We must be able to trust the FDA vaccine approval process

Susan R. Bailey, MD , Past President

The introduction of a safe and effective COVID-19 vaccine is an essential element in ending this devastating global pandemic. Both physicians and the public must have confidence that efforts to speed vaccine development have not interfered with a thorough, evidence-based review of vaccine candidates, or standards for safety and efficacy.

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As an allergist/immunologist for 30 years, I know firsthand the critical role physicians play as vaccine ambassadors for our patients. We need to assure them that a vaccine is not only safe and effective, but has undergone a rigorous review before being made available to the public. As much as we are all eager to see an end to the COVID-19 pandemic, we need to be reassured that the appropriate safeguards are in place despite the accelerated timeline for a COVID vaccine. We also know that you have many questions, and perhaps a few concerns, about the vaccine approval process.

Providing transparency into the vaccine approval, allocation and distribution processes is the goal of two AMA webinars that we are hosting along with the Food and Drug Administration, the Centers for Disease Control and Prevention, and the National Institutes of Health. The webinar with the FDA was held Oct. 7, and the second webinar, with the CDC, is set for Oct. 13. Registration for the second session is open now.



Trust and confidence in the regulatory review process for COVID-19 vaccines are critically important to widespread acceptance and broad uptake of the vaccine. The absence of trust will likely increase vaccine hesitancy already present in our society due to misinformation and other factors.

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Our ongoing experience with COVID-19 triggers multiple emotions, including anxiety and confidence. We are anxious that we may contract the virus or that it may strike those we care about. We take evidence-based precautions—wearing a mask, maintaining physical distance, washing our hands and limiting the time we spend indoors with others—with a degree of confidence that these steps will reduce the risk of infection and slow the overall spread of the virus.

The interplay between anxiety and confidence extends to the development and approval of vaccines that will safely and effectively protect us against COVID-19, with the hopes that a vaccine will eventually bring the SARS-CoV-2 virus under control in the same way a polio vaccine brought that virus under control a half-century ago. Back then, the polio vaccine developed by Jonas Salk, MD and his team was welcomed as the scientific marvel of the age; parents and children lined up for blocks to become immunized. The anxiety over contracting polio was overcome by public confidence trust in a vaccine, and that dreaded viral disease disappeared from the U.S. landscape by the 1970s.

Hesitancy and confidence remain in play today. The expedited process to develop a safe and effective COVID-19 vaccine must not be compromised in any way by political influence or any consideration that lies outside of evidence-based science. Lives are at stake, and the confidence needed to spur widespread public acceptance of this vaccine must not be jeopardized. Our collective response to this pandemic must be unified and based on scientific evidence. Science will defeat this virus, but we cannot wage war against science and hope to prevail.

For most of this year, the U.S. Food and Drug Administration and the National Institutes of Health have been working closely with pharmaceutical manufacturers and others to develop a COVID-19 vaccine, and phase 3 trials are well underway for multiple candidates. I trust that career scientists at the FDA—such as Peter Marks, MD, PhD, who directs the agency’s Center for Biologics Evaluation and Research—will observe scientific protocols throughout the vaccine approval process so that all of us can be fully confident in the final result.

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Ours is a different time, to be sure, a time when anxiety threatens to overcome confidence. And when the discussion turns to vaccines, I am saddened to see misinformation and disinformation about vaccine safety. The truth is that vaccines are one of the greatest advances in public health that modern medicine has ever achieved.

FDA experts continue to assure us that they will continue to follow a rigorous, fully transparent and evidence-based process to deliver a safe and effective vaccine against this virus, and we must continue to do what physicians have always done–-review the evidence and trust the science.