What does a niche vaccine-focused biotech from Gaithersburg, MD toiling in relative obscurity for years and a small Native American nation in the far Pacific Northwest have in common? COVID-19. A piece in Science recently suggested that the once small American vaccine development company, Novavax just a year ago toiling in obscurity—yet today slated to receive up to $2 billion from the U.S. government and others to develop and manufacture their moth cell-based COVID-19 vaccine—may actually be on to one of the most superior vaccine candidates. Why? Author Meredith Wadman suggests that their investigational vaccine candidate thus far outperforms most others when factoring in key measures on monkey and early-stage human studies. So how do the Lummi (Lhaq’temish or People of the Sea) fit into this picture? This Native American group, situated in the far Pacific Northwest at the Canadian border, represented by the Lummi Public Health Department, recently submitted an application to participate in the Novavax COVID-19 vaccine trial.
Previous COVID-19 Study: Communication Problems with Sponsor
Some relevant background is important as recently, Native News Online shared that citing a no-no in the world of trial site organizational 101s: sponsor communication problems. Apparently, at least from the Lummi Public Health’s point of view, AstraZeneca representatives appeared to have probably underperformed in their communicative duties during the recent U.S. Food and Drug Administration (FDA)-triggered safety delay. Transparency and consistent communication represents a foundational starting point for good sponsor to trial site relationships. But TrialSite does remind that this represents one point of view and not necessarily the reality, based on the totality of facts.
Safety was a Concern
However, another explanation for the pull out was concern about safety. Although a neurological-based safety incident did occur in the UK regulators (MHRA) there and in other locations (Brazil, South Africa and India) deemed the risk sufficiently low and thus soon thereafter continued the trial. On the other han,d the U.S. FDA put a pause on the whole thing in America and based on statements from the tribe’s medical director that the recent safety incident(s) may have been enough to sufficiently spook the tribal leadership. Dakotah Lane, the medical director, told the indigenous-focused news outlet: “Native peoples are at higher risk of severe symptoms or death from the coronavirus.” Mr. Lane continued, “The AstraZeneca trial was not a good fit, but we continue to believe it’s important for our people to have the opportunity to volunteer for a trial as we’re at much higher risk than other populations.”
The Lummi Study Participation Process
Native News Online reported that the tribe must undergone a three-part site qualification process for this particular clinical trial, including 1) Institutional Review Board (IRB) review by Indian College; 2) review by the Lummi Health and Family Services Commission and finally 3) approval by the Lummi Indian Business Council (LIBC). Actually a fourth step, seemingly more of a symbolic recognition is a decision by the six-member Lummi Tribal Health Commission. There, they do respond to any public concerns but more than likely at that stage the tribe is ready to participate.
Big Stakes & ‘National Disgrace’
With about 9.8 million COVID-19 cases reported, and nearly 240,000 deaths, the United States represents the epicenter of this horrific pandemic. Lizzie Wade emphasized in Science that when it comes to COVID-19 and Native Peoples, it’s just a “national disgrace.” That piece recently showcased the pressure by a Native health activist and chief research officer with NIH, Abigail Echo-Hawk, associated with a collective push to understand just how bad the disproportionate toll COVID-19 has been on Native Americans.
Apparently a number of inadequacies in the data coupled with various restricted access and delays in receiving data compound the challenge of understanding the true pandemic’s toll on this demographic cohort. Not just the number of cases and deaths but also compounding problems, socio-economic degradation, etc. Native reservations are in fact among the poorest of communities in the United States (if not the poorest) and undoubtedly the COVID-19 pandemic adversely rips through these communities like many other underrepresented and at risk communities.
The Potential Principal Investigator
Bellingham, Washington-based Dr. Dakotah Lane attended the prestigious Weill Cornell Medical College of Cornell University and appears to be a primary driver in the overall tribal effort in seeking to become a trial site location. He is to be commended for the vision, forward thinking and ability to not only conduct a practice and involve himself with myriad other supportive affairs, but also to help this small tribe get on the clinical trials map. It’s certainly important, the stakes are big and a vaccine, even if it just reduces the odds of infection by 50%, represents a critical step against this pathogen.
In a recent statement, Dr. Lane emphasized the stakes; the importance of overcoming COVID-19 declaring, “If the experts and community approve of proceeding with the Novavax vaccine trial, this will be just one more available option for our tribal members who want to participate.” TrialSite considers this an mission-critical imperative in the clinical research as a care option (CRAACO) movement. With already reeling health challenges on the reservations across America, participation in research, when done with quality and care, can offer not only an opportunity to combat COVID-19 but also afford members the ability to get checked up and receive medical attention. The community must be fully behind the initiative.
The Potential Trial Site Organization
The Lummi Public Health Department would interface with the sponsor, in this case Novavax, should the tribal process equate to an positive nod by the Lummi Tribal Health Commission. This department organization is led by General Manager Toni Jefferson.