The FDA and Its EUAs

We have learned that science is a method, not a product.  Science begins with an educated guess which is proven true by a series of experiments designed to show that the guess is false.  If the hypothesis cannot be proven false, it is accepted as true by the community of scientists.  Now that we’ve waded up to our armpits in philosophy of science, let’s move back into shallow waters and consider the process by which our FDA approves new drugs, medical devices, and laboratory tests in the United States.

First, I am going to reveal a personal bias.  I believe that the United States has the safest healthcare system in the world for individual patients.  Notice I did not say most efficient, cost effective, or optimized for populations.  But if I am sick or injured, I want my healthcare delivered by U.S. trained doctors in U.S. hospitals using drugs, devices and tests approved by the U.S. FDA.   

The FDA has been disparaged for being too slow to approve new therapies and methods. True enough, the FDA’s priority is not speed.  Instead, the FDA’s mandate is safety.  The FDA conducts a thorough, time-consuming review of all details of science supporting an application for approval, granting approval only after all questions have been answered satisfactorily.  The FDA conducts post-market surveillance of approved drugs, devices and tests, mandating reporting of adverse outcomes.  The FDA’s slow, methodical pace keeps Americans safe.

The FDA does not conduct science.  Rather, the FDA performs quality control for science, validating the logic, analytics and data supporting the claims of products submitted for approval.  Therefore, FDA approval implies a level of trustworthiness akin to science.  But like science, FDA approval takes time.  Time is something we do not have in a pandemic.

Enter the Emergency Use Authorization, known as EUA.  When time is short, the FDA may allow unapproved medical products to be used to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives.  All SARS-CoV-2 tests have been made available by EUA.   Convalescent plasma is transfused under EUA.  Antibody treatments for COVID-19 are prescribed under EUA.  Remdesivir, Baricitinib and the their combination are first line treatments for severe COVID-19, available for use by EUA.  And COVID-19 vaccines released by Pfizer and Moderna have been made available by EUA.  None have been approved by the FDA.  The trust conferred by FDA approval should not be transferred to the tests, treatments, or vaccines we are using in the fight against COVID-19.

Are there reasons to believe that the vaccines are safe and effective?  Yes, and good ones too.  But as with any experimental treatment or product, risks of adverse outcomes are elevated.  Individuals must evaluate whether the risks–both known and unknown–are outweighed by the potential benefits of the vaccine. In a recent article published in the New England Journal of Medicine, Dr. Mariana Castells and Dr. Elizabeth Phillips articulately summarize the outstanding questions about the vaccines currently available:

“In the world of Covid-19 and vaccines, many questions remain. What are the correlates of protective immunity after natural infection or vaccination? How long will immunity last? Will widespread immunity limit the spread of the virus in the population? Which component of the vaccine is responsible for allergic reactions? Are some vaccines less likely than others to cause IgE- and non-IgE–mediated reactions? Careful vaccine-safety surveillance over time, paired with elucidation of mechanisms of adverse events across different SARS-CoV-2 vaccine platforms, will be needed to inform a strategic and systematic approach to vaccine safety.”

Some may criticize me for suggesting that the vaccine is not risk-free and that it may be better for some to wait before receiving their shot.  However, honesty is one of the foundational characteristics of science.  We must be willing to follow the data where it leads, even if it leads to a place we do not want to go.  It is dishonest to say that any COVID-19 vaccine has FDA approval; to say that possible adverse effects—short term and long term–have been fully evaluated by the scientific method; to say that the protective immunity imparted by vaccine has been fully studied scientifically; to say that vaccine will alter the course of the pandemic or any infected person’s disease.  I am not saying the vaccines will cause harm, but likewise we cannot say the vaccines will not cause harm.  

The vaccines available now are associated with the risks of the unknown.  For some that risk is worth taking; for others it is not.  Whether you decide to take the vaccine or to wait, keep doing what we know slows the spread of disease: mask up, keep apart, and isolate when exposed.