This Week in Operation Warp Speed – Oct. 16, 2020

 Oct. 16, 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: 
Monday, Janssen announced a safety pause to their Phase 3 clinical trial. OWS remains committed to ensuring the highest standards of safety and well-being for volunteers.

In support of Phase 3 clinical trials, U.S. Army logistics officers supporting Operation Warp Speed facilitated several accelerated customs, transportation and registration approvals for movement of critical trial materials, including vaccine doses, lab kits and personal protective equipment. These efforts demonstrate the value of the collective, whole-of-America approach to accelerating vaccine development without compromising science or safety. 

The Centers for Disease Control and Prevention launched a new page on their website this week dedicated to education on the COVID-19 vaccine planning efforts: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/index.html. 

THERAPEUTICS DEVELOPMENT:
OWS and HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) leaders met with the Association of State and Territorial Health Officials this week to discuss future allocation and distribution plans for COVID-19 therapeutics to accelerate distribution if an FDA emergency use authorization (EUA) is granted.  

ACTIV-1 clinical trials, a public-private partnership supported by OWS to test immune modulators for hospitalized patients, launched this week with 34 sites identified in the U.S. and Latin America.

Outpatient clinical trials continue at more than 35 ACTIV-2 study sites for therapeutics, and volunteers are still needed in various trials to ensure representation across demographics. To volunteer for a therapeutics clinical trial, visit https://www.riseabovecovid.org. 

ACTIV-3 trials testing monoclonal antibody treatments in hospitalized patients have been paused following a recommendation by the trial’s independent Data Safety Monitoring Board. Ensuring the highest standards of science and safety remain OWS’ priority in all efforts to accelerate COVID-19 countermeasures, and pauses like these demonstrate that commitment.

MANUFACTURING, DISTRIBUTION AND ADMINISTRATION:
HHS and DoD announced today an unprecedented partnership with CVS and Walgreens to deliver safe and effective COVID-19 vaccines to one of our most vulnerable populations in long-term care facilities (LTCFs) across America. This program represents a significant step in OWS’ goal of providing easy access to vaccines for all Americans. 

HHS and DoD announced a $31 million agreement with Cytiva Oct. 13 to expand the company’s manufacturing capacity for products that are essential in producing COVID-19 vaccines, such as liquid and dry powder cell culture media, cell culture buffers, mixer bags, and XDR bioreactors. Cytiva is a major manufacturer of pharmaceutical consumables and hardware products and the primary supplier to many of the companies currently working with the U.S. government to develop COVID-19 vaccines. This capacity expansion will help Cytiva respond to the demand for COVID-19 vaccine consumables and hardware products without impacting current manufacturing output.

OWS conducted a leader distribution review today to rehearse distribution plans as described in the strategy announced Sept. 16. The session allowed the various government and industry partners involved in the effort to define roles and responsibilities, synchronize movements, identify gaps, and plan for potential challenges at every stage of the distribution process. 

The 64 jurisdictions – including the 50 states, 8 territories and 6 major metropolitan areas – began submitting their distribution plans today, based on the guidance in the interim playbook for jurisdiction operations. These plans, which are an important milestone in the path to distributing a COVID-19 vaccine, will evolve and continue to be refined in close coordination with OWS and the CDC. CDC will post summaries of each jurisdiction’s interim plan online later this month, allowing for transparency and a general understanding of each jurisdiction’s strategy.

In continued OWS coordination with Federal agencies who will receive vaccine distribution separately from the jurisdictions, the Indian Health Service posted online this week their COVID-19 Pandemic Vaccination Draft Plan, seeking input from tribes, tribal organizations and urban Indian organizations.

KEY ENGAGEMENTS:
Operation Warp Speed Chief Science Advisor Dr. Moncef Slaoui and Chief Operating Officer Gen. Gus Perna visited a McKesson Kitting Facility in Harrisburg, Pennsylvania, Thursday as part of their scheduled travel to sites supported by OWS. During these visits, the leaders discuss progress and advancements, as well as potential challenges and solutions, in development, manufacturing and distribution of therapeutics and vaccines. While in the Northeast for the site visit to McKesson, Dr. Slaoui and Gen. Perna took the opportunity to also meet with the Commissioner of Health for New York State to discuss the distribution planning efforts underway in the jurisdictions. The 64 jurisdictions will be critical to ensuring easy access to a safe and effective vaccine, once authorized for distribution.

Operation Warp Speed Chief Science Advisor Dr. Moncef Slaoui joined Dr. Oz for “What you need to know about Operation Warp Speed.”

HHS Secretary Azar provided an update to Stuart Varney on how science and data are driving every part of the Operation Warp Speed process.  

SENIOR LEADER QUOTES:
“Protecting the vulnerable has been the number one priority of our response to COVID-19, and that commitment will continue through distributing a safe and effective vaccine earliest to those who need it most. Our unprecedented public-private partnership with CVS and Walgreens will provide convenient and free vaccination to residents of nursing homes across America.” ~HHS Secretary Alex Azar

“We distribute 100 million doses of flu vaccine in a period of two or three months. I feel quite comfortable that using the current structure, with the Department of Defense's exquisite planning and logistics expertise, the distribution of a COVID-19 vaccine should be pretty smooth.” ~Dr. Moncef Slaoui, OWS Chief Advisor

“We will succeed because of the unparalleled expertise of HHS science, DoD planning and logistics capability, American industry ingenuity, and academia innovation.” ~Gen. Gus Perna, OWS Chief Operating Officer

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.