세계 최초 플라스틱 튜브형 경구용 콜레라 백신 ‘유비콜-플러스®’ 세계보건 시장 공급 개시
– 유바이오로직스의 새로운 경구용 콜레라 백신, 지난해 8월 WHO 사전적격성 평가 인증 획득 후 잠비아와 소말리아로 첫 출하
– 혁신적 포장으로 백신 단가 낮추고 사용 편의성 향상
– 세계시장 공급을 위해 연간 5,000만 도즈 생산 역량 확보
– 세계 공중보건을 위한 백신의 개선 목적으로 국제 공공-민간 협력을 통해 개발
유바이오로직스가 생산 공급하는 세계 최초의 플라스틱 튜브형 경구용 콜레라 백신(OCV)인 ‘유비콜-플러스®’ 245만 도즈가 5일 잠비아와 소말리아로 처음으로 출하되었다. 이 백신은 지난 8월 11일 세계보건기구(WHO) 사전적격성 평가인증(PQ)을 획득한 바 있으며, 현재 UN기구와 국제 구호기구 등이 구매할 수 있다.
유비콜-플러스는 획기적인 플라스틱 포장 제형의 저렴한 경구용 콜레라 백신으로, 국제백신연구소(IVI)의 기술이전으로 상용화된 유바이오로직스의 유리병 제형 OCV인 ‘유비콜’(2015년 WHO 승인)의 개선품이다. 이 새로운 플라스틱 포장으로 백신의 부피가 거의 30% 감소하고 무게도 50% 이상 줄어 백신 운송과 배포, 폐기물 관리가 쉬워졌다. 플라스틱 튜브는 기존의 유리병에 비해 개봉과 투여도 더 쉽다.
또한 유비콜-플러스는 가격이 도즈당 1달러 30센트로 기존 유비콜에 비해 25% 저렴하여 구호단체와 백신 접종기관에서 같은 비용으로 더 많은 백신을 조달할 수 있다. 만약 1년 전에 유비콜-플러스가 있어 유비콜 대신 공급되었다면, 미화 230만 달러 이상의 비용이 절감되어, 절감된 비용으로 약 180만 도즈의 유비콜-플러스를 추가로 구매할 수 있었을 것이다.
세계백신면역연합(Gavi)의 세스 버클리(Seth Berkley) CEO는 “최근 경구 콜레라 백신의 수요가 크게 늘고 있다”며 “콜레라 백신은 아이티에서 소말리아에 이르기까지 여러 국가에서 생명을 살리고 질병 확산을 막는데 사용되었다”고 밝혔다. 그는 또 “비용 대비 효과가 더 높은 신규 백신은 이러한 수요를 계속 충족할 수 있도록 할 것이며, 콜레라 백신이 꼭 필요한 원격지로의 백신 운송과 접종이 더 쉬워질 것”이라고 말했다.
글로벌콜레라퇴치사업단(GTFCC) 단장을 맡고 있는 미국 존스홉킨스대학 데이비드 색(David Sack) 교수는 “새로운 제형의 경구용 콜레라 백신 유비콜-플러스 덕분에 취약 계층에 백신을 보급하기가 매우 쉬워질 것”이라고 말했다. 그는 “이 백신은 기존 백신보다 배포하기 쉽고 접종도 간단하다”며 “접종과정에서 장애물을 최소화하는 것이 필수적인 인도주의 위기 상황에서는 특히 더욱 그렇다”고 설명했다.
유비콜-플러스는 춘천에 위치한 유바이오로직스의 신규 제조공장에서 생산되며, 글로벌헬스투자펀드(GHIF)와 국내 몇몇 벤처캐피털에서 자금 지원을 받았다. 유바이오로직스는 신규 시설을 이용해 연간 최대 5천만 도즈의 백신을 생산할 수 있으며, 이는 확대되고 있는 세계 OCV 수요를 충족하는 양이다. 유바이오로직스는 개발협력·구호단체들이 접종 사업에서 선호함에 따라, 현재 공급 중인 유비콜을 유비콜-플러스로 점차 대체할 계획이다.
