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?
The advantage of the lipo-capsule mRNA platform for vaccines, at least, is that it really is the same manufacturing chain no matter what vaccine it is. I think that's a huge and significant innovation in vaccine production that people are overlooking because the only mRNA vaccines on the market right now are for the same single disease, but it's genuinely going to be transformative over the next couple of decades.
This really could be something where we distribute regional (or even neighborhood) manufacturing capacity and then, when someone positive for a new disease is getting on a plane from Asia, we've sequenced the pathogen, derived the immunization target, and are already manufacturing doses of vaccine by the time the plane lands. In fact it's possible to imagine a household version of this manufacturing chain, producing 3-4 doses in a couple of hours that your family administers nasally as a vapor.
Yes! If I were in charge of building spare capacity, I would build an RNA lipid nanoparticle manufacturing suite for the reasons you mention. Hopefully the tech works for more than just covid.
I'll put a marker down that it can be made to work for just about anything, assuming you can find an appropriate immune target and the mRNA sequence for it isn't too big to package (I don't know the longest oligonucleotide that will fit in a lipid nanoparticle, but there must be one.)
There may even be cancer applications - potentially you could train the body's immune system against cancerous cells, if you can find a protein-based marker that distinguishes them from normal cells.
Just FYI, after watching a few hours of presentations from BioNTech and others on YT: it seems the LNP is formed by electrostatic attraction of the mRNA and some specific lipid in a solution (microfluidics helps very precisely control things for very high quality precision). So that kind of means that there's no real size limitation in the manufacturing process. Likely there are many biological limitations and efficiency goldilocks zones regarding size - eg. how long mRNA gets translated well inside the cell, how fast it gets broken down, how effectively it gets inside the target cells, etc.
There's got to be a middle ground between 2 and 3, where we have a permanently-employed "skeleton crew" whose job is two-fold:
1) Maintain the manufacturing pipeline. If we have to, continuously manufacture vaccine "blanks" in small quantities. There is probably a better solution to this where there is some baseline demand for mRNA vaccines outside of pandemic years where the demand is just 10x lower or whatever - the US gov could become the world's supplier, and if we just gave it away to poor countries (at least the ones that are friendly) we could reap some reputational benefits.
2) Maintain the skillset necessary to rapidly staff up to full capacity. Maybe this means signing deals with research programs at universities or in industry where their staff are "on call", with financial terms that are good enough(and competition for the spots fierce enough) that those programs are excited to enlist their best staff.
This obviously is not going to be free, or even cheap, but if we can pay $10B per year to create the capability to rapidly scale up a $300B per year vaccine/therapeutic capacity during pandemic years, it would easily be worth the cost. You can imagine a world in which we're completely back to normal right now because the US was able to provide vaccines worldwide in early 2021, effectively arresting COVID. I dunno how to calculate the value of ending the pandemic then vs our current state persisting for several years (as seems likely), but it has to be in the hundreds of billions just in terms of supply chain disruptions and the lost economic activity that results.
I'd like to think we'd keep putting up $10B/year to maintain this capacity, since it seems so cheap with such a huge payoff, but I doubt it would fly. Recall that Obama (Obama!) cut funding for the national PPE stockpile during sequester because of the "higher priority" of reducing the national debt. We stopped buying N95 masks!
When threats become less real and present to us -- as they do over time -- our willingness to cough up even modest amounts of cash tends to dwindle.
I think the staffing issue is one that is going to require a lot of work. I used to do a lot of RNA but I left the bio field years ago for another STEM field where I could make more money with more stability. I know plenty of others who made the same decision I could probably be trained to work in an mRNA facility relatively easily. I suspect that many people who could be trained would want some guarantee that they wouldn’t be laid off when no longer needed. Laying people off would be a pointless waste of skills. Given how the government has functioned as long as I can remember, it would take a lot to convince someone that they will have a reliable job. Switching the flu vaccine to an mRNA vaccine might create that capacity because it has to be updated to the new strains every year
One thing that would be a great use of these skills is working on a vaccine that elicits high levels of IgA, because that’s probably the most important antibody in the mucosa. Either making a nasal vaccine (with the bonus that it’s appealing for people who are afraid of needles) or working on adjuvants that might (I think this is less likely to work) would be a great way to do this.
The more that they can do vaccines that aren't needles, the better. I think a lot of medical professionals often forget *just* how opposed to needles a lot of people are. I would bet that if the covid vaccine didn't involve a needle, there would have been less than half as much opposition to it.
2. If you just need staff to keep busy and keep skills sharp (and the operating funding is there), there are plenty of infectious diseases they could work on.
I argued here that we should have national guard units that trained to make PPE. I think you could do the same for excess vaccine production.
Basically government pays industry to keep the extra production capacity on stand by. Then in case of emergency, national guard provides the extra bodies to actually make stuff. The two weeks of training a year could be firing everything up, and producing to rotate out national stock piles.
RE: 2 low hanging fruit would be to keep them operational and replace cash transfers to despotic regimes with vaccination programs.
But, however you decide to do it, they have to stay active. Anything that is mothballed until you need it is almost certainly not going to work when you need it.
For 1, I'd recommend nucleic acids since the tech is very flexible. You can make and encapsulate whatever sequence you want, thereby delivering any protein you want to present to the immune system. For 2 & 3, it's not like there's a shortage of non-pandemic disease that we could use vaccines against. If we can design a covid vaccine in 2 days, we didn't happen to gain that ability the day the covid-19 genome got release. We realistically had that ability for a while, and hadn't gotten around to scaling it up. We (as a civilization) *could* have had Moderna's tech in use, designing 2-3 new vaccines a week and having bigger companies put them through trials, if we lived under a system that made it economically viable to do so. That would be truly amazing even if only one in ten worked out. So yeah: have them running continuously, *trying to combat all the global diseases we could potentially (nearly) eradicate with new vaccines, but haven't.*
Have big mRNA facilities that, during a pandemic, crank out vaccines for that pandemic. If the pandemic goes away, convert them to cranking out flu vaccines or HPV vaccines or cold vaccines, or any other sort of vaccine for a mild disease that we don't *need* a vaccine for but it would be *nice* to vaccinate against.
