It seems some users will not be able to see the opinion piece I wrote with Ted Bailey on the WaPo site because of the Washington Post’s paywall. Here is the full text:
Speed up the FDA’s vaccine-approval process
By Eric. E Johnson and Theodore C. Bailey
With the coronavirus pandemic, our challenge is to move faster than a very fast-moving problem. Changing the law could help.
The estimated 12-to-18-month timeframe for getting a vaccine to market is largely because of safety and efficacy testing required by the Food and Drug Administration. Legislation could shorten that timeframe without compromising the science — if the testing process tolerates more risk on volunteer study participants.
The FDA’s long-standing approval process places a premium on keeping human subjects safe. For most problems, this represents a prudent calibration of risks and benefits. For the coronavirus, however, the tradeoffs are different. The general public faces imminent danger from a virus capable of exponential growth.
Over the years, Congress has repeatedly, and rightly, stepped in with legislation to speed the process. Now, Congress should act to sharpen the curve of innovation against covid-19 by pushing the FDA to suspend its rules and practices and navigate according to the judgment of its experts.
Regular FDA approval processes begin human testing with a phase-one trial that must run its course with a small number of subjects — studying safety before enrolling subjects for larger phase-two and phase-three trials to assess a vaccine’s effectiveness. Yet clinical trial phases that are typically sequential could be combined or overlapped.
Collapsing trial phases without compromising scientific standards will require exposing more individuals to uncertain risk. Yet to do otherwise in a rapidly expanding pandemic leaves the global population exposed to a bureaucratically protracted period of pandemic risk without medical mitigation.
In the current crisis, it is ethically defensible to expedite clinical research with the cooperation of well-informed and consenting clinical subjects. There is no “safe” choice; it’s a risk-risk tradeoff — a question of more risk for research subjects or a longer wait for an approved vaccine.
We should respect the will of selfless individuals to knowingly take on the risks of investigational vaccines as an act of service for the sake of ending the pandemic.
Eric. E Johnson is an associate professor of law at University of Oklahoma College of Law. Theodore C. Bailey is chief of the Division of Infectious Disease at Greater Baltimore Medical Center.