The Brighton collaboration standardized module for mpox vaccines, MVA-BN and LC16m8, benefit-risk assessment.

Abstract

Based on the rapidly evolving multi-country outbreak in Africa, WHO declared mpox a Public Health Emergency of International Concern (PHEIC) from August 2024 to September 2025. In this outbreak, to date, over 100,000 suspected mpox cases and 1700 deaths have been reported from the Democratic Republic of the Congo (DRC). The MVA-BN and LC16m8 mpox vaccines have been recommended by WHO, the MVA-BN vaccine was WHO prequalified and the first shipment of donated vaccine arrived in DRC in Sept 2024. DRC launched the first phase of the mpox vaccination campaign in October 2024 with the MVA-BN vaccine and both vaccines have been used to help control the outbreak. The benefit-risk assessment (BRA) for the MVA-BN and LC16m8 mpox vaccines on "Myocarditis following MVA-BN, and the LC16m8 Mpox vaccines: A Case Study based on global data" was prepared by the authors on an urgent basis for the DRC national regulatory authority, the Congolese Pharmaceutical Regulatory Authority (ACOREP), in September 2024. The module was developed to help guide the utilization of the donated mpox vaccines in DRC and was prepared utilizing publicly available data from epidemiological studies, clinical trials, post-marketing studies and real-world evidence. The analysis was conducted for all WHO recommended schedules for the vaccines, including the MVA-BN vaccine administered subcutaneously and intradermally (as a dose-sparing option), for pre- and post-exposure prophylaxis, for adults and immunocompromised adults and LC16m8 vaccine administered to adults. The BRA was repeated in 2026 as there was additional data on the vaccines available. The base case of mpox incidence in the updated analysis was the annualized incidence of mpox reported in DRC from January 2024 through March 2025 (from the beginning to the main peak of the epidemic in DRC). High and low incidence were 10 x and 1/10 of the base rate, respectively, incidence rates that were considered so that the BRA is useful for different incidence rates during the outbreak, among different risk groups, and for different regions of the country. The results of the analysis were similar. The benefits of the MVA-BN vaccine administered subcutaneously or intradermally, for pre- and post-exposure prophylaxis (PEP), for children and adults, including immunocompromised individuals and one dose of LC16m8 vaccine administered to >1 year of age strongly outweighed the risks for the base and base x 10 incidence rates and marginally for the base/10 incidence rate. The updated analysis is presented in this publication.