結核病疫苗加速者委員會:利用疫苗的力量結束結核病流行
資料來源:www.thelancet.com/infection Vol 23 November 2023
結核病是世界上最古老和最致命的傳染病之一。每年,超過 1,000 萬人感染結核病,超過 100 萬人死於該病,其中大多數是成人和青少年。每年有近 50 萬人感染抗藥性結核病,抗菌藥物的抗藥性風險使這種疾病變得更加致命和無法治癒。
在《終結結核病策略》和《永續發展目標》中,各國承諾到2030 年終結結核病流行,包括提供有效的新型結核病疫苗。迄今唯一獲得許可的結核病疫苗(稱為卡介苗)是一個世紀前經過多年開發而成的。卡介苗每年可以保護幼兒免受嚴重結核病的侵害,從而挽救數以千計人的生命,但它並不能充分保護青少年和成人,而青少年和成人是結核病傳播的主體。迫切需要新的結核病疫苗來大幅降低高風險族群的傳播和死亡率。
世衛組織已確定了優選的產品特性,以促進有效結核病疫苗的開發,目前至少有16 種候選結核病疫苗正在積極進行臨床開發。然而,這16 種候選疫苗中只有一種具有符合既定規格的初步結果。總體而言,結核病流行的速度超過了科學進步的速度,而對疫苗研究的投資仍然遠遠不足以推動候選藥物的更快開發或臨床開發渠道的多樣化。
在創紀錄的時間內針對 SARS-CoV-2開發出多種安全有效的疫苗,開啟了將科學研究快速轉化為疫苗開發(包括結核病)的可能性。 COVID-19 大流行最重要的教訓之一是,如果在政治上優先考慮並提供充足的資金,創新的衛生介入措施就可以快速實施。結核病和 COVID-19 帶來的挑戰不同,但加速科學、研究和創新的要素是相同的:緊急、預先的公共投資;慈善事業的支持;以及私營部門和社區的參與。
我們相信,結核病領域將受益於類似的高層協調,這就是為什麼世衛組織正在建立結核病疫苗加速者理事會,以促進資助者、全球機構、政府和社區之間的高層承諾、參與和協調,以確定並克服結核疫苗開發的主要障礙。該委員會將致力於透過基於夥伴關係的創新解決方案來縮小知識和融資方面的關鍵差距,促進結核病疫苗的研發,並促進安全有效的結核病疫苗的許可和使用。該委員會還將考慮如何在疫苗可用後,借鑒應對 COVID-19 大流行的經驗教訓,快速、公平、大規模地生產和分發疫苗。
投資結核病疫苗的理由很明確。世界衛生組織委託進行的一項研究估計,在25 年內,一種對預防青少年和成人疾病有50% 效果的疫苗可以避免多達7,600 萬例新增結核病病例、850 萬人死亡、4,200 萬個抗生素治療療程以及受結核病影響的家庭面臨 415 億美元的損失。若效率為 75% 的疫苗則可避免多達 1億1千萬新發結核病例和 1,230 萬人死亡。研究顯示,在避免健康成本和提高生產力方面,每投資 1 美元購買 50% 有效的疫苗就可以產生 7 美元的經濟回報。因此,解決結核病問題不僅是道義上的當務之急,也是經濟上的當務之急;它不是成本,而是對永續發展和公平的投資。
在繼續尋找新的結核病疫苗的同時,必須持續並加強對結核病流行的應對措施。在2018年聯合國大會結核病高階會議之政治宣言中,各國承諾加快對抗結核病的步伐,包括開發新的結核病疫苗;然而,這項承諾基本上沒有兌現。今年的聯合國大會對抗結核病高階會議及其政治宣言,為各國、社區和合作夥伴提供了一次獨特的機會,以克服扭轉多年來在結核病防治應對措施方面上取得進展的挑戰,例如持續衝擊影響的 COVID-19 大流行、武裝衝突、經濟危機和氣候變遷。我們呼籲所有國家和合作夥伴給予結核病應有的認真考慮,包括為緊急開發和提供安全、有效的結核病疫苗提供充分的政治和財政支持。
我們聲明沒有利益競爭問題。
*Tedros Adhanom Ghebreyesus、Nísia Trindade Lima drtedros@who.int
瑞士,日內瓦 1202,世界衛生組織 (TAG); 巴西,巴西利亞,衛生部 (NTL)
The TB Vaccine Accelerator Council: harnessing the power of vaccines to end the tuberculosis epidemic
www.thelancet.com/infection Vol 23 November 2023
Tuberculosis is one of the world’s oldest and deadliest infectious diseases. Every year, more than 10 million people fall ill with tuberculosis, and more than a million die from the disease, most of whom are adults and adolescents.1 With close to half a million people contracting drug-resistant forms of tuberculosis annually, antimicrobial resistance risks making the disease even more deadly and incurable.
