Pfizer/BioNTech and AZ were significant beneficiaries of state funding outside of the US, tho.
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.
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)
Any way I look at it, OWS has been an inspiring success: it proves that regardless of political divisions or uncertainties, we as a species can achieve wonderful things.
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.)
They secured the lowest prices and have a higher vaccination rate and overtook the US by now.
But it's also comparing apples and peers. It should be more reasonable to compare it with the UK. Where the US was indeed also faster.
I think the rollout in Europe ( and others ) was actually delayed because of Operation Warp Speed. Buying all vaccines at premium prices.
But regardless your own article claims production capacity in Europe was the problem (precisely the thing that OWS and the Defense Production Act rectified in the US):
> “Production was always going to be a problem,” said Schulthess. The industry had been pulling back from Europe for years — in part because of growing vaccine hesitancy. “It takes five years and a pile of cash to build a [vaccine factory] by the book,” said Schulthess.
And European infrastructure was unprepared for vaccine distribution (again from your own article):
> The Hague had bet so strongly on the Oxford/AstraZeneca jab being the first to be approved that it hadn’t finished preparing to transport mRNA vaccines, which need to be kept at temperatures far below freezing
And there were bureaucratic delays associated with getting other vaccine variants (same article):
> Countries can’t just follow the U.K.’s lead by unilaterally authorizing vaccines purchased by the EU — doses purchased by Brussels can only be released after they get the EMA’s signoff, according to the agreement. So even though Budapest tried to make a point by green-lighting the Oxford/AstraZeneca jab, it won’t get any shots before the rest of the bloc.
Please read your own article as it names and shames all the reasons of the European delay, of which merely one is price.
> have a higher vaccination rate and overtook the US by now
Yes, but we're discussing the impact of OWS which would only change how fast the initial rollout was. Obviously now there are a lot of antivaxers in the US who will never get the vaccine but that's unrelated to OWS.
Not only 5$ difference, but a higher accountability from pharma. That was almost all waved in the US as usual.
But you probably didn't notice how there were almost no issues with the western countries in the EU and the article talked about the issue with the eastern countries in the EU?
That's not a problem the EU can really solve for them.
A country was responsible for their rollout and procurement. The vaccine was bought together as an option and countries could decide to participate, that's the EU ( https://www.ft.com/content/c1575e05-70e5-4e5f-b58c-cde5c99ab... ) - all of them did.
Germany also publicly blamed the US for buying too much vaccines and sucking up all the production at a premium price in front of other countries. You didn't really read my previous point about that ( looked for the article, but it's hard to find it seems)
Let's be clear,
I'm from Belgium and I'm pretty sure that we could used some military law to force dips on vaccines we created ( Pfizer/Biontech) and could have done everything faster than the US if we wanted. But we didn't, since it's not fair, selfish and we wouldn't get away with it like the US :)
https://www.washingtonpost.com/world/europe/covid-vaccine-ex... ( read the part of Belgium)
Did we read the same article? It literally blames the Netherlands for having insufficient refrigeration infrastructure for mRNA vaccines.
> Germany also publicly blamed the US for buying too much vaccines and sucking up all the production at a premium price in front of other countries
Which as the article says, was politics to cover up for their own delays.
> I'm from Belgium and I'm pretty sure that we could used some military law to force dips on vaccines we created ( Pfizer/Biontech) and could have done everything faster than the US if we wanted. But we didn't, since it's not fair, selfish and we wouldn't get away with it like the US
That just seems like an excuse. The EU also failed to invest in sufficient production capacity by fronting capital to jump start production before the vaccines were approved. From your own FT link:
> But investments by the EU to help companies cover upfront costs appear to have been relatively modest compared with those agreed by the US. Mr Wojahn said the EU had pre-financed production capacity with roughly €2bn in the summer and early autumn. In contrast, Donald Trump’s administration in the US began funding vaccine producers through its Operation Warp Speed programme back in March. It has spent more than $12bn to date — more than a third of which was given to Boston-based biotech Moderna alone
Germany also blames the European Commission in your FT article:
> But German politicians, including Bavarian premier Markus Söder, who also leads one of Germany’s governing parties, the Christian Social Union, have said the blame sits with the EU. “There was probably too much bureaucracy at the European Commission . . . too few of the right vaccines were ordered and price debates went on for too long”, Mr Söder told German newspaper Bild am Sonntag.
And from your Washington Post article:
> Even as Brussels and European capitals cry foul over bearing the brunt of supply chain issues from manufacturers and point to continued exports, sluggish vaccination programs in many European countries mean millions of delivered doses haven’t been used. The E.U.’s most populous member state, Germany, has administered just over 8 million vaccine doses but still has a backlog of 4.3 million doses in storage, according to government figures.
Did you read your own articles or did you have an opinion you were looking to confirm coming into this conversation?
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.
