I’m a researcher in biopharma, and some of my colleagues have speculated similarly: that the US should have a gigantic vaccine manufacturing suite on standby, ready for the next pandemic. It’s theoretically possible, and I like to think through what that might involve.
1. What type of vaccine are we preparing for, bc there are many different kinds! nucleic acids encased in lipid nanoparticles, like the Moderna and Pfizer covid vaccines? The type of vaccine that’s made inside chicken eggs, like the flu vaccine? A vaccine made of recombinant proteins? All of these have completely different manufacturing pipelines.
2. Are our manufacturing suites perpetually active, to keep the staff sharp and the equipment maintained? What are they producing during non-emergency time periods and who is paying for it?
3. Or do we mothball the suites and then fire them up during emergencies, creating new manufacturing teams as quickly as possible, whose first order of business would be to identify what equipment still functions since the last emergency?
4. Who is supervising this manufacturing effort? Governments? Pharma companies? Somebody else?
5. Will the vaccines produced here go through a standard regulatory process or an expedited one?
Looking outside of the understandably American-centric view of Matt's post, I've always been a bit amazed at how globally ominpresent this is.
During Australia's lockdowns earlier this year, I saw a quote that shutting down Sydney for 6 days cost as much money as buying front-of-the-queue vaccines for the entire country. Yet Australia showed no urgency about acquiring vaccines. (To the point where the PM is now much derided for saying "it's not a race".)
China took half a year or more to secure the additional funding to build additional factories for Sinovac, which allows them to make billions of doses a year. Just a few hundred million dollars, IIRC. (Leaving aside that Sinovac turned out to be less effective than hoped, but I doubt that was the reason for how long it took to get funding.)
Vietnam didn't even really try to acquire vaccines, seemingly relying on keeping the coronavirus out until 2022 when locally developed vaccines would be available. Then Delta swept in and their largest city was in complete lockdown for months with people unable to get food supplies.
It is well-known that Europe haggled on vaccine prices rather than putting a priority on expediency.
Again and again, in governments around the world it seems like EVERYONE went for penny-wise, pound-foolish. So it isn't really anything about the US or its weird Congressional-gridlock or polarisation or people not trusting Facebook or the CDC sucks or whatever other American-exceptionalism explanation you want to try to cook up.
So I guess I'm wondering...what the heck is even going on? Is this just a fundamental human nature thing? Is there nothing that can done in institutional design to try to counteract this?
I am generally ignorant of how government agencies actually work, as I only worked in the private sector during my career. I've seen a small glimpse into non-profits by contributing my time to a local community foundation and generally chuckled at the bias for Process over Results.
So after reading this, I popped over to the FDA website to see what I might learn. 45 minutes later (damn you, Matt Yglesias!), I am amazed the FDA is able to accomplish anything at all. Their organization chart doesn't show a leader, but an Office of the Commissioner with 3 people in it. Currently listed in this Office are two "acting" people and one "vacant" position.
This Office has 19 direct reports, and one dotted-line report. The direct reports include an Office of External Affairs, Office of Regulatory Affairs, Office of the Counselor to the Commissioner (Vacant) and an Office of the Chief Counsel (seems redundant). It's not obvious how the responsibilities differ between the Counselor to the Commissioner versus the Chief Counsel, but I'm sure it makes sense to somebody. Oh, and of course, there are separate organizations for the Office of Minority Health & Health Equity and also the Office of Women's Health, which covers everyone except white males.
Many of the individual "Office of..." charts show a deputy director alongside the director, an organization construct I never saw in private industry.
My reading of this organization chart is that it is designed to avoid individual accountability for results, it is too flat (nobody can manage 19 direct reports in a white-collar setting) and it is bloated. It's no great insight to say a bureaucracy is bureaucratic, but my goodness!
