Virus Vaccine: Who gets the credit? Warp Speed?

On Friday, the Trump Administration announced the appointment of Moncef Slaoui as chief advisor and General Gustave F. Perna as chief operating officer of Operation Warp Speed (OWS), the administration’s national program to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (medical countermeasures).

Dr. Slaoui is a venture capitalist and, formerly, Chairman of Global Research and Development and Chairman of Global Vaccines at GlaxoSmithKline, where he led the development of five major novel vaccines. As the four-star general in charge of the U.S. Army Materiel Command, General Perna oversees the global supply chain and installation and materiel readiness for the U.S. Army, including more than 190,000 military, civilian, and contract employees.

Among its other objectives, Operation Warp Speed aims to have substantial quantities of a safe and effective vaccine available for Americans by January 2021.

“President Trump’s vision for a vaccine by January 2021 will be one of the greatest scientific and humanitarian accomplishments in history, and this is the team that can get it done,” said HHS Secretary Alex Azar. “Dr. Slaoui and General Perna are ideal leaders for this unprecedented effort to get vaccines, therapeutics, and diagnostics to American patients much faster than ever before. Since January, America’s scientists and innovators have been working day and night on this national effort. President Trump has refused to accept business-as-usual timelines for vaccines and other essential tools and instead has insisted that America, and the world, need answers faster. Under the President’s leadership, his administration and American industry will squeeze every last inefficiency out of the process and pour every resource we can into this effort.”

“In addition to deploying 62,000 military service members in direct support of fighting COVID-19 on frontlines across the globe, the Department of Defense is racing towards a vaccine,” said Defense Secretary Mark T. Esper. “Through our research and development labs such as DARPA and the Defense Health Agency, and our massive logistical knowledge and capacity, we are committed to achieving the goal of Operation Warp Speed for the American people. I am confident that, as with any mission our military undertakes, we will adapt and overcome all obstacles in our path.”

Elements of Operation Warp Speed

Operation Warp Speed is a public-private partnership to facilitate, at an unprecedented pace, the development, manufacturing, and distribution of COVID-19 countermeasures, between components of HHS, including CDC, FDA, NIH, and the Biomedical Advanced Research and Development Authority (BARDA); the Department of Defense; private firms; and other federal agencies, including the Department of Agriculture, the Department of Energy, and the Department of Veterans Affairs. It will coordinate existing HHS-wide efforts, including the NIH’s ACTIV partnership for vaccine and therapeutic development, NIH’s RADx initiative for diagnostic development, and work by BARDA.

• • Leadership: In addition to the expertise of Dr. Slaoui and General Perna, each countermeasure area will be overseen by a highly qualified and accomplished career HHS scientist:
    • Vaccines: Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research.
    • Therapeutics: Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research.
    • Diagnostics: Bruce Tromberg, Ph.D., Director of the NIH’s National Institute of Biomedical Imaging and Bioengineering.

The Department of the Defense (DoD) has identified subject matter experts to lead DoD support for five areas, including:

• • • Diagnostics: Major General Lee Payne, Assistant Director for Combat Support at the Defense Health Agency (DHA).
    • Therapeutics: Sean Biggerstaff, Ph.D., Acting Director for Research and Development at DHA.
    • Vaccines: Matt Hepburn, M.D., Joint Project Lead CBRN Defense Enabling Biotechnologies.
    • Production and Distribution: Stacy Cummings, Principal Deputy Assistant Secretary of Defense for Acquisition Enablers.
    • Security and Assistance: Andrew Kilianski, Chief Intelligence Officer for CBRN Defense.
  • Three focus areas: There are three core areas where the effort will accelerate the timeframe for countermeasures, including a vaccine, reaching the American public: 1) development, 2) manufacturing, and 3) distribution.
  • Commitment to affordability: The Trump Administration is committed to making these countermeasures affordable for the American people. As a condition of receiving support from Operation Warp Speed, companies will provide a donated allocation of countermeasures developed, including an eventual vaccine.
  • Financial resources: Congress has directed almost $10 billion to this effort through supplemental funding, including the CARES Act, and Congress has appropriated other flexible funding. Over $6.5 billion has been designated by Congress for countermeasure development through BARDA, along with $3 billion for NIH research.
  • Planned updates: Public updates on each step of Operation Warp Speed will depend on certain scientific milestones, which depend on the results of clinical trials (e.g., trials are sometimes halted before completion due to clear results).

Development

• • Operation Warp Speed will select the most promising countermeasure candidates and provide coordinated government support to support their development.
  • Protocols for the demonstration of safety and efficacy will be aligned, which will allow the trials to proceed more quickly.
  • The protocols for the trials will be overseen and set by the federal government, as opposed to traditional public-private partnerships, in which pharmaceutical companies decide on their own protocols.
    • For example, this process has proceeded for vaccines in the following manner:
    • Fourteen promising candidates have been chosen from the 100+ vaccine candidates currently in development—some of them already in clinical trials with U.S. government support.
    • The 14 vaccine candidates are being winnowed down to about eight candidates, which will go through further testing in early-stage small clinical trials.
    • Large-scale randomized trials for the demonstration of safety and efficacy will proceed for three to five of the candidates.
    • Additional non-clinical testing will be done in parallel to the extent possible. For instance, multiple animal models may be used to assess vaccine safety and efficacy in order to support the clinical development program.

