The Department of Veterans Affairs is recruiting 8,000 volunteers for the Phase III clinical trials of at least four COVID-19 vaccine candidates, a process playing out behind the scenes at 20 medical facilities across the U.S.
Officials with the VA and Operation Warp Speed, the Trump administration’s initiative to fast-track coronavirus vaccines and treatments, confirmed that participation, saying the effort allows veterans to continue contributing to the country in its time of need during the pandemic.
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"For our nation's veterans, this is another way they can continue to serve in this way, fighting the pandemic as a volunteer," said Dr. Matthew Hepburn, head of vaccine development for Operation Warp Speed, during a discussion hosted by the Heritage Foundation Oct. 27.
The effort follows a Defense Department announcement in September that it had partnered with AstraZeneca to recruit Phase III volunteers at five of its medical facilities.
The DoD is in talks with developers of other vaccine candidates, but Pentagon officials have declined to name them.
"There are a number of different vaccine Phase III trials in which the Army and the Department of Defense as a whole is involved in. Some of those are still in negotiations, in terms of the numbers and the sites that will be used," said Dr. Kayvon Modjarrad, director of emerging infectious diseases at Walter Reed Army Institute of Research, on Oct. 14.
The VA plans to recruit the volunteers for four trials at 20 of its medical centers, including 17 that will test Johnson & Johnson's candidate, made by subsidiary Janssen. Three other medical centers are recruiting or have completed recruitment for studies of candidates by Moderna, AstraZeneca and Pfizer, according to a VA website.
At the VA, the department is seeking to recruit healthy veterans between the ages of 18 and 65 who are not pregnant and may be at risk for exposure. As with trials conducted in civilian facilities and at the DoD, participants will be paid, with compensation being determined and provided by the developer, VA spokeswoman Christina Noel said.
VA nurses and case workers also are being asked to identify their sickest, most at-risk patients to determine who should be at the top of the list once a vaccine is approved.
This difference has some VA health providers worried.
"These people who volunteer for the trials are heroes -- the ones who raise their hands -- but I'm concerned about my patient population. If we are only testing the vaccine on healthy people, how are we going to know how it affects those who are sick?" asked a VA nurse who asked not to be named because she is not authorized to speak to the press. "All this time, I have worked so hard to keep my patients alive."
According to the nurse, the VA is prioritizing its patients to receive the vaccine. The priority groups are, in order: veterans in VA nursing homes; those age 85 in non-VA nursing facilities; veterans in other residential settings; vets over the age of 75; those receiving hemodialysis or chemotherapy; homeless veterans; those age 65 and over, and among those, "emphasize patients with CDC high-risk conditions like hypertension, obesity or COPD."
The DoD plans to recruit 3,000 volunteers at five military hospitals for the AstraZeneca trial, and additional volunteers for other companies, depending on their agreements.
DoD officials said the department is participating in the research because it requires a "diverse and representative population (demographics and distribution), including people who are most affected by COVID-19."
Retired Navy Rear Adm. Tom Cullison, former deputy surgeon general for the service, said Oct. 30 that it is not unusual for the DoD as well as the VA to participate in multicenter trials, as they have participated for years in cancer and trauma research.
"In general, standard recruiting for African Americans and other minorities for medical research is difficult, and the military provides a rich opportunity to find volunteers for those groups," Cullison said.
The DoD is seeking adult volunteers in the military health system, including active-duty personnel, retirees and family members. To be considered, volunteers must provide written informed consent to be screened and considered for participation, and they must have no known or planned change of location or deployments at the time of enrollment.
No U.S. service members will be required to participate in the COVID-19 vaccine trials, according to the DoD. All volunteers must agree to be monitored at the same location for the expected study time of two years.
Some active-duty members such as new recruits or boot camp participants will not be allowed to volunteer because they are "considered vulnerable from an ethical and regulatory standpoint," a DoD official said.
The VA and DoD did not disclose the financial arrangements they have with developers to support the research. Volunteers will be paid for participating in the trials; the amount they receive depends on developers.
To volunteer, inquire at your local VA medical center or complete a screening survey at Coronavirus Prevention Network.
-- Patricia Kime can be reached at Patricia.Kime@Monster.com. Follow her on Twitter @patriciakime
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