Operation Warp Speed (OWS) continues to accelerate development of safe and effective vaccines by supporting multiple candidates. In line with this unprecedented effort, Womack Army Medical Center, is the latest Department of Defense (DOD) location to join Phase 3 SARS-CoV-2 vaccine trials. This location has been identified to participate in the Phase 3 clinical trial evaluating the safety and efficacy of the Novavax vaccine candidate NVX-CoV2373.
The Phase 3 clinical trial design is harmonized with those of other leading companies and calls for the enrollment of up to 30,000 participants in the U.S. and Mexico. This clinical trial expects to include proportional representation among diverse populations most vulnerable to COVID-19 distributed across race/ethnicity, age and those living with co-morbidities. Participants will randomly receive either the investigational vaccine or placebo in two doses, 21 days apart. Two-thirds of volunteers will receive the investigational vaccine and one-third will receive the placebo.
“‘We are extraordinarily appreciative of volunteers who are willing to roll up their sleeves and help fight this pandemic,” said Dr. Matt Hepburn, the vaccine development lead for Operation Warp Speed. “That same spirit of volunteerism is the foundation of military service.”
Anyone wishing to volunteer to participate in any OWS Phase 3 vaccine or monoclonal antibody prevention trial should visit www.CoronavirusPreventionNetwork.org, click on “Volunteer Now” and complete the survey. Once the survey is completed, local study site coordinators will contact Military Health System beneficiary volunteers in their area who are a good match for participation in the study.
To assist in the screening process for the DOD locations, each site is assigned a site code that should be entered during the process. Military Health System beneficiaries can also contact the site team directly. For the Novavax clinical trial location the Coronavirus Prevention Network (CoVPN) site code for Womack Army Medical Center is WAMC. Military Health System beneficiaries interested in participating can also contact the site team directly at [email protected] or 253-316-3436.
“We greatly appreciate the effort and expertise of the DOD clinical teams in implementing the clinical research at the highest ethical and quality standards”, added Hepburn. “These clinical trials are essential in assessing these vaccines which are our best hope to end this pandemic.”
Womack (located on Fort Bragg, North Carolina) joins the five DOD facilities supporting the AstraZeneca Phase 3 trial, which is currently enrolling study participants in the United States. The codes and contact information for those locations are:
* Naval Medical Center San Diego, California – 253-341-5328 or 253-341-6007; [email protected]; (CoVPN Site Code: NMSD)
* Brooke Army Medical Center – 253-924-9458; [email protected]; (CoVPN Site Code: BAMC)
* Wilford Hall Ambulatory Surgical Center – 253-341-6170; [email protected]; (CoVPN Site Code: WHMC)
* Walter Reed National Military Medical Center – 253-341-6542; [email protected]; (CoVPN Site Code: WRMC)
* Fort Belvoir Community Hospital – 253-341-5163; [email protected]; (CoVPN Site Code: FBCH)
To ensure that the vaccines work to protect those at greatest risk, participation by people from communities that are hardest hit is critical. The studies are seeking participants who are at an increased risk of SARS-CoV-2 infection, which may include:
* 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 or working in congregated living facilities, such as correctional facilities or nursing homes
* A member of a community that has been hardest hit by this pandemic, such as older persons, persons with underlying health conditions, and racial/ethnic groups, such as African Americans, Latino, and Native American populations.
OWS is an U.S. government, interagency endeavor that is focused on delivering 300 million doses of a safe, effective vaccine for COVID-19 and is part of a broader strategy to accelerate the development, manufacturing, and distribution of vaccines, therapeutics, and diagnostics (countermeasures) for the virus.
Direct support for this effort is provided by the U.S. Department of Defense's (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 (DHA).