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How Pfizer delivered a Covid vaccine in record time
- tsjq 6y agohttps://archive.is/GiWV3 https://archive.is/GiWV3
- rc_mob 6y agotldr; they took a lot of shortcuts on the normal process
- Buttons840 6y agoWhat's something they would have done in the normal process that they skipped?
- JamisonM 6y agoAbsolutely nothing. In fact the acceleration in testing was mostly facilitated by the western world's absolute bungling of the COVID-19 response! If the planet were not blanketed in hotspots that match the demographic profiles required we would still be waiting for statistically significant results.
- ketamine__ 6y agoNot fast enough to save 300,000 lives despite the vaccine being made very quickly.
- kurthr 6y agoJust showing that testing on humans (for the level of safety desired) and physical delivery (the way humans like it to be done) are harder problems than developing even a new vaccine. To be honest, if these two were as malleable an objective as the development (usually R&D is easier to speed up) by allowing mass inoculation (rather than individually shipped vials) or reduced safety/efficacy then they could be sped up too. And of course, if the govt (leaders) was competent there wouldn't have been 300k lives lost, and arguably economic damage could have been minimized as well. I'd argue that's a goal post that moves independent of delivery time.
- ketamine__ 6y agoThat's grading on a curve. Ten years to one year is pointless if it doesn't save enough lives. > And of course, if the govt (leaders) was competent there wouldn't have been 300k lives lost, and arguably economic damage could have been minimized as well. I'd argue that's a goal post that moves independent of delivery time. Pure whataboutism. We are stuck with the world we live in now and need to optimize for that.
- that_guy_iain 6y ago> That's grading on a curve. Ten years to one year is pointless if it doesn't save enough lives. But, who says it won't save enough lives? It was estimated to wipe out millions, seems like saving millions is enough to me.
- ketamine__ 6y agoHow many lives were lost in New Zealand? Your argument doesn't make sense.
- that_guy_iain 6y agoThe argument of it saving millions of lives in the future, is not good enough for you? And there are more people in my city than in New Zealand. You can't compare the world to a tiny island. Your comparision is unfair and unrealistic. Europe for example couldn't just close it's borders, it's logistically impossible.
- ketamine__ 6y agoApproving vaccines faster does save lives going forward. That is the whole point.
- kurthr 6y agoUmm your argument is that we needed to speed up the delivery of vaccines to save 300k people who have already died, but also think that what happened in New Zealand is a reasonably likely possibility? So would you have also given an untested vaccine to everyone in New Zealand in March? Your answer seems to be yes... and it probably would have only killed or maimed 100ppm or ~5 thousand people, and it would have saved roughly 0.
- the8472 6y agoThose lives were not sacrificed on the altar of meticulous vaccine development. They were offered to the "business as usual" gods instead.
- ketamine__ 6y agoThe "meticulous vaccine development" is a religious belief in the middle of a pandemic. It helps no one but makes the elites feel better I guess?
- Siira 6y agoSpeak in facts, not vague political jargon. The vaccines were developed quickly, then delayed for months for testing purposes, and they have finally been declared effective (all of them, as far as I’ve heard). So it is a fact that if people were given an option not to wait for the authorization, a lot of suffering, disability and death would have been prevented, and the economy would be in a better shape, as well.
- __jem 6y agoTesting isn't a delay, unless you think being reckless is a scientific virtue.
- zaroth 6y agoPhase 1 testing had to be done. However, gambling on efficacy would have been a very reasonable approach and could have gotten tens or hundreds of millions of people vaccinated by now.
