新型结核病疫苗全球需求预测：早期规划与需求评估情景分析

Executivesummary Tuberculosis (TB) remains the leading infectiousdiseaseworldwide, causing 10.8 millioncases and 1.3 million deaths in 2023, with 90% of the burden concentrated inlow-and middle-incomecountries.While current prevention tools are inadequatetoeffectively eliminate TB,novelTBvaccinesfor adolescents and adultsare currently inadvanced clinical trialswith early Following the GaviBoard’s 2024‘inprinciple’approval to support novel TB vaccinesto informearlymarket shaping and planning efforts,Gavi,the Vaccine Alliance(Gavi),Clinton Health Access Initiative, Inc.(CHAI) andMMGHConsulting (MMGH) developedaglobal, supply-unconstrained demand forecast for 2030–2040, building onthe World HealthOrganization (WHO)’s MI4A methodology and consultations with more than 120 stakeholders The WHO TB Vaccine Accelerator Finance and Access Working Group reached consensusthat the high-demand scenario best balances health impact and feasibility. This scenario alsoaligns withcountry ambition expressed during consultations,assuming product characteristicsalign with theWHOPreferredProductCharacteristics(PPC), and the availability of fundingandaffordableprices. This approach combines routine immunisation of adolescentsand As a next step, Gaviwill develop and publish an early market shaping roadmap whichwillfurther evaluate the demand scenariosand state which scenario(s)will inform strategic market Context Tuberculosis (TB) is the world’s leading cause of death from an infectious agent,with 10.8million cases and 1.3 million deaths in 2023, predominantly in low-and middle-incomecountries.1The World Health Organization (WHO)has identified 49 countries as high-burden,which represent approximately 90% of the global TB burden.2 Eight of these countries As part of WHO’s End TB Strategy,countries planto reduce TB incidence by 90%andTBdeaths by 95%by2035compared to 2015 rates.3However, since 2015, incidence has onlyreduced by 8%, and deaths by 23%.4These shortcomings are in part due to insufficientprevention tools: the Bacille Calmette-Guérin (BCG) vaccine is administered to children soonafter birth and protects them against TB, especially severe forms like TB meningitis. However,the BCG vaccinehas shown waning effectiveness over time, leaving adolescents and adultswith littletono protection against TB.5TB preventive treatment requires costly screening toconfirm latent TB infection and rule out active TB disease, followed by long treatment regimens If successfully developed, novel TB vaccinestargeting adolescents and adultswill present animportant addition to the preventive measures against TB. While novel TB vaccine candidatesare still in clinical trials,with the most advancedcandidatesin phasethreeand expected toreach licensure earliest around 2030,8modelling as part of the 2022 WHO Investment Casefor New Tuberculosis Vaccines indicated that even a moderately effective TB vaccinetargeting Following the GaviBoard’s2024‘inprinciple’approvalto supportnovel TB vaccines,10Gaviperformed aglobaldemand and supplyanalysisto informearly marketshaping efforts toprepare for the introduction of novel TB vaccines targeting adolescents and adults,andtoensure an optimised launch.As part of these efforts,Gavi, the Vaccine Alliance (Gavi),Clinton Health Access Initiative, Inc.(CHAI) and MMGHConsulting (MMGH) developedademand forecast for novel TB vaccines to understand country programmatic ambitionand This demand forecast builds on previous efforts, including Gavi’sVaccine Investment Strategy(VIS)2024forecast. Its assumptions and scenarios are informed by more extensive countryand expert consultations,as well askey product-specific insights.12Much remains uncertainabout theeventual characteristics ofthe vaccines that areindevelopment (e.g. number ofdoses, efficacy,indication, policy recommendations,productprice),which will influence their The demand forecast quantifies the number of novel TB vaccine courses for adolescents andadults across all WHOMemberStates and covers the 2030–2040 period.Asnewinformationon thevaccinecandidates or country introduction plansbecomes available,this forecast will Methodology The TB vaccine demand forecast is based on WHO’s MI4A (Market Information for Access toVaccines) methodology, which has been endorsedbytheWHO Technical Advisory Group onMarket Access for Vaccines and has been used to develop global demand forecastsfor 13antigensto date.13 The methodology has been adapted to account for uncertainties School of Hygiene&Tropical Medicine, UNICEF, University of Cape Town, WHOand the TBVaccine Accelerator Finance and Access Working Group(seeAnnex A1),as well as countrystakeholders in nine high-TBburden countries accounting for 63% of global TB burden (Brazil,China, Democratic Republic of the Congo, India, Indonesia,14 Nigeria, Pakistan, South Country-level interviews included a broad range of stakeholders to capture a holistic view ofeachcountry’s ambition for novel TB vaccination.Depending on the count