PART II: Finish off Covid19. Hurry.
Time is of the essence. The Cosmopolitan Globalists offer a blueprint for ending the pandemic.
This is the second part of the Cosmopolitan Globalists’ blueprint for ending the pandemic. The first part is here.
By Robert Zubrin and the Cosmopolitan Globalists
Let employers test their workforces. Now.
The coronavirus, Covid19, emerged on the world stage one year ago. Since then, it has killed approximately 2.3 million people, including 460,000 in the United States. These tolls continue unabated, with 24,000 Americans and 100,000 people worldwide dying of CV19 in the past week alone. Effective action against this scourge is long overdue.
There are two ways to stop the pandemic: isolation of carriers and mass vaccination. Neither strategy has been implemented effectively in any Western country with which I am familiar. The results have been catastrophic.
Here is what needs to be done.
Any epidemic can be suppressed, even if no vaccines are available, by isolating its carriers. The virus is an organism. It is perishable. It needs to reproduce faster than it dies or it will go extinct. It will only succeed in surviving if, on average, each infected person infects at least one other person. If the batting average for the virus—known as R-naught (R0)—exceeds 1, cases will rise exponentially. If R-naught is less than 1, the pandemic will just as quickly collapse. How do we get R-naught below 1? The answer is simple: isolate carriers.
The authorities in most Western countries were not oblivious to this countermeasure. But their attempts to implement it have been largely ineffective, because their criteria for isolating people has been whether they are “essential” or not, rather than whether they are carriers or not.
To isolate carriers, they must be identified, and not after they become symptomatic, but as soon as possible. To do that requires mass testing. No such program has been attempted in any major Western nation. To the contrary, testing has been limited to those who are symptomatic and those who suspect they have been exposed to a carrier of the disease. That won’t do at all. If we wish to drive the virus to extinction, we need to go hunting for it, actively seeking to find and isolate carriers before their viral passengers have a chance to reproduce. In short, we need to test the bulk of the population on a time scale faster than the virus’ reproductive cycle.
Testing the entire employed workforce once per week would do the job. Government authorities have recoiled from any such program, no doubt because it would be an impossibly heavy lift for them. Currently, the United States is averaging about 1.5 million tests per day. Official test sites are nearly fully booked. To test the entire US workforce once per week would require 20 million tests per day; 30 million if it had to be done during weekdays. There is no way this could be done by the official testing system.
But employers themselves could do it easily. Fast tests are now available. They can be administered with minimal technical competence, and they provide results within 20 minutes. Any employer, big or small, could assign ten percent of its workforce to test itself and the other 90 percent. They could get the job done in the first hour of the work week and send any carriers home—or to an official test site for confirmation—by 9:00 a.m. Monday morning. This would make workplaces safer, and it would do much more. It would increase the virus’s casualty rate. If all employers were to do it, the virus would go extinct.
Note that while the virus continues to infect large numbers of new people, it is doing so at a roughly constant rate. It infects about the same number today as it did last November. It is not growing exponentially. I note this not to minimize the threat, but to point out the virus’s vulnerability. Because it is not growing exponentially, R-naught is right now very close to 1. Were we to hit it hard with a mass testing program, we could knock it well below 1 and wipe it out. But we need to do this now, before it mutates.
Rather than pursue such a program, however, authorities have stood in the way. The Food and Drug Administration has blocked or stalled the use of testing kits, many of which were quickly developed by universities or hospitals within weeks of the initial outbreak. When finally it approved some tests, it did so with the proviso that they be employed only by officially approved testing sites. Employers have effectively been banned from using fast testing kits to protect their workforces. Technical reports published by the European Centre for Disease Control and Prevention do not even mention the possibility of implementing such a program.
This is exactly the opposite of what needs to happen. Instead of blocking employer testing, national governments should be doing everything in their power to mobilize it. They could even subsidize it. Providing test equipment to every employer could be done for a small fraction of the funds to be appropriated as part of President Biden’s $1.9 trillion coronavirus relief bill. But government funding is probably unnecessary. Every employer I know would jump at a chance to implement an in-house fast testing program as soon as it is allowed, because the costs of a workplace infection are so much greater.
