Senators Call on Nation’s Top Health Agencies to Make Sure Clinical Trials Continue to Represent and Reflect Health Outcomes Across Communities

WASHINGTON, D.C. [12/17/20]—Today, U.S. Senators Tina Smith (D-Minn.) and Bob Menendez (D-N.J.) led a group of their Senate colleagues in calling on the U.S. Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), Operation Warp Speed and the U.S. Army Material Command (AMC) to make sure COVID-19 vaccine clinical trials continue to enroll a diverse group of participants.

In addition to underscoring this priority, Sens. Smith, Menendez and their colleagues are urging HHS Secretary Alex Azar, FDA Commissioner Stephen Hahn, Operation Warp Speed Chief Advisor Moncef Slaoui and General Gustave Perna to provide information on the demographics of current and future Phase III COVID-19 vaccine trial participants. 

“COVID-19 has disproportionately harmed communities of color. Compared to white Americans, Black Americans are one and a half times more likely to contract COVID-19, over three and a half times more likely to be hospitalized, and nearly three times as likely to die from the disease,” wrote the lawmakers. “Americans of color are also more likely to develop severe COVID-19, requiring hospitalization. Hispanic and Latino Americans are hospitalized at a rate over four times higher than non-Hispanic white Americans, and American Indian and Alaska Native people who contract COVID-19 are four times more likely to be hospitalized than white Americans.”

The senators continued: “Given this disparate impact, FDA and public health officials have stressed the need for clinical trials to enroll diverse populations. Clinical trials should enroll diverse participants to confirm that COVID-19 vaccine candidates are safe and effective for Americans of all racial and ethnic backgrounds. Diverse clinical trial participation also builds vaccine confidence, which is critical in light of the United States’ history of medical research exploitation and discrimination against minority patients.”

In addition to Sens. Smith and Menendez, the letter was signed by Sens. Amy Klobuchar (D-Minn.), Chris Van Hollen (D-Md.), Elizabeth Warren (D-Mass.), Cory Booker (D-N.J.), Sherrod Brown (D-Ohio), Jeff Merkley (D-Ore.) and Gary Peters (D-Mich.).

You can access full text of the letter below:

December 17, 2020

The Honorable Alex M. Azar II                     The Honorable Stephen Hahn, MD

Secretary of Health and Human Services       Commissioner

200 Independence Avenue, Southwest           Food and Drug Administration,
Washington, D.C. 20201                                Silver Spring, MD 20993

Dr. Moncef Slaoui                                          General Gustave F. Perna

Chief Advisor, Operation Warp Speed           Commanding General

Department of Health and Human Services   Army Materiel Command

200 Independence Avenue, Southwest           4400 Martin Road

Washington, DC 20201                                  Redstone Arsenal, AL 35898

Dear Secretary Azar, Commissioner Hahn, General Perna, and Dr. Slaoui:

We are writing to request information on how the Food and Drug Administration (FDA) and Operation Warp Speed (OWS) are ensuring that clinical trials for the development of vaccines against SARS-CoV-2 will continue to enroll participants in ways that are representative of the American population and reflect the differing risk of exposure and health outcomes across communities.

COVID-19 has disproportionately harmed communities of color. Compared to white Americans, Black Americans are one and a half times more likely to contract COVID-19, over three and a half times more likely to be hospitalized, and nearly three times as likely to die from the disease. Americans of color are also more likely to develop severe COVID-19, requiring hospitalization. Hispanic and Latino Americans are hospitalized at a rate over four times higher than non-Hispanic white Americans, and American Indian and Alaska Native people who contract COVID-19 are four times more likely to be hospitalized than white Americans.

Given this disparate impact, FDA and public health officials have stressed the need for clinical trials to enroll diverse populations. Clinical trials should enroll diverse participants to confirm that COVID-19 vaccine candidates are safe and effective for Americans of all racial and ethnic backgrounds. Diverse clinical trial participation also builds vaccine confidence, which is critical in light of the United States’ history of medical research exploitation and discrimination against minority patients. Pfizer and Moderna have provided public information about the demographics of participants enrolled in the Phase III clinical trials for their COVID-19 vaccine candidates. Among Pfizer’s U.S. participants, 30 percent were from “racially and ethnically diverse backgrounds,” and 37 percent of Moderna’s participants were from racial and ethnic minority groups. 

While these two companies have been transparent about the demographics of their COVID-19 vaccine clinical trial participants, comparable levels of transparency have not occurred with all COVID-19 vaccine candidates. The initial announcement on the effectiveness of the COVID-19 vaccine candidate developed by AstraZeneca and the University of Oxford did not include demographic data. Demographic information was only made publicly available after publication in an academic journal and did not include the demographic information of U.S. participants. Similarly, public information on the progress and participant demographics of trials for COVID-19 vaccine candidates developed by Janssen/Johnson & Johnson, Novavax, Sanofi/GlaxoSmithKline, and Merck/International AIDS Vaccine Initiative, which are the other candidates supported by OWS (according to public reports), remains limited or inaccessible.

These other candidates also need to be demonstrated as effective in diverse populations in order to build trust in their safety and efficacy. This is especially important as experts predict multiple COVID-19 vaccines may be needed to ensure widespread immunization to end the pandemic.8 For these reasons, the federal government, acting through OWS and the FDA, should encourage COVID-19 vaccine developers to publicize demographic information of Phase III trial participants on a timely basis. While the FDA’s investigational new drug application requires demographic information to be submitted as part of annual reports, communities of color should not be forced to wait months or years for such information. Additionally, the federal government should support COVID-19 vaccine developers in their efforts to enroll diverse participants in ongoing and future clinical trials. For example, OWS or FDA might provide best practices, technical assistance, or other support to companies as they work to overcome clinical trial access barriers, ensure language accessibility, hire diverse clinical personnel, and build effective community partnerships.

In the interim, we ask that you provide information on the demographics of current and future Phase III COVID-19 vaccine trial participants in the United States by responding to the questions below by January 4, 2021.

1. Operation Warp Speed was reported to be in contact with test sites during enrollment of Moderna’s Phase III trial to ensure diverse representation of trial participants.9 Are OWS or other federal agencies in contact with other COVID-19 vaccine developers or the investigators at their test sites regarding demographics of Phase III clinical trial participants?

2. Do OWS, FDA, or other federal agencies have information on the demographics of participants in the Phase III clinical trials of other COVID-19 vaccine candidates supported by OWS?

a. If yes, please share the racial and ethnic demographics of these trial populations. We also seek information on age and sex demographics.

b. If not, do OWS, FDA, or other federal agencies plan to request this information and make it public in the future?

3. What steps are OWS, FDA, and other federal agencies taking to ensure the diversity of clinical trial participants in ongoing and future COVID-19 vaccine trials? How are OWS, FDA, and other federal agencies supporting COVID-19 vaccine developers in their efforts to enroll diverse participants?

4. How is OWS encouraging and supporting companies and researchers to address vaccine hesitancy in diverse communities when enrolling participants?

Sincerely,

Issues