In the End TB Strategy and the Sustainable Development Goals, countries committed to end the tuberculosis epidemic by 2030, including by delivering effective new tuberculosis vaccines.2,3 The only licensed tuberculosis vaccine to date, known as the BCG vaccine, was developed over a century ago. The BCG vaccine saves thousands of lives every year by protecting young children from severe forms of tuberculosis, but it does not adequately protect adolescents and adults, who account for most tuberculosis transmission. There is an urgent need for new tuberculosis vaccines to sharply reduce transmission and mortality among those most at risk.
WHO has established preferred product characteristics to facilitate the development of effective tuberculosis vaccines, and today at least 16 candidate tuberculosis vaccines are in active clinical development.1,4,5 However, only one of the 16 candidates have preliminary results that meet the established specifications.6 Overall, the tuberculosis epidemic is outpacing scientific progress, and investments in vaccine research remain woefully inadequate to drive faster development of candidates or diversification of the clinical development pipeline.
The development of multiple safe and effective vaccines against SARS-CoV-2 in record time has unlocked the possibility of fast-tracking the translation of scientific research into vaccine development, including against tuberculosis. One of the most important lessons of the COVID-19 pandemic was that innovative health interventions can be delivered fast if they are prioritised politically and financed adequately. The challenges presented by tuberculosis and COVID-19 are different, but the ingredients that accelerate science, research, and innovation are the same: urgent, up-front public investment; support from philanthropy; and engagement of the private sector and communities.
We believe that the tuberculosis field will benefit from similar high-level coordination, which is why WHO is establishing the TB Vaccine Accelerator Council to catalyse high-level commitment, engagement, and alignment among funders, global agencies, governments, and communities, to identify and overcome the major barriers to tuberculosis vaccine development. The council will work to boost the tuberculosis vaccine pipeline and facilitate the licensing and use of safe and effective tuberculosis vaccines, through partnership-based, innovative solutions to close crucial gaps in knowledge and financing. The council would also consider how to rapidly manufacture and distribute vaccines equitably and at scale once they are available, drawing on lessons learned from the response to the COVID-19 pandemic.
The case for investment in tuberculosis vaccines is clear. A WHO-commissioned study estimates that, over 25 years, a vaccine that is 50% effective in preventing disease among adolescents and adults could avert up to 76 million new tuberculosis cases, 8·5 million deaths, 42 million courses of antibiotic treatment, and US$41·5 billion in costs faced by tuberculosisaffected households.9 A vaccine that is 75% effective could avert up to 110 million new tuberculosis cases and 12·3 million deaths. The study suggests that every $1 invested in a 50% effective vaccine could generate an economic return of $7, in terms of averted health costs and increased productivity. Addressing tuberculosis is therefore not just a moral imperative, it is also an economic imperative; not a cost, but an investment in sustainable development and equity.
While the quest for new tuberculosis vaccine continues, the response to the tuberculosis epidemic must be sustained and strengthened. In the 2018 Political Declaration of the High-level Meeting of the General Assembly on tuberculosis, countries pledged to accelerate the fight against tuberculosis, including through the development of new tuberculosis vaccines; however, that promise was largely unmet. This year’s UN High-level Meeting on the fight against tuberculosis and its political declaration present a unique opportunity for countries, communities, and partners to overcome challenges that have reversed years of progress in the tuberculosis response, such as the sustained impacts of the COVID-19 pandemic, armed conflicts, economic crises, and climate change. We call on all countries and partners to give tuberculosis the serious consideration it deserves, including full political and financial support for urgent development and delivery of safe, effective tuberculosis vaccines.
We declare no competing issues.
*Tedros Adhanom Ghebreyesus, Nísia Trindade Lima drtedros@who.int
World Health Organization, Geneva 1202, Switzerland (TAG); Ministry of Health, Brasília, Brazil (NTL)