{"database": "press", "table": "releases", "rows": [["https://www.menendez.senate.gov/newsroom/press/menendez-smith-lead-push-to-make-sure-covid-19-vaccine-clinical-trials-continue-to-enroll-diverse-participants", "Menendez, Smith Lead Push to Make Sure COVID-19 Vaccine Clinical Trials Continue to Enroll Diverse ParticipantsRead More", "2020-12-17", "2020", "2020-12", "Democrat", "House", "NJ", "Robert Menendez", "M000639", "www.menendez.senate.gov", null, null, "legacy", "WASHINGTON,\r\nD.C.  U.S. Senators Bob Menendez (D-N.J.) and Tina Smith (D-Minn.) today led a\r\ngroup of their Senate colleagues in calling on the U.S. Department of Health\r\nand Human Services (HHS), the Food and Drug Administration (FDA) Operation Warp\r\nSpeed and the U.S. Army Material Command (AMC) to make sure COVID-19 vaccine\r\nclinical trials continue to enroll a diverse group of participants. In addition to\r\nunderscoring this priority, the lawmakers are urging HHS Secretary Alex Azar,\r\nFDA Commissioner Stephen Hahn, Operation Warp Speed Chief Advisor Moncef Slaoui\r\nand General Gustave Perna to provide information on the demographics of current\r\nand future Phase III COVID-19 vaccine trial participants. COVID-19 has\r\ndisproportionately harmed communities of color. Compared to white Americans,\r\nBlack Americans are one and a half times more likely to contract COVID-19, over\r\nthree and a half times more likely to be hospitalized, and nearly three times\r\nas likely to die from the disease, wrote the lawmakers. Americans of\r\ncolor are also more likely to develop severe COVID-19, requiring\r\nhospitalization. Hispanic and Latino Americans are hospitalized at a rate over\r\nfour times higher than non-Hispanic white Americans, and American Indian and\r\nAlaska Native people who contract COVID-19 are four times more likely to be\r\nhospitalized than white Americans.Given this\r\ndisparate impact, FDA and public health officials have stressed the need for\r\nclinical trials to enroll diverse populations. Clinical trials should enroll\r\ndiverse participants to confirm that COVID-19 vaccine candidates are safe and\r\neffective for Americans of all racial and ethnic backgrounds, the letter\r\ncontinued. Diverse clinical trial participation also builds vaccine\r\nconfidence, which is critical in light of the United States' history of medical\r\nresearch exploitation and discrimination against minority patients. The letter was\r\nalso signed by Sens. Amy Klobuchar (D-Minn.), Chris Van Hollen (D-Md.),\r\nElizabeth Warren (D-Mass.), Cory Booker (D-N.J.), Sherrod Brown (D-Ohio), Jeff\r\nMerkley (D-Ore.) and Gary Peters (D-Mich.). Dear\r\nSecretary Azar, Commissioner Hahn, General Perna, and Dr. Slaoui:  We\r\nare writing to request information on how the Food and Drug Administration\r\n(FDA) and Operation Warp Speed (OWS) are ensuring that clinical trials for the\r\ndevelopment of vaccines against SARS-CoV-2 will continue to enroll participants\r\nin ways that are representative of the American population and reflect the\r\ndiffering risk of exposure and health outcomes across communities.  COVID-19\r\nhas disproportionately harmed communities of color. Compared to white\r\nAmericans, Black Americans are one and a half times more likely to contract\r\nCOVID-19, over three and a half times more likely to be hospitalized, and\r\nnearly three times as likely to die from the disease. Americans of color are\r\nalso more likely to develop severe COVID-19, requiring hospitalization.\r\nHispanic and Latino Americans are hospitalized at a rate over four times higher\r\nthan non-Hispanic white Americans, and American Indian and Alaska Native people\r\nwho contract COVID-19 are four times more likely to be hospitalized than white\r\nAmericans.  Given this\r\ndisparate impact, FDA and public health officials have stressed the need for\r\nclinical trials to enroll diverse populations. Clinical trials should enroll\r\ndiverse participants to confirm that COVID-19 vaccine candidates are safe and\r\neffective for Americans of all racial and ethnic backgrounds. Diverse clinical\r\ntrial participation also builds vaccine confidence, which is critical in light\r\nof the United States' history of medical research exploitation and\r\ndiscrimination against minority patients. Pfizer and Moderna have provided\r\npublic information about the demographics of participants enrolled in the Phase\r\nIII clinical trials for their COVID-19 vaccine candidates. Among Pfizer's U.S.