Recommendations for acceleration of vaccine development and emergency use filings for COVID-19 leveraging lessons from the novel oral polio vaccine

Abstract A new oral polio vaccine, nOPV2, has become the first vaccine to pursue a WHO Emergency Use Listing. Many lessons were learned as part of the accelerated development plan and submission, which have been categorized under the following sections: regulatory, clinical development, chemistry ma...

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Autores principales:	Natalie Thiel, Casey Selwyn, Georgina Murphy, Shmona Simpson, Ajoy C. Chakrabarti
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Immunologic diseases. Allergy RC581-607 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/7f2e418be62c46428654dc05ae26cd14
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spelling	oai:doaj.org-article:7f2e418be62c46428654dc05ae26cd142021-12-02T13:39:34ZRecommendations for acceleration of vaccine development and emergency use filings for COVID-19 leveraging lessons from the novel oral polio vaccine10.1038/s41541-021-00325-42059-0105https://doaj.org/article/7f2e418be62c46428654dc05ae26cd142021-04-01T00:00:00Zhttps://doi.org/10.1038/s41541-021-00325-4https://doaj.org/toc/2059-0105Abstract A new oral polio vaccine, nOPV2, has become the first vaccine to pursue a WHO Emergency Use Listing. Many lessons were learned as part of the accelerated development plan and submission, which have been categorized under the following sections: regulatory, clinical development, chemistry manufacturing and controls, and post-deployment monitoring. Efforts were made to adapt findings from these studies to COVID-19 vaccine candidates. Specific concepts for accelerating COVID-19 vaccine development across multiple functional domains were also included. The goals of this effort were twofold: (1) to help familiarize vaccine developers with the EUL process; and (2) to provide general guidance for faster development and preparations for launch during the COVID-19 pandemic.Natalie ThielCasey SelwynGeorgina MurphyShmona SimpsonAjoy C. ChakrabartiNature PortfolioarticleImmunologic diseases. AllergyRC581-607Neoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENnpj Vaccines, Vol 6, Iss 1, Pp 1-8 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Immunologic diseases. Allergy RC581-607 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	Immunologic diseases. Allergy RC581-607 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Natalie Thiel Casey Selwyn Georgina Murphy Shmona Simpson Ajoy C. Chakrabarti Recommendations for acceleration of vaccine development and emergency use filings for COVID-19 leveraging lessons from the novel oral polio vaccine
description	Abstract A new oral polio vaccine, nOPV2, has become the first vaccine to pursue a WHO Emergency Use Listing. Many lessons were learned as part of the accelerated development plan and submission, which have been categorized under the following sections: regulatory, clinical development, chemistry manufacturing and controls, and post-deployment monitoring. Efforts were made to adapt findings from these studies to COVID-19 vaccine candidates. Specific concepts for accelerating COVID-19 vaccine development across multiple functional domains were also included. The goals of this effort were twofold: (1) to help familiarize vaccine developers with the EUL process; and (2) to provide general guidance for faster development and preparations for launch during the COVID-19 pandemic.
format	article
author	Natalie Thiel Casey Selwyn Georgina Murphy Shmona Simpson Ajoy C. Chakrabarti
author_facet	Natalie Thiel Casey Selwyn Georgina Murphy Shmona Simpson Ajoy C. Chakrabarti
author_sort	Natalie Thiel
title	Recommendations for acceleration of vaccine development and emergency use filings for COVID-19 leveraging lessons from the novel oral polio vaccine
title_short	Recommendations for acceleration of vaccine development and emergency use filings for COVID-19 leveraging lessons from the novel oral polio vaccine
title_full	Recommendations for acceleration of vaccine development and emergency use filings for COVID-19 leveraging lessons from the novel oral polio vaccine
title_fullStr	Recommendations for acceleration of vaccine development and emergency use filings for COVID-19 leveraging lessons from the novel oral polio vaccine
title_full_unstemmed	Recommendations for acceleration of vaccine development and emergency use filings for COVID-19 leveraging lessons from the novel oral polio vaccine
title_sort	recommendations for acceleration of vaccine development and emergency use filings for covid-19 leveraging lessons from the novel oral polio vaccine
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/7f2e418be62c46428654dc05ae26cd14
work_keys_str_mv	AT nataliethiel recommendationsforaccelerationofvaccinedevelopmentandemergencyusefilingsforcovid19leveraginglessonsfromthenoveloralpoliovaccine AT caseyselwyn recommendationsforaccelerationofvaccinedevelopmentandemergencyusefilingsforcovid19leveraginglessonsfromthenoveloralpoliovaccine AT georginamurphy recommendationsforaccelerationofvaccinedevelopmentandemergencyusefilingsforcovid19leveraginglessonsfromthenoveloralpoliovaccine AT shmonasimpson recommendationsforaccelerationofvaccinedevelopmentandemergencyusefilingsforcovid19leveraginglessonsfromthenoveloralpoliovaccine AT ajoycchakrabarti recommendationsforaccelerationofvaccinedevelopmentandemergencyusefilingsforcovid19leveraginglessonsfromthenoveloralpoliovaccine
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Recommendations for acceleration of vaccine development and emergency use filings for COVID-19 leveraging lessons from the novel oral polio vaccine

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