Novavax is ensuring there is Black and Latino representation in clinical research.
Researchers have been concerned about the shortage of Black and Latino volunteers in COVID-19 clinical trials. Minorities have long been underrepresented in clinical research for some time. Yet, data suggests Black Americans are three times more likely to become infected with the coronavirus and twice as likely to die from it than whites.
Novavax, biotech company in Maryland, wanted to change the landscape of trial participation by boosting representation of minority groups during the phase 3 trial of their COVID-19 vaccine candidate NVX-CoV2373. With the help of Howard University in Washington, DC, the designed clinical site, the company developed a goal to secure 300 Black and Latino volunteers.
Lisa M. Dunkle, MD, vice president and global medical lead for coronavirus vaccine at Novavax, explained, “As part of our goal to achieve a representative trial population that includes communities who are disproportionately impacted by the pandemic, we sought out some of the HBCUs to include in our trial sites. We hoped that this might encourage people of color to enroll and to increase their comfort level with vaccines in general.”
“We have seen quite a good number of participants in the registry, and many are African American, who are the ones we are trying to reach in the trial,” explained Siham Mahgoub, MD, medical director of the Center of Infectious Diseases Management and Research and principal investigator for the Novavax trial at Howard University. “It’s very important for people of color to participate in the trial because we want to make sure these vaccines work in people of color.”
In 1993, Congress passed the Revitalization Act, which required for the first time that clinical trials conducted by the National Institutes of Health include women and members of minority groups, and yet, the specific proportions of such were not specified.
“There is certainly some dark history in how minorities have been treated by our healthcare system, and it’s not surprising that there is some fear and distrust,” Dunkle said. “By recruiting people of color into clinical trials that are governed with strict standards, we can begin to change perceptions and attitudes.”
At one point, Howard University President Wayne Frederick, MD, reached out to a pastor of a local Black church to seek increased enrollment. Congregation member Stephanie Williams responded to the call.
Williams said, “We had about three sessions where (Frederick) shared his experiences. He also shared some links to read about it more. When I saw that he took it, that gave me a lot of confidence. Since I’m going be going into the classroom, I wanted to be sure that I was well protected.”
“We believe that diverse participation in COVID-19 trials will go a long way toward encouraging potentially life-saving vaccination when it is available,” Frederick said. “Along with following COVID-19 prevention guidelines, effective vaccination is the most promising approach to mitigating and ending the pandemic. Our goal through participation is to ensure a safe and effective product is developed to address the needs of Black, Latino, and other minority communities.”
If trial results produce positive results, the vaccine could be a viable option in just a few months.Novavax This not only gives the public another means of becoming vaccinated but will offer a model for inclusivity.