COVID Response

Remdesivir

Veklury® (remdesivir) is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization.

View prescribing information here

FDA Info

On May 1, 2020, the FDA issued an Emergency Use Authorization (EUA) to permit the emergency use of Veklury® for treatment of hospitalized patients with severe 2019 coronavirus disease (COVID-19), pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3). Veklury is a direct acting antiviral drug that inhibits viral RNA synthesis.

On August 28, 2020, the FDA concluded that the drug was appropriate to protect the public health or safety under Section 564(g)(2) of the Act. This expanded the authorized use of Veklury by no longer limiting its use to the treatment of patients with severe disease.

On October 22, 2020, the FDA approved Veklury, which is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Veklury should be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.

https://www.fda.gov/media/137574/download

https://www.fda.gov/media/137564/download

Program Info

Distribution of the EUA remdesivir was initially controlled by the U.S. Government for use consistent with the terms and conditions of the EUA. Gilead supplied remdesivir to authorized distributors and directly to a U.S. Government agency, to distribute to hospitals and other healthcare facilities as directed by the U.S. Government in collaboration with state and local government authorities as needed.

USAMMDA’s FHP Division is the lead agency for the distribution of all EUA remdesivir product. Working in conjunction with the Defense Health Agency (DHA), FHP receives and processes all requests for product from medical treatment facilities (MTF), both within the continental U.S. (CONUS) and outside the continental United States (OCONUS). All products are shipped through the USAMMA in accordance with product requirements. FHP maintains the storage of all product prior to shipment, as well as tracking the inventories, product usage, and the number of patients that have been treated at each MTF. These duties will continue until all of the remaining allocated EUA product has been used by the facilities.

To date, EUA remdesivir has been distributed to 64 MTFs worldwide to include 18 Army facilities, nine Air Force facilities, 14 Naval facilities, 15 Naval ships, and eight forwarded locations that include Lakenheath AFB UK, U.S. Military Hospital Kuwait, Craig Joint Theater Hospital Bagram Afghanistan, NATO Multinational Medical Unit Afghanistan, Baghdad Iraq, Djibouti Expeditionary Medical Facility Africa, and Kosovo. To date, 16,551 vials of EUA Remdesivir have been shipped out, with 2,037 patients receiving treatment.

Remdesivir (Expanded Access Treatment Protocol)

Product Info

In December 2019, the Wuhan Municipal Health Committee (Wuhan, China) identified an outbreak of viral pneumonia cases of unknown cause. Coronavirus RNA was quickly identified in some of these patients. This novel coronavirus has been abbreviated as SARS-COV-2 and has 89 percent nucleotide identity with bat SARS-like-CoVZXC21 and 82 percent with that of human SARS-CoV (Chan et al-2020). The disease caused by this virus has been designated COVID-19. On January 5, 2020, there were 59 confirmed cases, 278 cases on January 20, 2020; 118 cases on January 26, 2020 rising to more than 97,853 confirmed cases and more than 3,300 deaths as of March 6, 2020, according to various international health reporting agencies. Outbreak forecasting and modeling suggest that these numbers would continue to rise (Wu et al-2020). Most of the infections outside China were travel-associated cases in those who had recently visited Wuhan City and are thought to have acquired the virus through contact with infected animals or contact with infected people. The disease progressed into a global pandemic, with significant spread to over 200 countries worldwide.

FDA Info

All patients treated with this Investigational New Drug were DOD-affiliated personnel as defined in DODI 6200.02, which included emergency-essential civilian employees, and/or contractor personnel subject to the same health risk as military personnel, have a COVID-19 diagnosis (laboratory-confirmed) with moderate to severe disease determined by the principal investigator, written informed consent, except in situations described in 21 CFR 50.23, agreed to comply with planned study procedures, and were available for clinical treatment and follow-up period.

Program Info

The Remdesivir Expanded Access Protocol (EAP) was first approved by the FDA on March 17, 2020, followed by the Institutional Review Board (IRB) on March 18, 2020, and 1100 doses of remdesivir was made available for use. The protocol included sites within NORTHCOM, EUCOM, AFRICOM, CENTCOM, and INDOPACOM areas of operations. The product was available in eight countries around the globe and 13 states within the continental U.S. In total, 26 sites were established for the protocol that included 20 primary sites and six sub-sites that fell under the Landstuhl Regional Medical Center site. These sites included Lakenheath Air Force Base in the United Kingdom; Baghdad, Iraq; U.S. Military Hospital in Kuwait; Craig Joint Theater Hospital in Afghanistan; the NATO Multinational Medical Unit in Afghanistan; and the Djibouti Expeditionary Medical Facility in Africa.

In total, 40 patients were treated under the EAP. Thirty-nine patients improved to be released from care, with only one patient death that was not related to product administration. The FDA granted Emergency Use Authorization (EUA) to remdesivir on May 1, 2020, for severe COVID-19 disease. This indication was expanded to adults hospitalized with COVID-19 on August 28, 2020, making the need for the expanded access treatment protocol unnecessary. Patient enrollment was closed on September 11, 2020, under the EAP. On October 22, 2020, Veklury® (remdesivir) was approved by the FDA.

