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Wait, getting multiple vaccines ready but none were from the US. The most used one is a partnership from Pfizer and was created by Biontech. The vaccine was pr

Wait, getting multiple vaccines ready but none were from the US. The most used one is a partnership from Pfizer and was created by Biontech. The vaccine was practically ready on day 2 of COVID due to mRNA. Pfizer even declined Warp speed funding ( but pre-orders were accepted in December during phase 3 trials) So I'm not sure why Warp speed is considered a success?

manuelabeledo 5y ago
> Wait, getting multiple vaccines ready but none were from the US. Wasn't the Moderna vaccine developed entirely in the US?
- SR2Z 5y ago
  And while the Pfizer one was majority developed by BioNTech, they lacked the expertise to actually produce it at scale.
  - NicoJuicy 5y ago
    And that happened at the existing Pfizer facility in Puurs ( Belgium). As far as I'm aware, no existing facilities were upgraded/expanded? https://www.politico.eu/article/belgium-town-puurs-spotlight-coronavirus-vaccine/ https://www.politico.eu/article/belgium-town-puurs-spotlight... A big up for Belgian pharma facilities. But I'm unsure about the role of operation Warp speed on this all. As far as I'm aware, Pfizer/BionTech explicitly avoided any funding through operation Warp Speed. They received an order in phase 3 of the clinical trials. The core issue ( why they partnered with Pfizer) for BionTech was also not production at scale, but handling clinical trials at this scale. Which ( again/also) was not related to Warp Speed.
    - yzmtf2008 5y ago
      > As far as I'm aware, no existing facilities were added? Nowhere in your linked article indicates that "no existing facilities were added". > As of January 2022, the Pfizer-BioNTech COVID-19 vaccine is manufactured between 11 sites across five countries, including the U.S., Germany, Belgium, Ireland, and Croatia, and engages more than 20 suppliers. https://www.pfizer.com/science/coronavirus/vaccine/manufacturing-and-distribution#:~:text=Where%20is%20the%20Pfizer%2DBioNTech%20COVID%2D19%20vaccine%20made%3F https://www.pfizer.com/science/coronavirus/vaccine/manufactu...
      - NicoJuicy 5y ago
        I'm from Belgium and i did follow up on Puurs and i hadn't encountered any news that they needed to upgrade facilities there. That's what you should have copied my whole sentence: "as far as I'm aware, no existing facilities were added". Which in retrospect should be upgraded actually. Didn't notice that mistake.
        b3orn 5y ago
        Biontech bought production facilities in Germany.
        NicoJuicy 5y ago
        Yeah, seems to be correct. https://www.brusselstimes.com/131709/biontech-buys-a-novartis-plant-to-increase-vaccine-production-capacity https://www.brusselstimes.com/131709/biontech-buys-a-novarti... But i did mention the facility in Puurs ( since it's from my country), i wasn't keeping track on all of them ofc
        deleted 5y ago
        [deleted]
  - freeflight 5y ago
    > they lacked the expertise to actually produce it at scale Scaling up production is not all about expertise, but mostly about existing production capacities and how quickly they can be retooled for another production.
tomohawk 5y ago
> ready on day 2 That's like some person in SV saying they had a great idea. Who cares? The level of execution in operation warp to get this past the FDA processes was enormous. The industrial mobilzation to create refrigeration units and transportation, and get all of the logistics alligned in a few months. That is the stuff of legend.
- NicoJuicy 5y ago
  And that seems to me as patting themselves on the back. Every country in Europe did this exact thing without patting themselves on the back or calling it "Warp speed" ( eg. For Refrigerator units/logistics) The biggest accomplishment/improvement to speed up things was doing simultaneous clinical trials, which wasn't even remotely related with Warp speed but was a emergency action ( = it existed as advice before COVID to be used if a pandemic would happen)
  - e4e78a06 5y ago
    The EU had a substantially delayed rollout of vaccines compared to the US [1]. You can see that the purple line (US) is about 2 months ahead of the yellow (EU). Especially in the early days of the rollout the EU was very behind. [1]: https://www.bmj.com/content/375/bmj.n2412 https://www.bmj.com/content/375/bmj.n2412
    - morelisp 5y ago
