There is little disagreement that the emergence and spread of COVID-19 has been a game-changing event for the world and for those involved in the development of vaccines. The U.S. effort to ramp up development put the Food and Drug Administration (FDA), in its role as primary regulatory and approving agency, under the spotlight to ensure that safety and efficacy were at the forefront during a rapid development process to deliver vaccines to combat the virus.
The FDA has always strived to balance two primary factors over the course of a typical approval process: Patient safety and drug efficacy. The COVID-19 world has been anything but typical. A new drug approval from the FDA can often take many years. A major reason for this is the bias toward patient safety, and the desire to examine as much development data as possible to ensure the ultimate product is both safe and effective. In a normal environment, this process can, and often does take eight to ten years.
Now take the timeline for the approval and release of at least two vaccines for COVID-19. Assuming development of these vaccines began at the very outset of the virus emergence into the public on a large scale, we would be starting in about February or March of 2020. Two pharmaceutical companies announced Emergency Use Authorization of their respective vaccines in November of 2020, approximately nine months after starting development. A helpful factor aiding in the speed of the process was prior research, as well as a close working partnership between pharmaceutical companies, outsource partners, and government agencies which oversee the approval process. Researchers were not starting from scratch when dealing with this virus. Scientists have been studying coronaviruses for more than 50 years. The environment of urgency for this project also ensured that bureaucratic hurdles and gates that are part of a ‘typical’ process were made easier to surmount.
The nature of the Covid-19 health emergency created an environment in which many components of the vaccine development process were moved to the front of the line at every step. Patient safety and efficacy remained the primary concern. Take Citation’s experience providing labels for many of these vaccine trials. Whenever a Covid vaccine related project came to us, that project was tagged with a priority status. The usual time ‘waiting in the queue’ was fast-tracked. Moreover, Covid vaccine projects were given additional resources, and moved through production quicker with the help of extra personnel working extended shifts. This shortened the time required to move ‘our’ finished product on to the next phase of development, where similar prioritization was given. All of this was taking place while other equally important non-Covid related drug development was occurring. The prioritization of these studies was probably the most significant factor in the rapid development and approval of the final formulations.
In short, it appears the main drivers of this unprecedented development pace were a high degree of supplier and vendor collaboration, and a world-wide prioritization of this project. There were numerous examples of collaboration during the vaccine product supply chain where the main players in formulation development were assisted by companies that in ‘normal’ times would be considered competitors. This collaboration took place along the entire supply chain, and work that would normally be awarded to preferred vendors was spread out to increase critical mass in development and therefore, shorten timelines. This involved packaging and labeling; test data analysis; clinical trials; and distribution logistics of the approved formulations.
To those of us who work within this supply chain, it was an amazing process to follow. Perhaps not since World War II, has such a cooperative and concerted effort been undertaken to meet national and indeed world goals to overcome a threat.