As far as intellectual property as a barrier to vaccine production goes, I'd note that China, with a huge intelligence apparatus which devotes a disproportionate effort to industrial espionage, has not yet produced an mRNA vaccine. That strongly suggests to me that Pfizer, Moderna, and all the patent holders on the various precursors to the vaccine itself, could waive their IP rights tomorrow and it wouldn't alter the availability of vaccines one iota for a couple of years at least.
Amateurs talk about funding, professionals talk about inputs.
I agree we should probably spend more on vaccine infrastructure, but Id like a deeper picture of what this money would buy. How many scientists are there with the smarts and the education to invent vaccines? What kind of money do they make? How quickly can new ones be trained? Are there enough qualified experts to train as many new ones as we can afford, or are there so few experts that there’s a meaningful constraint on our ability to train new ones? How long does it take to build a new vaccine factory? How much does it cost? How many people have the know how to design vaccine factories? What kinds of skills do the line workers need? How quickly can new engineers be trained? Are there any raw material constraints?
Saying we should spend $65 billion without more detail is dubious. That figure is 2.5x the annual tax revenues of the entire state of Georgia. Could anyone give me more detail on what human and material resources this money could buy?
On a slightly related note, I do not understand why so many people were so quick to jump to the "equity" point regarding Omicron...
First of equity proponents argue that equitable distribution is the best way for rich countries to protect themselves from variants. However, even if given perfectly equitable distribution (i.e. no boosters until the first course gets to everybody) to everyone who wants one, the anti-vax population is easily sufficient to be a breeding ground for new variants. So people in rich countries are clearly better off taking the boosters.
From a moral perspective, it clearly is "wellness optimizing" to prioritize old people in developing countries over kids in rich countries. However this is not the way calculations are performed for anything else... nobody blames people in the UK for getting much better cancer treatment than someone in Niger. In fact, the "Left" argument is that the US is a terrible country for not paying for its own citizens to get better healthcare, but there is no similar push to distribute more resources to Mozambique or whatever.
I think from a political perspective the reasoning here is obvious... from a station of abundance rich people and rich countries will spare relative scraps with developing countries. But if they are asked to make a real resource sacrifice it's not going to happen. Some journalists and public health people seem to have somewhat lost their minds on this though and are arguing that it's feasible to convince rich countries to sacrifice their own health and their kids health (even a little bit) for the sake of people an ocean away. Again, this is probably not a morally defensible position but its how basically every country has operated forever.
If we want to help people in developing countries we should try to get to a position of abundance.
Great post! One point about the antivirals: both must be given less than 5 days after symptom onset go be effective. Here is another logistical challenge: how to get people tested rapidly and then prescribed medicine as soon as possible? Can we loosen restrictions on pharmacists or nurses prescribing these drugs? Or can the treatment courses be handed out at rapid testing sites to anyone who tests positive? If people have to schedule doctor appointments to get scripts many will get the drugs too late to matter, which would be just tragic.
For as much as I agree with parts of this post, there are so many flaws.
Begin with the skewed priorities of BBB: "But even perfectly worthy ideas like larger maximum Pell grants ($11 billion), expanding the Low-Income Housing Tax Credit ($12 billion), or electrifying the federal vehicle fleet ($9 billion) are not three or four times as important as reducing the odds of future pandemics."
Yes, they are. They're addressing concrete issues with practical solutions that will yield actual benefits. A future pandemic is theoretical, especially one on the scale of the Spanish flu or COVID. It's hard to prepare for theoretical risks, especially when there's no assurance that the funds you put in now will yield benefits later. And we have lots of equally dangerous "theoretical" threats.
The San Andreas fault is going to go some day, busting the California aqueduct and depriving southern California of water. Should we put in spare desalination capacity to replace all that flow? The New Madrid fault is going to go again some day, with up to a 50% chance of up to a 7.0 magnitude in the next 50 years (and maybe a 10% chance of an 8.0). That will bring down every bridge in the Midwest (and probably every tall building). (https://www.sccmo.org/705/About-the-New-Madrid-Fault) Should we be reinforcing all ~3500 bridges in that part of the country? Terrorists may get MANPADs and be able to shoot down airliners. Should we install anti-missile warning devices on all planes? And maybe chaff dispensers or IR spoofing devices?