      > Especially in the early days of the rollout the EU was very behind. On one hand I agree, but on the other hand looking back now after 13-14 months, did it matter? Was any public health outcome significantly improved by that lead? (From the qualitative reports I've read I might believe there was in the UK - but not prima facie US vs. EU.)
      - e4e78a06 5y ago
        That's a pretty hard analysis to make. You'd have to compare people that 1) wanted to get vaccinated and 2) _could_ have been vaccinated if they were in the US instead of Europe and 3) died from COVID during the 2 month delay and see how many lives were saved. My uninformed guess just eyeballing the historical death graphs and vaccine rollout is probably low 5 figures range.
yzmtf2008 5y ago
> Wait, getting multiple vaccines ready but none were from the US. See sibling comment on Moderna. > The vaccine was practically ready on day 2 of COVID due to mRNA No. "ready" as in we can produce a vile in a lab? Sure. Ready as in tested in the general population, mass production facilities, distribution networks? Absolutely not. > So I'm not sure why Warp speed is considered a success? Producing a vaccine is about the easiest part of warp speed. Having the supply chain needed to vaccinate the whole population in such a brief time? That's the success. Also, it's literally the entire point of TFA.
- dnautics 5y ago
  If I'm not mistaken the mRNA production is kind of bonkers, it's outsourced to a bestiary of third party small contract manufacturers. I could be wrong, but I don't think that any newly released drug has rolled out like that at such a scale in the past (usually it's one/a few plants all controlled by the big pharma that gets certified by the FDA). It's REALLY impressive that the bureaucracy figured out exactly where to bend the rules and shepherded all of the small contract manufacturers into compliance to get reasonable batch-to-batch consistency and safety for these vaccines.
  - EGreg 5y ago
    “The bureaucracy” is doing a lot of work there THIS is what I want to hear more about. How was all this coordination done? Solving collective action problems is what government is supposed to do… was this a command economy, central planning, or some sort of intiative like we have now with the new “security best practices imperatives” that will use the infrastructure bill and standardize what small vendors will deliver?
    - dnautics 5y ago
      I don't necessarily think that government's job is to "solve collective action problems" (there are plenty of alternatives, actually free markets themselves are a solution to the collective action problem of "what should the price of X be") -- but if it's going to doit, it should be held to a high standard of effectiveness.
vlovich123 5y ago
mRNA was an accomplishment to be sure. It’s a necessary but not sufficient condition. If you look at the stories for the rollout, the logistics challenge posed by mRNA vaccines were quite substantial, particularly refrigeration but also supply chain logistics in general were complicated. Warp Speed definitely was run competently by all accounts.
- pyuser583 5y ago
  As the article pointed out, identifying MRNA as a viable option was one of Warp Speeds major accomplishments. There are tons of technologies that had to be explored. I’ve read this article in full several times (it’s dense). Warp Speed wasn’t like the Manhattan Project or the Apollo Project. It wasn’t hundreds of thousands of government employees working in one tech. It was hundreds of project managers with single tech portfolios, most of which were useless, trying to figure out which tech would solve the problem at hand. It was YComhinator investing applied to a major government project.
  - jounker 5y ago
    The Pfizer/BioNTech vaccine was pointedly not involved in Operation Warp Speed.
    - vlovich123 5y ago
