Manhattan Project to Fight Covid 19?

What many people are referring to as a modern version of the Manhattan Project that developed the atomic bombs that ended World War II to fight COVID 19 is apparently well underway. If this effort proves successful, it will stand out as a shining example of how a series of public-private partnerships can be used to create innovation on a massive scale - in this case to overcome a global pandemic.

Dubbed "Operation Warp Speed" (OWS) aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as countermeasures).

That’s much faster than the usual 12-18 months it can take to create a viable vaccine and get it to market. Operation Warp Speed is actually a public-private partnership that is coordinating efforts to overcome the COVID-19 virus on a massive scale.  

Leading the partnership are HHS Secretary Alex Azar and Defense Secretary Mark Esper oversee OWS, with Dr. Moncef Slaoui designated as chief advisor and General Gustave F. Perna nominated to be chief operating officer. To allow these OWS leaders to focus on operational work, in the near future the program will be announcing separate points of contact, with deep expertise and involvement in the program, for communication with Congress and the public.

At the federal level, Operation Warp Speed involves components of the Department of Health and Human Services (HHS), including the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), and the Department of Defense (DoD), the Department of Agriculture, the Department of Energy, and the Department of Veterans Affairs. Among the task force's responsibilities will be to coordinate existing HHS-wide efforts, including the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, NIH’s Rapid Acceleration of Diagnostics (RADx) initiative, and work by BARDA.

According to the New York Times, the five private companies selected to be included in the partnership are Moderna, a Massachusetts-based biotechnology firm, which Dr. Fauci said he expected would enter into the final phase of clinical trials next month; the combination of Oxford University and AstraZeneca, on a similar schedule; and three large pharmaceutical companies: Johnson & Johnson, Merck and Pfizer. Each is taking a somewhat different approach. By winnowing the field in a matter of weeks from a pool of around a dozen companies, the federal government is betting that it can identify the most promising vaccine projects at an early stage, speed along the process of determining which will work and ensure that the winner or winners can be quickly manufactured in huge quantities and distributed across the country.

Dr. Anthony S. Fauci, the federal government’s top epidemiologist and director of the National Institute of Allergy and Infectious Diseases, hinted at the coming action when he told a medical seminar that “by the beginning of 2021 we hope to have a couple of hundred million doses.”

The cost? No one knows for sure at this point, but a Bloomberg source estimated "billions of dollars," although it will be funded from "money already available to the government and won't require new authority from Congress.

Moderna, Johnson & Johnson and the Oxford-AstraZeneca group have apparently already received a total of $2.2 Billion in federal funding to support their vaccine programs. Their selection as finalists, along with Merck and Pfizer, will give all five companies access to additional government money, help in running clinical trials and financial and logistical support for a manufacturing base that is being built even before it is clear which if any of the vaccines in development will work.

Its also interesting to note that the task force is using proven agile project management methodologies to accelerate results. The federal government is making investments in the necessary manufacturing capacity at its own risk, giving firms confidence that they can invest aggressively in development and allowing faster distribution of an eventual vaccine. Manufacturing capacity for selected candidates will be advanced while they are still in development, rather than scaled up after approval or authorization. Manufacturing capacity developed will be used for whatever vaccine is eventually successful, if possible given the nature of the successful product, regardless of which firms have developed the capacity.

HHS plans for a tiered approach to vaccine distribution, which will build on allocation methodology developed as part of pandemic flu planning and be adjusted based on experience during the first wave of the COVID-19 response, data on the virus and its impact on populations and the performance of each vaccine, and the needs of the essential workforce. OWS will expand domestic manufacturing and supplies of specialized materials and resources, such as glass vials, that can be necessary for distribution. DoD’s involvement will enable faster distribution and administration than would have otherwise been possible.

In terms of manufacturing, protocols for the demonstration of safety and efficacy are being aligned, which will allow the trials to proceed more quickly, and the protocols for the trials will be overseen by the federal government, as opposed to traditional public-private partnerships, in which pharmaceutical companies decide on their own protocols. Rather than eliminating steps from traditional development timelines, steps will proceed simultaneously, such as starting manufacturing of the vaccine at industrial scale well before the demonstration of vaccine efficacy and safety as happens normally. This increases the financial risk, but not the product risk.

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