I have worked in public health for 20 years and in tobacco regulation at the Food and Drug Administration for 10 of those years. As a public health
I have worked in public health for 20 years and in tobacco regulation at the Food and Drug Administration for 10 of those years. As a public health professional, I know vaccines are one of the safest, most powerful tools medicine has to prevent disease. And yet, I had concerns about a COVID-19 vaccine.
That is, until I saw the FDA’s rigorous review process first-hand.
As COVID-19 vaccines have become a reality, many members of racial and ethnic minorities and underserved communities in the United states have voiced their hesitancy to take a new vaccine. I know how they feel.
I am an African American woman with a severe physical disability that occurred following a devastating natural gas explosion at my home. It left me paralyzed and with lasting health issues.
So, as a disabled woman of color, I understand on a personal level why members of these populations may feel hesitant to receive a new vaccine.
Since the earliest days of the pandemic, I have had the opportunity to work with the FDA’s COVID-19 response team to educate public health, nonprofit and consumer stakeholders about our role in fighting COVID-19.
Many of my colleagues have missed precious time with their families to make sure people living in the United States had the tools to fight COVID-19. And I have been so proud of our hard work.
My personal and professional lives merged when my beloved younger sister was diagnosed with COVID-19 and almost died during her 54-day hospital stay. During the day, I would develop materials for health care professionals to communicate about the therapies to help fight COVID-19. At night, I would be on the phone relaying my sister’s care and prognosis to the family.
When the FDA issued two Emergency Use Authorizations for vaccines to prevent COVID-19, I was nothing short of relieved.
When theory met reality, I was forced to think differently, and my former hesitancy and fear grew into hope and a willingness to receive a COVID-19 vaccine once I am eligible for it.
FDA conducted thorough review
Working on the COVID-19 response team, I saw the many careful steps the FDA took to ensure that COVID-19 vaccines were developed and reviewed efficiently, but with the same high standards used to develop and review other vaccines.
As part of the agency’s commitment to transparency, the FDA issued two guidance documents providing recommendations for vaccine developers regarding the nonclinical, clinical and manufacturing data needed to support emergency use authorization or approval of a COVID-19 vaccine. I know that the FDA encouraged manufacturers to ensure that ethnic and racial diversity was represented in the clinical trials for COVID-19 vaccines.
When it was time to review potential vaccine candidates, the agency engaged in a thorough, transparent review process of the available data that included input from outside scientific and public health experts — which was livestreamed for the public— before the agency’s scientists determined whether to authorize the vaccines. The transparency helped me feel comfortable that the COVID-19 vaccines met the FDA’s rigorous standards for quality, safety and effectiveness.
I also know that for the past several months, FDA scientists and physicians reviewing requests for an EUA for the COVID-19 vaccines have been committed to adhering to the FDA’s rigorous scientific standards for safety and effectiveness. These scientists concluded, among other things, that the known and potential benefits of these vaccines outweigh their known and potential risks, supporting the use of these vaccines in millions of people, including healthy individuals. The FDA has also developed plans for continued follow-up to monitor for any potential safety concerns.
And I have joined discussions in which agency officials met with public health, nonprofit and consumer leaders, including minority stakeholders, to make sure their members and consumers understood the agency’s science- and evidence-based approach to making COVID-19 vaccines available quickly without cutting any corners.
Vaccines can help end pandemic
For many of us, this pandemic has changed the way we approach daily life. I’m hopeful it also has changed the way many people approach vaccines. I understand the fears in communities of color and the disability community, and the distrust of the medical system. But I am no longer afraid of receiving a COVID-19 vaccine.
Get the vaccine. Please. Do it for your family. Do it for your friends. Most important, do it for yourself. When everyone gets vaccinated, we can help bring an end to this pandemic.
Tamara Maze is a health communications specialist with the FDA’s Center for Tobacco Products.