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Fast Tracking—Vaccine Safety, Efficacy, and Lessons Learned: A Narrative Review
(1) Background: The COVID-19 pandemic has led to the fast-tracked development of vaccines under emergency use authorization. In light of the growing concerns about fast-tracked vaccines, this article reviews the safety, efficacy, and lessons learned of previously fast-tracked vaccines. (2) Methods:...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9414382/ https://www.ncbi.nlm.nih.gov/pubmed/36016143 http://dx.doi.org/10.3390/vaccines10081256 |
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author | Wong, Jason C. Lao, Crystal T. Yousif, Melanie M. Luga, Jacqueline M. |
author_facet | Wong, Jason C. Lao, Crystal T. Yousif, Melanie M. Luga, Jacqueline M. |
author_sort | Wong, Jason C. |
collection | PubMed |
description | (1) Background: The COVID-19 pandemic has led to the fast-tracked development of vaccines under emergency use authorization. In light of the growing concerns about fast-tracked vaccines, this article reviews the safety, efficacy, and lessons learned of previously fast-tracked vaccines. (2) Methods: An article search regarding the safety and efficacy of fast-tracked vaccines was done in PubMed, Embase, Web of Science, and ScienceDirect. Of the 104 results, 24 articles were included. Five articles about BiovaxID, THERATOPE(®), Sipuleucel-T, and AIDSVAX were also reviewed. (3) Results: The overall efficacy was shown to be 77–100%, with seroprotection against the viruses ranging from 87 to 100%. The antibody responses for optimal protection against the viruses fall within 85–97%. Generally, the fast-tracked vaccines were well-tolerated and had few significant adverse events, except for the H1N1 pandemic vaccine and its association with narcolepsy. To have accurate, precise, and timely fast-tracked vaccines, communication, sharing resources/data, and improving the current structures/outbreak operations are crucial. (4) Conclusions: This review found the FDA’s fast-tracking process for vaccines to have rigorous standards similar to the normal process. The previous fast-tracked vaccines were safe and efficacious. The lessons drawn from previous studies highlighted the significance of planning and utilizing global resources during significant outbreaks. |
format | Online Article Text |
id | pubmed-9414382 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-94143822022-08-27 Fast Tracking—Vaccine Safety, Efficacy, and Lessons Learned: A Narrative Review Wong, Jason C. Lao, Crystal T. Yousif, Melanie M. Luga, Jacqueline M. Vaccines (Basel) Review (1) Background: The COVID-19 pandemic has led to the fast-tracked development of vaccines under emergency use authorization. In light of the growing concerns about fast-tracked vaccines, this article reviews the safety, efficacy, and lessons learned of previously fast-tracked vaccines. (2) Methods: An article search regarding the safety and efficacy of fast-tracked vaccines was done in PubMed, Embase, Web of Science, and ScienceDirect. Of the 104 results, 24 articles were included. Five articles about BiovaxID, THERATOPE(®), Sipuleucel-T, and AIDSVAX were also reviewed. (3) Results: The overall efficacy was shown to be 77–100%, with seroprotection against the viruses ranging from 87 to 100%. The antibody responses for optimal protection against the viruses fall within 85–97%. Generally, the fast-tracked vaccines were well-tolerated and had few significant adverse events, except for the H1N1 pandemic vaccine and its association with narcolepsy. To have accurate, precise, and timely fast-tracked vaccines, communication, sharing resources/data, and improving the current structures/outbreak operations are crucial. (4) Conclusions: This review found the FDA’s fast-tracking process for vaccines to have rigorous standards similar to the normal process. The previous fast-tracked vaccines were safe and efficacious. The lessons drawn from previous studies highlighted the significance of planning and utilizing global resources during significant outbreaks. MDPI 2022-08-04 /pmc/articles/PMC9414382/ /pubmed/36016143 http://dx.doi.org/10.3390/vaccines10081256 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Review Wong, Jason C. Lao, Crystal T. Yousif, Melanie M. Luga, Jacqueline M. Fast Tracking—Vaccine Safety, Efficacy, and Lessons Learned: A Narrative Review |
title | Fast Tracking—Vaccine Safety, Efficacy, and Lessons Learned: A Narrative Review |
title_full | Fast Tracking—Vaccine Safety, Efficacy, and Lessons Learned: A Narrative Review |
title_fullStr | Fast Tracking—Vaccine Safety, Efficacy, and Lessons Learned: A Narrative Review |
title_full_unstemmed | Fast Tracking—Vaccine Safety, Efficacy, and Lessons Learned: A Narrative Review |
title_short | Fast Tracking—Vaccine Safety, Efficacy, and Lessons Learned: A Narrative Review |
title_sort | fast tracking—vaccine safety, efficacy, and lessons learned: a narrative review |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9414382/ https://www.ncbi.nlm.nih.gov/pubmed/36016143 http://dx.doi.org/10.3390/vaccines10081256 |
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