COVID Convalescent Plasma

Coronavirus Disease 2019 (COVID-19) is a respiratory disease caused by a novel coronavirus, Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2), that causes substantial morbidity and mortality. During the COVID-19 pandemic, the FHP Division offered an expanded access treatment protocol using Anti-SARS-CoV-2 convalescent plasma (CCP) at military treatment facilities worldwide.

Historical use of convalescent plasma in prior outbreaks of respiratory viruses, certain preclinical evidence, small clinical trials results conducted early in the pandemic shown there may be some patient benefit to use convalescent plasma and safety risk was no more than a standard blood transfusion. This CCP Expanded Access Protocol (EAP) is designed to provide a treatment option for patients diagnosed and hospitalized with COVID-19. Plasma transfusions are generally safe and well-tolerated by most patients but can cause allergic reactions, transfusion-related acute lung injury (TRALI) and other side effects.

Three types of plasma were used in this protocol:

• Fresh Frozen Plasma (FFP)
• PF-24 or FP24 -
• Liquid Plasma -

The Armed Services Blood Program or other FDA-registered establishment is responsible for obtaining and distributing the investigational product to the treatment site. One or two doses of CCP are administered to patients that meet inclusion criteria and give informed consent to enroll into the treatment protocol.

The treatment protocol will close to new patients on 1 June 2021. CCP will still be available to Military Health System (MHS) physicians under the FDA Emergency Use Authorization (EUA) through the Armed Services Blood Program.

EAP statistics: The first patient was enrolled in June 2020 and 110 patients were enrolled/treated through May 2021; there are 36 sites/sub sites around the world that include Army MTFs (10 plus sub sites), Naval Hospitals (8), Air Force hospitals (6), Navy Air Craft Carriers (10) and Naval Surface Force Atlantic/ Fleet Surgical Team (multiple ships).

Monoclonal Antibodies Emergency Use Authorization (EUA)

Bamlanivimab / Casirivimab and Imdevimab / Etesevimab – Product Info

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. Bamlanivimab is a monoclonal antibody from Eli Lilly and Company, which is specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions. On November 9, 2020, the FDA authorized the use of Eli Lilly and Company’s bamlanivimab under the EUA.

Etesevimab is another monoclonal antibody from Eli Lilly and Company. Continued studies have shown that bamlanivimab and etesevimab given together are effective for the treatment of mild to moderate COVID-19 adult and pediatric patients. FDA granted use of bamlanivimab and etesevimab in combination for the treatment of COVID-19.

Casirivimab and imdevimab are recombinant human IgG1 monoclonal antibodies from Regeneron Pharmaceuticals that target the receptor binding domain of the spike protein of SARS-CoV-2. On November 21, 2020, the FDA authorized the use of Regeneron Pharmaceutical’s casirivimab/imdevimab monoclonal antibody cocktail under the EUA.

Program Info

Distribution of the authorized Bamlanivimab, Casirivimab and Imdevimab, and Etesevimab is controlled by the U.S. Government for use consistent with the terms and conditions of the EUA. Eli Lilly and Company will supply bamlanivimab to authorized distributor(s), who will distribute to healthcare facilities or healthcare providers as directed by the U.S. Government, in collaboration with state and local government authorities, as needed.

The bamlanivimab product, allocated to the DOD, has been shipped to 17 different medical treatment facilities (MTFs) both within the continental U.S. and outside the continental U.S. (OCONUS) and is stored and distributed by the FHP Division, USAMMDA.

Due to the discovery of SARS-CoV-2 variants worldwide influencing effectiveness of the bamlanivimab when used alone, the FDA granted an EUA for the combination of bamlanivimab and etesevimab to provide mitigation and effective treatment for at-risk patients diagnosed with COVID-19.

Monoclonal Antibodies EUA

Casirivimab / Imdevimab

In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated. On November 21, 2020, the FDA authorized the use of Regeneron Pharmaceuticals Inc.’s casirivimab and imdevimab under the EUA.

Casirivimab and imdevimab must be administered together by IV infusion.

Casirivimab and imdevimab are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. A benefit of casirivimab and imdevimab treatment has not been shown in patients hospitalized due to COVID-19. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation.

The casirivimab and imdevimab will be used only by healthcare providers to treat mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization; casirivimab and imdevimab may only be administered together.

Program Info

Authorized casirivimab and imdevimab was initially distributed by the U.S. Government for use consistent with the terms and conditions of this EUA. Regeneron supplies casirivimab and imdevimab to authorized distributor(s), who will distribute to healthcare facilities or healthcare providers as directed by the U.S. Government, in collaboration with state and local government authorities, as needed.

The casirivimab and imdevimab product has been shipped to two different MTFs OCONUS, and is stored and distributed by the FHP Division, USAMMDA.