유바이오로직스의 백영옥 대표이사는 “유비콜-플러스의 WHO 승인을 획득하고 공급을 시작하게되어 자랑스럽다”며, “이로써 OCV 생산량을 크게 늘리고 양질의 제품을 더 저렴한 가격에 공급할 수 있게 되었다. 유바이오로직스는 협력기관들과 함께 세계보건 시장에서의 안정적인 OCV 공급을 위해 노력을 배가할 것”이라고 밝혔다.
유비콜와 유비콜-플러스의 개발은 개발도상국을 위한 경구용 콜레라 백신 개발 및 보급을 촉진하기 위한 국제 공공민간 협력의 결과이다. 이 협력은 빌앤멜린다게이츠재단과 한국 및 스웨덴 정부의 지원으로 비영리 국제기구인 IVI가 주도했다.
IVI의 백신 임상개발 및 보급 담당 사무차장인 줄리아 린치(Julia Lynch) 박사는 “IVI는 유바이오로직스와 협력하여 유비콜 및 유비콜-플러스의 임상개발, 사용 승인, WHO 승인을 지원한 것을 기쁘게 생각한다”며, “유비콜-플러스는 성공적인 혁신 사례이며, IVI는 앞으로도 전 세계 파트너와 협력하여 백신분야 혁신을 촉진할 것”이라고 말했다.
2016년 국경없는의사회(MSF)는 콜레라 발병과 확산을 막기 위해 여러 나라에서 60여만명에게 경구용 콜레라 백신을 접종했다. 위기상황에서 수많은 사람들의 콜레라 발병과 사망을 막기 위해서는 백신접종을 적시에 하는 것이 매우 중요하다. MSF는 최근 몇년간 OCV 공급이 부족했음을 지적하며, 사용이 간편한 개선된 백신 제형의 WHO 승인을 적극 환영했다. MSF는 “부피가 작고 짜서 먹을 수 있는 플라스틱 튜브 제형은 백신접종 활동에 도움이 될 것”이라고 밝혔다.
경구용 콜레라 백신이 여타 백신과는 달리 온도에 민감하지 않은 것으로 추정되고 있는데, IVI는 곧 이 백신이 저온유통이 아닌 방식으로 유통된 경우에도 안전성과 효과성에 변함이 없는지 검증하기 위한 연구를 진행할 계획이다. 공중보건 전문가들은 내열성이 높은 OCV가 공급망 물류 및 배송 방식을 개선하고, 접종 준비과정의 오류 및 제품 낭비의 위험과 관련된 비용을 줄일 수 있어 콜레라 통제의 ‘획기적 수단’이 될 것으로 보고 있다.
콜레라는 콜레라균으로 오염된 음식이나 물을 섭취하여 감염되는 설사 질환으로, 인도주의 위기 상황에 있는 사람들에서 자주 발생한다. 세계적으로 매년 290만 명이 콜레라에 감염되고 9만 5천 명 정도가 사망하는 것으로 추산되며, 40여개 국가에서 여전히 풍토병으로 남아 있다. 콜레라는 치료가 가능하지만 치료을 받지 못하는 상황에서는 몇 시간 내에 환자가 사망할 수도 있다.
IVI(국제백신연구소)
IVI(국제백신연구소)는 개발도상국 국민, 특히 어린이들을 전염병으로부터 보호하기 위한 새로운 백신의 개발과 보급에 전념하는 세계 유일의 국제기구이자, 국내에 본부를 둔 최초의 국제기구이다. 1997년 유엔개발계획의 주도로 설립된 IVI는 현재 UN과는 분리된 독립적 국제기구로서 세계 35국과 세계보건기구(WHO)를 설립협정 서명국으로 하여 운영되고 있다. 현재 IVI는 콜레라와 장티푸스를 비롯한 설사병과 뎅기열, 메르스 등에 대한 백신연구를 아시아, 아프리카, 남미 등 세계 20 여개 국가에서 수행하고 있으며, 서울대학교연구공원에 위치한 본부에서 새로운 백신과 면역보강제, 분석기법 등을 개발하고 있다. 자세한 정보는 http://ivi-legacy.wpkorea.org 참조.