Oh, and asteroids crashing into the earth as well.
It's so easy to waste money on preparing for low probability/possibly distant events. "We need huge amounts of excess capacity in vaccine manufacturing. . . " No, we don't. Because it will not be kept up. Oh, maybe for five years or even ten. But trust me, more than ten years from inception to need will lead to decrepit, unusable facilities, as no one wants to pay to keep them up after COVID has become a distant memory. Should we do R&D on super vaccines? Sure! Scientists are great at R&D. But otherwise: nope.
And lastly, as someone who worked military logistics for decades, I appreciate the callout to that old expression about amateurs and professionals, but perhaps more telling and appropriate to the discussion is what is known as "the logistician's lament":
"Logisticians are a sad embittered race of men,
very much in demand in war, who sink resentfully
into obscurity in peace. They deal only with facts,
but must work for men who traffic in theories. They
Exactly. *Some* day (soon, I hope), we'll be entering the "peace" of the post-COVID world, and we'll return to the land of theories, which very much will not have any time or resources for maintaining the infrastructure for the next huge pandemic, may it come not soon at all.
You're being way too charitable to the FDA here. The problem is that the manufacturing pace here is dependent, in no small part on how the drug companies designed their supply chains, and how much money they throw at them - and that is inextricably intertwined with the fact that it's a huge risk of money for them to invest anything in producing any drug the FDA hasn't actually approved yet. If the FDA approved Paxlovid right now, it might be too late to speed things up much, but we're in this scenario in the first place because of the FDAs strong and consistent track record of delay and unilateral power to prevent drug manufacturing from being worthwhile. If the FDA was interested in saving lives, all they would have to do was make clear commitments to actual urgency at the start of the pandemic, and honor those with review of earlier theraputics. They didn't, and so Pfizer, Moderna, et al. correctly assumed that any investment in early manufacturing/capacity buildup would be pointless, as the FDA would drag their feet for months anyway.
The FDA created this supply chain problem, and continues to refuse to try and improve the situation, killing thousands. FDA delenda est.
Incidentally - are doses genuinely scarce right now? I've been under the impression that most African nations currently have more doses than they are able to administer, and the bottleneck is on the administration side. If they really can administer more, then we absolutely should be getting more doses to them, but I had been under the impression that there have been at least a few million doses gotten to most countries, and the difficulties involve logistics, supply chain, people to do the injections, etc. It would be good to be clear on this to know where the most help is needed.
This stuff is depressing. If we couldn't beat back Covid due to people not wanting masks or a few antivaxxers, we could just blame it on them. However, this all seems entirely solvable by Democrats. Fix the funding mechanisms, maybe do what the Reagan Administration did in the 80's and yell at the CDC and FDA to cut it with the parochial, overregulatory bs, message to the public that actual technological fixes are coming, make tests as cheap and easy to get as in Europe, and talk about ventilation. The last one especially gets me. It seems like no mentions it much, even though good ventilation and filters can do a lot, but instead it all leads back to masks and idiot anti-vaxxers.
Tangent on the "... professionals talk logistics" part:
All the analysis I've seen on the logistics delays / bottlenecks miss what's actually crippling the supply chains. So inventory is needed to balance supply and demand and the safety stock required to optimize that balance is driven by both the variability in lead time and finished goods demand. These are the squared terms in the Bowersox formula (below).
The shipping delays are increasing lead times but far more impactful is they're increasing the lead time variability. This is then driving up the safety stock required and creating a bullwhip effect on re-ordering. It's like a run on a bank but all they way down the supply chain. A vertically integrated supply chain can dampen this but lead times for shared suppliers are blowing up.