\r\nparticipants, 30 percent were from racially and ethnically diverse\r\nbackgrounds, and 37 percent of Moderna's participants were from racial and\r\nethnic minority groups. While these two companies have been transparent about the\r\ndemographics of their COVID-19 vaccine clinical trial participants, comparable\r\nlevels of transparency have not occurred with all COVID-19 vaccine candidates.\r\nThe initial announcement on the effectiveness of the COVID-19 vaccine candidate\r\ndeveloped by AstraZeneca and the University of Oxford did not include\r\ndemographic data. Demographic information was only made publicly available\r\nafter publication in an academic journal and did not include the demographic\r\ninformation of U.S. participants. Similarly, public information on the progress\r\nand participant demographics of trials for COVID-19 vaccine candidates\r\ndeveloped by Janssen/Johnson & Johnson, Novavax, Sanofi/GlaxoSmithKline,\r\nand Merck/International AIDS Vaccine Initiative, which are the other candidates\r\nsupported by OWS (according to public reports), remains limited or\r\ninaccessible. \r\nThese other candidates also need to be demonstrated as effective in diverse\r\npopulations in order to build trust in their safety and efficacy. This is\r\nespecially important as experts predict multiple COVID-19 vaccines may be\r\nneeded to ensure widespread immunization to end the pandemic.8 For these\r\nreasons, the federal government, acting through OWS and the FDA, should\r\nencourage COVID-19 vaccine developers to publicize demographic information of\r\nPhase III trial participants on a timely basis. While the FDA's investigational\r\nnew drug application requires demographic information to be submitted as part\r\nof annual reports, communities of color should not be forced to wait months or\r\nyears for such information. Additionally, the federal government should support\r\nCOVID-19 vaccine developers in their efforts to enroll diverse participants in\r\nongoing and future clinical trials. For example, OWS or FDA might provide best\r\npractices, technical assistance, or other support to companies as they work to\r\novercome clinical trial access barriers, ensure language accessibility, hire\r\ndiverse clinical personnel, and build effective community partnerships. \r\nIn the interim, we ask that you provide information on the demographics of\r\ncurrent and future Phase III COVID-19 vaccine trial participants in the United\r\nStates by responding to the questions below by January 4, 2021. 1. Operation Warp Speed was reported to be in contact with test sites during\r\nenrollment of Moderna's Phase III trial to ensure diverse representation of\r\ntrial participants.9 Are OWS or other federal agencies in contact with other\r\nCOVID-19 vaccine developers or the investigators at their test sites regarding\r\ndemographics of Phase III clinical trial participants? \r\n2. Do OWS, FDA, or other federal agencies have information on the demographics\r\nof participants in the Phase III clinical trials of other COVID-19 vaccine\r\ncandidates supported by OWS?  a. If yes,\r\nplease share the racial and ethnic demographics of these trial populations. We\r\nalso seek information on age and sex demographics.  b. If not, do\r\nOWS, FDA, or other federal agencies plan to request this information and make\r\nit public in the future?  3.\r\nWhat steps are OWS, FDA, and other federal agencies taking to ensure the\r\ndiversity of clinical trial participants in ongoing and future COVID-19 vaccine\r\ntrials? How are OWS, FDA, and other federal agencies supporting COVID-19\r\nvaccine developers in their efforts to enroll diverse participants?  4. How is OWS\r\nencouraging and supporting companies and researchers to address vaccine\r\nhesitancy in diverse communities when enrolling participants? Sincerely,   ###", 1, "2026-03-30T12:14:52Z", "2026-03-30T12:14:52Z"]], "columns": ["url", "title", "date", "year", "month", "party", "chamber", "state", "member_name", "bioguide_id", "domain", "scraper", "source", "date_source", "text", "has_text", "collected_at", "updated_at"], "primary_keys": ["url"], "primary_key_values": ["https://www.menendez.senate.gov/newsroom/press/menendez-smith-lead-push-to-make-sure-covid-19-vaccine-clinical-trials-continue-to-enroll-diverse-participants"], "units": {}, "query_ms": 1.5761880204081535, "source": "dwillis/congress-press", "source_url": "https://github.com/dwillis/congress-press", "license": "MIT", "license_url": "https://github.com/dwillis/congress-press/blob/main/LICENSE"}