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?
A lot of the organizations calling the shots (or being "trusted as the experts", in the vernacular) seem to have settled into posture of expecting unlimited patience and deference from the public, and I don't think that's helping.
It doesn't help that many of the loudest voices in private life are those who have made covid an integral part of their identity, which the latest omicron freakout has made abundantly clear. I've had my three shots and in a few weeks any 5+ whose parents wanted them could get them... six deaths this month in a highly-vaxxed county of more than half a million. Might trickle up to seven or eight with late reporting. That sounds a lot more like endemicity than emergency to me.
This is something I’d ignored, but points to one possibility I laid out in another comment:
“Or, alternatively, this is how things have always been, only rose-tinted glasses make us believe they were ever really different, and we’ll continue to muddle through even though we’re all idiots.”
If everywhere is like this, then the answer is probably “shit happens, but most of us live.”
Penny-wise pound-foolish is an incredibly apt description of the political response just about everywhere. It seems like policymakers and the public generally have refused to think much more than a few weeks into the future on most issues here.
I dunno - things have gotten significantly more partisan since then. I suspect the result of another 9/11 would be very different - though I hope we never find out.
If Gore had won in 2000, the result of the first 9/11 (assuming it still would have happened) would have been different. You would have seen nonstop attacks on him for killing the Americans who died.
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!
I dunno, I see most of the same bloat in the private sector, and most of the same ass-covering bullshit. It’s an American thing, not a public or private thing.
The answer I’d have given you two years ago:
The US is so damned rich that it’s isolated entirely from the consequences of how poorly it’s governed and how much rent-seeking occurs. Only a major catastrophe will shake that complacency.
The answer I’ll give now:
As above, but strike the second sentence. Our partisan politics are so profoundly, insanely poisonous that *nothing* I can envision will shake that complacency.
That means one of two things.
Either we will have to ride the whole damned country down in flames and suffer *immensely* before we can start having political conversations premised on meaningful information and choices instead of on ideological paradigms that are largely divorced from reality.
Or, alternatively, this is how things have always been, only rose-tinted glasses make us believe they were ever really different, and we’ll continue to muddle through even though we’re all idiots.
I hope to hell the cynicism pointing me at option one is wrong.
I suspect that there's the formal organization and there's another, more informal organization that applies when the organization *really* wants to get things done.
But, as Matt notes, why it's taken the Biden administration so long to get an confirmed FDA commissioner is one of the great mysteries of our time.
Yes, this is exactly right. How many of those jobs listed on the org. chart are just sinecures to staff the incompetent political appointees until their patrons lose interest? I would guess that such is why there are both directors and deputy directors: the director is the political appointee and gets the credit (or blame), but the deputy director is the longtime civil servant who knows how to get the job done.
Absolutely nothing you described involves core functions at FDA. FDA has diverse functions: food safety. nutrition, tobacco products, drug, biologics, animal health, devices. It's like trying to explain how Japan works by examining the Imperial Household Agency. Like the Emperor, the Commissioner has no real function other than leadership (although that can be important and not just symbolic)
"That's because he's not a leader. He's the product of internal promotion by his party. And his party has to decide who to appoint.... We're just not going to get that out of the traditional 2-party system"
Multiparty parliamentary systems are like this but wayyyyy more so. The PM is literally a product of internal promotion by the party! And the various parties in a coalition get to divvy up the various offices as they see fit. By contrast, Biden isn't at all- he was independently elected, and I think the party elites made pretty clear that he wasn't their choice. (You could argue that Hillary was their choice in 2016. But also 2008- certainly not Obama!)
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?
There's probably about 2,000 scientists who could have gone from the SARS-CoV-2 genome to a plausible mRNA immune target, and by next year 20,000 will be able to do it. But there's probably only 6 people in the world or fewer who could successfully build the manufacturing pipeline to distribute mRNA vaccines at scale in a year; by next year there might be twice that many.
But the upshot is that we don't need that many; the promise of the mRNA platform is that the same manufacturing chain works for any vaccine built on it. The actual content of the vaccine is information, after all - this technology is the moveable type of vaccine development and it's likely to be equally transformative.
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.
I think it was people who were saying several months ago that the US (and other wealthy countries that had more than enough vaccines) should be making more of an effort to get vaccines into arms in poorer countries since that's where variants were more likely to emerge.
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.
Southern California absolutely *should* have *some* sort of backup system, but I assume the cost-effective version is a few big reservoirs that can store several days (weeks?) of water until a repair is available.
On the New Madrid thing, there are some bridges that *should* be reinforced to ensure they can survive such a quake (I would particularly prioritize the Eads Bridge and the I-40 bridge and some others), but not *every* bridge.
I think it's absolutely a good thing that NASA is spending some amount of money learning how to divert an asteroid (https://www.nasa.gov/planetarydefense/dart), though given the amount they've spent cataloging all the near-earth objects and showing that there aren't many that pose a threat, they don't need to spend a lot on this.
We shouldn't spend unlimited amounts on pandemic mitigation, but it's almost certain that any bit of effective spending would produce more good over the next 50 years than electrifying the federal vehicle fleet before the current vehicles get replaced anyway.
Sure, you can't take care of every possible contingency, and rational cost-benefit calculations should drive you to doing those things of greatest value, as you note. But we aren't doing those things, while we sit here discussing massive preparation for the next great pandemic. Why? Because of the availability heuristic. It's important to spend lots of money on the next pandemic because we're in the present one. But the last big LA earthquake was 1994,(*) and New Madrid was 1812. Yawn.