The complaint that there isn’t enough testing gear right now to implement such a program is feckless nonsense. Allow people to place their orders, and producers will line up to make the stuff pretty damn quick.
Note that creating a capability for mass testing is essential regardless of the success of the vaccines against current Covid19 strains. Covid19 and other viruses are constantly mutating into new forms, some of which might eventually be proof against the vaccines. No pandemic, on the other hand, can be proof against effective isolation of its carriers.
Approve the vaccines. Now.
The other approach to fighting the virus is through vaccines. The world scientific community has come through triumphantly for humanity, developing highly effective vaccines to fight Covid19 in record time. Indeed, with the aid of the virus’s genetic sequence, provided by Chinese scientists, Moderna developed its vaccine within two days in January, 2020. Several more companies had vaccines ready for testing by spring.
But the authorities managed to snatch defeat from the jaws of this incredible victory by treating the vaccines as if they were commercially promising cures for baldness, not emergency measures to save millions of lives. Instead of putting the vaccines to work straight away after quick safety tests, they subjected them to six months of extended safety testing, followed by six months of efficacy testing. A case can be made for safety testing, but this can be done quickly. All you need to do is administer the drug to a thousand people. Allergic and other negative reactions will generally show up within weeks. The FDA insisted on a much longer two-phase safety testing program. Even so, this was completed in July 2020. By then, 680,000 people had died around the globe. The vaccines should have been immediately authorized at that point. Instead, the FDA chose to subject them to extended effectiveness testing.
To test a preventative medicine like a vaccine for efficacy takes time. You need to administer the drug to a large group, and a placebo to a comparable group, then wait to discover how many of the placebo group come down with the disease compared to those given the vaccine. It’s fine to do this sort of thing if you want to make an official assessment of a manufacturer’s claims about the efficacy of his toothpaste against tooth decay. It is absolutely barking mad nuts to to conduct these studies and stall the use of a lifesaving vaccine during an out-of-control pandemic that is killing millions.
Not only did the FDA do this, it is still doing it—even though 2.3 million are now dead, and virus variants are emerging right and left from a massive, infected host population. Particularly outrageous has been the FDA’s decision to delay approval of the AstraZeneca/Oxford vaccine until April to finish a study involving 30,000 people. The vaccine has already been administered to more than a million people in the United Kingdom. It is all the more crazy because the AstraZeneca/Oxford vaccine can be produced much faster and at a fifth the cost of the Pfizer and Moderna vaccines. It is widely licenced for production. It has been shown to be effective after just one dose (notwithstanding a recent South African test, involving only 42 people, that raised questions about its efficacy against the strain). It even stops people from transmitting the disease. Yet the FDA is blocking it. Why?
Note that it would not be the first time the FDA’s lack of alacrity has cost countless lives: Hundreds of thousands of Americans died because the FDA held up approval of effective anti-AIDS drugs for years, even though they had proven effective in Europe.
Executives must take charge. Now.
As the Cosmopolitan Globalists have noted previously, Europe’s response to the pandemic has been no better. Before the coronavirus, European health policy was in the hands of national governments. In the summer of 2020, Brussels took charge of vaccine procurement. Member states were free to opt out of the scheme, but none did. Europe’s procurement program has been a disaster. The process lacked all urgency and expertise. Orders were placed late. Instead of prioritising the speed and security of vaccine supplies, the EU worried about the price. It succeeded in negotiating a better deal for the vaccines than the US, paying 24 percent less for the Pfizer vaccine and 45 percent less for the Oxford/AstraZeneca. But the EU’s frugality is evidence of innumeracy at the highest level: The manufacturers have prioritized shipments to countries that paid the full price. With every day the pandemic continues, European economies lose far more than any small savings the negotiators might have achieved—and this is to say nothing of the loss of life. So far, only three percent of the EU’s citizens have received their first dose.
