Not since World War II and the Manhattan Project, has a project been so important to the world as Operations Warp Speed. Its goal was to take a process that normally takes years to complete, and bring the COVID-19 vaccine to the world.
As a result of its importance, a public-private effort using many resources sped the development of the vaccine. Under less urgent circumstances, vaccine development may take up to 10 years, billions of dollars, and have a high failure rate. Several COVID-19 vaccines have been developed and made ready for distribution in less than one year.
A variety of tactics were applied to the problem. One is the combination of private/government collaboration. Additionally, the US Federal Government allocated $10 billion in federal funds to support the effort.
This money allowed organizations to apply funding to crash activities, in order to reduce completion time. In many cases, activities normally completed in sequential fashion were completed simultaneously, or at least allowed to overlap. For example, many phases of the clinical trials were overlapped to reduce time.
Also, with government funding, production of the vaccines began before the clinical trials had ended. Under normal conditions, this rarely occurs.
- COVID-19: What is Operation Warp Speed? (Nov 24, 2020, ChristianaCare)
This post is based on the Sci Tech Daily article, The Most Rapid Vaccine Rollout in History: How Researchers Developed COVID-19 Vaccines So Quickly, by Alison Caldwell, February 11, 2021; the US Department of Defense site, Coronavirus: DOD Response; and the YouTube video in the Spotlight. Image source: Blue Planet Studio/Shutterstock
1. Take a look at this Department of Defense image of Operation Warp Speed’s accelerated vaccine process. What tactics were used to speed the development of the COVID-19 vaccine?
Guidance: In point 1, the time is reduced by using an existing vaccine platform.
Point 2 reduces time by quickly going into large Phase III clinical trials, and starting manufacturing of the vaccines before the completion of Phase III clinical trials.
Point 3 starts planning and developing the infrastructure for the distribution of the vaccines.
Point 4 uses existing planning for pandemic flu planning and applies it to the COVID-19 pandemic.
Finally, point 5 speeds the FDA approval process using information gained from the large-scale phase III clinical trials. In addition to that depicted in the image, the availability of federal money allows resources to be focused on the development of the vaccines.
2. What are the risks associated with reducing project completion time for the vaccines?
Guidance: Normally, such an approach would tend to increase the probability of failure. Most vaccine development only has a 10% chance of success. However, Pfizer, and Moderna have successfully developed their COVID-19 vaccines, and are in the process of distributing them. Both vaccines have high efficacy rates.
Another concern would be the safety of the vaccines. In less urgent circumstances, vaccines would be in clinical trials for a longer period of time. This provides better assurances against any long-term side effects of the vaccine.
One interesting problem related to bringing the vaccine to market so quickly, is the public’s willingness to take the vaccine. When people are concerned about the safety of the vaccine, they may not accept it when it becomes available.
3. Should the distribution of the vaccines be considered a project? Why?
Guidance: Just as vaccine development was a project, distribution of vaccines is a project as well. The distribution has a specific goal of having as many people as possible vaccinated as quickly as possible. Having a large number of people vaccinated will prevent the spread of the virus, as well as reduce the number of viral mutations.