And in 10 years pandemics will be a big yawn as well, so any requirement for continued large-scale spending will be buried by new "availability heuristic" priorities.
And meanwhile, I think electrifying the federal vehicle fleet is a great idea.
(*) Right after the Northridge earthquake, everyone was convinced another big earthquake was imminent (many moved away; others did their one-time emergency prep). But geology doesn't care about the availability heuristic.
Are we not doing those things? Does Los Angeles not have substantial capacity in its reservoir system? Are all the bridges in St. Louis seismically unsound? I assumed these things had been done, even though we haven't done the maximalist versions you were mentioning.
(1) No. We don't have enough to get through a drought. Also, there are few reservoirs in the LA area; we're reliant on out of area reservoirs and other sources (like the Colorado river).
(2) It's been a while since I drove through the New Madrid fault area, but the last time I did, I was struck by the spaghetti-thin poles holding up the bridges (compared to California Hulk-like supports). From my reading (e.g., https://www.nehrp.gov/pdf/SeismicWavesMar08.pdf) some work has been done, but only preliminary (e.g., Emerson Bridge) and only up to some level of a big earthquake. If it's above 7.0, good luck for the I-40 bridge. And that may be the smartest thing to do! You can't cover every risk. Which is my point on future pandemic spending.
Yes we actually should be preparing for unlikely but catastrophic events. Or at least do some kind of cost-benefit analysis. But human beings are terrible at planning for the future. At least we are good at adapting to the present.
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.
I’m in biopharma, and this statement doesn’t sound accurate to me: “ 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.”
I have read the FDA documents describing their requirements for demonstrating vaccine safety for a new product. (The product I work on isn’t a vaccine, but it is regulated that way.)
The FDA cares about:
1. Does the product actually work (I haven’t read those documents),
2. To these meticulously described standards of proof, show us you know exactly what is in your product, and get there isn’t anything unsafe in your product. (These are the ones I read.)
The documents are rigorous and scientific and sensible and quite good actually. We want to know the answers to these questions bc we don’t want to produce shit and we don’t want to harm people. I don’t think the FDA is the bad guy here.
Let's take a simple example: Paxlovid. I'm going to quote Zvi here, because there's no way I can improve on this summary:
```The trial was stopped due to ‘ethical considerations’ for being too effective. You see, we live in a world in which:
It is illegal to give this drug to any patients, because it hasn’t been proven safe and effective.
It is illegal to continue a trial to study the drug, because it has been proven so safe and effective that it isn’t ethical to not give the drug to half the patients.
Who, if they weren’t in the study, couldn’t get the drug at all, because it is illegal due to not being proven safe and effective yet.
So now no one gets added to the trial so those who would have been definitely don’t get Paxlovid, and are several times more likely to die.
But our treatment of them is now ‘ethical.’
For the rest of time we will now hear about how it was only seven deaths and we can’t be sure Paxlovid works or how well it works, and I expect to spend hours arguing over exactly how much it works.
For the rest of time people will argue the study wasn’t big enough so we don’t know the Paxlovid is safe.
Those arguments will then be used both by people arguing to not take Paxlovid, and people who want to require other interventions because of these concerns.
FDA Delenda Est.
I propose the Law of Efficacy, which states that the requirement to halt a trial due to a drug being ‘too effective’ is that the drug has been approved for public use by the regulatory authorities. ```
In a world where the default position is that it is illegal to sell a drug until you've convinced the FDA of your two points above, (but legal to take/prescribe it for all sorts of other things after the fact, even if it's basically deworming agent), there's no reason whatsoever to invest in production capacity before the FDA approves it - especially if it has a shelf-life, because you can't actually be certain that it will be approved, or how quickly it will be approved, and if it isn't approved, all the money invested in production might as well have been set on fire and dumped in Boston Harbor instead.
The reason we got COVID vaccines so quickly was that Trump's administration, in an unprecedented show of judgement and foresight, precommitted to buy a ton of doses, effectively funding manufacture *even if they didn't turn out to be safe and effective* instead of waiting for the FDA approval to start ramping up production. But everything other than the vaccines are going through the FDA approval process.
What's more, the FDA has plenty of latitude to issue EUAs ahead of normal approval, and we were able to get vaccines under EUA - most people who've been vaccinated for COVID were vaccinated with vaccines that had not yet been FDA approved, even when said vaccinations were mandatory for many people. I don't think it's unreasonable to suggest that the approval process isn't fast enough if we're talking about mandating vaccinations when several of the vaccines still haven't gotten that full approval.
The potential lives saved by approving something quickly needs to be balanced against the potential lives lost bc something is wrong with the product and you rushed the approval process, missing the data that indicated a problem.
Sorry, that was uncharitable. But the FDA's incentives don't cover any such balancing. Their mandate and purpose is to prevent lives being lost to medication, regardless of how many lives it might save to approve it early. That's just the incentives that are inherent to a bureaucracy, combined with their mandate.
So if they're doing a balancing test, EUA it immediately. It would still be possible to check for rare events, and provide updated guidance if needed, without murdering eight thousand people in the meantime.
For rare, but extremely dangerous events like Covid, could we maybe do something like this where the FDA basically says “We are fairly confident it’s safe and effective but given the nature of the events we can’t subject this to the same rigor and time we normally would, so be sure to report any unusual side effects to this hotline and to your doctor”?
I get it’s a balancing act, you can’t be too lax because too many mistakes and the agency loses all credibility, but they definitely have to become less risk averse when it comes to these types of events that we just don’t have the same level of confidence to back that up like we normally would?
Is there any evidence that the FDA does such validating? Because from the outside, it looks like they'd let thousands of people die from Covid to avoid working over Thanksgiving weekend.
I read into today's news that it's *possible* that the Merck COVID pill may pose dangers to developing fetuses. I want to get that pill out to everyone as soon as possible, but it sure would be good to know more about this before the pill is prescribed indiscriminately to pregnant women.
