Regulatory Pathways That Facilitated Timely Registration of a New Group A Meningococcal Conjugate Vaccine for Africa's Meningitis Belt Countries

Background. Through its normative and public health leadership roles, the World Health Organization (WHO) plays a key role in the availability of vaccine products in low-and middle-income countries. The recent introduction of a new group A meningococcal conjugate vaccine, PsA-TT (MenAfriVac), in Afr...

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Main Authors:	Dellepiane, Nora, Akanmori, Bartholomew Dicky, Gairola, Sunil, Jadhav, Suresh S., Parker, Cathy, Rodriguez, Carmen, Srivastava, Swati
Format:	Online
Language:	English
Published:	Oxford University Press 2015
Online Access:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4639481/

id	pubmed-4639481
recordtype	oai_dc
spelling	pubmed-46394812015-11-12 Regulatory Pathways That Facilitated Timely Registration of a New Group A Meningococcal Conjugate Vaccine for Africa's Meningitis Belt Countries Dellepiane, Nora Akanmori, Bartholomew Dicky Gairola, Sunil Jadhav, Suresh S. Parker, Cathy Rodriguez, Carmen Srivastava, Swati The Meningitis Vaccine Project: The Development, Licensure, Introduction, and Impact of a New Group a Meningococcal Conjugate Vaccine for Africa Background. Through its normative and public health leadership roles, the World Health Organization (WHO) plays a key role in the availability of vaccine products in low-and middle-income countries. The recent introduction of a new group A meningococcal conjugate vaccine, PsA-TT (MenAfriVac), in Africa exemplifies this process. WHO requires that any new vaccine to be introduced in countries for public health reasons and supplied through United Nations centralized mechanisms be licensed by the national regulatory agency (NRA) in the producing country, then prequalified and given a marketing authorization in the user countries. Oxford University Press 2015-11-15 2015-11-09 /pmc/articles/PMC4639481/ /pubmed/26553671 http://dx.doi.org/10.1093/cid/civ491 Text en © 2015 World Health Organization; licensee Oxford Journals. http://creativecommons.org/licenses/by/3.0/igo/legalcode This is an open access article distributed under the terms of the Creative Commons Attribution IGO License (http://creativecommons.org/licenses/by/3.0/igo/legalcode), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. In any reproduction of this article there should not be any suggestion that WHO or this article endorse any specific organisation or products. The use of the WHO logo is not permitted. This notice should be preserved along with the article's original URL
repository_type	Open Access Journal
institution_category	Foreign Institution
institution	US National Center for Biotechnology Information
building	NCBI PubMed
collection	Online Access
language	English
format	Online
author	Dellepiane, Nora Akanmori, Bartholomew Dicky Gairola, Sunil Jadhav, Suresh S. Parker, Cathy Rodriguez, Carmen Srivastava, Swati
spellingShingle	Dellepiane, Nora Akanmori, Bartholomew Dicky Gairola, Sunil Jadhav, Suresh S. Parker, Cathy Rodriguez, Carmen Srivastava, Swati Regulatory Pathways That Facilitated Timely Registration of a New Group A Meningococcal Conjugate Vaccine for Africa's Meningitis Belt Countries
author_facet	Dellepiane, Nora Akanmori, Bartholomew Dicky Gairola, Sunil Jadhav, Suresh S. Parker, Cathy Rodriguez, Carmen Srivastava, Swati
author_sort	Dellepiane, Nora
title	Regulatory Pathways That Facilitated Timely Registration of a New Group A Meningococcal Conjugate Vaccine for Africa's Meningitis Belt Countries
title_short	Regulatory Pathways That Facilitated Timely Registration of a New Group A Meningococcal Conjugate Vaccine for Africa's Meningitis Belt Countries
title_full	Regulatory Pathways That Facilitated Timely Registration of a New Group A Meningococcal Conjugate Vaccine for Africa's Meningitis Belt Countries
title_fullStr	Regulatory Pathways That Facilitated Timely Registration of a New Group A Meningococcal Conjugate Vaccine for Africa's Meningitis Belt Countries
title_full_unstemmed	Regulatory Pathways That Facilitated Timely Registration of a New Group A Meningococcal Conjugate Vaccine for Africa's Meningitis Belt Countries
title_sort	regulatory pathways that facilitated timely registration of a new group a meningococcal conjugate vaccine for africa's meningitis belt countries
description	Background. Through its normative and public health leadership roles, the World Health Organization (WHO) plays a key role in the availability of vaccine products in low-and middle-income countries. The recent introduction of a new group A meningococcal conjugate vaccine, PsA-TT (MenAfriVac), in Africa exemplifies this process. WHO requires that any new vaccine to be introduced in countries for public health reasons and supplied through United Nations centralized mechanisms be licensed by the national regulatory agency (NRA) in the producing country, then prequalified and given a marketing authorization in the user countries.
publisher	Oxford University Press
publishDate	2015
url	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4639481/
_version_	1613499251652820992

Regulatory Pathways That Facilitated Timely Registration of a New Group A Meningococcal Conjugate Vaccine for Africa's Meningitis Belt Countries

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