Is the Moderna COVID-19 vaccine study recruiting sufficient numbers of minorities—that is, particularly African Americans and Latinos? The Cambridge biotech sponsor has received over $900 million in public funds and these minority groups have been hit harder by the SARS-CoV-2 pandemic than many other demographic cohorts, hence, government pressure to ensure that the participation pool is sufficiently diverse. But is it? With frequent local media calls to action for minorities, are study enrollment budgets doubling down on local media to remind communities? Most recently, WSAV in Savannah reminded all in this part of the southeast that the time to participate in this historical trial is now. Principal Investigator Dr. Paul Bradley reminded the viewer of the dire situation COVID-19 represents for all. When asked what’s holding up the delivery of the vaccine to the public, the report shared 1) the amount of viral transmission in the community and 2) and whether his company can recruit more minorities (African Americans and Latinos) for the study. Why? Because minority groups such as African Americans face far graver risks for becoming seriously ill and dying.
Given the enormous sums of money poured into Moderna via Operation Warp Speed (BARDA, NIAID, etc.) and the unprecedented NIAID push to promote the research to participants nationwide, these research sites should be inundated with willing participants, including minorities. But is this the case? Based on the recent newscasts, including this one, minority participation is lagging in this and more than likely other studies, based on TrialSite observations, in at least some parts of the country.
TrialSite has detected a trend across the nation as minority participation must pick up for drug sponsors to meet their timelines. This begs the question if the COVID-19 sites are receiving adequate support for this historically relevant batch of vaccine trials? NIAID went out of its way to reorganized trial site networks to create the consolidated COVID-19 Prevention Network. But is this national, relatively top-down approach rippling down to the community, especially communities of color? Remember TrialSite’s commentary about the federal-led ACTIV group—the powerful group vetting all COVID-19 research that is to receive any federal dollars. What kinds of issues did TrialSite raise? Review for a dialogue. How could these observations impact minority and other populations considered at risk or underrepresented?
Savannah GA Population
But are there sufficient minority populations in Savannah, Georgia, for example. With a metropolitan population of about 400,000, the city is majority Black (55%), Whites make up 32.6% and Hispanics/Latinos just under 5%. Although the Latino population is lower than the national average, the Black population is quite high in Savannah. Based on Meridan’s presence and sophistication that there aren’t sufficient minority, especially African American (Black) numbers, based on the tone of the report, raises questions as to how well these massively government financed studies are connecting with local communities.
A Dire Situation
With over 6 million cases and nearly 185,000 deaths in just under half a year, minorities, the elderly and those with comorbidities have been hit very hard in this pandemic. The poor and those working in the lower paid services industry face the worst economic conditions since the Great Depression. Now professionalized white collar workers face layoffs. Tens of millions are out of work because of this pandemic and a vaccine must be found, along with effective therapies, whether economical off label to exotic monoclonal antibodies. By any means necessary, the U.S. and the world must break out of this crisis.
Dr. Bradley with Meridian Clinical Research in Savannah emphasized this reality. Noting that “Most people think ‘if I get it, it will be like the flu, you know, most of the time you live.” The investigator continued, “But the catch with COVID is if you get it, and you get that second phase, you don’t just die, you basically suffocate for several weeks and then you die.” This is an absolute horrific situation that must be overcome.
Minorities have faced this reality more, proportionally than others, hence the importance of these vaccine candidates and why Dr. Bradly commented to WSAV, “This is being heralded as the most important clinical trial in the history of mankind.”
Do Sites get the Support they Need?
Some of TrialSite’s principals have had deep experience with patient recruitment companies. That minority participation in clinical trials has been lacking for the most part Is not new news. TrialSite did a survey about African American participation which can be viewed here.
But the industry and government sponsors often don’t make sufficient changes in approach to drive deeper and more profound participation. There are significant success stories across the country, in fact, TrialSite just reported on one at Yale. Often the sponsors expect sites to pull off myriad mini-miracles with ever tighter budgets. In the case of the COVID-19 vaccine studies, that shouldn’t be an issue, given the enormous subsidy Moderna and others have received. But are they sharing sufficiently with sites?
Billions of taxpayer dollars are being spent on the sponsors and the considerable investment in government streamlining of patient recruitment operations. Is it working? It would appear perhaps in some locations possibly but in many others not as of yet. A root cause analysis along with detailed accounting should be considered if challenges in recruitment materially impact any timelines.
Call to Action: Check out the survey TrialSite did upon launch of the company.