These are tough tradeoff calculations. I wouldn't want to be the person in FDA responsible. It's possible this is not just a reflection of mindless bureaucratic procedures.
What about approving for EUA but not for those who are pregnant? (Is the risk that this would deter them later from getting the pill because they remember that it was "not available for those who are pregnant")?
Sure. I'm just using this to make the point that approval requires gathering lots of information (e.g., data on impact on pregnant women) and this doesn't happen instantaneously.
I read elsewhere that the difference might be that the test (which was stopped for ethical reasons) validated that the made-for-test doses of drug WORKED and wer SAFE.
But... that they have to approve the larger manufacturing pipeline to make sure that it can reliably deliver the same medicine they tested with.
That makes sense and would explain the difference. But right now I'm unable to find any official documentation from the FDA that says that's how they operate.
I'd be quite happy if the FDA review merely indicated a) the contents of the warning label, and b) the requirement that Insurance/Medicare/etc cover the costs of the drug. But at this point, I think if the FDA and CDC were dissolved, and replaced with a new agency, the new agency would probably start off with a lot more trust from the public.
If I were being particularly wonky, I'd set it up so that their mandate was focused on health outcomes, and I'd probably make sure that the only way to join when coming from the FDA is in a non-management role. But the FDA, through delay, has killed more Americans that car-crashes this year, and probably did last year as well. That's a simply unconscionable failure, and it needs addressing.
You might like the part in The Walking Dead where the CDC building in Atlanta self-destructs with the last scientist inside, and the ruins are left to be picked over by zombies. I'd never watched that show till the early days of the pandemic, when it seemed fitting.
I think the best institutionalists are those who fight to build and preserve institutional capacity. We don't have enough of those and have to many willing to destroy capacity in pursuit of rents or those who want to burn it down without recognizing just how hard it is to build a good institution in the first place.
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.
In Kenya, doses are not scarce currently, the main two issues (as I understand them) are demand and logistics. Just like in the US, there are plenty of people who have heard the wild misinformation about the vaccine and do not plan to get vaccinated. Also, plenty of people live far from the hospitals and clinics where vaccines are available, so the government needs to set up more efforts to run mobile clinics that can reach more remote populations.
The piece that I'm not sure about is cost. I believe that the shot is free, but patients still need to pay a nominal fee for the doctor's time. Even if the shot is completely free, people are used to the hidden costs that come with "free" (in "free" primary education, parents still have to pay for school uniforms, books, meals and various other fees that are tacked on), so might be wary of what it will really cost them (in addition to transportation and potentially, a day of lost wages from vaccine side effects).
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.
Spot on re: ventilation. We're in a liberal area and our school superintendent talks about frequent bathroom cleanings, handwashing, and masks, but no HEPA air filters.
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.
If companies recalculate their required safety stock based on what are likely to be temporary delays at the ports, TSMC, etc., then we'll definitely get a bullwhip effect, as their stock levels will get really large, and future orders will decline, leading to reductions in production, leading to future outages . . . rinse and repeat.
When calculating safety stock levels, you have to be careful about what events you include in your parameters. One-time events lead to very poor decisions.
I think a lot of companies are going to be looking at the balance between efficiency and resiliency a lot closer moving forward. IMHO, the scale tipped to far towards JIT inventory systems.
And whether it's an Earthquake in Japan, hurricanes or freezing in Texas, or a pandemic. It's always something,
For sure. "Resiliency" seems to be the new buzz word in supply chain design. Companies will have to pay up to build multi-source supply across different countries to mitigate this risk. Local source back into the US will be a huge new 10 year wave as well.
We'll see. Lowered inventory costs from JIT is a great temptation. Who will go first in accepting higher costs in order to buy some more security from impossible to predict future events?
I don't know how you wouldn't recalculate SS? The SS calculations are dynamic. If the lead time variability is increasing so must SS for optimal balance. I haven't heard of anyone discounting the LT increase as a 1x effect - maybe some are but my reading is the bullwhip effect was initiated back in Q4 2020 and the amplified impact has now hit raw material production.
It's your choice what data to include and how to manage the inputs. If you think the post-pandemic supply disruptions are a one-time event, and lead times will be much smaller in the future, then you're throwing money away by building excess stock levels.
Or, to put it another way, if it's hard to get supplies now so you buy more when they become available, you're addressing the problem after it has already been solved: the fact that you can now get your extra stocks simply means that the supply disruptions have been solved.
This may be cold comfort for this Christmas shopping season though, meaning that companies should have bought lots of extra stock on a one-time basis many months ago. Hard to be that prescient, of course.
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.
The advantage of the lipo-capsule mRNA platform for vaccines, at least, is that it really is the same manufacturing chain no matter what vaccine it is. I think that's a huge and significant innovation in vaccine production that people are overlooking because the only mRNA vaccines on the market right now are for the same single disease, but it's genuinely going to be transformative over the next couple of decades.
This really could be something where we distribute regional (or even neighborhood) manufacturing capacity and then, when someone positive for a new disease is getting on a plane from Asia, we've sequenced the pathogen, derived the immunization target, and are already manufacturing doses of vaccine by the time the plane lands. In fact it's possible to imagine a household version of this manufacturing chain, producing 3-4 doses in a couple of hours that your family administers nasally as a vapor.
Yes! If I were in charge of building spare capacity, I would build an RNA lipid nanoparticle manufacturing suite for the reasons you mention. Hopefully the tech works for more than just covid.
I'll put a marker down that it can be made to work for just about anything, assuming you can find an appropriate immune target and the mRNA sequence for it isn't too big to package (I don't know the longest oligonucleotide that will fit in a lipid nanoparticle, but there must be one.)
There may even be cancer applications - potentially you could train the body's immune system against cancerous cells, if you can find a protein-based marker that distinguishes them from normal cells.
