National control laboratory independent lot testing of COVID-19 vaccines: the UK experience

The past 18 months have seen an unprecedented approach to vaccine development in the global effort against the COVID-19 pandemic. The process from discovery research, through clinical trials and regulatory approval often takes more than 10 years. However, the critical need to expedite vaccine availa...

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Bibliographic Details
Published in:npj vaccines 2021-08, Vol.6 (1), p.100-100, Article 100
Main Authors: Rose, Nicola J., Stickings, Paul, Schepelmann, Silke, Bailey, Marc J. A., Burns, Chris
Format: Article
Language:English
Subjects:
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Biomedical and Life Sciences
Biomedicine
Clinical trials
Coronaviruses
COVID-19
COVID-19 vaccines
Infectious Diseases
Laboratories
Medical Microbiology
Pandemics
Perspective
Product development
Public Health
Regulatory approval
Vaccine
Vaccines
Virology
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Summary:The past 18 months have seen an unprecedented approach to vaccine development in the global effort against the COVID-19 pandemic. The process from discovery research, through clinical trials and regulatory approval often takes more than 10 years. However, the critical need to expedite vaccine availability in the pandemic has meant that new approaches to development, manufacturing, and regulation have been required: this has necessitated many stages of product development, clinical trials, and manufacturing to be undertaken in parallel at a global level. Through the development of these innovative products, the world has the best chance of finding individual, or combinations of, vaccines that will provide adequate protection for the world’s population. Despite the huge scientific and regulatory achievements and significant investment to accelerate vaccine availability, it is essential that safety measures are not compromised. Here we focus on the post regulatory approval testing by independent laboratories that provides an additional assurance of the safety and quality of a product, with an emphasis on the UK experience through the National Institute for Biological Standards and Control (NIBSC), an expert centre of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
ISSN:2059-0105
2059-0105
DOI:10.1038/s41541-021-00368-7