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How to prevent racial and ethnic disparities with a COVID-19 vaccine

How to prevent racial and ethnic disparities with a COVID-19 vaccine
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The vaccine race is sprinting ahead with 199 entrants vying for a medal. But in this contest, finishing first doesn't always mean you win since a new drug may work for some people but not others. If the vaccine testing process doesn't measure how it works for each person's race, ethnicity, sex, or other characteristics, the competition will be a flop. And right now, that could be where we are heading.

The opportunity is real. Precision medicine is a new effort to reduce the uncertainty over whether a drug will work for specific people. As part of this, each patient's biological makeup, including their genes, helps determine the best therapy for them. For this promising approach to work, however, we need to know how different drugs affected different people during clinical trials. For example, what if one vaccine worked well for white women but not Black women? That knowledge would help the health care community ensure people get the right medicine for their needs, allowing us to beat this pandemic far faster and more efficiently.

But, unfortunately, we are not guaranteed that knowledge. The federal government is not requiring basic demographic information to be collected during a clinical trial. Currently, the Department of Health and Human Services (HHS) is side-stepping a 1993 law, which requires that clinical trials be designed and carried out to provide valid analysis of how the trial affects women or members of minority groups differently from other subjects in the trial.

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As recently as June 2020, the Food and Drug Administration (FDA) said that it only "strongly recommends" inclusion of affected groups for COVID-19 vaccine trials. Although drug companies may be collecting this information voluntarily, without a guarantee COVID-19 vaccine clinical trials that fully include and produce findings for affected groups, we may not know about differences in safety and effectiveness. These differences should not be discovered later during the wide distribution of a vaccine.

With a new and evolving health threat in COVID-19, we need the best information promptly. We need to know what is happening under what conditions and to whom. This level of specificity is the only way to develop countermeasures that work. We need to be able to target our interventions and do so effectively; we have first to know who is getting ill and how and then to include them in a meaningful way in our efforts to address the problem.

This data is also critical to ensure confidence in a new vaccine. Polls show that Hispanics (37 percent) and non-Hispanic Blacks (25 percent) are less likely than non-Hispanic whites (56 percent) to report that they plan to get vaccinated against coronavirus. This distrust will only be exacerbated if vaccine trials cannot adequately include and report specific safety and effectiveness data for affected groups.

History shows that prioritizing and studying demographic data leads to better health outcomes. In 1985, a government Task Force on Black and Minority Health documented Hispanics' lack of mortality data. Up until then, there was no information on how many Hispanics died each year. Based on that report, death certificates were modified to include an option to identify the person as Hispanic. The new data fundamentally changed the view of Hispanic's health, allowing the health community to rethink care for that population.

We must do everything possible to measure and evaluate who vaccines will help. To do that, the Food and Drug Administration, who oversees the clinical testing process, should mandate that trials be carried out following principles of Community Based Participatory Research, which are designed to produce scientifically valid results for racial and ethnic groups, women, and persons with multiple chronic conditions or disabilities. That would make the FDA consistent with the 1993 law and HHS policy on the inclusion of race and ethnicity. The types of information we collect is also a reflection of what is important to us. It is a value statement about including everyone in America in our shared health needs and goals.

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Decades of research have provided ample evidence that necessary demographic information like race, ethnicity, age, and gender is essential to compiling meaningful information about the effectiveness of testing and other public health efforts. The government's failure to require it for the vaccine trials is not good for science and does not ensure an effective vaccine. We deserve better for the nation's investment of tens of billions of dollars.

Inadequate care is expensive and injures the very people who trust us with their health. When we have good information, we can tease out what is happening in each community and effectively mobilize the limited health care dollars to ensure the best health for all. It is long past time to guarantee that clinical trials of vaccines and treatments for COVID-19 reflect the great diversity in our country.

Jane L. Delgado, Ph.D., MS, is the president and CEO of the Healthy Americas Foundation and National Alliance for Hispanic Health. David Kendall is a senior fellow for Health and Fiscal Policy at Third Way.