      Wikipedia disagrees with you but depends on your meaning of "not involved". I think you could be right about the impact Warp Speed had on the selection aspect of mRNA but it's hard to say. From one perspective, BioNtech mRNA effort started in January 2020 before Warp Speed was a thing. From another Pfizer and BioNTech announced a deal in April 2020 around the time that Warp Speed legislation (and since legislation is lagging self-organizing work that was ongoing, it's hard to say). From the capacity perspective, it doesn't seem right [1]. > But on July 22, Operation Warp Speed placed an advance-purchase order of $2 billion with Pfizer to manufacture 100 million doses of a COVID-19 vaccine for use in the United States when the vaccine was shown to be safe, effective, licensed, and authorized by the Food and Drug Administration (FDA). On December 23, the Trump administration announced that they had ordered another 200 million doses from Pfizer. On November 9, the Pfizer–BioNTech partnership announced positive early results from its Phase III trial of the BNT162b2 vaccine candidate, and on December 11, the FDA provided emergency use authorization, initiating the distribution of the vaccine. > In September 2020, BioNTech received €375 million (US$445 million) from the government of Germany to accelerate the development and production capacity of the Pfizer–BioNTech COVID-19 vaccine So looks like they needed significant government help getting distribution and logistics. [1] https://en.wikipedia.org/wiki/Operation_Warp_Speed#Pfizer%E2%80%93BioNTech https://en.wikipedia.org/wiki/Operation_Warp_Speed#Pfizer%E2...
Spooky23 5y ago
Nooo. There was a ton of logistics. The military was a key part of the last mile distribution initially and for some time. Trump is a loathsome character, but OWS was a well executed initiative.
- tandymodel100 5y ago
  The last mile distribution wasn’t well considered at all. Between tweets denying he lost the election he just said it would be up to the states to furnish last mile.
  - Spooky23 5y ago
    I think OWS had some autonomy outside of the crazy day to day bloviating. The initial Pfizer environmental requirements were difficult to meet, and the military through the national guard were a big part of delivery. Outside of those logistics everything was an evil shitshow.
EGreg 5y ago
What I want to know is, what happened to all that “warp” speed since then? We had been waiting for delta vaccine and whatever else, for over a year. They can surely churn them out quick with mRNA (they even did it for HIV!) but they don’t. The profit motive happened. With government and media carrying water for these vaccine manufacturers, and forcing everyone to get an outdated vaccine, why would they cannibalize their own profits? It’s like if everyone were told you must install Windows 98 to get on the Internet or do any sort of work, why would Microsoft want to release Windows NT? Meanwhile, you can see how the US Army with no profit motive has outdone them and created a vaccine for ALL the variants: https://www.defenseone.com/technology/2021/12/us-army-creates-single-vaccine-effective-against-all-covid-sars-variants/360089/ https://www.defenseone.com/technology/2021/12/us-army-create... This just goes to show that government and industry often work together and market failures often result, while institutions with no profit motive can overtake them (Wikipedia, NGinX, Linux, Wordpress, WebKit and many others overtook their capitalist counterparts.)
- jimmygrapes 5y ago
  What happened was, well, as you said, profit came in, but also we had an election and brought in a change of guard that for whatever reason didn't continue that particular mission. It seems to me that once the initial vaccines were out, the mission became "we have the solution, now make everyone accept it" rather than continuous improvement. It's like they refuse to do the last steps of a process (evaluate effectiveness and refine as needed) and got stuck on implementation, not recognizing that implementation itself needs to be evaluated and refined.
  - jonway 5y ago
    After reading TFA, I have learned that Operation Warp Speed essentially bought the risk and supplied scaling capital to bootstrap domestic biomedical manufacturing. OWS supplied capital for hardware, people, project management, brokered manufacturing agreements and organized large scale trials. Article mentions that moderna had a big weakness: Inexperienced at executing clinical trials and large scale manufacturing of its vaccine technology, it could produce a prototype vaccine in several days but had no existing pipeline to deliver industrial quantities. >It seems to me that once the initial vaccines were out, the mission became "we have the solution, now make everyone accept it" rather than continuous improvement. The vaccines were out in a couple of months. Amazingly, it turns out that the hard part is scaling to global quantities of a new product line. Re-engineering a global production is way hard, too. I agree that we should continue to fund the scaleout of domestic biomedical manufacturing.
