Covid-19 vaccines: the factors that enabled unprecedented timelines for clinical development and regulatory authorisation
A healthcare worker prepares the Pfizer-BioNTech (Comirnaty) covid-19 vaccine during the vaccination campaign.
This report identifies the factors that enabled the rapid clinical development and emergency use authorisation of Covid-19 vaccines.
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.
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.