- giantrobot 6y agoEven with tens of millions vaccinated COVID is too contagious and deadly to avoid social mitigation like restricting businesses, large gathering, mandating masks, and even lockdowns. The long incubation period and asymptomatic carriers makes for easy spread of the virus. It's hospitalization rate means a wide spread will literally shut down hospitals in whole regions. At current infection rates we're seeing hospitals being overwhelmed at regional levels. Even if vaccines had been delivered after a Phase 1 trial of "no one died immediately" in the trial group, we wouldn't have enough vaccinated people to avoid social mitigation. We'd be in a similar situation as we're in right now. It will take something like 75% of the population to be immune (by vaccine or previous infection) to have effective herd immunity. Even if vaccines had started distributing months ago it would still be a long time before we hit that 75%. Distributing vaccines after the phase 1 trials might ultimately get an immune population to that 75% sooner but it wouldn't stop any of the damage happening until that number is reached. Even if no one died from COVID the "long hauler" after effects can be crippling. Some 10-20% of COVID patients end up "long haulers". If the virus were to spread to significant portions of the population because no one practiced social spread mitigation because they assumed the vaccine would fix everything you're still in a terrible situation.
- fnord77 6y agopolitics and incompetence are responsible for a large chunk of those deaths.
- jariel 6y agoIt's interesting there wasn't direct economic injection from governments. Both the humanitarian and economic toll of COVID is off the charts. 20% contraction in the economy, is like 4 Trillion in GDP loss for the US alone, maybe 20 Trillion for the world. And that's just the money, not the human loss. Given that, I don't get why nations didn't give them basically blank cheques, enabled the socialization/commandeering of factories and equipment, 5-10% of the Armed Forces for whatever needs etc.. Literally every drug company can 'report their assets' to the COVID task force and they will get deployed as needed. The companies will be happy to do that because they'll earn 3-10x return on those assets otherwise anyhow. That seems a little dramatic but it's basically nothing compared to the damage COVID is causing. Also: they didn't go into the actual manufacturing details to much, sadly. Edit: also interesting would be the sunk cost / opportunity cost calculation on ramping up production of untested vaccines. If opportunity cost didn't factor in i.e. if ramping up one vaccine didn't come at the cost of another, my bet is that it would have been worth any price. If the US had spent $2B on ramping up every vaccine candidate before they were approved, and only 1 out of 10 came through, costing $20B for the first massive batch and accelerating subsequent batches, instead of merely $2B - would it have been worth it? $200 a dose instead of $20 dose? The math would say it's way beyond worth it. There's a case for 'prepping' every single vaccine candidate to the extent it's possible and even starting to manufacture in quantities way ahead of time. This financial calculus doesn't work in the context of Pfizer - it doesn't make sense for them - however it absolutely does in the bigger picture. A 'remedy' for this could have been to offer Pfizer massively increased price per dose for earlier delivery, in which case it would have made sense for the to spend $20B instead of $2, or simply some kind of national 'blank cheque' intervention. The former concept is neat but would be hard to nail down, the later is probably more workable. Given that vaccine manufacture is 1/2 the equation, not just the R&D, I hope the 'after action reports' will put this in context.
- culopatin 6y agoIf we didn’t waste so much time in dealing with politics and formal gossiping we’d would be living in the future.
- gleb 6y agoThe article answers this. Because further government involvement would slow down the process. E.g. “To assemble its mRNA production network, Pfizer used its own money and didn’t take any from the federal government. Executives said they didn’t want to give agencies outside the FDA more leverage over the design of the trials.” “Rival Moderna, which took funding from a division of the U.S. Department of Health and Human Services, suffered a three-week delay in completing its own mRNA trial after federal officials there asked the company to slow down enrollment to boost the racial and ethnic diversity of study subjects.”
- hikerclimb 6y agoI hope millions of people die from this vaccine.
- blakesterz 6y ago"Pfizer couldn’t meet every target set by its chief executive. Mr. Bourla wanted the vaccine done by October and as many as 100 million doses by year’s close, enough for 50 million people. Instead about half that will be produced." It'll be very interesting to see just how many people will take the vaccine over the next 6 months or so. I just had two nurses tell me that they will NOT be taking the vaccine, they are too scared of it. Based on what other folks have said, I'm guessing the number is going to be much lower than hoped. I am really hoping I'm wrong. It doesn't worry me at all.