Just FYI, after watching a few hours of presentations from BioNTech and others on YT: it seems the LNP is formed by electrostatic attraction of the mRNA and some specific lipid in a solution (microfluidics helps very precisely control things for very high quality precision). So that kind of means that there's no real size limitation in the manufacturing process. Likely there are many biological limitations and efficiency goldilocks zones regarding size - eg. how long mRNA gets translated well inside the cell, how fast it gets broken down, how effectively it gets inside the target cells, etc.
Yeah! I’m similarly optimistic, I just like to leave room for alternative outcomes.
There's got to be a middle ground between 2 and 3, where we have a permanently-employed "skeleton crew" whose job is two-fold:
1) Maintain the manufacturing pipeline. If we have to, continuously manufacture vaccine "blanks" in small quantities. There is probably a better solution to this where there is some baseline demand for mRNA vaccines outside of pandemic years where the demand is just 10x lower or whatever - the US gov could become the world's supplier, and if we just gave it away to poor countries (at least the ones that are friendly) we could reap some reputational benefits.
2) Maintain the skillset necessary to rapidly staff up to full capacity. Maybe this means signing deals with research programs at universities or in industry where their staff are "on call", with financial terms that are good enough(and competition for the spots fierce enough) that those programs are excited to enlist their best staff.
This obviously is not going to be free, or even cheap, but if we can pay $10B per year to create the capability to rapidly scale up a $300B per year vaccine/therapeutic capacity during pandemic years, it would easily be worth the cost. You can imagine a world in which we're completely back to normal right now because the US was able to provide vaccines worldwide in early 2021, effectively arresting COVID. I dunno how to calculate the value of ending the pandemic then vs our current state persisting for several years (as seems likely), but it has to be in the hundreds of billions just in terms of supply chain disruptions and the lost economic activity that results.
I'd like to think we'd keep putting up $10B/year to maintain this capacity, since it seems so cheap with such a huge payoff, but I doubt it would fly. Recall that Obama (Obama!) cut funding for the national PPE stockpile during sequester because of the "higher priority" of reducing the national debt. We stopped buying N95 masks!
When threats become less real and present to us -- as they do over time -- our willingness to cough up even modest amounts of cash tends to dwindle.
I think the staffing issue is one that is going to require a lot of work. I used to do a lot of RNA but I left the bio field years ago for another STEM field where I could make more money with more stability. I know plenty of others who made the same decision I could probably be trained to work in an mRNA facility relatively easily. I suspect that many people who could be trained would want some guarantee that they wouldn’t be laid off when no longer needed. Laying people off would be a pointless waste of skills. Given how the government has functioned as long as I can remember, it would take a lot to convince someone that they will have a reliable job. Switching the flu vaccine to an mRNA vaccine might create that capacity because it has to be updated to the new strains every year
One thing that would be a great use of these skills is working on a vaccine that elicits high levels of IgA, because that’s probably the most important antibody in the mucosa. Either making a nasal vaccine (with the bonus that it’s appealing for people who are afraid of needles) or working on adjuvants that might (I think this is less likely to work) would be a great way to do this.
The more that they can do vaccines that aren't needles, the better. I think a lot of medical professionals often forget *just* how opposed to needles a lot of people are. I would bet that if the covid vaccine didn't involve a needle, there would have been less than half as much opposition to it.
2. If you just need staff to keep busy and keep skills sharp (and the operating funding is there), there are plenty of infectious diseases they could work on.
I argued here that we should have national guard units that trained to make PPE. I think you could do the same for excess vaccine production.
Basically government pays industry to keep the extra production capacity on stand by. Then in case of emergency, national guard provides the extra bodies to actually make stuff. The two weeks of training a year could be firing everything up, and producing to rotate out national stock piles.
https://medium.com/the-national-discussion/face-masks-use-them-love-them-24c627ab9f3d
RE: 2 low hanging fruit would be to keep them operational and replace cash transfers to despotic regimes with vaccination programs.
But, however you decide to do it, they have to stay active. Anything that is mothballed until you need it is almost certainly not going to work when you need it.
1. mRNA, until someone comes up with something better.
2., 3., and 4., Let the pharma companies figure it out. The government should concentrate on being a good customer.
5., Perhaps expedited, depending on the particulars of a pandemic, but the standard process needs a complete overhaul.
For 1, I'd recommend nucleic acids since the tech is very flexible. You can make and encapsulate whatever sequence you want, thereby delivering any protein you want to present to the immune system. For 2 & 3, it's not like there's a shortage of non-pandemic disease that we could use vaccines against. If we can design a covid vaccine in 2 days, we didn't happen to gain that ability the day the covid-19 genome got release. We realistically had that ability for a while, and hadn't gotten around to scaling it up. We (as a civilization) *could* have had Moderna's tech in use, designing 2-3 new vaccines a week and having bigger companies put them through trials, if we lived under a system that made it economically viable to do so. That would be truly amazing even if only one in ten worked out. So yeah: have them running continuously, *trying to combat all the global diseases we could potentially (nearly) eradicate with new vaccines, but haven't.*
Have big mRNA facilities that, during a pandemic, crank out vaccines for that pandemic. If the pandemic goes away, convert them to cranking out flu vaccines or HPV vaccines or cold vaccines, or any other sort of vaccine for a mild disease that we don't *need* a vaccine for but it would be *nice* to vaccinate against.
Or cure cancer:
https://www.pennmedicine.org/news/news-blog/2021/june/how-mrna-vaccines-help-fight-cancer-tumors-too
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?
A lot of the organizations calling the shots (or being "trusted as the experts", in the vernacular) seem to have settled into posture of expecting unlimited patience and deference from the public, and I don't think that's helping.