Sarah B asked some very very good questions. And I'd like to add a few. I will begin by observing that the people who babble about liberating patents have almost certainly never read one. Or understand what they do and do not do. Nor do they understand the transnational nature of patents as they would apply to the supply chain. Right down those chains are also many companies whose products are also patent protected. They are often unique purveyors of equipment or chemical precursors or QC equipment or any of the numerous elements that you need to build a manufacturing facility for ANYTHING. All of these things have lead times for delivery and when it comes to manufacturing pharmaceuticals or vaccines I do not believe it is possible to anticipate what you will need.
The logistics of watching a scale up from pilot plant to full production is something amazing to observe. As is refitting a given production facility to, say, switch models at an automotive manufacturing plant. Which generally involves ripping almost everything out and replacing it with completely different equipment. It takes years of planning and competent system integrators to make it all work. and then you retrain the workforce to use it.
I love your ambition but I do not think it is in any way practicable to try and produce generic plants to make anything like these products. Nor is it in any way practicable to staff such a facility with the array of personnel needed to operate such a facility when they don't know what they will be making and have them sit around waiting to find out.
There are things you could do though. And the principal one is identifying the equipment and supplies you will likely need for a broad array of vaccines and invest in removing bottlenecks and reducing delivery lead times. Much can be stockpiled and these can be maintained current with projected life expectancy and expiration date. Given the very strict environmental controls these sorts of plants require you could also prebuild empty facilities ready to be equipped with what you do need in terms of large scale production for any given pharmaceutical. Agility is the goal.
The big thing to be avoided at all costs is to have some sort of stampede for a specific vaccine production and have a whole bunch of dilettantes trying to milk the same supply chains for the same necessities. That cure is worse than the disease and it never works out. It is a much better strategy to let any organization that does know how to do anything scale up their own production. Just provide the tools they need.
I would contend that some of the deadliest mistakes of FDA and CDC have made in this pandemic were from not considering the costs of inaction while they wait for better data. This is especially true for actions that have a well-know safety profile but where there is uncertainty around efficacy.
Let's take their tragically flawed vaccine booster decision. CDC data on vaccine breakthrough deaths is woefully inadequate, but thankfully some states are tracking this. For example, Oregon has been publishing weekly breakthrough case data for some time. Here's their latest report:
Table 6 on page 7 shows the proportion of breakthrough deaths over time. In the most recent week reported, 26% of people who died of covid in the state were fully vaccinated. Given the trendline in the data, it seems reasonable to assume that the proportion of breakthrough deaths now could now be as high as 1/3 of total deaths (their latest data is a month old).
The US is averaging over 1,000 covid deaths per day. If we extrapolate Oregon's vaxed/unvaxxed proportion nationally, we get around 300 breakthrough deaths per day. That's nearly 10,000 breakthrough deaths per month.
Did the FDA and CDC consider how many preventable deaths happened as they delayed action on boosters for nearly 2 months? Depending of what proportion of those breakthrough deaths would have been prevented by earlier boosters, the absolute number of unnecessary deaths is likely in the thousands, perhaps even the tens of thousands over the total period of their delayed action.
My question is: Did anyone at the FDA or CDC project out possible "deaths due to delayed boosters" and if so what numbers did they come up with?
Yes, it's a big fucking deal. We cannot prevent future pandemics, nor their associated loss of life and disruptions, but we can certainly do better than we've done with this one. As you say, both money and administrative repair are needed, as well as continued focus and attention by politicians and pundits.
Virus defense should be a key part of the US military mission. What if China beats us to a universal COVID vaccine or even develops a virus and vaccinates its own people so they can use the virus against enemies? Does anyone trust China to do the right thing for the world?
I’m a researcher in biopharma, and some of my colleagues have speculated similarly: that the US should have a gigantic vaccine manufacturing suite on standby, ready for the next pandemic. It’s theoretically possible, and I like to think through what that might involve.
