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Re:Operation Warp Speed: A new model for industrial policy by arcticbull on Sunday January 30, 2022 @08:49PM (#30143516)
Pfizer was developed by BioNTech in Germany, funded by the German government. Pfizers involvement was limited to a co-branding arrangement where they ramped and scaled production. Pfizer also did not receive any money from Warp Speed, and one of their scientists at a point even stated they weren't participating at all. This was hastily walked back, but it's not really clear they were anything more than a vendor, IMO. [1]

[1] https://en.wikipedia.org/wiki/Operation_Warp_Speed

Re:Operation Warp Speed: A new model for industrial policy by refurb on Sunday January 30, 2022 @09:01PM (#30143614)
As someone who has been involved in development of new drugs, you are massively understating Pfizer’s role. BioNTech never could have got the drug to market without Pfizer.

Pfizer had to: 1) conduct animal testing, 2) scale up synthesis to billions of units, 3) work with the FDA to align on clinical studies [where OWS helped], 4) conduct global clinical studies in dozens of countries, 5) collect, analyze the clinical study data, 6) assemble a new drug application for dozen of regulatory agencies across the globe [typically 1000's of pages long], 7) actually manufacture billions of sterile doses to the FDA’s requirements, 8) negotiate purchase agreements with 100+ countries, 9) actually distribute the vaccine globally despite the need for -78C temperature.

BioNTech maybe could have done step 1. They had never gotten a drug approved before. Pfizer has brought over 100 drugs to market.

BioNTech’s role is like creating an iPhone app and saying it’s the same as a building a multi billion dollar business like Uber.

Re:Operation Warp Speed: A new model for industrial policy by NicoJuicy on Monday January 31, 2022 @05:19AM (#30146496)
Wait what?

Then why didn't Pfizer create the "iPhone app".

You are seriously underestimating BionTech's advanced lead in mRNA. A fair comparison would be to create an iphone app without an SDK in existence yet, but an app store in place.

Pfizer was there because it's existing infrastructure for trials and experience. While the timeline was seriously reduced, they didn't had to do much "new" that they hadn't done before yet.

Additionally, requirements in the fridge was reduced to -20° which made it a lot easier than your -60°-80° and was assisted by many more than just Pfizer ( see UNICEF and their "cold chain unit" for this or how covax delivered > 1 billion doses)

> Back in 1974, the World Health Organization (WHO) established the Expanded Programme on Immunization (EPI). In order to assess the feasibility of a single, global immunisation schedule incorporating vaccines against polio, measles, tuberculosis, tetanus, diphtheria and pertussis, the EPI was initially piloted in Ghana.

> One major challenge quickly became apparent: as vaccines were temperature-sensitive biological products, they needed to be continuously stored in a limited temperature range from the time they were manufactured until the moment of vaccination. Any exposure to temperatures outside this range would irreversibly affect vaccine potency, diminishing the ability of vaccines to protect vaccinated patients.

> The solution was a workable “cold chain". A term adopted in 1976, it described a global network of cold rooms, cold boxes, vaccine carriers, refrigerators, and freezers that kept vaccines at the WHO-recommended temperature during the long journey from the manufacturing line to the syringe.

Similarly, Ebola also needed cold chain infrastructure.

Creds for doing it this fast, yes! But it's not something new and i won't pretend it is. Pfizer was the best choice for bringing it to market, definitely.

Re:Operation Warp Speed: A new model for industrial policy by refurb on Monday January 31, 2022 @06:25AM (#30146869)
The point is - BioNTech could not have brought it to market.

Having a promising vaccine is about 5% of the work and cost to get it into people.

And to say getting a brand new vaccine scaled up and approved in record time is “not something new” tells me you aren’t that close to the process.

There were a million ways the process could have failed (see J&J, AZ screw ups).

Pfizer pulled it off almost flawlessly. That’s never been done before.

Re:Operation Warp Speed: A new model for industrial policy by NicoJuicy on Monday January 31, 2022 @07:08AM (#30147094)
Ebola set the way forward for faster approvals : https://www.nature.com/articles/s41541-020-0204-7 it also ( luckily) uncovered many flaws in the process that were improved upon.

The faster approvals were because of prioritisation of the government's during a pandemic and nearly flawless execution of Pfizer.

But doing something faster doesn't mean it's new. In many cases it means you made your existing processes more efficient. Not changed them.

You are also changing your point. You said Biontech did almost nothing and compared it to a iphone app, lol. They could have chosen someone else and there aren't many that failed approvals. ( Except if you count Russia). But as mentioned, Pfizer was the best choice.

The largest difference in making it faster was an in-place term that allowed simultaneous clinical trials, which was unique and funded by the government due to extra costs and risks for pharma. This was not due to Pfizer and shouldn't be attributed to them as you are trying too.

Without that regulation it would have taken multiple years like before.

The government's also quickened feedback from months to weeks, which was an additional efficiency improvement.

If you're "in the know", you sure are forgetting the most important "details" for cutting the duration till approval vs. the past.

In the context of this article, it's important to note that the first authorized vaccine was not funded by the program.

Re:Operation Warp Speed: A new model for industrial policy by NicoJuicy on Monday January 31, 2022 @11:56AM (#30150224)
Found an interesting article about what Pfizer did and how they upscaled. Which is without a doubt impressive work:

https://www.pfizer.com/news/articles/shot_of_a_lifetime_how_...