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...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Nature Portfolio
2021-04-01
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| Series: | npj Vaccines |
| Online Access: | https://doi.org/10.1038/s41541-021-00325-4 |
| _version_ | 1797421330722717696 |
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| 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 |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-03-09T07:15:37Z |
| format | Article |
| id | doaj.art-7f2e418be62c46428654dc05ae26cd14 |
| institution | Directory Open Access Journal |
| issn | 2059-0105 |
| language | English |
| last_indexed | 2024-03-09T07:15:37Z |
| publishDate | 2021-04-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | npj Vaccines |
| spelling | doaj.art-7f2e418be62c46428654dc05ae26cd142023-12-03T08:35:12ZengNature Portfolionpj Vaccines2059-01052021-04-01611810.1038/s41541-021-00325-4Recommendations for acceleration of vaccine development and emergency use filings for COVID-19 leveraging lessons from the novel oral polio vaccineNatalie Thiel0Casey Selwyn1Georgina Murphy2Shmona Simpson3Ajoy C. Chakrabarti4University of Washington, School of Public HealthBill & Melinda Gates FoundationBill & Melinda Gates FoundationBill & Melinda Gates FoundationBill & Melinda Gates FoundationAbstract 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.https://doi.org/10.1038/s41541-021-00325-4 |
| spellingShingle | 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 npj Vaccines |
| title | 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_short | 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 |
| url | https://doi.org/10.1038/s41541-021-00325-4 |
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