Using Population-Based Structures to Actively Monitor AEFIs during a Mass Immunization Campaign—A Case of Measles–Rubella and Polio Vaccines

Active vaccine pharmacovigilance complements the standard passive or spontaneous surveillance system, which suffers from low reporting rates. This study aimed at utilizing population-based structures to report and profile adverse events following immunization (AEFI) with the measles and rubella vacc...

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Autores principales:	Dan Kajungu, Victoria Nambasa, Michael Muhoozi, Joan Tusabe, Beate Kampmann, Jim Todd
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	active monitoring pharmacovigilance AEFIs mass vaccination campaigns Medicine R
Acceso en línea:	https://doaj.org/article/65160cb90117433c8a789f8182e55a84
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spelling	oai:doaj.org-article:65160cb90117433c8a789f8182e55a842021-11-25T19:11:00ZUsing Population-Based Structures to Actively Monitor AEFIs during a Mass Immunization Campaign—A Case of Measles–Rubella and Polio Vaccines10.3390/vaccines91112932076-393Xhttps://doaj.org/article/65160cb90117433c8a789f8182e55a842021-11-01T00:00:00Zhttps://www.mdpi.com/2076-393X/9/11/1293https://doaj.org/toc/2076-393XActive vaccine pharmacovigilance complements the standard passive or spontaneous surveillance system, which suffers from low reporting rates. This study aimed at utilizing population-based structures to report and profile adverse events following immunization (AEFI) with the measles and rubella vaccine (MR), or MR in combination with the bivalent oral polio vaccine (bOPV 1&3) (MR & bOPV), during mass vaccination in Uganda. Caretakers of children at home (less than 5 years) and schoolgoing children were followed up on and encouraged to report any AEFIs on day one, 2–3 days, 10 days, and 14 days after vaccination at school by their teachers and at-home, community-based village health teams. Out of 9798 children followed up on, 382 (3.9%) reported at least one AEFI, and in total, 517 AEFIs were reported. For MR, high temperature (21%), general feeling of weakness (19.3%), and headache (13%) were the most reported AEFIs, though there were variations on the days when they were reported. For the combination dose of MR & bOPV, high temperature (44%), rash (17%), general feeling of weakness (13%), and diarrhoea (8%) were the most common adverse events following immunization reported by caretakers. All 382 children cleared the AEFIs within 2 days, with 343 (90%) children reporting mild or moderate AEFIs and only 39 (10%) reporting severe AEFIs. The reported AEFIs are known and are mentioned in the vaccine leaflets with similar severity classification. Rates of AEFIs differed with the number of days after receiving the immunization. Conclusion: Active surveillance for AEFIs provides additional important information to national vaccine regulatory bodies. It reassures the public that vaccines are safe and that their safety is being taken seriously in Uganda, which would improve vaccine acceptability and confidence in the health system. Piggybacking on existing structures such as village health team members (for children at home) and teachers (for schoolgoing children) facilitates reaching vaccine recipients and increases reporting rates. Therefore, studies using active reporting of AEFIs should be conducted at regular intervals to report the overall incidence of AEs and to monitor trends and changes.Dan KajunguVictoria NambasaMichael MuhooziJoan TusabeBeate KampmannJim ToddMDPI AGarticleactive monitoringpharmacovigilanceAEFIsmass vaccination campaignsMedicineRENVaccines, Vol 9, Iss 1293, p 1293 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	active monitoring pharmacovigilance AEFIs mass vaccination campaigns Medicine R
spellingShingle	active monitoring pharmacovigilance AEFIs mass vaccination campaigns Medicine R Dan Kajungu Victoria Nambasa Michael Muhoozi Joan Tusabe Beate Kampmann Jim Todd Using Population-Based Structures to Actively Monitor AEFIs during a Mass Immunization Campaign—A Case of Measles–Rubella and Polio Vaccines
description	Active vaccine pharmacovigilance complements the standard passive or spontaneous surveillance system, which suffers from low reporting rates. This study aimed at utilizing population-based structures to report and profile adverse events following immunization (AEFI) with the measles and rubella vaccine (MR), or MR in combination with the bivalent oral polio vaccine (bOPV 1&3) (MR & bOPV), during mass vaccination in Uganda. Caretakers of children at home (less than 5 years) and schoolgoing children were followed up on and encouraged to report any AEFIs on day one, 2–3 days, 10 days, and 14 days after vaccination at school by their teachers and at-home, community-based village health teams. Out of 9798 children followed up on, 382 (3.9%) reported at least one AEFI, and in total, 517 AEFIs were reported. For MR, high temperature (21%), general feeling of weakness (19.3%), and headache (13%) were the most reported AEFIs, though there were variations on the days when they were reported. For the combination dose of MR & bOPV, high temperature (44%), rash (17%), general feeling of weakness (13%), and diarrhoea (8%) were the most common adverse events following immunization reported by caretakers. All 382 children cleared the AEFIs within 2 days, with 343 (90%) children reporting mild or moderate AEFIs and only 39 (10%) reporting severe AEFIs. The reported AEFIs are known and are mentioned in the vaccine leaflets with similar severity classification. Rates of AEFIs differed with the number of days after receiving the immunization. Conclusion: Active surveillance for AEFIs provides additional important information to national vaccine regulatory bodies. It reassures the public that vaccines are safe and that their safety is being taken seriously in Uganda, which would improve vaccine acceptability and confidence in the health system. Piggybacking on existing structures such as village health team members (for children at home) and teachers (for schoolgoing children) facilitates reaching vaccine recipients and increases reporting rates. Therefore, studies using active reporting of AEFIs should be conducted at regular intervals to report the overall incidence of AEs and to monitor trends and changes.
format	article
author	Dan Kajungu Victoria Nambasa Michael Muhoozi Joan Tusabe Beate Kampmann Jim Todd
author_facet	Dan Kajungu Victoria Nambasa Michael Muhoozi Joan Tusabe Beate Kampmann Jim Todd
author_sort	Dan Kajungu
title	Using Population-Based Structures to Actively Monitor AEFIs during a Mass Immunization Campaign—A Case of Measles–Rubella and Polio Vaccines
title_short	Using Population-Based Structures to Actively Monitor AEFIs during a Mass Immunization Campaign—A Case of Measles–Rubella and Polio Vaccines
title_full	Using Population-Based Structures to Actively Monitor AEFIs during a Mass Immunization Campaign—A Case of Measles–Rubella and Polio Vaccines
title_fullStr	Using Population-Based Structures to Actively Monitor AEFIs during a Mass Immunization Campaign—A Case of Measles–Rubella and Polio Vaccines
title_full_unstemmed	Using Population-Based Structures to Actively Monitor AEFIs during a Mass Immunization Campaign—A Case of Measles–Rubella and Polio Vaccines
title_sort	using population-based structures to actively monitor aefis during a mass immunization campaign—a case of measles–rubella and polio vaccines
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/65160cb90117433c8a789f8182e55a84
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Using Population-Based Structures to Actively Monitor AEFIs during a Mass Immunization Campaign—A Case of Measles–Rubella and Polio Vaccines

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