The first U.S. phase three trial of a coronavirus vaccine has failed to attract a sufficient number of racial minorities, according to experts.
The lack of diversity among participants reflects a long-standing obstacle and concern among health experts about drug trials. And while diversity in clinical trials is always essential, it's even more vital in developing an effective COVID-19 vaccine, because the coronavirus has disproportionately affected minority communities.
"It's important that all clinical trials – not just vaccine trials – reflect the populations that will use the product or therapy in the real world," said Bunny Ellerin, director of the Healthcare and Pharmaceutical Management Program at Columbia Business School.
Biotech Moderna, which is developing the vaccine, said on Friday that "Black or African American, Latinx, American Indian and Alaska Native individuals" made up just 18% of the phase three trial's more than 13,000 participants, according to a statement from the company, roughly half of their combined percentage in the overall U.S. population.
That percentage is also far lower than the rates at which people of color are contracting COVID-19. A U.S. Centers for Disease Control and Prevention study found that in a review of nearly 600,000 coronavirus cases, 22% of cases were among Black individuals, who account for 13% of the overall U.S. population, and 33% of cases were among Latinx persons, who represent 18% of the U.S. population.
"Black and Brown communities were disproportionately impacted by the pandemic. Therefore, their participation is vital so that the results reflect their experience," said Ellerin. "Clinical trials that aren't racially and ethnically diverse lead to less reliable outcomes in real-world settings."
Still, while not sufficient, 18% is far higher than the rock-bottom participation rates of people of color in other trials. Melody Goodman, associate dean for research at New York University, said minorities sometimes make up just 4% of a clinical trial's enrollment.
"Eighteen percent is not ideal, but a lot of trials are well below that," Goodman said.
Lagging minority participation is nothing new, according to experts. African Americans have long been skeptical of the health care system, and for good reason: They have a harder time accessing pain medications in hospitals and emergency rooms compared with their white counterparts; and suffer other injustices, according to numerous studies.
For example, Dr. Fauci, in an interview with BET last month, acknowledged that emergency medical facilities are sometimes reluctant to give African Americans the pain medication they need to treat "terrible" pain related to sickle cell anemia.
There is hesitancy among African Americans to participate in clinical trials, too, relating back to the infamous Tuskegee experiment in the 1930s, in which the federal government secretly began conducting a 40-year trial on the effects of syphilis on the body, involving 600 Black men who agreed to be examined or treated for the disease. The participants were misled to believe they would receive medical care for the disease, but were secretly denied diagnosis and treatment, even after the effectiveness of penicillin in treating syphilis became known.
"In the African American community, the Tuskegee experiment still resonates to this day," said Dr. Emmanuel Peprah, an assistant professor of global health at NYU.
He said that while 66% minority participation in the Moderna trial would be ideal, a 50% participation rate would also yield strong, evidence-based results. Otherwise, the outcome could be dire. "All vaccines have a certain range of effectiveness, and if you don't have all the possible genetic components housed in the diversity of people tested, you will know less about the effectiveness of a particular vaccine, given that people of different genders, ethnicities, have different responses to vaccines," Dr. Peprah said.
Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, has also suggested that 66% of clinical trial participants should be people of color.
Dr. Fauci told CNN that pharmaceutical companies should aim to enroll double the number of racial minorities represented across the U.S. population in their tests of COVID-19 vaccine candidates, because of the virus' effect on different ethnic groups.
In a worst-case scenario, if it's not tested on a sufficient number of Black, Latinx and Indigenous participants, a vaccine candidate could demonstrate deceptively positive results.
"Worst case scenario, they haven't tested enough Black people, and it has more negative outcomes that Moderna is unaware of because it didn't test it widely enough in Black and Brown people," Dr. Peprah said.
Moderna, in its latest enrollment update, said the company appreciates the importance of diversity, and is working to enroll volunteers who are at increased risk for COVID-19 disease in the study. "Working together with collaborators, the company hopes to achieve a shared goal that the participants in the COVE Study are representative of the communities at highest risk for COVID-19 and of our diverse society," the company said.