By: RADM Richardae Araojo, Pharm.D., M.S., Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity, and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research
Each April we celebrate National Minority Health Month and this year’s theme is “Vaccine Ready.” There are many questions about how we effectively diagnose, treat, and prevent COVID-19, which continues to disproportionately impact racial and ethnic minority communities, Tribal communities, and other diverse groups. Many Black and Hispanic Americans have been getting vaccinated against COVID-19 at lower rates than white Americans, but are more likely to contract COVID-19, be hospitalized, and die from the disease.
The U.S. Food and Drug Administration has been working around the clock with our U.S. government partners, our international partners, and medical product manufacturers to address the COVID-19 pandemic. The issuance of emergency use authorizations (EUAs) for three new COVID-19 vaccines from Pfizer-BioNTech, Moderna, and Janssen were welcomed milestones. Issuing these EUAs is a major public health step to help end this pandemic, but we know many communities have questions about the safety and efficacy of these vaccines. Unfortunately, many racial and ethnic minorities continue to also be the target of misinformation and disinformation related to COVID-19.
The FDA takes very seriously our obligation to adhere to the regulatory review process. All the authorized vaccines were tested in clinical trials that included thousands of participants from racial and ethnic minority, American Indian and Alaska Native, and other diverse communities. The FDA’s Center for Biologics Evaluation and Research (CBER) is responsible for regulating vaccines and has been integral in overseeing the process to develop and authorize the vaccines to prevent COVID-19, working with manufacturers in order to get the vaccines to the public as quickly as possible, while adhering to the FDA’s rigorous scientific and regulatory review process. As part of the vaccine development process, the FDA expects vaccine developers to follow the FDA’s rigorous scientific and regulatory process. The FDA will only approve or authorize a vaccine for emergency use if it meets the FDA’s rigorous standards for safety and effectiveness. We have a dedicated group of career scientists that reflect our nation’s diversity reviewing the medical product applications to make sound, scientific decisions about these vaccines. These career staff are globally recognized as experts in vaccine development, clinical trials, and data analysis.
The FDA has not and will not sacrifice scientific integrity to bring a medical product to the market. As part of the process for the EUAs, CBER also sought input from the Vaccines and Related Biological Products Advisory Committee. This committee is made up of independent experts in fields related to vaccine development, policy, safety, evaluation, and data analysis. Over the past year, this committee has met publicly to discuss the development of COVID-19 vaccines and to review the data for each of the vaccines that have been authorized for emergency use.
CBER is working hand-in-hand with the FDA’s Office of Minority Health and Health Equity (OMHHE) to address concerns about vaccines among diverse communities. OMHHE is in turn committed to protecting and promoting the health of diverse populations by focusing its efforts on research and outreach and communication strategies that address health disparities. During the COVID-19 Pandemic, OMHHE has been swift to collaboratively engage with the FDA Centers/Offices and external stakeholders to better understand and address the needs of racial and ethnic minority communities. Specific efforts to address vaccine confidence concerns include the following:
- Holding listening sessions with diverse health professional organizations and other stakeholders to learn more about the gaps and needs of racial and ethnic minority communities and to share information on COVID-19 activities;
- Building awareness about clinical trial diversity (clinical trials are how medical products like vaccines get to the market);
- Providing weekly COVID-19 communications to our stakeholders;
- Supporting development and translation of information for the COVID-19 Multilingual Resources webpage that features a growing collection of educational materials in more than 20 languages including Spanish, Simplified Chinese, Korean, and Vietnamese. These educational materials provide information and details on pertinent COVID-19 topics such as social distancing, diagnostic testing, vaccine development, fraudulent medical products, blood and plasma donation, and EUAs.
- Launching a COVID-19 Bilingual (English/Spanish) Social Media Toolkit. This shareable toolkit allows stakeholders to have ready to use messages that can be shared with their community to ensure accurate and consistent messaging.
- Releasing videos in English and Spanish that talk about the importance of getting vaccinated; and,
- Hosting a webinar to shed light on the vaccine approval process and key information for minority communities to be aware of.
The FDA is committed to addressing health disparities and making health equity a reality. The COVID-19 pandemic requires all of us to work together and bring our collective expertise and wisdom to help end this pandemic. The sooner we all get vaccinated (once a vaccine becomes available to you), the sooner we can get back to doing the things we love and enjoy.
For more information about OMHHE, visit www.fda.gov/healthequity.
For more information about CBER, visit https://www.fda.gov/about-fda/fda-organization/center-biologics-evaluation-and-research-cber.
For more information about COVID-19, visit www.fda.gov/coronavirus or www.fda.gov/covid19vaccines.