Operation Warp Speed Plan Released for COVID Vaccine Distribution

Recently, the White House released its COVID-19 vaccine distribution strategy through the U.S. Department of Health and Human Services (HHS) and the Department of Defense (DoD). The two departments, along with the Centers for Disease Control and Prevention (CDC), stated their plan provides a “playbook” for state and local public health programs on how to plan and operationalize a vaccination program for COVID-19.

This plan or "playbook" is called Operation Warp Speed (OWS) which is framed as a way to administer the vaccine as soon as “it meets FDA’s gold standard.”

While the plan is comprehensive, it centers on four key steps:

• Engage with local constituents and the public to communicate information around the vaccine and promote vaccine confidence.
• Distribute vaccines immediately upon the granting of Emergency Use Authorization/Biologics License Application.
• Ensure safe administration of the vaccine along with availability of administration supplies.
• Monitor the data from the vaccine program to track distribution, administration and other data.

Associate Professor of Operations Management & Business Analytics at Johns Hopkins University Carey Business School, Tinglong Dai, PhD, says development of OWS has been the main focus so far, with a $10 billion investment committed to supporting a portfolio of manufacturers’ ongoing R&D effort.

"Building at-risk manufacturing capability in parallel to the development effort is equally important, as it helps ensure speed delivery once a safe and effective vaccine is approved," Dai says. "Distribution and administration have been getting an increasing amount of attention, as we approach the promised time that the vaccine would be available to priority groups."

Currently, nine vaccines are under Phase III clinical trials as of September 22, 2020. Among those vaccines, OWS supports vaccines developed by AstraZeneca, Moderna, and Pfizer.

According to Dai, the low-temperature requirements of several vaccine candidates will be an important consideration in building the COVID-19 vaccine supply chain.

Once any of these nine vaccines are officially approved to become the first COVID-19 vaccine and so on, they will be approved through an Emergency Use Authorization (EUA).

Dai says EUA's can be very fast, because they do not require the typical, lengthy procedures required for approving a vaccine. A typical approval process would take much longer, although can be accelerated under OWS, he says. After approval, due to OWS, millions of pre-manufactured doses of vaccines can be distributed to administration sides.

While very the plan seems promising in the factor of timing, the effectiveness of the plan is too early to tell, Dai adds.

"The billions of dollars poured into vaccine development has certainly been effective in inspiring vaccine manufacturers to develop a vaccine with a seemingly impossible timeline," he says. "We are starting to find out more about the important groundwork that OWS is building related to early at-risk manufacturing and smooth distribution. We will be able to evaluate its effectiveness in the coming months."