For faster vaccine development, we need less regulation

By historical standards, the development and approval of coronavirus vaccines was very quick. They became available, though not widespread, within a year. By contrast, measles vaccines took about a decade and polio vaccines more than 40 years. Yet coronavirus vaccines could have been delivered faster still. The design for the Moderna vaccine, which reported a 94.5 per cent effectiveness rate on Nov. 16, was actually completed by Jan. 13 — nearly a month before the first coronavirus death in the United States and two months before the first death in Canada.

Why were the vaccines, designed in January, not available until December? The reason for this lengthy delay, in large part, was government. Before people are allowed access to a new medicine, governments must certify its safety and effectiveness. In Canada, the certification is done by Health Canada; in the U.S., by the Food and Drug Administration (FDA). Government approval is supposed to protect consumers but in this case the result was the opposite: regulatory delay meant longer and more restrictive lockdowns.

As a result of these lockdowns, tens of millions of people around the world were thrown into dire poverty, some even put at risk of starvation. Surgeries

and cancer screenings were delayed or cancelled. Children's education was retarded by school closures. Civil liberties were drastically curtailed. Mental health problems were exacerbated. Unemployment soared. The quality of life fell sharply for hundreds of millions of people, while trillions of dollars in economic value were destroyed. If governments applied the same standards for safety and effectiveness to their lockdowns that they require for new pharmaceutical products, they never would never have been allowed. Whatever the harmful side effects of potentially unsafe vaccines, it is hard to imagine their causing as much destruction as the lockdowns.

Especially because government actions involve coercion, it makes no sense for governments to subject pharmaceutical companies to higher standards for safety and effectiveness than they apply to themselves. If people had wanted to take a vaccine from Moderna in May, after interim Phase 1 trial results had demonstrated it to be generally safe, and if Moderna had been willing to market its vaccine at that stage, that would have been their own, voluntary choice.

By contrast, there is nothing voluntary about governments putting entire populations under semi-house arrest. If anything, government lockdowns should be subjected to higher safety standards than vaccines.

But if the government doesn't verify that medicines are safe and effective before they can be sold, how will consumers be protected? The answer is that it is in the self-interest of pharmaceutical companies to be very certain of the quality of their products. First, they have to convince people their products are good before anyone will buy them, for example, by having a private thirdparty company (why does it have to be the government?) verify that they are safe and effective. Second, they know that if their products turn out to be harmful, then tens of billions of dollars of their shareholders' equity could be wiped out by class action lawsuits.

But what about thalidomide, an anti-morning sickness drug sold in Canada and Europe in the late 1950s and early 1960s, which caused thousands of birth defects, among other harmful effects? The FDA stopped it from being sold in the U.S. Doesn't that prove Big Government is more reliable than Big Pharma? Not exactly. In the thalidomide case, a pharmaceutical company did make a mistake, a big one, and caused widespread harm. But governments also make mistakes that cause widespread harm. In retrospect, historians may find widespread anti-COVID lockdowns were a case in point. The question is whether private companies or governments are more likely to strike the right balance between speedy delivery and rigorous testing of products.

Government regulators' strong self-interest is to be late in approving new medicines, since the harm caused by delayed approvals is generally less visible than the harm caused by approving unsafe products. But less visible harm is not the same as less harm. Milton Friedman favoured abolishing the FDA, arguing that government vetting of pharmaceutical products discouraged innovation and delayed public access to new medicines, and therefore very likely did far more harm than good.

Unlike government regulators, pharmaceutical companies are answerable to consumers, so they have a powerful incentive to achieve the right balance between speed and safety. It makes much more sense, both during pandemics and in other times, too, to rely on the judgment of Big Pharma instead of Big Government.

LOCKDOWNS SHOULD BE SUBJECTED TO HIGHER SAFETY STANDARDS THAN VACCINES.