Manufacturing

• • The federal government is making investments in manufacturing and distribution at its own risk much earlier than usual, giving firms confidence that they can invest aggressively in the development of countermeasures.
  • Manufacturing capacity for selected candidates, including the three to five selected vaccines, will be advanced while they are still in development, rather than scaled up after approval or authorization, as is the case with traditional development timelines.
  • The manufacturing capacity developed will be used, to the extent practicable, for whatever vaccine is eventually successful, regardless of which firms have developed the capacity.

Distribution

• • Before the countermeasures are approved or authorized, the program will build the necessary plans and infrastructure for distributing them, especially the unprecedented effort that will be necessary to deliver a vaccine to hundreds of millions of Americans in a timely manner.
  • OWS will also focus on expanding the supplies of specialized materials and resources, such as cold-chain storage, glass vials, and other materials, that can be necessary for the distribution of countermeasures.
  • Once a product such as a vaccine is ready, the Department of Defense’s involvement will enable faster distribution and administration than would have otherwise been possible using the wholly private medical infrastructure.

Leadership Biographies

Moncef Slaoui

Dr. Slaoui is, most recently, a Partner at Medicxi Venture Capital and serves as the Chairman of the Board at Galvani, a bioelectronics R&D company company jointly owned by GlaxoSmithKline (GSK) and Verily Life Sciences. As Chairman of GSK R&D, Dr. Slaoui led a restructuring to improve focus on innovation and productivity. As Chairman of Global Vaccines, Dr. Slaoui was directly involved in the company’s vaccine pipeline, which led the industry during his time, with the broadest portfolio of vaccines of any company—48—and the creation of 14 new vaccines in ten years. Dr. Slaoui led the development of a number of novel vaccines, including Cervarix, to prevent cervical cancer; Mosquirix, a candidate to prevent malaria; Rotarix, to prevent rotavirus gastroenteritis; Shingrix, to prevent shingles; and Synflorix, to prevent pneumococcal disease.

Among other honors, in 2016, Dr. Slaoui was recognized as one of Fortune’s 50 Greatest World Leaders for his work in under-researched diseases common in the developing world, served on the Advisory Committee to the Director of the NIH from 2011 to 2016, and has advised U.S. President’s Council of Advisors on Science and Technology.

Dr. Slaoui holds a Ph.D. in Molecular Biology and Immunology from the Université Libre de Bruxelles, in Belgium; completed postdoctoral studies at Harvard Medical School and Tufts University School of Medicine; and has been a professor of Immunology at the University of Mons, Belgium.

General Gustave F. Perna

General Gustave F. Perna – PDF assumed duties as the 19th Commander of the U.S. Army Materiel Command (AMC) 30 September 2016. General Perna served for two years as the Army’s Deputy Chief of Staff, G-4 in his previous assignment. He oversaw policies and procedures used by all Army logisticians throughout the world. Prior to joining the Army staff he served for two years as Deputy Chief of Staff, G-3/4, U.S. Army Materiel Command, one of the Army’s largest commands with 190,000 military, civilian and contractor employees, impacting all 50 states and 152 countries.

The General’s other command assignments include: Commander, Joint Munitions Command and Joint Munitions and Lethality Lifecycle Management Command, responsible for the lifecycle management of $40 billion of conventional ammunition; Commander, Defense Supply Center Philadelphia, Defense Logistics Agency, responsible for the procurement of more than $14.5 billion worth of food, clothing, textiles, medicines, medical supplies, construction and equipment items for America’s Warfighters and other customers worldwide; Commander, 4th Sustainment Brigade, where he deployed the brigade to combat operations during OIF 05-07; Commander, 64th Forward Support Battalion,3rd Brigade, 4th Infantry Division, Fort Carson, Colorado, where he deployed the battalion to combat operations during OIF I; Deputy Commanding Officer, 64th Corps Support Group, 13th Corps Support Command, Fort Hood, Texas; and Commander, B Company, 143rd Ordnance Battalion, Aberdeen Proving Ground, Maryland.

General Perna’s key staff assignments include: Director of Logistics, J4, U.S. Forces-Iraq, responsible for sustainment plans and policies for strategic and operational logistics to sustain coalition and joint forces; Executive Officer to the Director of the Defense Logistics Agency, supporting the Director’s mission of providing Army, Navy, Air Force, Marine Corps and other federal agencies with logistics, acquisitions and technical services support; Ordnance Branch Chief, Human Resources Command; DISCOM Executive Officer and G4, 1st Cavalry Division, where he deployed to Bosnia; 544th Maintenance Battalion Support Operations Officer and Battalion Executive Officer, 13th COSCOM; and G4 Maintenance Officer, 13th COSCOM, where he deployed to Somalia as a member of Joint Task Force Support Command.

He graduated from Valley Forge Military Academy with an Associate’s degree in Business Administration. Graduating as a Distinguished Military Graduate, he was commissioned as a Second Lieutenant, Infantry Officer. He earned a Bachelor’s degree in Business Management from the University of Maryland and a Master’s degree in Logistics Management from Florida Institute of Technology.

His awards and decorations include: Distinguished Service Medal with two Oak Leaf Clusters, Defense Superior Service Medal with Oak Leaf Cluster, Legion of Merit, Bronze Star Medal with Oak Leaf Cluster, Defense Meritorious Service Medal, Meritorious Service Medal with four Oak Leaf Clusters, and the Parachutist and Air Assault Badges.