1. What type of vaccine are we preparing for, bc there are many different kinds! nucleic acids encased in lipid nanoparticles, like the Moderna and Pfizer covid vaccines? The type of vaccine that’s made inside chicken eggs, like the flu vaccine? A vaccine made of recombinant proteins? All of these have completely different manufacturing pipelines.
2. Are our manufacturing suites perpetually active, to keep the staff sharp and the equipment maintained? What are they producing during non-emergency time periods and who is paying for it?
3. Or do we mothball the suites and then fire them up during emergencies, creating new manufacturing teams as quickly as possible, whose first order of business would be to identify what equipment still functions since the last emergency?
4. Who is supervising this manufacturing effort? Governments? Pharma companies? Somebody else?
5. Will the vaccines produced here go through a standard regulatory process or an expedited one?
Those are the questions that come to mind for me.
Looking outside of the understandably American-centric view of Matt's post, I've always been a bit amazed at how globally ominpresent this is.
During Australia's lockdowns earlier this year, I saw a quote that shutting down Sydney for 6 days cost as much money as buying front-of-the-queue vaccines for the entire country. Yet Australia showed no urgency about acquiring vaccines. (To the point where the PM is now much derided for saying "it's not a race".)
China took half a year or more to secure the additional funding to build additional factories for Sinovac, which allows them to make billions of doses a year. Just a few hundred million dollars, IIRC. (Leaving aside that Sinovac turned out to be less effective than hoped, but I doubt that was the reason for how long it took to get funding.)
Vietnam didn't even really try to acquire vaccines, seemingly relying on keeping the coronavirus out until 2022 when locally developed vaccines would be available. Then Delta swept in and their largest city was in complete lockdown for months with people unable to get food supplies.
It is well-known that Europe haggled on vaccine prices rather than putting a priority on expediency.
Again and again, in governments around the world it seems like EVERYONE went for penny-wise, pound-foolish. So it isn't really anything about the US or its weird Congressional-gridlock or polarisation or people not trusting Facebook or the CDC sucks or whatever other American-exceptionalism explanation you want to try to cook up.
So I guess I'm wondering...what the heck is even going on? Is this just a fundamental human nature thing? Is there nothing that can done in institutional design to try to counteract this?
I am generally ignorant of how government agencies actually work, as I only worked in the private sector during my career. I've seen a small glimpse into non-profits by contributing my time to a local community foundation and generally chuckled at the bias for Process over Results.
So after reading this, I popped over to the FDA website to see what I might learn. 45 minutes later (damn you, Matt Yglesias!), I am amazed the FDA is able to accomplish anything at all. Their organization chart doesn't show a leader, but an Office of the Commissioner with 3 people in it. Currently listed in this Office are two "acting" people and one "vacant" position.
This Office has 19 direct reports, and one dotted-line report. The direct reports include an Office of External Affairs, Office of Regulatory Affairs, Office of the Counselor to the Commissioner (Vacant) and an Office of the Chief Counsel (seems redundant). It's not obvious how the responsibilities differ between the Counselor to the Commissioner versus the Chief Counsel, but I'm sure it makes sense to somebody. Oh, and of course, there are separate organizations for the Office of Minority Health & Health Equity and also the Office of Women's Health, which covers everyone except white males.
Many of the individual "Office of..." charts show a deputy director alongside the director, an organization construct I never saw in private industry.
My reading of this organization chart is that it is designed to avoid individual accountability for results, it is too flat (nobody can manage 19 direct reports in a white-collar setting) and it is bloated. It's no great insight to say a bureaucracy is bureaucratic, but my goodness!
As far as intellectual property as a barrier to vaccine production goes, I'd note that China, with a huge intelligence apparatus which devotes a disproportionate effort to industrial espionage, has not yet produced an mRNA vaccine. That strongly suggests to me that Pfizer, Moderna, and all the patent holders on the various precursors to the vaccine itself, could waive their IP rights tomorrow and it wouldn't alter the availability of vaccines one iota for a couple of years at least.