- bpodgursky 6y agoHopefully the highly-vulnerable populations (elderly, obese) are willing to take the small unknown risk enough to drive down death rates. I'm not personally super bothered of a bunch of young and healthy people choose to forgo the vaccine pending more time and studies.
- mattr47 6y agoUnfortunately the testing was done on healthy people, not the elderly or those with pre existing conditions.
- neals 6y agoOne of the issues is that young people also end up on the IC. If you were to just 'let young people' out and about, hospitals would still be overwhelmed.
- macspoofing 6y ago>One of the issues is that young people also end up on the IC. The rate is important. If the rate is miniscule, then it may still be an issue, but not an overly important one. >If you were to just 'let young people' out and about, hospitals would still be overwhelmed. Are we sure about that? Any numbers you can share?
- chiefalchemist 6y agoIt's important to realize, in today's (Western) world, young is not longer synonymous with healthy. Obesity, diabetes, addiction, vaping, etc. are all close to the broader population. That said, young + healthy generally mitigates the risk of Covid 19.
- sh1mmer 6y agoA lot of the articles I’ve read (including this one) say that Pfizer had to invest $2B to develop this vaccine. However this article says they bought seven $200M machines to manufacture lipid nanoparticles. This implies to me that $1.4B of $2B Pfizer is supposed to have spent on development was actually just updating their supply chain for mRNA based vaccines. While I’m happy that they made such a dramatic investment in the interests of bringing a product to market as fast as possible I think it’s also fair to imply it’s R&D that can’t be applied to other products later.
- maxerickson 6y agoAre you sure the amounts overlap?
- throwaway2245 6y agoOverlapping doesn't matter - large multinationals' decisions over spending are more likely to look like: "if we receive $X from the government to spend on Y, then we'll have a spare $X to spend on Z"
- maxerickson 6y agoIf the development spending happened prior to negotiating the manufacturing deals it matters (they had been working on mRNA vaccines for other viruses). The decision to spend the money on the development wasn't necessarily made with knowledge of the government purchase guarantee.
- sho_hn 6y agoPfizer is BioNTech's manufacturing partner and did logistics for clinical trials, they didn't do the R&D. There are other international licensees of the same vaccine, e.g. Fosun in China. And I suppose they spent a handy sum on marketing to pull off this being known as the "Pfizer vaccine" in domestic media despite this. Note the article headline is "How Pfizer Delivered ..." not "Developed".
- im3w1l 6y ago
- sh1mmer 6y ago> To assemble its mRNA production network, Pfizer used its own money and didn’t take any from the federal government. Executives said they didn’t want to give agencies outside the FDA more leverage over the design of the trials. > Rival Moderna, which took funding from a division of the U.S. Department of Health and Human Services, suffered a three-week delay in completing its own mRNA trial after federal officials there asked the company to slow down enrollment to boost the racial and ethnic diversity of study subjects.
- deleted 6y ago[deleted]
- CydeWeys 6y agoSounds like the 3 week delay was merited if Moderna originally had a mostly white study group and thus wasn't properly testing the effects on the entire population. This is very important to do in medicine. And I wonder if that means that Pfizer did not use a broad sample set of the population and DHS was not there to keep them in line? Or maybe they did this correctly from the get-go and it was sheer luck that Moderna had the additional needed oversight?
- Exmoor 6y agoPfizer trial demographics are on page 31 of this PDF: https://www.fda.gov/media/144246/download https://www.fda.gov/media/144246/download You can compare that with the demographic table of the US. Looks like they don't quite align, but are presumably within the guidelines. FWIW, all the comments I saw from people more familiar with medical data were pretty positive about the demographic spread. https://en.wikipedia.org/wiki/Race_and_ethnicity_in_the_United_States#Racial_categories https://en.wikipedia.org/wiki/Race_and_ethnicity_in_the_Unit...
