结核病疫苗加速委员会的最新进展报告：2025年3月至12月

PROGRESS UPDATEMarch–December 2025 ABOUT THIS UPDATE Now, at the end of its second year, thisupdatereviews activitiesachieved by the tuberculosis(TB) Vaccine Accelerator and its Secretariat between March and December 2025,understrategic steerfrom the TB Vaccine Accelerator Council.Substantialprogress hasbeen madeinthree technical and strategicareas,namelyProductDevelopment,Manufacturing andPolicy(related toWorking Group 2 (WG2));Finance and Access (WG3) andCountry Readiness,Advocacy and Community Partnership (WG4). Information presented here is drawn from the activities of the Secretariat and theAcceleratorworking groups. The Update specifically highlights progress on implementing the followingrecommendations made by the Council to the Secretariat at its third meeting in May 2025: •To prioritize the establishment of Working Group 4 (WG4) on Country Readiness,Advocacy and Community Partnership. •To leverage theOctober 2025G20 Health Ministers Meeting to elevate TB vaccinefinancing and access on the global health agenda and toencourage increased domesticfinancing for novel TB vaccines and regionally diversified manufacturing, with the aim tofoster long-term sustainability.•To support evaluation of the potential impact of new TB vaccines within an integratedapproach to TB prevention, including within the context of innovation in TB diagnosticsandpreventative treatment,and countries’immunization national immunizationstrategies. As of 2025, theSecretariatand the activities described hereinhave beenfundedbythe GatesFoundation and Wellcome Trust. TheUpdate is structured as follows: 1.Strategic Advisory Group of Experts onImmunization (SAGE) session on new tuberculosisvaccines (related to WG2) 2.Launch ofFinanceand Accesssolutionsat G20Health Ministers Meetingin South Africa(WG3)3.Update on the establishment of theWorkingGroup4onCountryReadiness,Advocacy andCommunityPartnership(WG4)4.Ongoing activities and next steps 1.Strategic Advisory Group of Experts (SAGE)session on newtuberculosis vaccines As a preliminary steptoestablishingAcceleratorWorkingGroup 2onproduct development,manufacturingand policy, WHO has established aTechnical Advisory Group (TAG) on Evidencefor Clinical and Policy Considerations for New Tuberculosis (TB) Vaccines. The TAGinitiatedits work in early 2025,undertaking consultationswith developersas partofpreparationsfor a session on new TB vaccines with the WHO Strategic Advisory Group ofExpertsinImmunization(SAGE) in September 2025. The purpose of the session was to providean overview of the TB vaccine pipeline, to discuss the data anticipated from ongoing or plannedpivotal efficacy trials for the most advanced candidates and to discuss how thesemayinform aglobal policy recommendation. SAGE noted that the results of multi-country, multi-region vaccine clinical trials that will onlyhave adequate statistical power to detect efficacy in one or two high tuberculosis burdencountries or single-country clinical trialscanbe extrapolated to other countries unless there aremajor epidemiological differences. Immunobridging studies, if a suitable correlate of protectionis established, or Phase 4 impact studies may be required to determine effectiveness in othersettings or in priority groups where clinical trials were not sufficient for subgroup assessment. Considering that only a limited number of Interferon Gamma Release Assay (IGRA) negativesubjects will be enrolled in the pivotal clinical trials, SAGE advised that provisions should bemade to collect adequate data on thesafety and immunogenicity of the vaccine in IGRAnegative individuals to inform recommendations,since such individuals are likely to bevaccinated during programmatic rollout of the vaccines. In anticipation of potential trial outcomes (specifically related to differences in IGRA positive vsIGRA negative individuals), SAGE proposed conducting scenario analyses, risk assessment andcontingency planning, including the potential efficacy in IGRA negatives, to proactively align andinform decision making. It will be important to ensure commitment from developers and donorsto generate these additionaldata and evidence. The TAG also initiated a discussionwith SAGEon the potential role of asymptomatic TB as aclinical endpoint for future efficacy trials and sought advice on the proposed steps to generatetheevidencetoassessthe clinical relevance of asymptomatic TB.Based on current knowledge,SAGE cautioned that inclusion of asymptomatic tuberculosis as a component of a compositeclinical trial endpoint may compromise the demonstration of efficacy against severetuberculosis, which is considered the most robust strategy for vaccine licensure. Therefore,SAGE supported theassessment of gapsto generate evidence on the characteristics ofasymptomatic tuberculosis to enable decision-making with regards to the use ofpotentialcomposite endpoints in pivotal tuberculosis vaccine trials. A summary of the full discussion andoutcomes of the SAGE meeting