rsynnott 5y ago
Moderna was American and accepted US funding, so it wasn’t a total loss. Though the article certainly overstates it a bit. Pfizer/BioNTech and AZ were significant beneficiaries of state funding outside of the US, tho.
blibble 5y ago
yes, the entire article is singing the praise of the necessity of darpa and OWS when biontech and pfizer succeeded without any of it
- rsynnott 5y ago
  BioNTech did receive significant funding from the German government, however.
  - NicoJuicy 5y ago
    That's not related to Warp speed. Those are subsidies for eg. doing simultaneous clinical trials and to compensate it's additional costs.
- anonymousiam 5y ago
  There's a separate element of Warp Speed that nobody is discussing. It's not about funding the development, but about allowing use on humans with reduced trials beforehand. That part was enormously successful.
  - NicoJuicy 5y ago
    That's not operation Warp speed. That's pandemic 101 from the WHO. And it's not reduced trials, it's doing them simultaneously. I mentioned it before in another comment 3 hours ago: https://news.ycombinator.com/item?id=30141967 https://news.ycombinator.com/item?id=30141967
    - deleted 5y ago
      [deleted]
refurb 5y ago
3 of the 4 of the key vaccines were manufactured by US companies - Pfizer, Moderna and J&J. You realize a part of Warp Speed was the coordination of manufacturers and the FDA? So while Pfizer accepted no funding, it benefited from the streamlined regulatory process.
- arcticbull 5y ago
  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 https://en.wikipedia.org/wiki/Operation_Warp_Speed
  - refurb 5y ago
    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.
    - NicoJuicy 5y ago
      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.
HWR_14 5y ago
Pfizer accepted preorders in June before phase 3 in the amount of $2 billion. They declined warp speed funding for the research, not the manufacture.
- NicoJuicy 5y ago
  Pfizer accepted orders, but had a very special contract that meant the US needed to back off. They did manufacturer outside the US just fine. A simple Google search could have given that info.
  - HWR_14 5y ago
    Pfizer had multiple manufacturing processes in multiple parts of the world. The EU plants definitely did worse than the US plants. That's probably not due to any government program, but the US based manufacture didn't have to shutdown and restart or waste, I think it was a month. That said, the primary reason OWS worked at all is they parallelized anything they could. In this case, they paid Pfizer $2 billion to start producing a vaccine before they knew if it would work or be FDA approved, although there was good reason to believe it would. It wasn't brilliant. It was a good idea. Worst cast we waste $2 billion. Best case we end a pandemic 6 months early. Putting more money at risk for faster results is reasonable in emergencies. Outside emergencies we have a process for a reason - to reduce waste and fraud.
    - NicoJuicy 5y ago
      I call bs. Show me. What's the source of a month shutdown? I've never heard of that. Pfizer, additionally, already had positive trials before the order from the US came! OWS had nothing to do with the quickest delivered vaccine, since Pfizer wanted NO political interference. The contract was not funding at all. They didn't receive the money upfront and it had to be approved by FDA before the contract was considered valid. Israel had the fastest vaccination rate/program in the world and it was supplied by the Belgian manufacturing part of Pfizer in Puurs. https://nsl.consilium.europa.eu/104100/GeneralNewsletter/4od5l4siyvf7z5zx5ai27sxp5i/Html https://nsl.consilium.europa.eu/104100/GeneralNewsletter/4od... > Most vaccination technologies have been initiated or developed in Europe. Most of the doses with which Israel embarked on its mass vaccination programme were sent from Belgium. There's a big difference in supplying the world with enough vaccines ( EU ) versus buying all available ones at a premium ( US). I don't even know where your fraud argument comes from... But worst case is definitely not 2 billion $ waste. But a 10 billion $ risk of funds taken from hospitals for COVID care that could need it, which paid for "operation Warp speed" - https://www.statnews.com/2021/03/02/trump-administration-quietly-spent-billions-in-hospital-funds-on-operation-warp-speed/ https://www.statnews.com/2021/03/02/trump-administration-qui...