Amateurs talk about funding, professionals talk about inputs.
I agree we should probably spend more on vaccine infrastructure, but Id like a deeper picture of what this money would buy. How many scientists are there with the smarts and the education to invent vaccines? What kind of money do they make? How quickly can new ones be trained? Are there enough qualified experts to train as many new ones as we can afford, or are there so few experts that there’s a meaningful constraint on our ability to train new ones? How long does it take to build a new vaccine factory? How much does it cost? How many people have the know how to design vaccine factories? What kinds of skills do the line workers need? How quickly can new engineers be trained? Are there any raw material constraints?
Saying we should spend $65 billion without more detail is dubious. That figure is 2.5x the annual tax revenues of the entire state of Georgia. Could anyone give me more detail on what human and material resources this money could buy?
On a slightly related note, I do not understand why so many people were so quick to jump to the "equity" point regarding Omicron...
First of equity proponents argue that equitable distribution is the best way for rich countries to protect themselves from variants. However, even if given perfectly equitable distribution (i.e. no boosters until the first course gets to everybody) to everyone who wants one, the anti-vax population is easily sufficient to be a breeding ground for new variants. So people in rich countries are clearly better off taking the boosters.
From a moral perspective, it clearly is "wellness optimizing" to prioritize old people in developing countries over kids in rich countries. However this is not the way calculations are performed for anything else... nobody blames people in the UK for getting much better cancer treatment than someone in Niger. In fact, the "Left" argument is that the US is a terrible country for not paying for its own citizens to get better healthcare, but there is no similar push to distribute more resources to Mozambique or whatever.
I think from a political perspective the reasoning here is obvious... from a station of abundance rich people and rich countries will spare relative scraps with developing countries. But if they are asked to make a real resource sacrifice it's not going to happen. Some journalists and public health people seem to have somewhat lost their minds on this though and are arguing that it's feasible to convince rich countries to sacrifice their own health and their kids health (even a little bit) for the sake of people an ocean away. Again, this is probably not a morally defensible position but its how basically every country has operated forever.
If we want to help people in developing countries we should try to get to a position of abundance.
Great post! One point about the antivirals: both must be given less than 5 days after symptom onset go be effective. Here is another logistical challenge: how to get people tested rapidly and then prescribed medicine as soon as possible? Can we loosen restrictions on pharmacists or nurses prescribing these drugs? Or can the treatment courses be handed out at rapid testing sites to anyone who tests positive? If people have to schedule doctor appointments to get scripts many will get the drugs too late to matter, which would be just tragic.
For as much as I agree with parts of this post, there are so many flaws.
Begin with the skewed priorities of BBB: "But even perfectly worthy ideas like larger maximum Pell grants ($11 billion), expanding the Low-Income Housing Tax Credit ($12 billion), or electrifying the federal vehicle fleet ($9 billion) are not three or four times as important as reducing the odds of future pandemics."
Yes, they are. They're addressing concrete issues with practical solutions that will yield actual benefits. A future pandemic is theoretical, especially one on the scale of the Spanish flu or COVID. It's hard to prepare for theoretical risks, especially when there's no assurance that the funds you put in now will yield benefits later. And we have lots of equally dangerous "theoretical" threats.
The San Andreas fault is going to go some day, busting the California aqueduct and depriving southern California of water. Should we put in spare desalination capacity to replace all that flow? The New Madrid fault is going to go again some day, with up to a 50% chance of up to a 7.0 magnitude in the next 50 years (and maybe a 10% chance of an 8.0). That will bring down every bridge in the Midwest (and probably every tall building). (https://www.sccmo.org/705/About-the-New-Madrid-Fault) Should we be reinforcing all ~3500 bridges in that part of the country? Terrorists may get MANPADs and be able to shoot down airliners. Should we install anti-missile warning devices on all planes? And maybe chaff dispensers or IR spoofing devices?
