| アブストラクト | BACKGROUND: The African meningitis belt remains prone to recurrent invasive meningococcal disease (IMD) outbreaks, mainly from serogroups C, W, and X. In 2024, Niger and Nigeria conducted the first large-scale, real-world use of the pentavalent meningococcal conjugate vaccine (MMCV), covering Neisseria meningitidis serogroups A, C, W, Y, and X. This study describes enhanced passive safety surveillance implemented during these campaigns. METHODS: Enhanced passive safety surveillance was conducted during MMCV campaigns in Niger (May-July 2024) and Nigeria (March-June 2024). Surveillance included systematic adverse event reporting, digital tools (MedSafety App(R) in Nigeria, ODK Collect(R) in Niger), integrated supervision and systematic data monitoring. Adverse Events Following Immunization (AEFI) were analyzed by demographics, seriousness, and System Organ Class (SOC). Disproportionality analysis was performed using VigiBase(R) and Vigilyze(R) to identify potential safety signals. FINDINGS: A total of 4,881,027 individuals were vaccinated (Niger: 2,697,934; Nigeria: 2,183,093). There were 1109 AEFI reports (reporting rate: 22.7 per 100,000 vaccinees), with 11 (0.99%) classified as serious, including one death. Most AEFIs were mild and occurred on the day of vaccination; the most frequent were pyrexia, injection site reactions, myalgia, arthralgia, and headache. The majority of AEFI reports were among children aged 2-12 years (61.9%), followed by adolescents (17.4%) and young adults (15.2%). INTERPRETATION: The introduction of MMCV in Niger and Nigeria confirmed a robust safety profile in real-world outbreak settings, with very low rates of serious adverse events and no new safety signals detected. Enhanced passive surveillance, supported by digital tools and integrated supervision, enabled timely and comprehensive AEFI reporting. The observed safety outcomes were consistent with clinical trial data and previous vaccine introductions, reinforcing the reliability and generalizability of MMCV's safety. Sustained investment in pharmacovigilance infrastructure and ongoing training for healthcare workers remain essential for effective vaccine safety monitoring. |
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| ジャーナル名 | Vaccine |
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| Pubmed追加日 | 2026/3/7 |
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| 投稿者 | Menang, Olga; Gambo, Moustapha; Keoulon, Kolie Cece-Vieux; Babale, Sufiyan Muawiyyah; Elemuwa, Uchenna; Who, Mor Diaw; Hamzat, Omotayo; Agbenu, Edinam; Baruch, Joaquin; Pezzoli, Lorenzo; Camara, Ibrahima; Dadjo, Crepin Hilaire; Bwaka, Ado; Fouda, Andre Arsene Bita |
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| 組織名 | Independent Expert, Switzerland. Electronic address: omenang@gmail.com.;The Directorate of Pharmacy, Laboratories and Traditional Medicines, Niger.;World Health Organization, Guinea.;Ahmadu Bello University, Zaria, Nigeria.;National Agency for Food and Drug Administration and Control, NAFDAC, Nigeria.;World Health Organization, Niger.;World Health Organization, Nigeria.;World Health Organization, Intercountry support team, Burkina Faso.;World Health Organization, Switzerland.;Independent expert, Guinea.;World Health Organization, Regional Office for Africa, Republic of Congo. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41791242/ |
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