Scientists at the Food and Drug Administration (FDA) have devoted countless hours to ensuring that the COVID-19 vaccines being deployed and those in the development pipeline are safe and effective. But it’s another task being done outside of the lab that’s growing in importance—helping to ensure public confidence in vaccines.

What doctors wish patients knew

Keep patients up-to-date on how to safely navigate the pandemic with insights from physician colleagues in this special edition of AMA Moving Medicine.

“Ultimately, all of what we do is for naught if people aren't willing to take the vaccines that come through the development process,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

Dr. Marks made his comments while appearing with AMA President Susan R. Bailey, MD, in the fifth installment of an AMA-hosted "COVID-19: What physicians Need to Know" webinar series to discuss current issues and next steps in vaccine safety and delivery.

Dr. Bailey, a Fort Worth-based allergist and immunologist, began the program by paying tribute to front-line health care workers and to those behind the scenes racing to develop vaccines that could end the pandemic.

“Despite the hope that comes with safe and effective vaccines for COVID-19 that are in the early stages of distribution, the case numbers continue to exhaust our hospitals and ICUs and put physicians and other health care workers at serious risk,” Dr. Bailey said. “They are truly the heroes of this moment, but so too are the scientists and researchers who have been working and continue to work around the clock to develop safe and effective vaccines in record time.”

Read why Dr. Bailey says the effort to restore trust in science must begin now.

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In addition to the role it’s most known for—ensuring the safety and efficacy of vaccines and other drugs—Dr. Marks shared how the FDA collaborates with the Centers for Disease Control and Prevention in monitoring for any adverse events that are revealed after pharmaceutical products are approved. The agency is also working to improve vaccine technology and learning how to make vaccines in a more efficient and effective manner.

Despite these efforts, there is growing skepticism about vaccines. A research letter published by JAMA in early December reported on a national survey that found only 56% of respondents said they were somewhat or very likely to get a COVID-19 vaccination.

“It has not escaped us that vaccine confidence is very much something that, over the past few years, has dipped downwards,” Dr. Marks.

So, in addition to its scientific workload, the FDA has endeavored to learn and address public concerns about COVID-19 vaccines and the accelerated emergency use authorization process. It engaged in a series of listening sessions conducted with the Reagan-Udall Foundation, an independent nonprofit corporation created to advance the FDA’s mission.

Called the “COVID-19 Vaccine Confidence Project,” the effort developed a series of messages that were then tested for effectiveness. Top-performing messages included:

  • The FDA is publicly sharing information about COVID-19 vaccines so you can see the evidence for yourself.
  • Only safe and effective COVID-19 vaccines that have been rigorously tested on tens of thousands of volunteers will be approved.
  • Scientists and career public health officials, not politicians or their appointees, will decide when a COVID-19 vaccine is safe, effective, and ready for public use.

The messages that resonated most broadly were these:

  • By getting a COVID-19 vaccine, you are protecting yourself, your children, parents, grandparents, and other loved ones.
  • COVID-19 vaccine development is moving faster than normal because the medical and scientific community have made it their highest priority, not because any steps have been skipped.

Vaccines were rapidly developed because the “white space” was taken out of the vaccine-development process, Dr. Marks said, explaining that the months-long waits that typically take place between stages of the development process were eliminated and vaccine manufacturing began when approval seemed likely, not when it was granted.

He added that, by creating this streamlined process, the FDA is more nimble and it should be able to pivot quickly if vaccines need to be adjusted to combat emerging and more virulent strains of the coronavirus.

Learn more with the AMA about COVID-19 and vaccine development.

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While the first two FDA-authorized COVID-19 vaccines achieved around 95% efficacy in clinical trials and subsequent vaccines may have a rate that is lower, Dr. Marks said these candidates for FDA authorized may have other qualities that make them attractive such as easier storage or fewer side effects.

Other qualities might include being more effective with certain populations or achieving efficacy with only one dose.

“When you're in a situation like we are now with so much uncertainty, and with so much need to get this pandemic under control, I think we can't ignore any tool in the tool chest,” he said.

Dr. Marks also discouraged any movement to only get one dose of a vaccine that requires a two-dose regimen.

“Why mess with success?” he asked. “You've got something that’s really working well. I think most of us were really incredibly happy to see, beyond some of our highest expectations, really high efficacy rates with these mRNA vaccines. We should try to keep them up there by giving them appropriately.”

Dr. Marks added that the concept of not completing the full regimen for the vaccines “personally disturbs” him because some people have interpreted the data as showing that one dose offers protection—even though there is no way of knowing how long that protection will last as most people in the clinical trials received two shots.

Watch as Dr. Bailey recaps the webinar discussion with Dr. Marks in a recent episode of the “AMA COVID-19 Update.”

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