Senators Urge Pharmaceutical Companies to Prioritize Diversity in COVID-19 Vaccine Trials

New Jersey Senators Cory Booker and Bob Menendez have urged 15 pharmaceutical companies engaged in COVID-19 related work to prioritize diversity in vaccine or trial development, citing the disproportionate impact of the pandemic on communities of color and other minority groups. The senators argue that comprehensive demographic and racial data are crucial to ensure new treatments work for all Americans, and that the private sector must take proactive steps to enroll a diverse set of participants in COVID-19-related trials.

Key Takeaways:

  • The COVID-19 pandemic has disproportionately affected communities of color and other minority groups, with alarming research showing that African Americans represent 12% of the national population but only 5% of all clinical trial participants, and Hispanics make up 1% of clinical trial participants despite comprising 16% of the national population.
  • The senators argue that clinical trials for vaccines and therapeutic treatments of COVID-19 must include participants that racially, socioeconomically, and otherwise demographically represent the United States.
  • The Food and Drug Administration (FDA) has issued guidance on the collection of race and ethnicity data in clinical trials and created a Minorities in Clinical Trials Initiative to address the underrepresentation of minority populations in clinical trials.
  • In New Jersey, Hispanics and African Americans account for 25.8% and 25.7% of COVID-19 cases, respectively, despite making up only 20.6% and 15% of the state's population, respectively.
  • In Chicago, African American residents have died at a rate six times that of whites, and in Michigan, African Americans account for 13.4% of the population but make up a disproportionate 33% of COVID-19 cases and 40% of deaths.
  • The senators urge pharmaceutical companies to examine new and creative ways to enroll a diverse set of participants in COVID-19-related trials, such as reducing barriers to clinical trials, utilizing diverse clinical trial personnel, ensuring language accessibility, and investing in participant recruitment by partnering with minority health and community advocacy groups.

Statistics:

  • African Americans represent 12% of the national population but only 5% of all clinical trial participants (Source: Senate letter).
  • Hispanics comprise 16% of the national population but make up only 1% of clinical trial participants (Source: Senate letter).
  • In New Jersey, Hispanics and African Americans account for 25.8% and 25.7% of COVID-19 cases, respectively (Source: Senate letter).
  • In Chicago, African American residents have died at a rate six times that of whites (Source: Washington Post analysis).
  • In Michigan, African Americans account for 13.4% of the population but make up a disproportionate 33% of COVID-19 cases and 40% of deaths (Source: Senate letter).

Sources:

  • Senate letter to pharmaceutical companies (no date)
  • Washington Post analysis (no date)
  • Senate letter to Trump Administration (no date)
  • FDA guidance on the collection of race and ethnicity data in clinical trials (no date)
  • Minorities in Clinical Trials Initiative (no date)