10/02/2023

COVID-19 Vaccine Development: 7 Learnings for Agile

Author: David Wildt

Researchers were under pressure to develop a COVID-19 vaccine after the rising number of deaths in early 2020 associated with the coronavirus. In this case of vaccine development, time was of the essence – new ways of working and regulatory processes needed to be applied. After less than a year, the first vaccine doses against the coronavirus were administered – thanks to Agile.

For software development or any business, an agile working approach has become a central way of thinking and acting – directly influencing success. How important agile working can be, is seen in the success of the development of the Covid-19 vaccines. 

The typical timeline of vaccine development

Vaccine development is a highly complex process, and it can take years before a new vaccine is brought to market. Every vaccine development goes through phases, the “vaccine development life cycle”, and each step needs to be completed before continuing. It is only after the third trial phase and regulatory approval that manufacturing capacity is scaled up.  The traditional method, although accurate, is not efficient enough for vaccines, where time is especially crucial.

The traditional approach shows similarities to the sequential method

Analysing the traditional vaccine development approach shows similarities to what project managers refer to as the sequential software development design method. In a sequential process, each phase follows the other only after completion. The last phase, testing and deployment, often happens months or years after the initial analysis. This sequential approach was too slow to be feasible for the development of the COVID-19 vaccine. 

How did pharmaceutical companies develop a vaccine so quickly without compromising on quality or safety?

Focus and resources:  Funded by entities like the European Medicines Agency (EMA), researchers all over the world were focusing solely on this goal.
Existing knowledge: Since the coronavirus turned out to be similar to diseases like SARS and MERS, existing knowledge and insights could be applied.
Agile working: An incremental and iterative development process was carried out in every phase. Development, evaluation, and authorization benefitted particularly from effective project management.
Sufficient data: In the trial, a large testing group was involved, before the vaccines were made available to the market.

Infografik über die zeitlichen Unterschiede

Comparison of vaccine development methods.

Succeed together

Characterized by an iterative and incremental approach, agile working is about staying dynamic and the ability to adapt to fast-changing environments. An excellent team and established frameworks enable success. A cross-functional COVID-19 Emergency Task Force (ETF) consisting of non-clinical, clinical, and quality experts from relevant disciplines was established. Developers were able to interact with the ETF via video calls as needed. The importance of such continuous and timely communication is also highlighted in the fourth principle of the Agile Manifesto for software development: work together daily. 

Parallelization of phases

Due to the ongoing support from able entities, all required resources were mobilized in a much shorter period. This allowed for the parallelization of phases – something else familiar to the agile approach. The phases were broken down into smaller steps. Instead of waiting, early results were already considered in later steps, which enabled an earlier start. Similar to the research and clinical trial phases overlapping, scientific evaluation and authorization by the European Medicines Agency (EMA) also started at the same time – this approach enables a much shorter development without sacrificing quality, safety, or efficacy. 

Key Takeaways for agile practices:

The development of the COVID-19 vaccines has shown that agile methods can speed up any development process, without compromising on quality. These are the takeaways for any business trying to go Agile:

Prioritizing tasks and focusing on high-priority issues enables efficient time management and omits long discussions about what to do first.
Mobilizing and pooling resources and staff allows for an excellent team with different people from various skill levels and expertise in every task area, enabling the best results.
Breaking tasks down into smaller steps helps with tracking processes, problem-solving and goal-setting.
Regularly reviewing progress to ensure being on schedule is equally as important as tracking processes.
Making sure high-quality and safety standards are met is especially crucial in the parallelization of work processes.
A task force ensuring these standards fulfil requirements can be helpful when trying to implement agile methods.
Finally, continuing to use what is already available, resources and tools that are already to hand, offers a great opportunity to focus on more relevant tasks.