Bruno Maçães, Portugal’s former Europe minister, aptly describes Europe’s lethal complacency:
The contrast with the health calamity in the United States made European officials forget that the pandemic was in fact a state of emergency requiring a decisive approach to vaccination. Instead, most believed that vaccines would eventually be needed to root out the problem, but the process could be conducted against the background of a waning pandemic, at least in Europe. There was no urgency in signing the necessary contracts with the most promising manufacturers, with protracted haggling over prices further delaying the process.
We now know that time was of critical importance and that the sooner procedures could be tested and perfected, the sooner a high yield of vaccine doses could be expected. The lack of urgency was also reflected in the attempt to bring a number of exogenous considerations into the process. For many months the European Union seemed more interested in scoring political points on solidarity, market power and negotiating clout than in focusing laser-like on the task at hand: getting as many vaccines as fast as possible into the arms of its citizens.
This is a pandemic. The people charged with defending the public from mass death need to think—and not just think, but think fast.
Let’s take the FDA’s excuse at face value. They say they are simply following standard procedure. Standard procedure can be a very fine thing to have. It works splendidly in ensuring everyone pays the same price for bus tickets. But consider the following dialogue:
Fighter Pilot: Hot Dog to Base. Enemy bombers approach New York. Request permission to engage.
Base: Hold your horses there, Hot Dog. We need to file an environmental impact statement with the EPA before we can authorize anything. Engagement with enemy aircraft is at least six months out.
No matter how good and numerous its fighter planes might be, any air defense system would fail completely were it saddled with such a command-and-control system. Like enemy aircraft, a virus can move fast. In any form of combat, be it a boxing match or a dogfight, you need to move at least as fast as your opponent if you’re to have any chance of defending yourself. Having regulatory agencies like the FDA and the European Medicines Agency in command of pandemic defense makes as much sense as having the Environmental Protection Agency in command of air raid defense. These are the wrong types of organization for the job.
Negotiating a deal for vaccinations the way you negotiate a fisheries treaty for Brexit (and using the very same people to negotiate) is just as insane. Wolfgang Münchau correctly described the vaccine procurement policy as the worst error the EU had ever made. “The EU’s DNA is that of a producers’ cartel. Its priority is not to secure supplies, but reduce costs and achieve some balance between French and German interests. Triangulation is what Brussels does for a living. Whatever-it-takes is not part of its culture.”
Western countries lack properly-constituted civil defense organization charged with pandemic defense and endowed with the required command structure. They lack employees who are mentally equipped to act quickly. The only competent authorities in Western countries who could deal with this situation are the chief executives. President Biden, for example, must cease deferring to the FDA on pandemic defense. He is the president, so the buck stops with him. He has the power to overrule the FDA, authorize the AstraZeneca/Oxford vaccine, the Johnson & Johnson vaccine, and any other vaccine immediately. He must do this, or hundreds of thousands will needlessly die.
Put vaccines in the public domain. Now.
Then there is the issue of production. The Pfizer vaccine was developed with company cash, so it is private intellectual property. But Moderna’s vaccine development effort was paid for by American taxpayers, so the federal government owns the rights.
Moderna is a very innovative company. It deserves great credit for its development of a highly effective vaccine against Covid19 in two days in January, 2020. But the pharmaceutical industry is worth USD $1.3 trillion, and in this ecosystem, Moderna is a shrimp among whales. Moderna’s total revenue from drug sales was USD $187 million in 2019. Here is a list of the top twenty American pharmaceutical companies. Roche, at the top, brought in USD $48 billion in revenues in 2019. At the bottom is Biogen with $11.3 billion. Collectively, these twenty companies possess thousands of times Moderna’s production capacity. Merck alone, which has abandoned its vaccine development effort, has 200 times Moderna’s drug production capacity.
Instead of waiting months or years for little Moderna to produce its—or rather our—vaccine in sufficient quantities to meet the emergency, the Biden Administration should license it to Merck and to every other qualified company who can produce it, then put in massive orders. The US government could, and should, declare the Moderna vaccine to be public domain, allowing the huge generic drug industry to produce it worldwide in vast quantities. Indeed, Moderna has already volunteered:
Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic. Further, to eliminate any perceived IP barriers to vaccine development during the pandemic period, upon request we are also willing to license our intellectual property for COVID-19 vaccines to others for the post pandemic period.
