Cargando…

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:...

Descripción completa

Detalles Bibliográficos
Autores principales: Wong, Jason C., Lao, Crystal T., Yousif, Melanie M., Luga, Jacqueline M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
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
_version_ 1784775973410963456
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
work_keys_str_mv AT wongjasonc fasttrackingvaccinesafetyefficacyandlessonslearnedanarrativereview
AT laocrystalt fasttrackingvaccinesafetyefficacyandlessonslearnedanarrativereview
AT yousifmelaniem fasttrackingvaccinesafetyefficacyandlessonslearnedanarrativereview
AT lugajacquelinem fasttrackingvaccinesafetyefficacyandlessonslearnedanarrativereview