Vaccines

How the Government Timidly Stood in the Way of COVID-Fighting Innovations

Without the feds in the way, we could have rolled out at-home diagnostic testing, set up human challenge trials, approved vaccines sooner, and vaccinated Americans more quickly.

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"Are We Much Too Timid in the Way We Fight Covid-19?" asks New York Times columnist Ezra Klein in today's paper. When it comes to developing and distributing tests and vaccines, we have indeed been too timid—not by choice, but because bureaucrats forced us to be.

The first big bureaucratic failure occurred when the Centers for Disease Control and Prevention (CDC) insisted that state public health agencies use a COVID-19 diagnostic test it developed. For about two months, the government forbade biotech companies and academic laboratories from developing and deploying their own tests. But the CDC test was so flawed that it was useless, and the undetected virus spread widely. Contrast that with the public health authorities in South Korea, who worked with private companies to develop and deploy a COVID-19 diagnostic test within a week after the first 4 cases had been detected.

In March 2020, I urged that the Food and Drug Administration (FDA) get out of the way of at-home COVID-19 testing, which private companies were already developing that month. Instead, the agency ordered them to stop and to destroy the patient samples they had collected. It took the FDA until December to finally get around to approving a supposedly over-the-counter at-home COVID-19 antigen diagnostic test—and it's still unavailable to consumers. And yesterday, that's right, yesterday, the FDA approved two more over-the-counter at-home COVID-19 diagnostic tests.

Thanks to the unprecedentedly rapid roll out of various COVID-19 vaccines, the end of the pandemic is in sight, at least for rich countries like the United States. On the positive side, these clinical trials were developed in less than a year—compared to an average of 10.7 years for earlier vaccines. But the rollout could have been so much faster.

Moderna devised the recipe for its COVID-19 vaccine in just two days, and the company injected it into the first volunteer on March 16, 2020. But FDA bureaucrats insisted that the vaccine makers follow the usual path of Phases 1, 2, and 3 clinical trials for testing safety and efficacy. It would have made much more sense to authorize human challenge trials, in which young volunteers are given either the vaccine candidate or a placebo and then exposed to the virus to see if the shot works. Instead of waiting around for the virus to find both vaccinated and unvaccinated folks in the wild, as researchers do in regular Phase 3 trials, this would speed things up by bringing the virus to the volunteers.

If this had been done, we could have known by last summer how amazingly effective the new vaccines are. Keep in mind that by September 1, 2020, some 6.4 million and 190,000 Americans had been diagnosed and died respectively of the disease. Now the disease has been diagnosed in some 31 million Americans and has killed 565,000.

On April 29, 2020 the Trump administration unveiled Operation Warp Speed, with a goal of making 300 million doses of effective COVID-19 vaccines available by January 2021. On May 4, George Mason University economist Alex Tabarrok and colleagues proposed that the U.S. government "go big" and commit $70 billion to encourage pharmaceutical companies to build out facilities for manufacturing COVID-19 vaccines. Ultimately, the Trump administration allocated about $13 billion to Operation Warp Speed. That's some of the best money that the U.S. government has ever spent.

But again Americans faced unnecessary limits. Back in December, the clinical trial results from the Pfizer/BioNTech and Moderna vaccines showed that they were about 90 percent effective at preventing COVID-19 after just one dose. Given those data, some of us asked, why use two doses when one dose works almost as well? By delaying the second doses for the vaccines, we could double the number of Americans protected from the severe COVID-19 infections.

So far, nearly 100 million Americans have received at least one dose of the two-dose vaccines and 56 million are fully vaccinated. Had the second doses been delayed, 156 million Americans could now have been vaccinated—nearly 50 percent of the population.

Even more Americans could have been vaccinated by now if the FDA would accept the safety and efficacy evaluations of brother bureaucracies such as the United Kingdom's Medicines and Healthcare Products Regulatory Agency. Britain's regulators approved the Oxford/AstraZeneca vaccine three months ago, on December 30. The U.S. is sitting on a stockpile of around 30 million doses of that vaccine. Nevertheless, the FDA has yet to approve it, despite clinical trial results indicating that it is 76 percent effective against symptomatic COVID-19 and 100 percent effective against hospitalization and deaths.

