A pair of hands with surgical gloves poking an injection through a small bottle.

Pongmanat Tasiri/SOPA Images/LightRocket via Getty Images

A healthcare worker prepares the Pfizer-BioNTech (Comirnaty) covid-19 vaccine during the vaccination campaign.

Report summary

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

This report identifies the factors that enabled the rapid clinical development and emergency use authorisation of Covid-19 vaccines.

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

What's inside

  • the impact of the current vaccine ecosystem on clinical development of vaccines
  • a list of the factors that accelerated the development and approval of Covid-19 vaccines
  • translating lessons learned for action and investment.

Who this is for

  • policy makers
  • public, private and philanthropic funders
  • regulatory authorities
  • clinical developers.

Key findings 

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. 


Contact us 

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