It doesn't help that many of the loudest voices in private life are those who have made covid an integral part of their identity, which the latest omicron freakout has made abundantly clear. I've had my three shots and in a few weeks any 5+ whose parents wanted them could get them... six deaths this month in a highly-vaxxed county of more than half a million. Might trickle up to seven or eight with late reporting. That sounds a lot more like endemicity than emergency to me.
This is something I’d ignored, but points to one possibility I laid out in another comment:
“Or, alternatively, this is how things have always been, only rose-tinted glasses make us believe they were ever really different, and we’ll continue to muddle through even though we’re all idiots.”
If everywhere is like this, then the answer is probably “shit happens, but most of us live.”
Penny-wise pound-foolish is an incredibly apt description of the political response just about everywhere. It seems like policymakers and the public generally have refused to think much more than a few weeks into the future on most issues here.
Agreed. But contrast this to the response over 9/11.
Governments just seem to have a hard time acting proactively for a pandemic. But terrorists will easily get them to lose their mind
I dunno - things have gotten significantly more partisan since then. I suspect the result of another 9/11 would be very different - though I hope we never find out.
If Gore had won in 2000, the result of the first 9/11 (assuming it still would have happened) would have been different. You would have seen nonstop attacks on him for killing the Americans who died.
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!
I dunno, I see most of the same bloat in the private sector, and most of the same ass-covering bullshit. It’s an American thing, not a public or private thing.
The answer I’d have given you two years ago:
The US is so damned rich that it’s isolated entirely from the consequences of how poorly it’s governed and how much rent-seeking occurs. Only a major catastrophe will shake that complacency.
The answer I’ll give now:
As above, but strike the second sentence. Our partisan politics are so profoundly, insanely poisonous that *nothing* I can envision will shake that complacency.
That means one of two things.
Either we will have to ride the whole damned country down in flames and suffer *immensely* before we can start having political conversations premised on meaningful information and choices instead of on ideological paradigms that are largely divorced from reality.
Or, alternatively, this is how things have always been, only rose-tinted glasses make us believe they were ever really different, and we’ll continue to muddle through even though we’re all idiots.
I hope to hell the cynicism pointing me at option one is wrong.
I suspect that there's the formal organization and there's another, more informal organization that applies when the organization *really* wants to get things done.
But, as Matt notes, why it's taken the Biden administration so long to get an confirmed FDA commissioner is one of the great mysteries of our time.
What I read somewhere is that they've approached a bunch of people and nobody wants the job.
Yes, this is exactly right. How many of those jobs listed on the org. chart are just sinecures to staff the incompetent political appointees until their patrons lose interest? I would guess that such is why there are both directors and deputy directors: the director is the political appointee and gets the credit (or blame), but the deputy director is the longtime civil servant who knows how to get the job done.
Absolutely nothing you described involves core functions at FDA. FDA has diverse functions: food safety. nutrition, tobacco products, drug, biologics, animal health, devices. It's like trying to explain how Japan works by examining the Imperial Household Agency. Like the Emperor, the Commissioner has no real function other than leadership (although that can be important and not just symbolic)
No, because that mentality is very much in the military as well. And the GOP is big time military supporter.
"That's because he's not a leader. He's the product of internal promotion by his party. And his party has to decide who to appoint.... We're just not going to get that out of the traditional 2-party system"
Multiparty parliamentary systems are like this but wayyyyy more so. The PM is literally a product of internal promotion by the party! And the various parties in a coalition get to divvy up the various offices as they see fit. By contrast, Biden isn't at all- he was independently elected, and I think the party elites made pretty clear that he wasn't their choice. (You could argue that Hillary was their choice in 2016. But also 2008- certainly not Obama!)
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?
There's probably about 2,000 scientists who could have gone from the SARS-CoV-2 genome to a plausible mRNA immune target, and by next year 20,000 will be able to do it. But there's probably only 6 people in the world or fewer who could successfully build the manufacturing pipeline to distribute mRNA vaccines at scale in a year; by next year there might be twice that many.
But the upshot is that we don't need that many; the promise of the mRNA platform is that the same manufacturing chain works for any vaccine built on it. The actual content of the vaccine is information, after all - this technology is the moveable type of vaccine development and it's likely to be equally transformative.
Where do your numbers come from?
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.
I would add that there appears to be a fanciful assumption that vaccines will be distributed quickly and equitably once they reach poor countries.
I think it was people who were saying several months ago that the US (and other wealthy countries that had more than enough vaccines) should be making more of an effort to get vaccines into arms in poorer countries since that's where variants were more likely to emerge.
For example: https://www.slowboring.com/p/rochelle-wolensky/comments#comment-2209059
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.
Southern California absolutely *should* have *some* sort of backup system, but I assume the cost-effective version is a few big reservoirs that can store several days (weeks?) of water until a repair is available.
On the New Madrid thing, there are some bridges that *should* be reinforced to ensure they can survive such a quake (I would particularly prioritize the Eads Bridge and the I-40 bridge and some others), but not *every* bridge.
I think it's absolutely a good thing that NASA is spending some amount of money learning how to divert an asteroid (https://www.nasa.gov/planetarydefense/dart), though given the amount they've spent cataloging all the near-earth objects and showing that there aren't many that pose a threat, they don't need to spend a lot on this.
We shouldn't spend unlimited amounts on pandemic mitigation, but it's almost certain that any bit of effective spending would produce more good over the next 50 years than electrifying the federal vehicle fleet before the current vehicles get replaced anyway.
Sure, you can't take care of every possible contingency, and rational cost-benefit calculations should drive you to doing those things of greatest value, as you note. But we aren't doing those things, while we sit here discussing massive preparation for the next great pandemic. Why? Because of the availability heuristic. It's important to spend lots of money on the next pandemic because we're in the present one. But the last big LA earthquake was 1994,(*) and New Madrid was 1812. Yawn.
And in 10 years pandemics will be a big yawn as well, so any requirement for continued large-scale spending will be buried by new "availability heuristic" priorities.