- Herodotus38 6y agoNotably, specifically look at the phase 1 demographics. It was 100% white. I’m not saying anything for or against this, but I bet it was in the first phase where the concerns for equity were brought up. Edit: the difficulty becomes the argument between recruiting equitably vs recruiting quickly, both are going to have downsides. Ideally you would do both at once, the question becomes why is this so hard in the US, and there are lots of reasons.
- macspoofing 6y agoI'm surprised Pfizer or pharmaceutical industry in general, didn't get Time Person of the Year - development of COVID vaccines in record time is BY FAR the most consequential action in this crazy year, perhaps this century.
- input_sh 6y agoWho cares? Time is pretty irrelevant as a magazine, not even in the top 10 by distribution in the United States. Gamestop's Game Informer has almost 3x the circulation, and I'm pretty the majority of the people here don't really care about either of them.
- nceqs3 6y agoTime is owned by Mark Benioff lol.
- jariel 6y agoThe BioNTech team who made the vaccine probably should get a lot of public 'credit'.
- fnord77 6y agothe hard, pioneering work was done by the NIH and universities. Pharma refined it, applied it to covid and creating the distribution infrastructure
- macspoofing 6y agoYes, I have no doubt that that preliminary research in part or wholly originated from universities. Big Pharma should get this recognition anyway because as you said: "Pharma refined it, applied it to covid and creating the distribution infrastructure" Don't worry though. Time would never give this award to Big Pharma, as evidenced by the fact they gave it to Biden/Harris, one of the most milquetoast tickets in recent history, in a year where the first big pandemic in a century is ravaging the world. I'm also surprised they didn't go down the feel-good route of giving it to frontline healthcare workers, but Trump is a bigger deal, apparently.
- Dowwie 6y agoRelated to this topic is a conversation Steve Levitt had the other day with Moncef Slaoui, who has been a scientific lead for "Operation Warp Speed": https://podcasts.apple.com/us/podcast/moncef-slaoui-its-unfortunate-that-it-takes-crisis/id1525936566?i=1000502139321 https://podcasts.apple.com/us/podcast/moncef-slaoui-its-unfo...
- hikerclimber 6y agoit probably won't work since they rushed it.
- guruz 6y agoA German(+Pfizer) vaccine which is still not approved in EU (it is in UK). Time is a bit pressing here.
- tinus_hn 6y agoSsshh you can’t say that on HackerNews!
- H8crilA 6y agoIt's going to take many months (over a year?) to fully distribute, and the first few months of vaccinations are going to deliver the most important phase IV data points. Waiting just a little bit longer isn't entirely unreasonable. Why take chances if the Brits and the Americans are willing to do the final tests? The main reason why vaccines are so safe (and why the anti-vax movement is so silly) is that they've been tested on hundreds of millions of people. But until you vaccinate those millions you cannot be absolutely sure about the safety.
- burnett2k 6y agopaywalled...
