HHS, DOD Collaborate With Merck to Continue the Development and Large-Scale Manufacturing of Investigational COVID-19 Treatment

 Dec. 23, 2020

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The U.S. Department of the Health and Human Services (HHS) and the Department of Defense (DOD) jointly announced an agreement with Merck to support advanced development and large-scale manufacturing of the their investigational therapeutic MK-7110 to treat hospitalized patients with severe or critical COVID-19.

The investigational therapeutic is a promising first-in-class fusion protein and immune modulator. Immune modulators have the potential to minimize the damaging effects of an overactive immune response to COVID-19. This overactive response can contribute to the severity of the illness.

“Our agreement with Merck is the latest example of how industry and government are coming together under Operation Warp Speed to move potential therapeutics all the way from development through to manufacturing, enabling faster distribution,” said HHS Secretary Alex Azar. “More good news about COVID-19 therapeutics is constantly emerging, and President Trump’s commitment to supporting lifesaving therapeutics has already helped deliver hundreds of thousands of Operation Warp Speed-supported therapeutics to the frontlines.”

The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, collaborated with the DOD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and Army Contracting Command (ACC-APG), to provide approximately $356 million to Merck. This funding allows for development of MK-7110, including completing activities required to request Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), and for delivery of up to 100,000 doses of MK-7110 by June 30, 2021.

With this approach, doses will be packaged and ready to ship in the first half of 2021, in the event FDA determines MK-7110 meets the statutory criteria for issuance of an EUA. The federal government would allocate these doses to treat severe and critical COVID-19 patients using the same approach that has been used successfully to allocate supplies of other COVID-19 therapeutic treatments. The doses will be made available to the American public at no cost. However, there may be costs associated with hospitalization.

Interim analysis of a Phase 3 clinical trial in September 2020 indicated that patients who received a single dose of the therapeutic had a 60 percent greater chance of clinical recovery than those who received a placebo. Preliminary analysis also showed that the treatment potentially reduces the risk of respiratory failure or death by 50 percent compared to the standard of care. The study is still ongoing.

About Operation Warp Speed (OWS):

OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

Vaccine Prep

 

Army Spc. Ying Chen, a New York National Guardsman, prepares a dosage of the Pfizer-BioNTech COVID-19 vaccine at the Camp Smith Training Site Medical Readiness Clinic, N.Y., Dec. 18, 2020. The New York National Guard is administering 44,000 doses of the Pfizer vaccine to front line medical personnel at 16 locations around the world as part of a pilot program.

Welcome Home

 

An Oregon National Guard soldier returns from a 10-month deployment in Kosovo to Fort Bliss, Texas, Dec. 18, 2020.

DOD Awards $4.8 Million Indefinite Delivery/Indefinite Quantity to a Calibre Scientific Subsidiary, Anatrace, to Increase Domestic Production Capacity of COVID-19 Testing Reagents

 Dec. 21, 2020

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On Dec. 20, 2020, the Department of Defense (DOD), in coordination with the Department of Health and Human Services (HHS), awarded an Indefinite Delivery/Indefinite Quantity contract to Anatrace Products, LLC. to support increased testing demands for COVID-19.  COVID-19 diagnostics requires the key reagents Polyadenylic Acid (Poly A), Guanidinium Thiocyanate (GTC), and Proteinase K (Pro K) to process samples.  Supply chain analysis has identified the severe impact of the limited availability of these reagents on laboratories preparing samples for SARS-CoV-2 testing.

This industrial base expansion effort, with a not-to-exceed value of $4.8 million, will allow Anatrace to increase production capacity for the three key extraction reagents (Poly A, GTC and Pro K) at their facility in Holland, Ohio.  This expansion initiative will increase their current production 10-fold, with production activities beginning January 2021.  Anatrace anticipates full production increases for Poly A (increase to at least 1,600 grams) and Pro K (increase to at least 100 grams) by July 2021 and for GTC (increase to 25,000 kgs) by September 2021. 

DOD’s Defense Assisted Acquisition (DA2) Cell led this effort in coordination with the Department of the Air Force’s Acquisition COVID-19 Task Force (DAF ACT).  The effort was funded through the Health Care Enhancement Act (HCEA) to enable and support domestic industrial base expansion for critical medical resources.

This Week in Operation Warp Speed - Dec. 18, 2020

 Dec. 18, 2020

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Below is a compilation of initiatives, actions and accomplishments across Operation Warp Speed (OWS)’s primary efforts in the past week. To learn more about OWS, visit the Department of Health and Human Services (HHS) website and Department of Defense (DOD) website. 

VACCINE DEVELOPMENT: 

The U.S. Food and Drug Administration granted Emergency Use Authorization for the Pfizer COVID-19 vaccine Dec. 11. The Vaccines and Related Biological Products Advisory Committee convened Dec. 17 to review and evaluate data concerning the safety and effectiveness and appropriate use of the Moderna vaccine candidate. The committee overwhelmingly voted to recommend Emergency Use Authorization for the vaccine. The meeting was public and related material is available for independent and public review. A recommendation from the FDA is anticipated soon.