And meanwhile, I think electrifying the federal vehicle fleet is a great idea.
(*) Right after the Northridge earthquake, everyone was convinced another big earthquake was imminent (many moved away; others did their one-time emergency prep). But geology doesn't care about the availability heuristic.
Are we not doing those things? Does Los Angeles not have substantial capacity in its reservoir system? Are all the bridges in St. Louis seismically unsound? I assumed these things had been done, even though we haven't done the maximalist versions you were mentioning.
(1) No. We don't have enough to get through a drought. Also, there are few reservoirs in the LA area; we're reliant on out of area reservoirs and other sources (like the Colorado river).
(2) It's been a while since I drove through the New Madrid fault area, but the last time I did, I was struck by the spaghetti-thin poles holding up the bridges (compared to California Hulk-like supports). From my reading (e.g., https://www.nehrp.gov/pdf/SeismicWavesMar08.pdf) some work has been done, but only preliminary (e.g., Emerson Bridge) and only up to some level of a big earthquake. If it's above 7.0, good luck for the I-40 bridge. And that may be the smartest thing to do! You can't cover every risk. Which is my point on future pandemic spending.
Yes we actually should be preparing for unlikely but catastrophic events. Or at least do some kind of cost-benefit analysis. But human beings are terrible at planning for the future. At least we are good at adapting to the present.
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.
I’m in biopharma, and this statement doesn’t sound accurate to me: “ 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.”
I have read the FDA documents describing their requirements for demonstrating vaccine safety for a new product. (The product I work on isn’t a vaccine, but it is regulated that way.)
The FDA cares about:
1. Does the product actually work (I haven’t read those documents),
2. To these meticulously described standards of proof, show us you know exactly what is in your product, and get there isn’t anything unsafe in your product. (These are the ones I read.)
The documents are rigorous and scientific and sensible and quite good actually. We want to know the answers to these questions bc we don’t want to produce shit and we don’t want to harm people. I don’t think the FDA is the bad guy here.
Let's take a simple example: Paxlovid. I'm going to quote Zvi here, because there's no way I can improve on this summary:
```The trial was stopped due to ‘ethical considerations’ for being too effective. You see, we live in a world in which:
It is illegal to give this drug to any patients, because it hasn’t been proven safe and effective.
It is illegal to continue a trial to study the drug, because it has been proven so safe and effective that it isn’t ethical to not give the drug to half the patients.
Who, if they weren’t in the study, couldn’t get the drug at all, because it is illegal due to not being proven safe and effective yet.
So now no one gets added to the trial so those who would have been definitely don’t get Paxlovid, and are several times more likely to die.
But our treatment of them is now ‘ethical.’
For the rest of time we will now hear about how it was only seven deaths and we can’t be sure Paxlovid works or how well it works, and I expect to spend hours arguing over exactly how much it works.
For the rest of time people will argue the study wasn’t big enough so we don’t know the Paxlovid is safe.
Those arguments will then be used both by people arguing to not take Paxlovid, and people who want to require other interventions because of these concerns.
FDA Delenda Est.
I propose the Law of Efficacy, which states that the requirement to halt a trial due to a drug being ‘too effective’ is that the drug has been approved for public use by the regulatory authorities. ```
In a world where the default position is that it is illegal to sell a drug until you've convinced the FDA of your two points above, (but legal to take/prescribe it for all sorts of other things after the fact, even if it's basically deworming agent), there's no reason whatsoever to invest in production capacity before the FDA approves it - especially if it has a shelf-life, because you can't actually be certain that it will be approved, or how quickly it will be approved, and if it isn't approved, all the money invested in production might as well have been set on fire and dumped in Boston Harbor instead.
The reason we got COVID vaccines so quickly was that Trump's administration, in an unprecedented show of judgement and foresight, precommitted to buy a ton of doses, effectively funding manufacture *even if they didn't turn out to be safe and effective* instead of waiting for the FDA approval to start ramping up production. But everything other than the vaccines are going through the FDA approval process.
What's more, the FDA has plenty of latitude to issue EUAs ahead of normal approval, and we were able to get vaccines under EUA - most people who've been vaccinated for COVID were vaccinated with vaccines that had not yet been FDA approved, even when said vaccinations were mandatory for many people. I don't think it's unreasonable to suggest that the approval process isn't fast enough if we're talking about mandating vaccinations when several of the vaccines still haven't gotten that full approval.
The potential lives saved by approving something quickly needs to be balanced against the potential lives lost bc something is wrong with the product and you rushed the approval process, missing the data that indicated a problem.
Sorry, that was uncharitable. But the FDA's incentives don't cover any such balancing. Their mandate and purpose is to prevent lives being lost to medication, regardless of how many lives it might save to approve it early. That's just the incentives that are inherent to a bureaucracy, combined with their mandate.
Well, what’s the alternative? “Yeah, it’s probably fine, we don’t need to check for rare events?”
Right now, it looks like the FDA's delay on Paxlovid will kill at least 8255 people. (estimates from https://moreisdifferent.substack.com/p/the-fda-has-blood-on-their-hands)
So if they're doing a balancing test, EUA it immediately. It would still be possible to check for rare events, and provide updated guidance if needed, without murdering eight thousand people in the meantime.
The alternative is pretty goddamned clear: “Rare events are rare, deaths from the disease this treats are common, so fuck off already.”
The standard for tort in the US poisons everything even peripherally related to it.
For rare, but extremely dangerous events like Covid, could we maybe do something like this where the FDA basically says “We are fairly confident it’s safe and effective but given the nature of the events we can’t subject this to the same rigor and time we normally would, so be sure to report any unusual side effects to this hotline and to your doctor”?
I get it’s a balancing act, you can’t be too lax because too many mistakes and the agency loses all credibility, but they definitely have to become less risk averse when it comes to these types of events that we just don’t have the same level of confidence to back that up like we normally would?
