Donald Trump has just established what could be the defining action in his presidency. Should the new federal government-driven Operation Warp Speed prove successful, he could turn what has been perceived as a weak and lackluster response to the deadly viral tsunami that is COVID-19, to one deemed a masterful leveraging of national power to drive biomedical progress of unprecedented historical precedence. With an incredibly ambitious series of targets, including the establishment of a safe and healthy COVID-19 vaccine by January 2021, will this initiative fall short—evidencing yet more federal government waste or lead to a federally-led endeavor driving historic, life-saving results? With 30 million Americans out of work and almost 90,000 dead due to an invisible but deadly invading army of pathogens known as COVID-19, America needs a strong leader driving historic bi-partisan collaboration and cooperation, not to mention historic results. The petty, or not so petty differences among American constituencies must dissipate into a greater cause—beating back SARS-CoV-2 for good and jointly championing a transition out of mean-spirited, combative mode—driven by fear, uncertainty and doubt into a social, economic, and political renaissance powering a more harmonious future. A successful Operation Warp Speed would reshape the Trump presidency and his legacy in the history books.
The Trump Administration announced the appointment of Moncef Slaoui as chief advisor and General Gustave F Perna as chief operating officer of Operation Warm Speed (OWS), the administration’s national program to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. Congress has allocated $10 billion for the 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.
This will be one of the biggest tests of the Trump Administration. Initially caught flatfooted, Trump didn’t understand, or failed to deal with the harsh realities associated with the viral tsunami sweeping over both oceans, like an invisible—yet deadly—invading army, as evidenced by a fairly Laissez-faire approach to the initial federal response. In many cases, it appeared states had to deal with the situation on their own. The CDC’s testing technology was delayed by many weeks; there weren’t enough tests or federally coordinated support for that matter. The overall response to the initial onslaught of the invading army of invisible pathogens didn’t earn Trump high marks.
This of course started to change as America itself became the actual epicenter of the COVID-19 pandemic. With a far more severe situation than many contemplated, now Trump has to establish a mission for himself and the country: tapping into his business, entrepreneurial and restless energy to beat back the deadly pathogen.
In the process, Trump must evolve—let down his guard while understanding the price many have paid for national delays under his watch—and embrace his adversaries in a way that he is unaccustomed to doing. But this is the path forward to a better tomorrow.
Trump appears to be now driving a bold and ambitious target—that there will be substantial quantities of a safe and effective vaccine available for Americans by January 2021. TrialSite News has suggested that far stronger national leadership would be required to overcome this historically challenging public health crisis. It looks like Trump is taking on that challenge, and we applaud the move.
What is Operation Warp Speed?
A public-private partnership, Trump now commands that the effort drive a COVID-19 vaccine by January 2021. How will this happen? The new federal government-inspired entity will drive 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.
Who are the players behind Operation Warp Speed?
Dr. Slaou 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 Material Command, General Perna oversees the global supply chain and installation and material readiness of the U.S. Army, including over 190,000 military, civilian, and contract employees.
A Vaccine by January 21, 2021—this would be Unprecedented
The group seeks to have substantial quantities of a safe and effective vaccine available for Americans by January 2021. Stated more ambitiously, Secretary Alex Azar commented that this vision, promulgated by Trump, “will be one of the greatest scientific and humanitarian accomplishments in history.”
Marketing and Politics or Reality?
According to the HHS press release, Trump has challenged all involved within the drug development world, but especially those stakeholders constituting Operation Warp Speed to not only work day and night, but push the envelope even harder and more creatively to deliver palpable results. When it comes to any inefficiency, it won’t be accepted any more as Trump will “squeeze every last inefficiency out of the process (of drug development) and pour every resource we can into this effort.”
Mobilizing the Department of Defense for Vaccine Effort
It would appear that Trump is getting more serious about mobilizing and marshaling national power to take on the deadly pathogen—which has killed nearly 90,000 Americans. Defense Secretary Mark T. Esper commented “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.”
Hence Esper noted the commitment of research and development operations such as DARPA and the Defense Health Agency (DHA) combined with “massive logistical knowledge and capacity” to support the direct targets Trump established with Operation Warp Speed.
In addition to Dr. Slaoui and General Perna, the following leadership have been selected to participate in this operation:
· Vaccines: Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research
· Therapeutics: Janet Woodcock, MD, Director of the FDA’s Center for Drug Evaluation and Research
· Diagnostics: Bruce Tromberg, PhD, Director of the NIH’s National Institute of Biomedical Imaging and Bioengineering
Within the Department of Defense (DOD) the following players are involved with the effort:
· Diagnostics: Major General Lee Payne, Assistant Director for Combat Support and the Defense Health Agency (DHA)
· Therapeutics: Sean Biggerstaff, PhD, Acting Director for Research and Development at DHA
· Vaccines: Matt Hepburn, MD, Joint Project Lead CBRN Defense Enabling Biotechnologies
· Production & Distribution: Stacy Cummings, Principal Deputy Assistant Secretary of Defense for Acquisition Enablers
· Security & Assistance: Andrew Kilianksi, Chief Intelligence Officer for CBRN Defense
Follow the link below to the U.S. Department of Health and Human Services (HHS) press release for more details.
Call to Action: TrialSite News will be following Operation Warp Speed with great interest and enthusiasm.