 million for Germany’s 80 million inhabitants or 200 million worth of it for the world population.