manuelabeledo 5y ago

> Wait, getting multiple vaccines ready but none were from the US. Wasn't the Moderna vaccine developed entirely in the US?

SR2Z 5y ago
And while the Pfizer one was majority developed by BioNTech, they lacked the expertise to actually produce it at scale.
- NicoJuicy 5y ago
  And that happened at the existing Pfizer facility in Puurs ( Belgium). As far as I'm aware, no existing facilities were upgraded/expanded? https://www.politico.eu/article/belgium-town-puurs-spotlight-coronavirus-vaccine/ https://www.politico.eu/article/belgium-town-puurs-spotlight... A big up for Belgian pharma facilities. But I'm unsure about the role of operation Warp speed on this all. As far as I'm aware, Pfizer/BionTech explicitly avoided any funding through operation Warp Speed. They received an order in phase 3 of the clinical trials. The core issue ( why they partnered with Pfizer) for BionTech was also not production at scale, but handling clinical trials at this scale. Which ( again/also) was not related to Warp Speed.
  - yzmtf2008 5y ago
    > As far as I'm aware, no existing facilities were added? Nowhere in your linked article indicates that "no existing facilities were added". > As of January 2022, the Pfizer-BioNTech COVID-19 vaccine is manufactured between 11 sites across five countries, including the U.S., Germany, Belgium, Ireland, and Croatia, and engages more than 20 suppliers. https://www.pfizer.com/science/coronavirus/vaccine/manufacturing-and-distribution#:~:text=Where%20is%20the%20Pfizer%2DBioNTech%20COVID%2D19%20vaccine%20made%3F https://www.pfizer.com/science/coronavirus/vaccine/manufactu...
    - NicoJuicy 5y ago
      I'm from Belgium and i did follow up on Puurs and i hadn't encountered any news that they needed to upgrade facilities there. That's what you should have copied my whole sentence: "as far as I'm aware, no existing facilities were added". Which in retrospect should be upgraded actually. Didn't notice that mistake.
      - b3orn 5y ago
        Biontech bought production facilities in Germany.
        NicoJuicy 5y ago
        Yeah, seems to be correct. https://www.brusselstimes.com/131709/biontech-buys-a-novartis-plant-to-increase-vaccine-production-capacity https://www.brusselstimes.com/131709/biontech-buys-a-novarti... But i did mention the facility in Puurs ( since it's from my country), i wasn't keeping track on all of them ofc
      - deleted 5y ago
        [deleted]
- freeflight 5y ago
  > they lacked the expertise to actually produce it at scale Scaling up production is not all about expertise, but mostly about existing production capacities and how quickly they can be retooled for another production.

tomohawk 5y ago

> ready on day 2 That's like some person in SV saying they had a great idea. Who cares? The level of execution in operation warp to get this past the FDA processes was enormous. The industrial mobilzation to create refrigeration units and transportation, and get all of the logistics alligned in a few months. That is the stuff of legend.

