The U.S. government has invested billions of dollars now via Operation Warp Speed in a bid to target COVID-19 vaccines and therapies now moving into pivotal Phase 3 clinical trials. Sponsors and the federal government (NIAID, FDA, DOD, White House, etc.) face mounting pressure to recruit volunteers and complete these critical studies and, ultimately, demonstrate results. COVID-19 has caused untold devastation that can’t just be quantified by total numbers infected (6.38 million cases) and toll to human life (191,144 deaths), establishing the nation as the global epicenter of the disease. Given the influence of the Social Determinants of Health (SDoH) and the pandemic, the vast economic contagion intertwined with this public health crisis impacts at-risk groups at far greater severity levels. Consequently, the incredible pressure to find safe and effective vaccines and therapies for all involved. Evidencing this imperative, recently the U.S. Department of Defense (DoD) selected five trial site organizations across several states for COVID-19 vaccine trials, including Naval Medical Center San Diego, CA, Joint Base San Antonio Brooke Army Medical Center, Texas, Wilford Hall Ambulatory Surgical Center at Walter Reed National Medical Center in Maryland, and Fort Belvoir Community Hospital in Virginia. Collectively, these military hospitals have the ability to recruit larger numbers of volunteers.
Vast Government Effort
The U.S government effort known as Operation Warp Speed (OWS) represents an interagency endeavor focusing on the delivery of 300 million doses of a safe and effective vaccine for COVID-19—part of a broader strategy by the government to accelerate the development, manufacturing and distribution of vaccines, therapeutics and diagnostics (countermeasures) targeting COVID-19.
This latest effort to bring together military hospitals is the result of collaboration with the U.S. Department of Defenses (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in coordination with the Office of the Assistant Secretary of Defense for Health affairs (OASD(HA)) and the Defense Health Agency.
Coordination with COVID-19 Prevention Network
As TrialSite has chronicled, the National Institute of Allergy & Infectious Diseases (NIAID) reorganized and streamlined numerous trial site networks to centralize in the COVID-19 Prevention Network or CoVPN—see the following website. In this way, the government seeks to optimize its response to the COVID-19 global pandemic. Partners of CoVPN include the HIV Vaccine Trials Network, HIV Prevention Trials Network, Infectious Disease Clinical Research Consoritum and the AIDS Clinical Trials Group.
NIAID, part of the NIH, again is the overarching sponsor and has established operations centers for 1) Vaccine Studies with the Fred Hutchinson Cancer Research Center in Seattle, and 2) Monoclonal Antibody (mAb) studies at FHI 360, a non-profit employing over 4,000 people located in Durham, NC.
Its important to note that the vast resources of the U.S. federal government in the case of CoVPN are marshalled for very specific studies, including A) vaccine trials, and B) monoclonal antibody studies (e.g. Regeneron, Eli Lilly, etc.). Ultimately, just a few companies are involved and have the potential to economically benefit from this focused mission, while a range of various treatments evidencing some promise, developed by primarily smaller biotech firms or existing off-label treatments showing potential aren’t considered, at least publicly.
Study Seeks Participants
Now, DOD provider facilities will be mobilized to help drive vaccine study participation. As reported in the Defense Department press release, study participants fall into the following categories:
· Working in an essential job, such as healthcare professions, emergency response personnel, grocery workers, meat-packing plants, restaurant staff, public transit, etc.
· Living in densely populated residential environments
· Living in or working in congregated living facilities such as correctional facilities or nursing homes
· Ethnic minorities that have been hit harder by the pandemic, such as African Americans and Latinos or Native Americans.
Notes on the Social Determinants of Health & COVID-19
TrialSite principals have had extensive experience deploying technology systems to support social determinants of health (SDoH)-based care coordination endeavors in states and major counties across America.
SDoH represents factors found in one’s living and working conditions (distribution of income, influence, education, etc.) rather than individual risk factors (behavioral risk factors or genetics) that influence the risk of a disease, or vulnerability to disease or injury.
Its quite apparent that COVID-19 has profoundly impacted certain groups influenced by the SDoH. For example, the DOD seeks not only essential workers but also those living in densely populated areas (often lower income households in multi-family unit dwellings, correctional facilities (prisoners most often lower income and minority) and nursing homes (elderly). That Blacks, Hispanics, and Natives are hit harder by COVID-19 isn’t a surprise considering SDoH.
COVID-19 raises uncomfortable deeper and more broad-based questions about health care in the U.S., access to care, and the factors driving greater risk for what in reality is a substantial percentage of a population of 330 million.
COVID-19 has ravaged some of these at risk communities. In some cases, for example, African Americans have died at 3 to 4 times the rates as of Whites. The economic devastation can’t be fully known at this point, which feeds back into the cycle of SDoH. Hence the importance of overcoming this pandemic.
Call to Action: Volunteers can visit CoVPN and learn more. Military personnel are encouraged to complete the survey. Once completed, local study site coordinators will contact Military Health System beneficiary volunteers in the individual’s specific areas who are a good match for the study.