So far, the pandemic has brought us tens of millions of infections, nearly a million hospitalizations, and 565,000 deaths. Economically, millions of jobs were lost, the economy shrank by 3.5 percent, and the U.S. government has wracked up trillions more in debt. Speedier rollouts of both testing and vaccines could have substantially ameliorated these losses. But timid bureaucrats stood in our way.

NEXT: The CDC vs. the Constitution

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  1. Economically, millions of jobs were lost, the economy shrank by 3.5 percent, and the U.S. government has wracked up trillions more in debt.

    Yeah, but this part wasn’t about timidly standing in the way of innovation. This was about arbitrarily and capriciously exercising emergency powers that in many cases the courts say they didn’t have, or shouldn’t have had in the first place.

    That said, Ron, not disagreeing with your main premise.

    1. Ron wrote of the federal government, not state or city governments, mostly run by Democrats, that chose to shut down their economy.

      Which is a good argument for a republic, such as the one we kind of have (when the feds don’t overstep their boundaries) so we can see the results of the different approaches to a problem government attempts to address.

      I agree with Ron the bureaucrats slow things down. Consider Russia had the Sputnik vaccine approved 8/11/2020, while the US didn’t have one approved until Jan 2021. I agree with him the money spent for operation warp speed was well spent. I disagree with his choice to not mention Trump or give him any credit for speeding things up. Libertarians should celebrate those who seek to remove some of those bureaucratic barriers and succeed.

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  2. “…timid bureaucrats…” ??

    How about power-mad? From my experience in working for County and State governments, the go-to job description, is to say “no.”

  3. Wait, the locking down of America and its economy was a novel, never-before-seen innovation. They didn’t seem to timidly stand in the way of that.

  4. Testing wouldn’t have moved the needle much at all especially PCR testing. That crap just fueled the bogus idea that asymptomatics drive transmission which was the main excuse for lock downs and masks.

  5. Vaccine created and approved in what 9 months?

    I mean this is like Homer Simpson waiting for food in the microwave and getting impatient.

    1. Could have been 3 months.

    2. While 9 months is fast by historical standards for vaccine development, the appropriate comparison isn’t to the polio vaccine or the flu vaccine development process, but to what could have happened if we’d done things differently.

  6. Moderna devised the recipe for its COVID-19 vaccine in just two days

    Ron, one suspects that doesn’t make folks wary of the Emergency Use Authorization feel much better.

    1. It was scribbled on a paper napkin on lunchtime at the strip club.

  7. What will the future of train/high speed rail look like in a post-covid USA, and will it take over as a safer alternative to flying domestically?

    1. Why would it? You are still trapped in a metal tube with a bunch of other people, (most of them overweight), only this time for longer periods.

    2. And there won’t be a post Covid USA.

  8. https://twitter.com/TaraLaRosa/status/1377769349260439557?s=19

    “If everything is reopened, … how are we going to incentivize people to actually get the vaccine? The CDC and the Biden administration needs to come out a lot bolder and say if you’re vaccinated you can do all these things, here are all these freedoms that you can have.”

    1. Fucking disgusting.

  9. Title Correction — How the USA Government turned Nazi (def; National Socialist) and defied all concepts of Individual Liberty and Justice for tyrannical dictation.

  10. It would have made much more sense to authorize human challenge trials, in which young volunteers are given either the vaccine candidate or a placebo and then exposed to the virus to see if the shot works.

    This is massively unethical imo. It gives a huge incentive for vaccine developers to lie through their teeth about the virus itself in order to get a first-mover advantage re a vaccine product. All it takes is a couple of lawyers to write an impossible to understand consent approval. If things go south – tie things up in court with the relatives of dead people – for decades.

    See Tuskegee.