NicoJuicy 5y ago
And that seems to me as patting themselves on the back. Every country in Europe did this exact thing without patting themselves on the back or calling it "Warp speed" ( eg. For Refrigerator units/logistics) The biggest accomplishment/improvement to speed up things was doing simultaneous clinical trials, which wasn't even remotely related with Warp speed but was a emergency action ( = it existed as advice before COVID to be used if a pandemic would happen)
- e4e78a06 5y ago
  The EU had a substantially delayed rollout of vaccines compared to the US [1]. You can see that the purple line (US) is about 2 months ahead of the yellow (EU). Especially in the early days of the rollout the EU was very behind. [1]: https://www.bmj.com/content/375/bmj.n2412 https://www.bmj.com/content/375/bmj.n2412
  - morelisp 5y ago
    > Especially in the early days of the rollout the EU was very behind. On one hand I agree, but on the other hand looking back now after 13-14 months, did it matter? Was any public health outcome significantly improved by that lead? (From the qualitative reports I've read I might believe there was in the UK - but not prima facie US vs. EU.)
    - e4e78a06 5y ago
      That's a pretty hard analysis to make. You'd have to compare people that 1) wanted to get vaccinated and 2) _could_ have been vaccinated if they were in the US instead of Europe and 3) died from COVID during the 2 month delay and see how many lives were saved. My uninformed guess just eyeballing the historical death graphs and vaccine rollout is probably low 5 figures range.

yzmtf2008 5y ago

> Wait, getting multiple vaccines ready but none were from the US. See sibling comment on Moderna. > The vaccine was practically ready on day 2 of COVID due to mRNA No. "ready" as in we can produce a vile in a lab? Sure. Ready as in tested in the general population, mass production facilities, distribution networks? Absolutely not. > So I'm not sure why Warp speed is considered a success? Producing a vaccine is about the easiest part of warp speed. Having the supply chain needed to vaccinate the whole population in such a brief time? That's the success. Also, it's literally the entire point of TFA.

dnautics 5y ago
If I'm not mistaken the mRNA production is kind of bonkers, it's outsourced to a bestiary of third party small contract manufacturers. I could be wrong, but I don't think that any newly released drug has rolled out like that at such a scale in the past (usually it's one/a few plants all controlled by the big pharma that gets certified by the FDA). It's REALLY impressive that the bureaucracy figured out exactly where to bend the rules and shepherded all of the small contract manufacturers into compliance to get reasonable batch-to-batch consistency and safety for these vaccines.
- EGreg 5y ago
  “The bureaucracy” is doing a lot of work there THIS is what I want to hear more about. How was all this coordination done? Solving collective action problems is what government is supposed to do… was this a command economy, central planning, or some sort of intiative like we have now with the new “security best practices imperatives” that will use the infrastructure bill and standardize what small vendors will deliver?
  - dnautics 5y ago
    I don't necessarily think that government's job is to "solve collective action problems" (there are plenty of alternatives, actually free markets themselves are a solution to the collective action problem of "what should the price of X be") -- but if it's going to doit, it should be held to a high standard of effectiveness.

vlovich123 5y ago

mRNA was an accomplishment to be sure. It’s a necessary but not sufficient condition. If you look at the stories for the rollout, the logistics challenge posed by mRNA vaccines were quite substantial, particularly refrigeration but also supply chain logistics in general were complicated. Warp Speed definitely was run competently by all accounts.

pyuser583 5y ago
As the article pointed out, identifying MRNA as a viable option was one of Warp Speeds major accomplishments. There are tons of technologies that had to be explored. I’ve read this article in full several times (it’s dense). Warp Speed wasn’t like the Manhattan Project or the Apollo Project. It wasn’t hundreds of thousands of government employees working in one tech. It was hundreds of project managers with single tech portfolios, most of which were useless, trying to figure out which tech would solve the problem at hand. It was YComhinator investing applied to a major government project.
- jounker 5y ago
  The Pfizer/BioNTech vaccine was pointedly not involved in Operation Warp Speed.
  - vlovich123 5y ago
    Wikipedia disagrees with you but depends on your meaning of "not involved". I think you could be right about the impact Warp Speed had on the selection aspect of mRNA but it's hard to say. From one perspective, BioNtech mRNA effort started in January 2020 before Warp Speed was a thing. From another Pfizer and BioNTech announced a deal in April 2020 around the time that Warp Speed legislation (and since legislation is lagging self-organizing work that was ongoing, it's hard to say). From the capacity perspective, it doesn't seem right [1]. > But on July 22, Operation Warp Speed placed an advance-purchase order of $2 billion with Pfizer to manufacture 100 million doses of a COVID-19 vaccine for use in the United States when the vaccine was shown to be safe, effective, licensed, and authorized by the Food and Drug Administration (FDA). On December 23, the Trump administration announced that they had ordered another 200 million doses from Pfizer. On November 9, the Pfizer–BioNTech partnership announced positive early results from its Phase III trial of the BNT162b2 vaccine candidate, and on December 11, the FDA provided emergency use authorization, initiating the distribution of the vaccine. > In September 2020, BioNTech received €375 million (US$445 million) from the government of Germany to accelerate the development and production capacity of the Pfizer–BioNTech COVID-19 vaccine So looks like they needed significant government help getting distribution and logistics. [1] https://en.wikipedia.org/wiki/Operation_Warp_Speed#Pfizer%E2%80%93BioNTech https://en.wikipedia.org/wiki/Operation_Warp_Speed#Pfizer%E2...

