Covid-19 vaccines: the factors that enabled unprecedented timelines for clinical development and regulatory authorisation

Wellcome Trust

Historically, clinical development and approval of vaccines have spanned approximately 10 years with only ~16% of vaccine candidates ever receiving market authorisation. The long timelines and the low success rates are the product of the complex ecosystem where each vaccine candidate faces multitudes of challenges. However, the SARS-CoV-2 pandemic overcame many of these historical challenges, and within 12 months of the detection of the first SARS-CoV-2 case, at least six vaccines had received emergency use authorisation. Further, as of December 2021, just two years following the detection of the first SARS-CoV-2 case, there are 28 vaccines that have been approved by at least one country. This rapid pace to develop and authorise COVID-19 vaccines raised the question of whether any of the actions employed to develop COVID-19 vaccines could be replicated for vaccine development in the future. The Wellcome Trust sought to identify and understand the impact of the different factors that enabled the rapid clinical development and emergency use authorisation of COVID-19 vaccines to take forward any lessons learned to improve the vaccine ecosystem for future vaccine development, for pandemics, epidemics of emerging pathogens, and endemic diseases.

This research builds on the prior research conducted on the vaccine ecosystem, which identified 10 barriers that impacted the time to market for vaccine candidates. It focuses on exploring the contextual changes and actions that accelerated COVID-19 vaccine development and authorisation timelines. To achieve the stated research objective, this research utilised a mixed-methods approach, combining a review of 683 published and unpublished literature articles, consultations with 88 experts, and quantitative analyses