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

It sets out the lessons learned to improve the vaccine ecosystem for future vaccine development, for pandemics, epidemics of emerging pathogens, and endemic diseases.

The SARS-CoV-2 pandemic triggered concerted action by governments, funders, regulators and industry to overcome many of the historical challenges that vaccines usually face during development and authorisation.  

In 2021, Wellcome commissioned a report to identify the factors that enabled the rapid clinical development and emergency use authorisation of Covid-19 vaccines. The aim was to identify actions that would improve the development ecosystem for all vaccines.  

Key findings include: 

• The significant health, economic and social impacts of the pandemic led to high levels of political commitment to develop vaccines against Covid-19. 
• Unprecedented levels of investment spread the financial risks for developers and contributed to more efficient decision-making. 
• A proactive approach by regulators giving clear indications of data requirements from the outset, coupled with prioritisation of human resources and increased collaborations resulted in accelerated review processes. 
• The availability of existing research on coronaviruses, vaccine platform technologies, and strong clinical trial infrastructure combined with streamlined clinical testing processes resulted in faster development. 

Recommendations for actions: 

• Commit sustained financial support for scientists and foundational science. 
• Establish strong, flexible clinical trial infrastructure.  
• Support and strengthen global funding mechanisms. 
• Facilitate communication between regulatory authorities and other stakeholders by developing forums. 

For more information, contact Deborah King, Research Lead, Vaccines at D.King@wellcome.org.