Spooky23 5y ago

Nooo. There was a ton of logistics. The military was a key part of the last mile distribution initially and for some time. Trump is a loathsome character, but OWS was a well executed initiative.

tandymodel100 5y ago
The last mile distribution wasn’t well considered at all. Between tweets denying he lost the election he just said it would be up to the states to furnish last mile.
- Spooky23 5y ago
  I think OWS had some autonomy outside of the crazy day to day bloviating. The initial Pfizer environmental requirements were difficult to meet, and the military through the national guard were a big part of delivery. Outside of those logistics everything was an evil shitshow.

EGreg 5y ago

What I want to know is, what happened to all that “warp” speed since then? We had been waiting for delta vaccine and whatever else, for over a year. They can surely churn them out quick with mRNA (they even did it for HIV!) but they don’t. The profit motive happened. With government and media carrying water for these vaccine manufacturers, and forcing everyone to get an outdated vaccine, why would they cannibalize their own profits? It’s like if everyone were told you must install Windows 98 to get on the Internet or do any sort of work, why would Microsoft want to release Windows NT? Meanwhile, you can see how the US Army with no profit motive has outdone them and created a vaccine for ALL the variants: https://www.defenseone.com/technology/2021/12/us-army-creates-single-vaccine-effective-against-all-covid-sars-variants/360089/ https://www.defenseone.com/technology/2021/12/us-army-create... This just goes to show that government and industry often work together and market failures often result, while institutions with no profit motive can overtake them (Wikipedia, NGinX, Linux, Wordpress, WebKit and many others overtook their capitalist counterparts.)

jimmygrapes 5y ago
What happened was, well, as you said, profit came in, but also we had an election and brought in a change of guard that for whatever reason didn't continue that particular mission. It seems to me that once the initial vaccines were out, the mission became "we have the solution, now make everyone accept it" rather than continuous improvement. It's like they refuse to do the last steps of a process (evaluate effectiveness and refine as needed) and got stuck on implementation, not recognizing that implementation itself needs to be evaluated and refined.
- jonway 5y ago
  After reading TFA, I have learned that Operation Warp Speed essentially bought the risk and supplied scaling capital to bootstrap domestic biomedical manufacturing. OWS supplied capital for hardware, people, project management, brokered manufacturing agreements and organized large scale trials. Article mentions that moderna had a big weakness: Inexperienced at executing clinical trials and large scale manufacturing of its vaccine technology, it could produce a prototype vaccine in several days but had no existing pipeline to deliver industrial quantities. >It seems to me that once the initial vaccines were out, the mission became "we have the solution, now make everyone accept it" rather than continuous improvement. The vaccines were out in a couple of months. Amazingly, it turns out that the hard part is scaling to global quantities of a new product line. Re-engineering a global production is way hard, too. I agree that we should continue to fund the scaleout of domestic biomedical manufacturing.