- adictator 6y agoMere Coincidence or Conspiracy or Conspiracy theory? > "The Chinese biological laboratory in Wuhan is owned by Glaxosmithkline, who happens to own Pfizer! (The one who delivered the vaccine in Record Time)
- lampenrad 6y agoThis article is very US-centric and self congratulatory. The vaccine is called BNT162b2, because it was fundamentally developed at Biontech. https://en.wikipedia.org/wiki/Tozinameran https://en.wikipedia.org/wiki/Tozinameran >Tozinameran[1] (INN), codenamed BNT162b2 and more commonly known as the Pfizer COVID-19 vaccine, is a COVID-19 vaccine developed by BioNTech and manufactured and distributed by Pfizer https://www.thelocal.de/20201110/biontech-four-things-to-know-about-the-german-firm-leading-the-covid-19-vaccine-race https://www.thelocal.de/20201110/biontech-four-things-to-kno... >While global headlines tend to lead with Pfizer's involvement, Şahin insisted to Spiegel: "It is our technology." It bothers me how Americanized the Western media has become. If Biontech was a US company and Pfizer was European, exactly 0 US media would call it the „Pfizer vaccine“. Yet most European media outlets have adopted the US-spin and now call it „Pfizer Vaccine“ (or „Pfizer-Biontech“ at most). > In a series of interviews over more than seven months, senior Pfizer executives and other managers shed new light on how the vaccine project took shape. Reading the article, it doesn’t look like the spoke to anyone at Biontech. > BioNTech simply plugged the genetic code for the spike protein into its software. On Jan. 25, BioNTech Chief Executive Ugur Sahin designed 10 candidates himself. Ah yes, the Germans simply plugged it into their software. Disregard over a decade of fundamental research done by hundreds of scientists with hundreds of millions of Euros in funding. Now let‘s focus on all the hard work American pharmaceutical Managers did. >To assemble its mRNA production network, Pfizer used its own money and didn’t take any from the federal government. Executives said they didn’t want to give agencies outside the FDA more leverage over the design of the trials. Yes, but: https://en.wikipedia.org/wiki/Tozinameran https://en.wikipedia.org/wiki/Tozinameran >In September 2020, the German government granted BioNTech 375 million euros ($445 million) for its COVID-19 vaccine development program at a time when Pfizer funded its portion of development costs without government funding.[20] BioNTech had also received 100 million euros ($119 million) in financing from the European Commission and European Investment Bank in mid-2020.[21] Also: https://www.bloomberg.com/news/articles/2020-11-09/pfizer-vaccine-s-funding-came-from-berlin-not-washington https://www.bloomberg.com/news/articles/2020-11-09/pfizer-va... And speaking of „Operation Warp Speed“: Coincidentally, „Light Speed“, the name Biontech gave its vaccine development effort, started in mid January. A time when almost nobody had even heard of the virus. Operation Warp Speed wasn‘t announced until April 29, three and a half months later.
- deleted 6y ago[deleted]
- rawland 6y agoTLDR: They bought it and scaled it.
- divbzero 6y agoI like this article too [1] which describes the long prior research that led up to mRNA vaccines at BioNTech and Moderna. [1]: https://www.statnews.com/2020/11/10/the-story-of-mrna-how-a-once-dismissed-idea-became-a-leading-technology-in-the-covid-vaccine-race/ https://www.statnews.com/2020/11/10/the-story-of-mrna-how-a-...
- economusty 6y agoI think Pfizer also has some proprietary processes that they wouldn't want to share, something about special lipid capsules that protect the mrna while to traverses the intercellular medium.
- roody15 6y agoHonestly the Russian vaccine and possibly the astrazeneca Vaccine appears to be the safest bet. No mRNA just the old school modified cold virus delivery mechanism. Method been done for years .. easier and cheaper to manufacture and distribute. Call me a cynic but I think the US (and UK) will push through a somewhat experimental version by Pfizer because “money”. Hope I am wrong. But I would imagine in a year or so we will “discover” that the cheaper vaccine works great (after giving Pfizer plenty of time for $$)
- selimthegrim 6y agoAren’t there issues with adenovirus vectors?
- roody15 6y agoYes but these are known variables. Hypothetically the newer mrna vaccines should be safe .... but there honestly is no long term information. A MRna vaccine has never been approved for human use until now.
- divbzero 6y agoI believe the same is true for adenovirus vector vaccines: none have previously been approved for human use. [1] That said, both mRNA vaccines and adenovirus vector vaccines have a history of clinical trials stretching back at least a decade. [1] [2] So in addition to there being no major long-term risk in theory, we do have some real world experience with both types of vaccines in tests. [1]: https://cen.acs.org/pharmaceuticals/vaccines/Adenoviral-vectors-new-COVID-19/98/i19 https://cen.acs.org/pharmaceuticals/vaccines/Adenoviral-vect... [2]: https://www.nature.com/articles/nrd.2017.243/tables/2 https://www.nature.com/articles/nrd.2017.243/tables/2
- ibraheemmmoosa 6y agoHow to read this without subscribing?