The United States, along with the rest of the world, has been pushing forward with full force on developing an effective COVID-19 vaccine. With 7 COVID-19 vaccine prospects in phase-three trials, and 17 in or having completed phase-two trials, [I] the idea of having a COVID-19 vaccine by the end of the year calls attention to an important tradeoff: rapid development versus effectiveness for diverse populations.
Given the rapidly evolving COVID-19 situation and the need for a vaccine increasing day-by-day, pressure is mounting for speed to be the priority. Yet the populations that have demonstrated a need for the vaccine the most are often excluded from clinical vaccine trials. This is often due to a lack of desired participation, lack of transportation options, and exclusion due to their underlying health conditions. [II]
Black Americans continue to die from and contract COVID-19 at much higher rates, [III] being over twice as likely to die from COVID-19 as White and Asian populations. [IV] Now many are asking whether we will see a heavier percentage of Black Americans in COVID-19 vaccine trials to account for this. For this to occur, however, trial participation rates for people of color would have to change drastically from the current rates. According to the FDA, while Black Americans make up 13.4% of the U.S. population, they only make up 5% of clinical trial participants. Latinos, while making up 18.1% of the population, only account for 1% of clinical trial participants. [V]
Another group that is not typically well represented in clinical trials is the elderly. The elderly are another group that has poorer outcomes from COVID. Immunocompromised individuals, those at greatest risk of poor outcomes from COVID-19, are usually those excluded from participating in vaccine trials due to their susceptibility to poor outcomes during clinical trials.
The FDA has released guidance that clinical vaccine trial “participation is especially low for certain populations, including adults age 75 or older and people from certain racial and ethnic groups. That’s why the FDA is encouraging more patients to participate in clinical trials, especially people of different ages, races, ethnic groups, and genders.” However, the FDA does not require that this guidance is followed, and pharmaceutical companies are not required to publicly disclose their demographic goals. [VI] Attracting a diverse participation group requires more effort and flexibility, often requiring greater outreach and aid in overcoming obstacles such as transportation.
According to survey results by Politico, 60% of voters think the U.S. should fully test any coronavirus vaccine, even if it delays rollout. [VII] Without diverse representation in vaccine development, minority and elderly communities may not consider the clinical trials as fully tested for themselves, potentially creating an even larger gap in vaccination participation.