Oh, and asteroids crashing into the earth as well.
It's so easy to waste money on preparing for low probability/possibly distant events. "We need huge amounts of excess capacity in vaccine manufacturing. . . " No, we don't. Because it will not be kept up. Oh, maybe for five years or even ten. But trust me, more than ten years from inception to need will lead to decrepit, unusable facilities, as no one wants to pay to keep them up after COVID has become a distant memory. Should we do R&D on super vaccines? Sure! Scientists are great at R&D. But otherwise: nope.
And lastly, as someone who worked military logistics for decades, I appreciate the callout to that old expression about amateurs and professionals, but perhaps more telling and appropriate to the discussion is what is known as "the logistician's lament":
"Logisticians are a sad embittered race of men,
very much in demand in war, who sink resentfully
into obscurity in peace. They deal only with facts,
but must work for men who traffic in theories. They
emerge during war because war is very much fact.
They disappear in peace because, in peace, war is
mostly theory."
(https://www.globalsecurity.org/military/library/report/1989/HGJ.htm)
Exactly. *Some* day (soon, I hope), we'll be entering the "peace" of the post-COVID world, and we'll return to the land of theories, which very much will not have any time or resources for maintaining the infrastructure for the next huge pandemic, may it come not soon at all.
You're being way too charitable to the FDA here. The problem is that the manufacturing pace here is dependent, in no small part on how the drug companies designed their supply chains, and how much money they throw at them - and that is inextricably intertwined with the fact that it's a huge risk of money for them to invest anything in producing any drug the FDA hasn't actually approved yet. If the FDA approved Paxlovid right now, it might be too late to speed things up much, but we're in this scenario in the first place because of the FDAs strong and consistent track record of delay and unilateral power to prevent drug manufacturing from being worthwhile. If the FDA was interested in saving lives, all they would have to do was make clear commitments to actual urgency at the start of the pandemic, and honor those with review of earlier theraputics. They didn't, and so Pfizer, Moderna, et al. correctly assumed that any investment in early manufacturing/capacity buildup would be pointless, as the FDA would drag their feet for months anyway.
The FDA created this supply chain problem, and continues to refuse to try and improve the situation, killing thousands. FDA delenda est.
Incidentally - are doses genuinely scarce right now? I've been under the impression that most African nations currently have more doses than they are able to administer, and the bottleneck is on the administration side. If they really can administer more, then we absolutely should be getting more doses to them, but I had been under the impression that there have been at least a few million doses gotten to most countries, and the difficulties involve logistics, supply chain, people to do the injections, etc. It would be good to be clear on this to know where the most help is needed.
This stuff is depressing. If we couldn't beat back Covid due to people not wanting masks or a few antivaxxers, we could just blame it on them. However, this all seems entirely solvable by Democrats. Fix the funding mechanisms, maybe do what the Reagan Administration did in the 80's and yell at the CDC and FDA to cut it with the parochial, overregulatory bs, message to the public that actual technological fixes are coming, make tests as cheap and easy to get as in Europe, and talk about ventilation. The last one especially gets me. It seems like no mentions it much, even though good ventilation and filters can do a lot, but instead it all leads back to masks and idiot anti-vaxxers.
Tangent on the "... professionals talk logistics" part:
All the analysis I've seen on the logistics delays / bottlenecks miss what's actually crippling the supply chains. So inventory is needed to balance supply and demand and the safety stock required to optimize that balance is driven by both the variability in lead time and finished goods demand. These are the squared terms in the Bowersox formula (below).
The shipping delays are increasing lead times but far more impactful is they're increasing the lead time variability. This is then driving up the safety stock required and creating a bullwhip effect on re-ordering. It's like a run on a bank but all they way down the supply chain. A vertically integrated supply chain can dampen this but lead times for shared suppliers are blowing up.