    1. As an aside – there is also an ethical problem with keeping the epidemic in a state where vaccines can be tested. If you reduce the spread of the virus enough so that it effectively disappears, then you eliminate the ability to test the vaccine because those who receive the vaccine/placebo do not get exposed to the virus itself in sufficient numbers/time to test the vaccine/placebo effect.

      That imo is the real reason the federal level of govt chose to do nothing re public health. Their objective was to test the vaccine quickly – which can only occur if the virus is spreading in the population. They were essentially corrupted by either vaccine companies or the vaccine-as-a-solution mindset. UK had the same issue with the AstraZeneca-Oxford vaccine (and their trials in UK, Brazil, South Africa)

      The alternative – of stamping out the virus itself – is the Chinese model. They stamped out the virus itself so effectively that they could no longer test the Chinese vaccine. So they had to cobble together agreements with other countries to test the vaccine there during the waves of the epidemic there.

      It is no accident that the vaccines were tested in those countries which completely fail at suppressing the spread of the virus. It is one path or the other – and the money comes from following the vaccine path rather than the suppression path.

    2. The only unethical part is consent forms being unreadable lawyerese. Consent forms should be in plain english, with reasonable compensation in case of poor outcomes, and a court should never have to hear it.

      There’s nothing unethical about challenge trials themselves.

      There is, however, something deeply unethical about China’s policy that you laud in your follow up post. Liberty is not just a constitutional principle, its a moral good. Nor is it clear that China’s lockdowns were successful – there’s no trustworthy data out of China to use to determine success. Not to mention they suppressed knowledge of Covid-19 for months, which left the world incapable of preparing ahead of time. If China had come clean early (and bureaucrats got out of the way), we could have had vaccines before it *was* a pandemic.

      (Certainly in the rest of the world, degree of lockdown had very little correlation with subsequent course of the pandemic).

      1. Nor is it clear that China’s lockdowns were successful – there’s no trustworthy data out of China to use to determine success.

        No it is actually very clear that their Wuhan lockdown was successful. That does not mean ‘good’ or ‘ethical’ or ‘doable anywhere else’. It simply means that the means (lockdown) achieved the ends (suppress the virus).

        There is no question that there was a time in early Feb 2020 where they were lying through their teeth about the data. I was one of the first to post those problems here – and I believed the problems were bad enough to dismiss everything from China. Which is why I started following Singapore, South Korea, Italy, etc then. But I also saw one of those youtube videos about the Wuhan lockdown. And it became deductively obvious that the data outside Wuhan was reasonably accurate and the numbers inside Wuhan was overwhelmed in Feb2020 (so fine – say the reality there is 10x worse than reported).

        Like it or not, China stamped out the virus. And their policies now – eg evidence of vaccination of visitors to China still requires a full 14 day isolation – are evidence of that. That they are a generally non-immune still-unexposed population and that virus is now mostly a foreign-import threat.

        1. China suppressed the virus/
          Did it? What data do we have out of China that’s independently verifiable or trustworthy? China has been lying about daily cases since ~*November 2019* (not just since February 2020), where they delayed international recognition that there was a looming disease threat by covering up its existence.

          Youtube videos/
          What youtube video out of china would you trust to not be Chinese propaganda. Inherently, nothing out of China is trustworthy, because the only information flows are those the government approves of.

          China’s policies are going to be tailored to support the official narrative that they’ve stamped out the virus, no matter what the internal situation actually is. Pointing to their isolation of visitors policy doesn’t mean anything about internal dynamics, because they know these things will influence international perception. You’re not skeptical enough.

  11. The economy has shrunk a lot more than the numbers indicate. We’ve printed trillions of new dollars and that money artificially makes the economy seem bigger than it actually is.

    1. This is an important point – malinvestment is caused by ‘fake’ value being injected into the economy artificially by government. No goods or services were created to support the existence of that money, it was just magicked into being. (And since there’s no goods or services backing that money, people will overconsume resources, killing future investment, which is basically delayed consumption).

  12. Bureaucrats is the wrong name. They’re technocrats with highly specialized knowledge that limits their ability to see past the end of their noses.

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