A military hospital at Fort Bragg, North Carolina, has been selected to participate in research on a new coronavirus vaccine that uses a stabilized form of the SARS-CoV-2 spike protein to generate an immune response.
The Department of Defense announced Tuesday that Womack Army Medical Center will support Phase 3 clinical trial research of the vaccine made by Novavax. A Gaithersburg, Maryland, biotech firm, it wasn't initially chosen as part of Operation Warp Speed, but received a $60 million DoD contract on June 4, 2020, to research and manufacture its vaccine.
Womack joins five other military treatment facilities supporting end-stage COVID-19 vaccine research: Hospitals in California, Texas, Maryland and Virginia have been recruiting volunteers since September for clinical trials of a vaccine developed by Oxford University and AstraZeneca.
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Novavax's two-dose vaccine uses recombinant protein nanotechnology to introduce the spike protein to cells and generate an immune response. The protein alone cannot cause COVID-19.
The vaccine also includes a proprietary booster, known as an adjuvant, to bolster the body's immune system. The hope is that the vaccine will prove effective in preventing the development of COVID-19 in those exposed to the SARS-CoV-2 virus, adding to vaccines currently being distributed under emergency use.
"We've come this far, this fast, but we need to get to the finish line," said Dr. Francis Collins, director of the National Institutes of Health, on Dec. 28. "That will require multiple vaccines using different approaches to ensure everyone is protected safely and effectively from this deadly disease."
Phase 3 trials are conducted to continue monitoring safety concerns and determine the efficacy of a vaccine -- how well it works in a research environment on a large group of people. The company hopes to enroll up to 30,000 participants in the U.S. and Mexico, at least 25% of whom are 65 or older.
The DoD patient population spans age and ethnicities -- a crucial component for any effective clinical trial, experts say.
In addition, military hospital clinical teams are experts at "implementing research at the highest ethical and quality standards," said Dr. Matt Hepburn, the vaccine development lead for Operation Warp Speed.
"These clinical trials are essential in assessing these vaccines, which are our best hope to end this pandemic," Hepburn said in a release Tuesday.
The DoD is currently distributing its allotment of the Pfizer and Moderna vaccines to health workers and frontline emergency and safety personnel. Once those tier 1 personnel are vaccinated or decline the immunization, the DoD will distribute vaccines in a phased format to other prioritized personnel.
Once priority personnel and beneficiaries living in communal settings, including the Armed Forces Retirement Homes, are vaccinated, dependents, retirees and family members will be able to get the vaccine, subject to availability.
To date, the DoD has received 248,200 doses of COVID-19 vaccine, but had given out only 67,766 first doses as of Monday, according to the Centers for Disease Control and Prevention.
More than 4.2 million people in the U.S. have received their first dose of a COVID-19 vaccine, but the immunizations remain scarce and in demand among those not targeted by the first allocation -- health care workers and those who live in communal settings.
Dr. Moncef Slaoui, the chief scientific adviser for Operation Warp Speed, said Sunday that the Food and Drug Administration will meet this week to consider whether half doses of Moderna's vaccine could be given to people ages 18 to 55 -- a change that would let twice as many people in that age group get the vaccine.
Slaoui said Sunday on CBS' Face the Nation that "half of the dose" given to people in that age range "induces identical immune response" to the currently authorized dose.
Nearly 17,000 cases of COVID-19 have been diagnosed in DoD personnel, employees and family members since the beginning of the outbreak nearly a year ago. Current hospitalizations are at an all-time high: 2,381 as of Monday.
Fourteen service members, nine family members, 118 DoD civilian employees and 42 defense contractors have died, according to data provided by the Pentagon.
Those who want to participate in vaccine or COVID-19 prevention research can go to the Coronavirus Prevention Network site and complete a survey.
Each DoD site has an assigned code that must be entered in the screening process if a volunteer wants to go to a certain location or facility.
The following is a list of DoD sites supporting the research, contact information and codes:
- Womack Army Medical Center, North Carolina -- phone 253-316-3436; covidwamc@genevausa.org; site code WAMC.
- Naval Medical Center San Diego, California -- phone 253-341-5328 or 253-341-6007; covidnmcsd@genevausa.org; site code NMSD.
- Brooke Army Medical Center -- phone 253-924-9458; covidbamc@genevausa.org; site code BAMC.
- Wilford Hall Ambulatory Surgical Center -- phone 253-341-6170; covidwhasc@genevausa.org; site code WHMC.
- Walter Reed National Military Medical Center -- phone 253-341-6542; covidwrnmmc@genevausa.org; site code WRMC.
- Fort Belvoir Community Hospital -- phone 253-341-5163; covidfbch@genevausa.org; site code FBCH.
-- Patricia Kime can be reached at Patricia.Kime@Monster.com. Follow her on Twitter @patriciakime.
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