Safety Stock = Square Root of [(L * σd^2) + (d^2 * σl^2)], where:
L = Lead time (in days)
d = the average daily demand
σd = the standard deviation of daily demand (demand variability)
σl = The standard deviation of lead time
Sarah B asked some very very good questions. And I'd like to add a few. I will begin by observing that the people who babble about liberating patents have almost certainly never read one. Or understand what they do and do not do. Nor do they understand the transnational nature of patents as they would apply to the supply chain. Right down those chains are also many companies whose products are also patent protected. They are often unique purveyors of equipment or chemical precursors or QC equipment or any of the numerous elements that you need to build a manufacturing facility for ANYTHING. All of these things have lead times for delivery and when it comes to manufacturing pharmaceuticals or vaccines I do not believe it is possible to anticipate what you will need.
The logistics of watching a scale up from pilot plant to full production is something amazing to observe. As is refitting a given production facility to, say, switch models at an automotive manufacturing plant. Which generally involves ripping almost everything out and replacing it with completely different equipment. It takes years of planning and competent system integrators to make it all work. and then you retrain the workforce to use it.
I love your ambition but I do not think it is in any way practicable to try and produce generic plants to make anything like these products. Nor is it in any way practicable to staff such a facility with the array of personnel needed to operate such a facility when they don't know what they will be making and have them sit around waiting to find out.
There are things you could do though. And the principal one is identifying the equipment and supplies you will likely need for a broad array of vaccines and invest in removing bottlenecks and reducing delivery lead times. Much can be stockpiled and these can be maintained current with projected life expectancy and expiration date. Given the very strict environmental controls these sorts of plants require you could also prebuild empty facilities ready to be equipped with what you do need in terms of large scale production for any given pharmaceutical. Agility is the goal.
The big thing to be avoided at all costs is to have some sort of stampede for a specific vaccine production and have a whole bunch of dilettantes trying to milk the same supply chains for the same necessities. That cure is worse than the disease and it never works out. It is a much better strategy to let any organization that does know how to do anything scale up their own production. Just provide the tools they need.
I would contend that some of the deadliest mistakes of FDA and CDC have made in this pandemic were from not considering the costs of inaction while they wait for better data. This is especially true for actions that have a well-know safety profile but where there is uncertainty around efficacy.
Let's take their tragically flawed vaccine booster decision. CDC data on vaccine breakthrough deaths is woefully inadequate, but thankfully some states are tracking this. For example, Oregon has been publishing weekly breakthrough case data for some time. Here's their latest report:
https://www.oregon.gov/oha/covid19/Documents/DataReports/Breakthrough-Case-Report.pdf
Table 6 on page 7 shows the proportion of breakthrough deaths over time. In the most recent week reported, 26% of people who died of covid in the state were fully vaccinated. Given the trendline in the data, it seems reasonable to assume that the proportion of breakthrough deaths now could now be as high as 1/3 of total deaths (their latest data is a month old).
The US is averaging over 1,000 covid deaths per day. If we extrapolate Oregon's vaxed/unvaxxed proportion nationally, we get around 300 breakthrough deaths per day. That's nearly 10,000 breakthrough deaths per month.
Did the FDA and CDC consider how many preventable deaths happened as they delayed action on boosters for nearly 2 months? Depending of what proportion of those breakthrough deaths would have been prevented by earlier boosters, the absolute number of unnecessary deaths is likely in the thousands, perhaps even the tens of thousands over the total period of their delayed action.
My question is: Did anyone at the FDA or CDC project out possible "deaths due to delayed boosters" and if so what numbers did they come up with?
Yes, it's a big fucking deal. We cannot prevent future pandemics, nor their associated loss of life and disruptions, but we can certainly do better than we've done with this one. As you say, both money and administrative repair are needed, as well as continued focus and attention by politicians and pundits.
Virus defense should be a key part of the US military mission. What if China beats us to a universal COVID vaccine or even develops a virus and vaccinates its own people so they can use the virus against enemies? Does anyone trust China to do the right thing for the world?