Cargando…

Global regulatory reforms to promote equitable vaccine access in the next pandemic

There is broad consensus that the global response to the Covid-19 pandemic was inadequate, leading to unacceptable levels of avoidable morbidity and mortality. Three strategic missteps led to the lack of equitable vaccine access: The heavy reliance on commercial vaccine manufacturers in high-income...

Descripción completa

Detalles Bibliográficos
Autores principales: Mahoney, Richard, Hotez, Peter J., Bottazzi, Maria Elena
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10584090/
https://www.ncbi.nlm.nih.gov/pubmed/37851688
http://dx.doi.org/10.1371/journal.pgph.0002482
_version_ 1785122676993425408
author Mahoney, Richard
Hotez, Peter J.
Bottazzi, Maria Elena
author_facet Mahoney, Richard
Hotez, Peter J.
Bottazzi, Maria Elena
author_sort Mahoney, Richard
collection PubMed
description There is broad consensus that the global response to the Covid-19 pandemic was inadequate, leading to unacceptable levels of avoidable morbidity and mortality. Three strategic missteps led to the lack of equitable vaccine access: The heavy reliance on commercial vaccine manufacturers in high-income countries (HICs) versus low- and middle-income countries (LMICs); the emergence of vaccine nationalism restricting and delaying the supply of vaccines to LMICs; and an inadequate support or recognition for LMIC national regulatory authorities. To avoid these inequities in a future pandemic, we focus on three successful vaccine development and technology transfer case studies–the Hepatitis B vaccine produced in South Korea in the 1980s; the Meningitis A vaccine for Africa led by Program for Appropriate Technologies in Health (PATH) and the World Health Organization (WHO) in the 2000s; and a recombinant SARS CoV-2 protein-based vaccine technology from the Texas Children’s Hospital transferred to India and to Indonesia. In addition to expanding support for academic or non-profit product development partnerships, our analysis finds that an essential step is the strengthening of selected LMIC regulatory systems to become Stringent Regulatory Authorities (SRAs), together with a re-prioritization of the WHO Prequalification (PQ) system to ensure early vaccine availability in LMICs especially during pandemics. Advancing LMIC National Regulatory Authorities (NRAs) to Stringent Regulatory Authorities (SRAs) status will require substantial resources, but the benefits for future pandemic control and for health in LMIC would be immense. We call on the WHO, United Nation (UN) agencies and SRAs, to collaborate and implement a comprehensive roadmap to support LMIC regulators to achieve stringent status by 2030.
format Online
Article
Text
id pubmed-10584090
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Public Library of Science
record_format MEDLINE/PubMed
spelling pubmed-105840902023-10-19 Global regulatory reforms to promote equitable vaccine access in the next pandemic Mahoney, Richard Hotez, Peter J. Bottazzi, Maria Elena PLOS Glob Public Health Review There is broad consensus that the global response to the Covid-19 pandemic was inadequate, leading to unacceptable levels of avoidable morbidity and mortality. Three strategic missteps led to the lack of equitable vaccine access: The heavy reliance on commercial vaccine manufacturers in high-income countries (HICs) versus low- and middle-income countries (LMICs); the emergence of vaccine nationalism restricting and delaying the supply of vaccines to LMICs; and an inadequate support or recognition for LMIC national regulatory authorities. To avoid these inequities in a future pandemic, we focus on three successful vaccine development and technology transfer case studies–the Hepatitis B vaccine produced in South Korea in the 1980s; the Meningitis A vaccine for Africa led by Program for Appropriate Technologies in Health (PATH) and the World Health Organization (WHO) in the 2000s; and a recombinant SARS CoV-2 protein-based vaccine technology from the Texas Children’s Hospital transferred to India and to Indonesia. In addition to expanding support for academic or non-profit product development partnerships, our analysis finds that an essential step is the strengthening of selected LMIC regulatory systems to become Stringent Regulatory Authorities (SRAs), together with a re-prioritization of the WHO Prequalification (PQ) system to ensure early vaccine availability in LMICs especially during pandemics. Advancing LMIC National Regulatory Authorities (NRAs) to Stringent Regulatory Authorities (SRAs) status will require substantial resources, but the benefits for future pandemic control and for health in LMIC would be immense. We call on the WHO, United Nation (UN) agencies and SRAs, to collaborate and implement a comprehensive roadmap to support LMIC regulators to achieve stringent status by 2030. Public Library of Science 2023-10-18 /pmc/articles/PMC10584090/ /pubmed/37851688 http://dx.doi.org/10.1371/journal.pgph.0002482 Text en © 2023 Mahoney et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Review
Mahoney, Richard
Hotez, Peter J.
Bottazzi, Maria Elena
Global regulatory reforms to promote equitable vaccine access in the next pandemic
title Global regulatory reforms to promote equitable vaccine access in the next pandemic
title_full Global regulatory reforms to promote equitable vaccine access in the next pandemic
title_fullStr Global regulatory reforms to promote equitable vaccine access in the next pandemic
title_full_unstemmed Global regulatory reforms to promote equitable vaccine access in the next pandemic
title_short Global regulatory reforms to promote equitable vaccine access in the next pandemic
title_sort global regulatory reforms to promote equitable vaccine access in the next pandemic
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10584090/
https://www.ncbi.nlm.nih.gov/pubmed/37851688
http://dx.doi.org/10.1371/journal.pgph.0002482
work_keys_str_mv AT mahoneyrichard globalregulatoryreformstopromoteequitablevaccineaccessinthenextpandemic
AT hotezpeterj globalregulatoryreformstopromoteequitablevaccineaccessinthenextpandemic
AT bottazzimariaelena globalregulatoryreformstopromoteequitablevaccineaccessinthenextpandemic