Introduction
This interview focuses on the Defense Advanced Research Projects Agency (DARPA) and its Pandemic Prevention Platform (P3) program in the context of the COVID-19 outbreak. Our dialogue features John Hawkins (Interviewer), a freelance journalist, and responses from Dr. James E. Crowe of Vanderbilt University (a P3 performer), and Stacey Wierzba (DARPA Public Affairs contractor), who provided official program details.
Part I: P3 Foundations and Vanderbilts Role (Dr. James E. Crowe)Interviewer (Q): Dr. Crowe, I am interested in Vanderbilt's P3 association with DARPA, particularly regarding the rapid response "war games" conducted in the year leading up to the emergence of COVID-19. At the end of your "capabilities demonstration," were you successful with monoclonal antibodies for earlier threats like MERS, Zika, or the flu?
Dr. James E. Crowe (A): Yes, Vanderbilt is a P3 performer. We conducted "capabilities demonstrations" for rapid discovery of antibodies prior to COVID-19. Specifically, the discovery program we conducted in P3 for SARS-CoV2 led to the development and approval of Evusheld. Furthermore, antibodies that we isolated for Zika, flu, and others are currently in development for clinical testing.
Q: When DARPA initially set up these programs, was the goal to develop temporary monoclonal solutions, or were you aiming for permanent protection? And did the involvement of Emergency Use Authorization (EUA) change the calculus during the pandemic?.
A: DARPA told me years ago that monoclonal solutions were the safest but not permanent solutions. However, without their wide distribution, it would have been a wiser way to proceed during the pandemic while vaccines were still being fully tested as usual, which would have meant proceeding without EUA involvement.
Part II: The AbCellera/LY-CoV555 Breakthrough (Stacey Wierzba)Q: DARPA had promised that its P3 pipeline could deliver a solution to a drug manufacturer within 60 days of receiving a COVID-19 survivors antibodies. The resulting therapeutic, LY-CoV555 (developed by AbCellera and Lilly), seems to have accelerated rapidly. We were told testing would start around August 1st, but reports suggest testing started much earlier, potentially two months ahead of schedule. Is this rapid timeline accurate, and does this success mean a useable short-term solution will be available before the end of the year?.
Stacey Wierzba (A): We remain optimistic that the antibody therapeutic for COVID-19 being developed by AbCellera will be successful, but any such effort must be thoroughly reviewed by the FDA for human safety and efficacy prior to distribution. Regarding the August 1st target, where science is concerned, you can never be certain that you will hit a milestone until proven, but based on the data received at that point, we were fairly confident that we would meet the deadline.
Q: Can you explain in laymans terms the process that allows P3 performers like AbCellera to identify candidate antibodies so quickly?.
A: The P3 performers used proprietary microfluidic technologies to rapidly screen and select candidate antibodies.
Q: Which specific agency handed over the first antibodies from the Washington state survivor to AbCellera in Februarywas it CDC, DARPA, or some affiliate?.
A: The decision to send some of the first patient samples was made by an intergovernmental working group organized by ASPR.
Q: Canada-based AbCellera was chosen for this critical role over American companies. Is there a specific reason for choosing a foreign partner for this breakthrough?.
A: The DARPA selection process is competitive and open to qualified individuals around the world. In accordance with Department of Defense (DoD) policy, Canada is considered part and parcel of the defense industry and is not just an ally but a partner.
Part III: Therapeutic Deployment and Program LongevityQ: Assuming this antibody regimen is deployed, who will receive the solution first?.
A: Yes, the Solution will be distributed first to health workers. Our goal is to have antibodies available for front line workers first, including healthcare workers, service members, and those with the most medical need.
Q: Regarding its effectiveness, is this solution repeatable? If it wears off in weeks or months, can the subject repeat the dose and get relief again?.
A: The antibody regimen is for near immediate, non-permanent protection and is not meant to be a replacement for vaccines. One advantage of the gene-based platform capability is that it can be re-administered (it is not a vector-based immune response).
Q: Following up on that, if this Solution is a stop-gap measure until a vaccine is available, how long does the protection last? Does the gene-encoded medical countermeasure provide protection for longer than three days?.
A: Correct, the gene-encoded medical countermeasure provides protection in less than three days. It lasts only for months, not days. It is a prophylactic for temporary protection before a vaccine is available or elicits an immune response.
Q: What is the target date for actual public access, and will the FDA approval process be accelerated?.
A: We have no way of knowing how long it will take for FDA review. That process and timeline are entirely up to the FDA, and DARPAnor any other government agencydoes not have the authority to request accelerated review.
Q: Finally, back in April 2020, Jared Adams told me the P3 program was set for two years into a four-year effort, with the goal of being able to identify and respond to a viral threat that is "not fully mature." Will the P3 program be ending as scheduled this year, and why put a deadline on it when other viruses and variants are emerging?.
A: All DARPA programs are time limited by design, as is the tenure of the program managers who run them. That deadline fuels the signature DARPA urgency to achieve success in less time than might be considered reasonable in a conventional setting, to ensure new and innovative ideas are always coming in the door. The agency has successfully followed that model for the P3 initiative, which was announced in February 2017 as a four-year effort.
Part IV: Other Bio-Defense and Future ProgramsQ: I am interested in finding out more about DARPAs Reimagining Protein Manufacturing (RPM) program. Aside from battlefield medical mitigation, what specific kinds of products is RPM expected to yield for the public, such as vaccines, antibodies, or perhaps even a cure for cancer?.
A: (Stacey Wierzba previously indicated she would reach out to the RPM Program Manager to determine their availability to respond to this inquiry).
Q: Lastly, in a more general vein, copper has been reported as highly effective in neutralizing COVID-19 on surfaces. Do your scientists have any insights on this, or perhaps an opinion on whether people should be grinding up old pennies?.
A: (No response regarding the efficacy or use of copper was found in the correspondence.)
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