The US Government Moves Forward with Plans for Accelerating Manufacturing of COVID-19 Vaccines and Treatments

A May 15, 2020 press release from the US Department of Health and Human Services (HHS) described some of the focus areas and announced the Trump Administration’s appointment of the leaders of Operation Warp Speed (OWS), the administration's national program to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. Dr. Moncef Slaoui, a venture capitalist and former chairman at GlaxoSmithKline, where he led the development of five major novel vaccines, will be chief advisor for OWS, and General Gustave F. Perna, who oversees the global supply chain and installation and materiel readiness for the US Army, will be chief operating officer.

HHS Secretary Alex Azar noted in the press release that the effort is moving at unprecedented speed and that the administration and industry will “squeeze every last inefficiency out of the process and pour every resource we can into this effort." 

Defense Secretary Mark T. Esper said in the press release: "Through our research and development labs such as DARPA [Defense Advanced Research Projects Agency] 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."

The public-private partnership to facilitate COVID-19 medical countermeasures will include efforts of components of HHS, including the Centers for Disease Control and Prevention (CDC), FDA, the National Institutes of Health (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 also 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, according to the press release.

Each countermeasure area will be overseen by HHS experts. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, will oversee the vaccines area; Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, will oversee the therapeutics area; and Bruce Tromberg, director of the NIH's National Institute of Biomedical Imaging and Bioengineering, will oversee the diagnostics area. 

Subject matter experts from the US Department of the Defense (DoD) will lead DoD support for five areas:

• Diagnostics: Major General Lee Payne, assistant director for combat support at the Defense Health Agency (DHA).

• Therapeutics: Sean Biggerstaff, acting director for research and development at DHA.

• Vaccines: Matt Hepburn, joint project lead CBRN [the US Army’s Chemical, Biological, Radiological, and Nuclear Operations] 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.

The effort is being funded by the US government, and as a condition of receiving support, companies will provide a donated allocation of countermeasures developed, including an eventual vaccine. According to the press release, the US Congress has directed almost $10 billion to this effort. Over $6.5 billion has been designated by Congress for countermeasure development through BARDA, along with $3 billion for NIH research.

OWS will select the most promising countermeasure candidates and provide coordinated government efforts to support their development. According to the press release, the protocols for clinical 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. 

Among its other objectives, OWS aims to have substantial quantities of a safe and effective vaccine available for Americans by January 2021. According to the press release, 14 promising candidates have been chosen from the more than 100 vaccine candidates currently in development. Eight of these candidates 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.

Traditionally, manufacturing capacity is scaled up after approval or authorization. In this effort, however, manufacturing capacity for selected candidates, including the three to five selected vaccines, will be advanced while they are still in development, with investments from the federal government. The HHS press release said that 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.

At the same time, the program is building infrastructure and developing plans for distribution, particularly of vaccines. The effort will expand the supplies of materials and resources, such as cold-chain storage, glass vials, and other materials, needed for distribution. 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 wholly private medical infrastructure, HHS said in the release. 

Source: HHS