National control laboratory independent lot testing of COVID-19 vaccines: the UK experience
Abstract 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 vacci...
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doaj-b34105000438424991c08c16431010942021-08-15T11:07:11ZengNature Publishing Groupnpj Vaccines2059-01052021-08-01611410.1038/s41541-021-00368-7National control laboratory independent lot testing of COVID-19 vaccines: the UK experienceNicola J. Rose0Paul Stickings1Silke Schepelmann2Marc J. A. Bailey3Chris Burns4The National Institute for Biological Standards and Control, a Centre of the Medicines and Healthcare products Regulatory Agency, Division of VirologyThe National Institute for Biological Standards and Control, a Centre of the Medicines and Healthcare products Regulatory Agency, Division of BacteriologyThe National Institute for Biological Standards and Control, a Centre of the Medicines and Healthcare products Regulatory Agency, Division of VirologyThe National Institute for Biological Standards and Control, a Centre of the Medicines and Healthcare products Regulatory AgencyThe National Institute for Biological Standards and Control, a Centre of the Medicines and Healthcare products Regulatory Agency, Division of BiotherapeuticsAbstract 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).https://doi.org/10.1038/s41541-021-00368-7 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Nicola J. Rose Paul Stickings Silke Schepelmann Marc J. A. Bailey Chris Burns |
spellingShingle |
Nicola J. Rose Paul Stickings Silke Schepelmann Marc J. A. Bailey Chris Burns National control laboratory independent lot testing of COVID-19 vaccines: the UK experience npj Vaccines |
author_facet |
Nicola J. Rose Paul Stickings Silke Schepelmann Marc J. A. Bailey Chris Burns |
author_sort |
Nicola J. Rose |
title |
National control laboratory independent lot testing of COVID-19 vaccines: the UK experience |
title_short |
National control laboratory independent lot testing of COVID-19 vaccines: the UK experience |
title_full |
National control laboratory independent lot testing of COVID-19 vaccines: the UK experience |
title_fullStr |
National control laboratory independent lot testing of COVID-19 vaccines: the UK experience |
title_full_unstemmed |
National control laboratory independent lot testing of COVID-19 vaccines: the UK experience |
title_sort |
national control laboratory independent lot testing of covid-19 vaccines: the uk experience |
publisher |
Nature Publishing Group |
series |
npj Vaccines |
issn |
2059-0105 |
publishDate |
2021-08-01 |
description |
Abstract 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). |
url |
https://doi.org/10.1038/s41541-021-00368-7 |
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