PANDEMIC RESPONSE
WEIGHING DONATIONS
U.S. Naval Hospital Guam Hospitalman Apprentice Rebekah Morrison records the weight of convalescent plasma units collected from Sailors who recovered from COVID-19. (Photo by Jaciyn Matanane, Naval Medical Forces Pacific)
help temporarily boost the body’s ability to fight coronavirus. Te idea to provide this treatment was developed through a collaboration between FHP and the U.S. Army Institute of Surgical Research. Tis treatment had enough anecdotal usage for other diseases to show that it might have some value by strengthening the immune system against COVID-19. Te process of collecting plasma is already licensed and validated for the Armed Services Blood Program. Te potential benefit of using convalescent plasma outweighed the low safety risk of transfusion plasma. FHP submitted its own investigational new drug application and expanded access protocol for convalescent plasma through the FDA for approval. However, before moving a product and processes forward, FHP requires approval from Thomas McCaffery, the assistant secretary of defense for health affairs.
Patients being treated with convalescent plasma receive no more than two units of plasma, depending on the physician’s recommendation. After treatment, the physician follows up with the patient to ensure there are no safety issues related to the product, and provides regular updates
on clinical progress and laboratory test results to FHP. Follow-ups for the patients treated with convalescent plasma continue for up to 31 days post-treatment.
EMERGENCY USE AUTHORIZATION DISTRIBUTION FHP and USAMRDC’s Office of Regu- lated Activities got the expanded access protocol for remdesivir, as well as convales- cent plasma, written and approved faster than any of their previous expanded access protocols. Tis resulted in the Defense Health Agency selecting FHP to receive, store, distribute, and track remdesivir under an emergency use authorization.
FHP has managed the distribution of remdesivir to 63 sites worldwide as of November 2020. Before COVID-19, a typical protocol managed by FHP may have included three sites to oversee. At this writing, FHP has already shipped prod- uct for treating 648 patients and received 142 resupply requests solely related to COVID-19.
Marianne Erlichman has been working for USAMMDA’s FHP division for 12 years.
She has played a major role in coordinat- ing the protocol sites and says FHP has never before managed this many sites and patients simultaneously.
“Tis has been a learning experience for everybody involved,” said Erlichman. “Whenever we add a site, we have to do an amendment request to the USAMRDC HQ IRB. I am already up to amend- ment number 39 in just a few months. Normally, after several years, I might be at amendment number eight.”
FHP has treatment sites all around the globe and throughout the United States. International sites include Japan, Guam, Djibouti, Afghanistan, Kuwait and others. Te FHP team has not traveled to the sites, but instead conducted all set-up coordina- tion remotely through phone and email correspondence.
Any DOD-owned military treatment facil- ities, including aircraft carriers, deployed field hospitals—both inside and outside the continental United States—and hospi- tal ships such as the United States Navy Ship Comfort, can request to be a treat- ment location by contacting FHP with an
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