There is no excuse for not taking these actions immediately. There are literally hundreds of millions of lives at stake. Unless we stop the virus, now, mutant strains will outflank our vaccines.
As General Douglas MacArthur said, “The history of the failure of war can almost be summed up in two words: Too late.”
We must not continue to be too late.
Robert Zubrin—@robert_zubrin—is an aerospace engineer, the founder of the Mars Society and the president of Pioneer Astronautics. His latest book, The Case for Space: How the Revolution in Spaceflight Opens Up a Future of Limitless Possibility, was recently published by Prometheus Books.
Here’s another example of a massive regulatory failure by the Americans and Europeans. The reason the J&J vaccine is somewhat less efficacious then the mRNA vaccines is that it’s a one dose vaccine instead of two doses. The AZ vaccine was also less efficacious in one dose rather than two, which is why it’s now given in two shots spaced apart by weeks.
You can bet the house that the J&J vaccine will be even more effective as a two dose rather than a one dose vaccine. J&J is currently running a clinical trial to find out for sure; but here again is another example of regulators standing in the way of saving lives. Rather than wait until the summer for proof that the J&J vaccine is even more effective in two doses than one, it would make far more sense to run a safety trial which could be completed in a couple of months. Waiting to prove efficacy for the second dose is absurd; everyone with a brain knows that it will almost certainly be better. How many people have to become sick or die to satisfy the impulses of regulators with a civil service mentality?
What regulators should be insisting on for the adenovirus-vector vaccines is a trial with the first dose being the J&J vaccine with the second dose being AZ’s vaccine (or vice-versa; the order doesn’t matter)
As Dr. Zubrin pointed out in the first article in this series, giving second doses of the same vector can be problematic because the body mounts a immune response to the vector (which is, after all, a virus though a harmless one). If the vector is destroyed it can’t drop off its payload-the genetic instructions to produce spike protein.
J&J had exactly this problem with it Ad26 Ebola vaccine. It’s a two shot vaccine but J&J needed a different vector for the second shot. The problem was solved when J&J contracted with Bavarian Nordic A/S a company which produces a different viral vector.
The solution in the present circumstance is obvious; a two shot regimen consisting of the J&J and AZ vaccines. Would this work to increase the efficacy of the adenovirus vaccines? Probably yes. Will it ever be tried? Maybe some day in a galaxy far, far away. The problem is that the regulatory hurdle of proving efficacy (as opposed to safety) is so substantial that in the absence of a mandate from the regulators there’s no incentive to give it a try.
Other combinations are intriguing. How about a two shot regimen of the mRNA vaccines with the protein vaccines or the protein vaccines with the adenovirus vaccines. We need to test whether these combinations are safe, but if we wait to prove to a statistical certainty that they are efficacious, the trials will never happen. After all, how many 30,000 patient trials is it possible to run, especially if cases begin to plummet?
The other problem sure to arise is how long it will take to run trials of vaccines targeting emerging variants. If the FDA and European regulators require proof of efficacy of new vaccines targeting emerging variants it will be years before we put Covid-19 behind us.
Sadly, the regulators who should be protecting us have instead turned out to be the biggest problem of all.
There’s no surprise there; the administrative state strikes again and we are all poorer, sicker, angrier and less healthy as a result.
Almost everything the author says in this article is spectacularly correct. Actually, it’s not almost everything, it’s everything. At some future date, we need to figure out why the experts who work in pharma performed a miracle in creating several vaccines at warp speed while the experts who work for government couldn’t get out of their own way. Part of it is that private industry pays more (a lot more) so it can recruit more talented people; but it’s more than that. Government experts who’ve spent years or decades in a regulatory capacity have been stripped of all of their entrepreneurial tendencies-that is, if they ever had those tendencies in the first place.
The regulators in the United States and Europe condemned hundreds of thousands of people to an unnecessary death by refusing to grant approval to the vaccines based merely on safety data, this type of data could have been obtained in several weeks. Everyone (with an ounce of common sense) knew the vaccines would be efficacious based merely on the primate data obtained by the NIAID-NIH last March. That they turned out to be as efficacious as they are, is merely gravy.
