Opinion: Warp Speed to a united or divided America? COVID-19 vaccine trials must include at-risk groups

By Upendra Marathi and Lionel D. Lewis Aug. 3, 2020

This summer and fall thousands of people will volunteer to be research participants in Phase 3 trials of the U.S. government’s five vaccine candidates aimed at minimizing the spread of SARS-CoV-2, the virus responsible for the COVID-19 pandemic.

The goal of the government’s effort, Operation Warp Speed, is to begin inoculating people in 2021, an ambitious schedule reflecting time is of the essence. As of Monday, the virus had infected 18 million people worldwide and killed nearly 689,000 in just nine months. The United States led all nations with 4.75 million COVID-19 cases and 157,000 deaths.

To achieve its goal, the government is paying the biopharmaceutical industry for a remarkable effort to decrease vaccine development times from years to months. But it also raises concerns because the enrollment of research participants could favor speed over diligence of including those most at risk of dying from the disease.

The U.S. Centers for Disease Control and Prevention (CDC) reports Black people, Hispanics, Latinos and Native Americans have suffered higher rates of severe illness and death than white people. The CDC also notes adults over 60 are at greater risk of death than younger people because of age-related conditions.

The U.S. Food and Drug Administration (FDA), which regulates clinical trials of investigational agents, issued guidance in May, urging biopharmaceutical industry sponsors to include these at-risk population groups. The FDA guidance, however, is not a requirement.

To encourage participation, drug makers and the U.S. government should commit to making the vaccines accessible and affordable to everyone and to ensuring at-risk people are among the first protected.

The FDA also should require industry sponsors to report publicly and periodically during the trials on the demographics of the research participants enrolled in federally funded Phase 3 vaccine studies. Institutional review boards, which oversee clinical trials to ensure ethical treatment of research participants, could collect this information to ensure that racial, ethnic, gender and age disparities are minimized.

Medical and scientific experts all recognize participation of the most at-risk groups is essential to ensure the vaccines will benefit them. However, minority groups traditionally are underrepresented in clinical trials, in part, because disparities in health care and past abuses in medical research on these minority groups have created mistrust. Senior citizens’ underlying illnesses, which make them more vulnerable, also make it risky for them to participate in trials of an unproven vaccine.

It will take a concerted effort by industry sponsors to follow the FDA guidance. However, past practice doesn’t bode well for success. In a 2019 report, the FDA found that participants in all clinical trials for approval of 48 new drugs were predominantly white. Houston is among the clinical trial sites for the vaccines. Its population is 22.5 percent Black, 44.8 percent Hispanic or Latino, 6.9 percent Asian, and 10.3 percent 65 and older. The challenge to engage these population groups should be embraced, and not sidelined for the sake of speeding vaccine candidates to market.

Faced with this dangerous pandemic killing so many, participating in the vaccine trials would seem an easy choice, particularly for those most at risk. But the political divisiveness in America and racial disparities exposed by the virus have exacerbated suspicions and will require extra effort to overcome.

Development of vaccines to end the coronavirus pandemic should be a 1969-style moon landing moment, bringing people together in an uplifting celebration of an extraordinary achievement. In the end, however, such success and pride of accomplishment in defeating COVID-19 will depend on proof that all people will have the opportunity to benefit.

Marathi is the CEO and Lewis is the chief medical officer of 7 Hills Pharma, a Houston-based company developing a unique immunostimulant to improve the effectiveness of SARS-CoV-2 vaccinations.

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