Is there any evidence that the FDA does such validating? Because from the outside, it looks like they'd let thousands of people die from Covid to avoid working over Thanksgiving weekend.
I read into today's news that it's *possible* that the Merck COVID pill may pose dangers to developing fetuses. I want to get that pill out to everyone as soon as possible, but it sure would be good to know more about this before the pill is prescribed indiscriminately to pregnant women.
These are tough tradeoff calculations. I wouldn't want to be the person in FDA responsible. It's possible this is not just a reflection of mindless bureaucratic procedures.
What about approving for EUA but not for those who are pregnant? (Is the risk that this would deter them later from getting the pill because they remember that it was "not available for those who are pregnant")?
Sure. I'm just using this to make the point that approval requires gathering lots of information (e.g., data on impact on pregnant women) and this doesn't happen instantaneously.
I read elsewhere that the difference might be that the test (which was stopped for ethical reasons) validated that the made-for-test doses of drug WORKED and wer SAFE.
But... that they have to approve the larger manufacturing pipeline to make sure that it can reliably deliver the same medicine they tested with.
That makes sense and would explain the difference. But right now I'm unable to find any official documentation from the FDA that says that's how they operate.
(This may be the closest: https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps )
It’s not. They approve the drug and regulate the manufacturing process separately.
This is basically the “pro-institution/resist” crowd doing the FDA’s ass-covering for it.
otoh, how many people would trust vaccines if the FDA were destroyed for not approving them quickly enough? This situations calls for greater subtlety
I'd be quite happy if the FDA review merely indicated a) the contents of the warning label, and b) the requirement that Insurance/Medicare/etc cover the costs of the drug. But at this point, I think if the FDA and CDC were dissolved, and replaced with a new agency, the new agency would probably start off with a lot more trust from the public.
If I were being particularly wonky, I'd set it up so that their mandate was focused on health outcomes, and I'd probably make sure that the only way to join when coming from the FDA is in a non-management role. But the FDA, through delay, has killed more Americans that car-crashes this year, and probably did last year as well. That's a simply unconscionable failure, and it needs addressing.
Up until December 2019 I was an avid institutionalist.
Now, with all the fervor of the recent convert: burn it all to the ground and shoot the survivors as they flee the exits.
You might like the part in The Walking Dead where the CDC building in Atlanta self-destructs with the last scientist inside, and the ruins are left to be picked over by zombies. I'd never watched that show till the early days of the pandemic, when it seemed fitting.
I think the best institutionalists are those who fight to build and preserve institutional capacity. We don't have enough of those and have to many willing to destroy capacity in pursuit of rents or those who want to burn it down without recognizing just how hard it is to build a good institution in the first place.
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.
In Kenya, doses are not scarce currently, the main two issues (as I understand them) are demand and logistics. Just like in the US, there are plenty of people who have heard the wild misinformation about the vaccine and do not plan to get vaccinated. Also, plenty of people live far from the hospitals and clinics where vaccines are available, so the government needs to set up more efforts to run mobile clinics that can reach more remote populations.
The piece that I'm not sure about is cost. I believe that the shot is free, but patients still need to pay a nominal fee for the doctor's time. Even if the shot is completely free, people are used to the hidden costs that come with "free" (in "free" primary education, parents still have to pay for school uniforms, books, meals and various other fees that are tacked on), so might be wary of what it will really cost them (in addition to transportation and potentially, a day of lost wages from vaccine side effects).
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.
Spot on re: ventilation. We're in a liberal area and our school superintendent talks about frequent bathroom cleanings, handwashing, and masks, but no HEPA air filters.
It’s way easier to criticize identities and behaviors rather than come up with solutions and implement them!
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
If companies recalculate their required safety stock based on what are likely to be temporary delays at the ports, TSMC, etc., then we'll definitely get a bullwhip effect, as their stock levels will get really large, and future orders will decline, leading to reductions in production, leading to future outages . . . rinse and repeat.
When calculating safety stock levels, you have to be careful about what events you include in your parameters. One-time events lead to very poor decisions.
I think a lot of companies are going to be looking at the balance between efficiency and resiliency a lot closer moving forward. IMHO, the scale tipped to far towards JIT inventory systems.
And whether it's an Earthquake in Japan, hurricanes or freezing in Texas, or a pandemic. It's always something,
For sure. "Resiliency" seems to be the new buzz word in supply chain design. Companies will have to pay up to build multi-source supply across different countries to mitigate this risk. Local source back into the US will be a huge new 10 year wave as well.
We'll see. Lowered inventory costs from JIT is a great temptation. Who will go first in accepting higher costs in order to buy some more security from impossible to predict future events?
Agreed the race to the bottom on costs/prices is hard to fight
I don't know how you wouldn't recalculate SS? The SS calculations are dynamic. If the lead time variability is increasing so must SS for optimal balance. I haven't heard of anyone discounting the LT increase as a 1x effect - maybe some are but my reading is the bullwhip effect was initiated back in Q4 2020 and the amplified impact has now hit raw material production.
It's your choice what data to include and how to manage the inputs. If you think the post-pandemic supply disruptions are a one-time event, and lead times will be much smaller in the future, then you're throwing money away by building excess stock levels.
Or, to put it another way, if it's hard to get supplies now so you buy more when they become available, you're addressing the problem after it has already been solved: the fact that you can now get your extra stocks simply means that the supply disruptions have been solved.
This may be cold comfort for this Christmas shopping season though, meaning that companies should have bought lots of extra stock on a one-time basis many months ago. Hard to be that prescient, of course.
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.
This patent author and biopharma manufacturing research scientist says ENDORSE
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?
Hmm, I wonder if we can use this talking point to manipulate the next GOP government into doing this.
“They released the last plague, we need to be ready for the next one!”