THERAPEUTICS DEVELOPMENT:

The U.S. Department of Health and Human Services continues to publish allocations for monoclonal antibody treatments. As of this week, more than 400,000 doses of monoclonal antibodies have been allocated to the states and territories. Facilities that have utilized their allocated monoclonal antibodies can request additional patient courses through their state/territory health department. If another healthcare facility does not accept or want its allocated amount, those patient courses can be reallocated by the state to other healthcare facilities within their jurisdiction.

MANUFACTURING, DISTRIBUTION AND ADMINISTRATION:

The Advisory Committee on Immunization Practices (ACIP) issued interim considerations recommending the Pfizer vaccine for people 16 years and older. The clinical considerations are informed by FDA-submitted data, best practice guidelines and expert opinion. 

Pfizer vaccine distribution began within 24 hours of the FDA granting Emergency Use Authorization. More than 1,500 individual shipments were delivered in the first week. Pfizer will continue to ship its product weekly, fulfilling orders among 64 jurisdictions and five federal entities. The Operation Warp Speed feature page includes updated photos. 

KEY ENGAGEMENTS/OUTREACH:

HHS Secretary Azar joined the National Ceremonial COVID-19 Vaccination Kick Off Event with Surgeon General Jerome Adams on Monday, December 14, and visited another hospital to see more frontline healthcare workers receive vaccinations on Wednesday, December 16. 

Operation Warp Speed Deputy Director of Supply, Production and Distribution Maj. Gen. Chris Sharpsten and Deputy Secretary of the Department of Health and Human Services Eric Hargan visited the Washington, D.C. Veterans Affairs Medical Center as the first doses of the Pfizer COVID-19 vaccine were administered to healthcare workers.   

Operation Warp Speed’s Supply, Production and Distribution Deputy Chief Marion Whicker and Manufacturing lead Col. Mike Post conducted quality checks at Pfizer’s plant in Kalamazoo, Michigan, observing the pick-and-pack process, and following a vaccine shipment from the plant to an administration site.
 
Operation Warp Speed will hold a press conference following any announcements granting EUA for the Moderna vaccine. Sign up for email updates.  

SENIOR LEADER QUOTES:

“It is nothing short of a medical miracle to have FDA authorization of a vaccine for COVID-19 just over 11 months since the virus was made known to the world. This vaccine, like any vaccine FDA potentially authorizes, has been through multiple stages of safety review, and it has shown extraordinary effectiveness in protecting people from the virus. Vaccines will help bring this pandemic to an end, which is all the more reason to double down on the public health measures we need to stay safe in the coming months.” ~ U.S. Secretary of Health and Human Services Alex Azar

“Fortunately for the nation, some of the greatest logistical minds in the country are working daily at Operation Warp Speed with one goal – delivering safe and effective vaccines to the American people,” ~ Operation Warp Speed Deputy Chief Supply, Production and Distribution Marion Whicker. 

“This is a monumental week for us all as we distribute the first millions of doses of vaccines to the American people.  But each week that follows, we will have more doses ready for allocation and distribution.  We are also posturing to phase in the Moderna vaccine, if they receive an EUA.  This is about a steady cadence of delivery to bring the American people to a place of confidence that vaccine is coming.  We want to ensure the vaccine arrives safely and that it can be effectively administered once arrival occurs.” ~Operation Warp Speed Chief Operating Officer GEN Gus Perna

Operation Warp Speed is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostics.

Statement on New Appointments to the Defense Science Board

 Dec. 18, 2020

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Today, the Department of Defense announced that Acting Secretary Chris Miller intends to appoint former Assistant Secretary of the Air Force (Manpower & Reserve Affairs) Tidal McCoy and former NASA CFO Jeff DeWit to the Defense Science Board (DSB).
 
“The Defense Science Board has a long and storied history of providing senior leaders advice on some of the most complex tech issues facing our nation and we’re proud to have Mr. McCoy and Mr. DeWit join the board,” said Dave Vasquez, a Department of Defense Spokesman. “Both of these patriotic Americans have a distinguished record of public service at senior levels of the Department of Defense and NASA respectively.”
 
About the Defense Science Board

The Defense Science Board provides independent advice and recommendations on matters concerning science, technology, manufacturing and acquisition processes which support the Department of Defense’s (DoD) scientific and technical enterprise.

NIJ Funds Almost $17M in Forensic Science Research and Development

 

NIJ announced almost $17 million in funding to support 36 forensic science research and development projects in fiscal year 2020 under its Research and Development in Forensic Science for Criminal Justice Purposes (Forensic Science R&D) program. Through its R&D grant funding, NIJ continues to advance the speed, accuracy, and reliability of forensic analysis, which ultimately bolsters the administration of justice. REVIEW AWARDS