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Lessons Learned From Enhancing Vaccine Pharmacovigilance Activities During PsA-TT Introduction in African Countries, 2010–2013

Background. The rollout of the group A meningococcal vaccine, PsA-TT, in Africa's meningitis belt countries represented the first introduction of a vaccine specifically designed for this part of the world. During the first year alone, the number of people who received the vaccine through mass v...

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Autores principales: Diomandé, Fabien V. K., Yaméogo, Téné M., Vannice, Kirsten S., Preziosi, Marie-Pierre, Viviani, Simonetta, Ouandaogo, Claude-Roger, Keita, Modibo, Djingarey, Mamoudou H., Mbakuliyemo, Nehemie, Akanmori, Bartholomew Dicky, Sow, Samba O., Zuber, Patrick L. F.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4639501/
https://www.ncbi.nlm.nih.gov/pubmed/26553675
http://dx.doi.org/10.1093/cid/civ599
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author Diomandé, Fabien V. K.
Yaméogo, Téné M.
Vannice, Kirsten S.
Preziosi, Marie-Pierre
Viviani, Simonetta
Ouandaogo, Claude-Roger
Keita, Modibo
Djingarey, Mamoudou H.
Mbakuliyemo, Nehemie
Akanmori, Bartholomew Dicky
Sow, Samba O.
Zuber, Patrick L. F.
author_facet Diomandé, Fabien V. K.
Yaméogo, Téné M.
Vannice, Kirsten S.
Preziosi, Marie-Pierre
Viviani, Simonetta
Ouandaogo, Claude-Roger
Keita, Modibo
Djingarey, Mamoudou H.
Mbakuliyemo, Nehemie
Akanmori, Bartholomew Dicky
Sow, Samba O.
Zuber, Patrick L. F.
author_sort Diomandé, Fabien V. K.
collection PubMed
description Background. The rollout of the group A meningococcal vaccine, PsA-TT, in Africa's meningitis belt countries represented the first introduction of a vaccine specifically designed for this part of the world. During the first year alone, the number of people who received the vaccine through mass vaccination campaigns was several hundredfold higher than that of subjects who participated in the closely monitored clinical trials. Implementation of a system to identify rare but potentially serious vaccine reactions was therefore a high priority in the design and implementation of those campaigns. Methods. National authorities and their technical partners set up effective vaccine pharmacovigilance systems, including conducting active surveillance projects. Results. Implementation of national expert advisory groups to review serious adverse events following immunization in all countries and active monitoring of conditions of interest in 3 early-adopter countries did not identify particular concerns with the safety profile of PsA-TT, which had already provided tremendous public health benefits. Conclusions. Lessons learned from this experience will help to improve preparations for future vaccine introductions in resource-poor settings and capitalize on such efforts to advance vaccine safety systems in the future.
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spelling pubmed-46395012015-11-12 Lessons Learned From Enhancing Vaccine Pharmacovigilance Activities During PsA-TT Introduction in African Countries, 2010–2013 Diomandé, Fabien V. K. Yaméogo, Téné M. Vannice, Kirsten S. Preziosi, Marie-Pierre Viviani, Simonetta Ouandaogo, Claude-Roger Keita, Modibo Djingarey, Mamoudou H. Mbakuliyemo, Nehemie Akanmori, Bartholomew Dicky Sow, Samba O. Zuber, Patrick L. F. Clin Infect Dis The Meningitis Vaccine Project: The Development, Licensure, Introduction, and Impact of a New Group a Meningococcal Conjugate Vaccine for Africa Background. The rollout of the group A meningococcal vaccine, PsA-TT, in Africa's meningitis belt countries represented the first introduction of a vaccine specifically designed for this part of the world. During the first year alone, the number of people who received the vaccine through mass vaccination campaigns was several hundredfold higher than that of subjects who participated in the closely monitored clinical trials. Implementation of a system to identify rare but potentially serious vaccine reactions was therefore a high priority in the design and implementation of those campaigns. Methods. National authorities and their technical partners set up effective vaccine pharmacovigilance systems, including conducting active surveillance projects. Results. Implementation of national expert advisory groups to review serious adverse events following immunization in all countries and active monitoring of conditions of interest in 3 early-adopter countries did not identify particular concerns with the safety profile of PsA-TT, which had already provided tremendous public health benefits. Conclusions. Lessons learned from this experience will help to improve preparations for future vaccine introductions in resource-poor settings and capitalize on such efforts to advance vaccine safety systems in the future. Oxford University Press 2015-11-15 2015-11-09 /pmc/articles/PMC4639501/ /pubmed/26553675 http://dx.doi.org/10.1093/cid/civ599 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 organization or products. The use of the WHO logo is not permitted. This notice should be preserved along with the article's original URL
spellingShingle The Meningitis Vaccine Project: The Development, Licensure, Introduction, and Impact of a New Group a Meningococcal Conjugate Vaccine for Africa
Diomandé, Fabien V. K.
Yaméogo, Téné M.
Vannice, Kirsten S.
Preziosi, Marie-Pierre
Viviani, Simonetta
Ouandaogo, Claude-Roger
Keita, Modibo
Djingarey, Mamoudou H.
Mbakuliyemo, Nehemie
Akanmori, Bartholomew Dicky
Sow, Samba O.
Zuber, Patrick L. F.
Lessons Learned From Enhancing Vaccine Pharmacovigilance Activities During PsA-TT Introduction in African Countries, 2010–2013
title Lessons Learned From Enhancing Vaccine Pharmacovigilance Activities During PsA-TT Introduction in African Countries, 2010–2013
title_full Lessons Learned From Enhancing Vaccine Pharmacovigilance Activities During PsA-TT Introduction in African Countries, 2010–2013
title_fullStr Lessons Learned From Enhancing Vaccine Pharmacovigilance Activities During PsA-TT Introduction in African Countries, 2010–2013
title_full_unstemmed Lessons Learned From Enhancing Vaccine Pharmacovigilance Activities During PsA-TT Introduction in African Countries, 2010–2013
title_short Lessons Learned From Enhancing Vaccine Pharmacovigilance Activities During PsA-TT Introduction in African Countries, 2010–2013
title_sort lessons learned from enhancing vaccine pharmacovigilance activities during psa-tt introduction in african countries, 2010–2013
topic The Meningitis Vaccine Project: The Development, Licensure, Introduction, and Impact of a New Group a Meningococcal Conjugate Vaccine for Africa
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4639501/
https://www.ncbi.nlm.nih.gov/pubmed/26553675
http://dx.doi.org/10.1093/cid/civ599
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