Issues & Insights

Regulatory Reform Paves Way For Coronavirus Breakthroughs

Cpl. Jackeline M. Perez Rivera

As the world restlessly waits for an end to the coronavirus pandemic, it’s increasingly clear that “normal” will not be possible absent pharmaceutical innovation.

Fortunately, indications abound that coronavirus vaccines and cures will emerge far sooner than anyone would have initially predicted. Research and development outcomes have already been staggering and the degree of innovation unprecedented. As of today, there are an incredible 1,297 clinical trials underway, with 427 unique treatments and 19 unique vaccines already undergoing trial.

New treatments under development ranging from “antiviral therapies, anti-inflammatory, anticoagulant and antimicrobial treatments to steroids, cell therapy and others” are already resulting in far lower mortality rates for hospitalized patients than just a few months ago. But by far, the most promising expedited path to normalcy is the development of a vaccine.

And incredibly, it is highly likely that vaccines will enter production at the end of summer, the most rapid development of any new medicine in human history. 

To understand this warranted optimism, it’s critical to examine the exact nature of vaccine research presently been undertaken. More than 10 radically different approaches are currently under development, each one sharing almost nothing in common with the others aside from the general principle of developing an immunity to the virus.

Some of these are based on the premise undergirding most of today’s vaccines. Typically, an inactivated form of the virus is introduced which teaches the immune system to provide necessary antibodies without causing any of the symptoms of the virus to manifest. This is probably the form of vaccination that most people are used to.

But other, more ambitious projects are attempting a different approach by altering a person’s RNA (the “messenger” carrying instructions within all cells) to “teach” it to synthesize the antigen. This novel approach will save months, as there’s no need to cultivate weakened versions of the virus during this process.

Still other approaches can be found in trials using a dormant type of virus vector to slip into cells and unload the gene like a Trojan Horse, effectively using a virus to combat a virus. Finally, some approaches engineer small proteins which mimic the virus yet still allow the immune system to learn how to fight it.

It remains unknown which of these strategies will prove most successful. However, companies are already committing to producing hundreds of millions of doses of the vaccines before trials are even completed, at huge risks to their bottom lines. This way, if all phases of clinical trials are proven successful, and a vaccine is effective and safe, distribution can immediately commence without delay.  

None of this would be possible without an array of regulatory reforms. The Food and Drug Administration, which has been long criticized for unreasonable delays and tacking unnecessary costs onto the  development of new treatments, is starting to adopt a more flexible approach. This is part of a larger trend across the government. In fact, 800 regulations have been suspended in the midst of this pandemic. In the same way that open-container laws have been suspended without the world caving in, the initial success of FDA reform is improving health care rather than compromising patient safety. There is no reason that similar miraculous breakthroughs cannot continue if the FDA continues its march toward reform.

In addition, companies are taking significant chances spending billions of dollars in researching and developing new vaccines and committing them to production before they even know they are effective. Many producers will almost certainly lose considerable sums of money as a result.

However, this trial and error is possible only because of the robust protection of intellectual property rights. Were the government to simply nationalize the means of vaccine production and nullify IP protections, as is advocated by many on the left, companies would see little point in continued production. This would jeopardize countless lives in this, and any future, pandemic.

By suspending regulatory burdens and protecting intellectual property rights, policymakers are empowering producers to create one of the greatest medical breakthroughs in recent human history. Our leaders must recognize this and act accordingly so that similar breakthroughs can occur again and again.

Tim Andrews is a senior fellow for the Taxpayers Protection Alliance.

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1 comment

  • The FDA’s “flexible approach” toward PCR tests for the coronavirus RNA (which detects active or resolving infection) or blood antibodies to the virus (which detects past infection) permitted hundreds of fraudulent or inaccurate tests to be sold without any vetting of their validation. This caused chaos in the medical and research communities.

    This is what happens when you perform regulatory reform with a machete instead of a scalpel. Moreover, if you bothered to read FDA’s guidance to industry, “Development and Licensure of Vaccines to Prevent COVID-19” (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-and-licensure-vaccines-prevent-covid-19), published last month, you’d find that the requirements are the same for other vaccines.

  • [print-me target="#post-%ID%"]

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