Derek Lowes “In the Pipeline” column has a number of articles relating to mRNA vaccine manufacturing:
https://www.science.org/content/blog-post/more-mrna-vaccine-... https://www.science.org/content/blog-post/myths-vaccine-manu...
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?
when biontech and pfizer succeeded without any of it
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
Those are subsidies for eg. doing simultaneous clinical trials and to compensate it's additional costs.
They did manufacturer outside the US just fine. A simple Google search could have given that info.
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.
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/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-qui...
It was in late January/early February of 2021 that the Purus plant shut down. I mean, it did that to upgrade the plant, and it caught back up later in 2021. And they fell behind schedule getting Marburg online in early 2021. So they had to rely on precursors shipping from Missouri during that time.
I tried to find a link, but it's non-trivial.
Not that it matters. The random distribution of plants in the US and EU and the easy of converting them over is not really that significant.
Israel had the faster vaccination rate because the government (cleverly) offered to turn the entire country into a sales/research tool and promised a ton of data transparency back to Pfizer. It's how some new variants moving through vaccinated populations get modeled.
The contract was purchasing the doses even if the FDA didn't approve them. Even if they made people frog people, the US government would pay Pfizer. They did turn down the US research money, but instead took money from Germany and China (technically, a "totally independent* Chinese company). And they walked back the "never took OWS money" line.
I'm not sure why "money up front" matters. If the US government commits to buy 100 million things from you for $2billion, it's trivial to get external or internal financing.
I was saying the worst case from writing a check to Pfizer was 2 billion.
> a 10 billion $ risk of funds taken from hospitals for COVID care that could need it, which paid for "operation Warp speed"
Look, the fact that instead of getting Congress to authorize additional money (which they would have) and instead proceeded to waste a bunch, try to (successfully?) skim off some for themselves and then fail at most administrative tasks because they tried to work around instead of through the bureaucracy was really bad. Buying vaccines of unknown quality in massive quantities was a good, if obvious, idea.
> I don't even know where your fraud argument comes from
Oh, it's a minor point. Most US regulations around contracts specify that the existence of the regulation is to prevent "waste, fraud or abuse". My only point is that, in an emergency, optimizing for reducing those over saving lives is a bad idea. Of course, we hope that we go back and prosecute those engaging in them after the fact.
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.
Which is definitely not something unique and hard.
Why do you rely on it? A serious question. Why trust this article and this author?
It’s simply a very dense and well cited article that is best understood by being read multiple times.
The first time I read it, I hardly understood a word. So I read it again and again and it became clearer.
Doesn’t mean the article is right or wrong. Just means you have to put some work into understanding and evaluating it.
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...
Wasn't the Moderna vaccine developed entirely in the US?
As far as I'm aware, no existing facilities were upgraded/expanded? 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.
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/manufactu...
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.
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
Scaling up production is not all about expertise, but mostly about existing production capacities and how quickly they can be retooled for another production.
Trump is a loathsome character, but OWS was a well executed initiative.
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.
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-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.)
Omicron-targeting boosters are currently being trialed, and might see the light of day if Omicron hangs around for a bit.
If the next Big Variant had been closely related to Delta (as might have not unreasonably been expected), the Delta-targeting booster might have been a bigger deal; as it is, Omicron is quite different. If whatever comes next happens to be Delta-related, the Delta-targeting boosters will presumably be revived.
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.
> 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.
I think OWS highlighted what could be done if incentives were aligned, and the only things that stopped it from being an inarguable success were 1) the same thing that made it a success (speed and comms to get shit done), which caused a lot of people to say "hey that's weird the government never does anything right when they move fast" based on most of their lived understanding and experience; and, 2) the utter failure of honesty from the institutions most needed to be honest.
If the CDC etc. had remained publicly politically unbiased throughout Trump's admin, they would not have been so distrusted, I think. If the Biden admin (and Democrats in general) had not campaigned almost entirely as anti-everything-Trump and instead recognized the few good things done, the polarized Republicans (and listless independents/others) might not have had such a visceral negative reaction.
All it would have taken to prevent a large majority of "vaccine hesitation" would be to have had Biden and Trump on stage together saying "Hey we might disagree on a lot but we need to work together on this." Maybe one or both parties refused to do this or maybe they didn't think to, I don't know. But I do know, deep down inside, it would have helped. Now, though? Way too late.
Do you have any support for these statements? Biden had much better support for Covid than Trump, especially at the beginning when vaccine availability was a crisis and people remembered Trump's actual performance, not the revisionist history that accompanies everything he did.
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.
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.
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.
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.
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.
https://www.pfizer.com/news/articles/shot_of_a_lifetime_how_...
It is so unrelated to Covid that FDA’s description of the fast track program hasn’t even been updated since 2018. https://www.fda.gov/patients/fast-track-breakthrough-therapy...
The vaccines were approved through Emergency Use Authorization. Since no Covid vaccine had ever been produced before, the manufacturers and FDA had to come to an agreement on trial design, data needs and minimum thresholds.
That’s what OWS helped facilitate.
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?