rsynnott 5y ago

Moderna was American and accepted US funding, so it wasn’t a total loss. Though the article certainly overstates it a bit. Pfizer/BioNTech and AZ were significant beneficiaries of state funding outside of the US, tho.

blibble 5y ago

yes, the entire article is singing the praise of the necessity of darpa and OWS when biontech and pfizer succeeded without any of it

rsynnott 5y ago
BioNTech did receive significant funding from the German government, however.
- NicoJuicy 5y ago
  That's not related to Warp speed. Those are subsidies for eg. doing simultaneous clinical trials and to compensate it's additional costs.
anonymousiam 5y ago
There's a separate element of Warp Speed that nobody is discussing. It's not about funding the development, but about allowing use on humans with reduced trials beforehand. That part was enormously successful.
- NicoJuicy 5y ago
  That's not operation Warp speed. That's pandemic 101 from the WHO. And it's not reduced trials, it's doing them simultaneously. I mentioned it before in another comment 3 hours ago: https://news.ycombinator.com/item?id=30141967 https://news.ycombinator.com/item?id=30141967
  - deleted 5y ago
    [deleted]

refurb 5y ago

3 of the 4 of the key vaccines were manufactured by US companies - Pfizer, Moderna and J&J. You realize a part of Warp Speed was the coordination of manufacturers and the FDA? So while Pfizer accepted no funding, it benefited from the streamlined regulatory process.

arcticbull 5y ago
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 https://en.wikipedia.org/wiki/Operation_Warp_Speed
- refurb 5y ago
  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.
  - NicoJuicy 5y ago
    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.

HWR_14 5y ago

Pfizer accepted preorders in June before phase 3 in the amount of $2 billion. They declined warp speed funding for the research, not the manufacture.

NicoJuicy 5y ago
Pfizer accepted orders, but had a very special contract that meant the US needed to back off. They did manufacturer outside the US just fine. A simple Google search could have given that info.
- HWR_14 5y ago
  Pfizer had multiple manufacturing processes in multiple parts of the world. The EU plants definitely did worse than the US plants. That's probably not due to any government program, but the US based manufacture didn't have to shutdown and restart or waste, I think it was a month. That said, the primary reason OWS worked at all is they parallelized anything they could. In this case, they paid Pfizer $2 billion to start producing a vaccine before they knew if it would work or be FDA approved, although there was good reason to believe it would. It wasn't brilliant. It was a good idea. Worst cast we waste $2 billion. Best case we end a pandemic 6 months early. Putting more money at risk for faster results is reasonable in emergencies. Outside emergencies we have a process for a reason - to reduce waste and fraud.
  - NicoJuicy 5y ago
    I call bs. Show me. What's the source of a month shutdown? I've never heard of that. Pfizer, additionally, already had positive trials before the order from the US came! OWS had nothing to do with the quickest delivered vaccine, since Pfizer wanted NO political interference. The contract was not funding at all. They didn't receive the money upfront and it had to be approved by FDA before the contract was considered valid. Israel had the fastest vaccination rate/program in the world and it was supplied by the Belgian manufacturing part of Pfizer in Puurs. https://nsl.consilium.europa.eu/104100/GeneralNewsletter/4od5l4siyvf7z5zx5ai27sxp5i/Html https://nsl.consilium.europa.eu/104100/GeneralNewsletter/4od... > Most vaccination technologies have been initiated or developed in Europe. Most of the doses with which Israel embarked on its mass vaccination programme were sent from Belgium. There's a big difference in supplying the world with enough vaccines ( EU ) versus buying all available ones at a premium ( US). I don't even know where your fraud argument comes from... But worst case is definitely not 2 billion $ waste. But a 10 billion $ risk of funds taken from hospitals for COVID care that could need it, which paid for "operation Warp speed" - https://www.statnews.com/2021/03/02/trump-administration-quietly-spent-billions-in-hospital-funds-on-operation-warp-speed/ https://www.statnews.com/2021/03/02/trump-administration-qui...