There are so many other regulatory deficiencies that our friends at the “Cosmopolitan Globalists” didn’t mention.
(1) For one, the failure to execute “challenge trials” was immoral. Instead of needing 30,000 patients, challenge trials could have been run with 500-1,000. These trials wouldn’t have required a placebo arm. Patients would have been vaccinated and then exposed to SARS-CoV-2 via a nasal swab. Given the incredibly low death rate from Covid itself in people under 40 years of age, the risk of a challenge trial was extremely remote and certainly no worse than drug trials which routinely recruit healthy volunteers. We could have determined the efficacy of the vaccine (at least in younger people) in a matter of weeks while putting the experimental subjects at little to no risk. If the vaccine was efficacious in younger people it would be a reasonable extrapolation to assume that it would be effective (though perhaps less effective) in older people. Those who claim that challenge trials are unethical are ethically challenged themselves. Their obtuse attitude turned out to be a death sentence for tens of thousands of innocent people.
(2) The vast majority of people who contract Covid-19 recover fully from it. Most patients don’t need to be hospitalized, most never see the inside of an ICU, most are never hooked up to a ventilator and most never die. The long haul phenomenon is real but impacts a relatively small number of patients. The patients far and away at the highest risk are older (older than 60 but especially older than 80) and younger patients with comorbidities. In light of this, wouldn’t it have made sense to focus on these groups when running the trials seeking to determine safety and efficacy?Remarkably the regulators never insisted on it. The number of elderly patients in the trials was quite small and to this day, no one is quite sure of efficacy rates in the patients most at risk from Covid-19. And speaking of high risk patients; why are we vaccinating 20 year old waiters and grocery clerks before 64 year old smokers with Type II diabetes?
(3) Are the regulators so dense that it never occurred to them to mandate bake-off trials where the safety and efficacy of one vaccine technology is compared to another. The current crop of vaccines rely on three different technologies, mRNA (Pfizer and Moderna) Adenovirus-vector (J&J and AstraZeneca) and protein based (Novavax and maybe eventually Sanofi). Each technology has advantages and disadvantages in terms of cost, transport, administration, safety, side-effect profile and efficacy. Because all of the clinical trials were run separately using different entrance criteria and secondary endpoints (they all shared the same primary endpoint mandated by the FDA) it is impossible to get a clear and granular picture of exactly how one vaccine compares to another. Perhaps the more efficacious mRNA vaccines should be reserved for the elderly even though the two dose regimen is onerous while the one dose J&J vaccine should be reserved for younger people who are far less likely to die. Does this strategy make sense? We will never know. What we do know is that whether or not it makes sense, it will never be implemented. What a shame. This isn’t a failure of vaccine technology, it is purely a regulatory failure.
(4) Then there’s the issue of sterilizing immunity. Do the vaccines provide it? If you’re vaccinated, can you still be contagious? It seems like this is a pretty important question. Why aren’t there any answers? AstraZeneca has presented some extremely preliminary evidence that subjects who’ve received their vaccine are less contagious but the whole issue is a mess. Arriving at definitive answers is not easy, but getting reasonably good data is. How do you do it? You experiment with primates. Remember, every single vaccine currently approved or approaching approval was tested on primates at NIH. This work was paid for by the U.S. government (providing yet another example of Europe’s free-riding). It would be quick and easy to test whether the vaccines provide sterilizing immunity in primates. If the vaccines did, would that prove that the vaccines provide sterilizing immunity in humans? Of course not, but it would give a pretty good indication. To my knowledge, there has not been a single publication in a reputable medical journal about this.
There are many more failures that I could outline. Suffice it to say, the author of this article is right; the scope of the failure of American and European regulators is as enormous as the success of the pharmaceutical industry in producing vaccines in record time.
The epic failure of western governments is emblematic of so many of the problems that afflict us. The demise of the West has nothing to do with ignoring science. It has everything to do with cultural failure.