The Food and Drug Administration is preparing for the eventual rollout of one or more COVID-19 vaccines — by identifying the concerns that some people have about taking such a vaccine.
At a meeting Thursday of experts advising the FDA on COVID-19 vaccines, the concerns of front-line workers and people of color were read aloud verbatim, highlighting the crucial project of communicating the safety and effectiveness of a vaccine in an environment of deep political distrust.
Those concerns were gathered at a series of listening sessions organized by the Reagan-Udall Foundation, a nonprofit that aims to advance the work of the FDA.
Susan Winckler, the foundation's CEO, noted that its study was rather narrow, with a focus on the role of the FDA in vaccine review and approval.
Nonetheless, participants in the sessions voiced a range of concerns:
- "I would not be first in line and I would want to see some data."
- "When I hear the FDA say they have a particular process, but then I hear the White House say they can cut it in half or negate it – it brings more distrust."
- "We are not going to be guinea pigs again."
- "African Americans are treated differently by doctors."
- "I am looking for an organization I can trust that does not have a tainted history and has not been bought out by some big pharma."
The listening sessions focused on two groups. One was front-line workers in service, retail and health care settings. The second focused on people who are often underrepresented and are at increased risk for COVID-19: Black, Hispanic and Indigenous/Native American communities.
Eight such sessions have been conducted so far, and a few more are slated for the coming weeks. The foundation said its goal is to understand the perceptions that may lead Americans to feel hesitant about receiving a COVID-19 vaccine – and to use that information to craft messaging that addresses those concerns.
Winckler noted that the participants' concerns often shared certain themes: concerns about the speed of the process, distrust of government and government agencies, distrust of the health care system, and concern that politics and economics will be prioritized over science.
People of color also voiced worries that the vaccine won't work for minority populations. Among their statements:
- "Need to know other minorities have taken it. Are other minorities ok? We're all built different. How do we know?"
- "I need to know that all the minorities who took it are okay. I need to know it works for everybody. I am not trying to be harmed."
Participants also expressed fears based on past experiences. One person expressed a worry that "this is another Tuskegee experiment."
Vaccine hesitancy was a frequent topic at Thursday's FDA meeting — recognition that the introduction of COVID-19 vaccines will be a nationwide communications effort as much as a scientific one.
The FDA meeting was one effort to demonstrate that the vaccine development process in the U.S. is safe and is being handled with great care and transparency.
Marion Gruber, director of the FDA's Office of Vaccines Research and Review, said that development of a vaccine is happening as quickly as it can – but no faster.
"Vaccine development can be expedited," she said. "However, I want to stress that it cannot and must not be rushed."