유바이오로직스
유바이오로직스는 세계 공중보건 증진에 기여할 수 있는 안전하고 효과적인 백신보급을 목표로 새로운 백신제품을 개발하는 동시에, 바이오 의약품 연구 및 생산에 적합한 선진시설과 전문인력, 해당 분야에 대한 풍부한 경험을 바탕으로 다양한 바이오의약품에 대한 CRMO (Contract Research and Manufacturing Organization)서비스를 제공하고 있는 전문 바이오 기업입니다. 2010년 3월 설립된 유바이오로직스는 같은 해 9월 국제백신연구소(IVI)의 경구용 콜레라 백신에 대한 국내 독점 기술이전 대상으로 선정되어 비임상, 임상1 및 3상 등 상업화 연구를 진행해 왔고, 이로부터 5년만인 2015년 12월, 유비콜이 세계보건기구(WHO)의 사전적격성평가((Prequalification, 이하 PQ) 인증을 받는 성과를 거두었으며, 유비콜-플러스도 2016년 8월 사전적격성평가 인증을 받았습니다. 유바이오로직스는 2017년 1월 코스닥시장에 상장되었으며, 경구용 콜레라 백신 외에 장티푸스백신, 폐렴구균백신, 수막구균 백신을 개발하고 있습니다.
관련문의
국제백신연구소(IVI) 변태경 공보관
전화: 02-881-1159
휴대폰: 010-8773-6071
이메일: tkbyun@ivi.int
Date:Tuesday, 29 November 2022
Objectives:
A total of 39 participants from Bangladesh, Malawi, Nepal, and Uganda participated in the webinar, together with those from IVI-RADAAR and EVIPNet/WHO.
The preparatory work outlined in Webinar 7 was to:
Session 15: Presentation of Formative Evidence Brief for Policy
The final Webinar/Session focused on the Presentation of Formative EBP. Participants from Bangladesh, Malawi, Nepal, and Uganda presented their EBP, with a peer review, and feedback and comments from the EVIPNet/K2P team. The session finished with reflections on the next steps, including the potential for scale-up.
Wrap-up and closing
Date:Thursday, 10 November2022
Objectives:
A total of 39 participants from Bangladesh, Malawi, Nepal, and Uganda participated in the webinar, together with those from IVI-RADAAR and EVIPNet/WHO.
The preparatory work outlined in Webinar 6 was to:
Feedback from country teams on preparatory work/progress to date:
Uganda, Malawi, Nepal briefly shared progress and EVIPNet/K2P team commented on the progress.
Webinar Session 13: Organizing a policy dialogue presented by EVIPNet-K2P Center, focusing on how policy dialogues influence the use of evidence in health policy and decision-making including:
Considerations for conducting policy dialogues, i.e., does the dialogue address a high priority issue? Does it provide opportunities to discuss/address the issue, and considerations for implementation? Is there fair representation among those involved in/affected by future decisions related to the issue? Are follow-up activities undertaken to support action?
Preparation for policy dialogues, i.e., informed by pre-circulated evidence on the policy issue.
Stakeholder selection, i.e., degree of involvement in/knowledge about the issue and relevant solutions; ability to constructively engage in discussions; ability to take forward recommended actions within respective constituencies; and the importance of the dialogue facilitator’s role.
Dialogue summary, i.e., tools to outline the results of the discussions during the policy dialogue; and post-dialogue summaries.
Session 14: Data visualization and role of media in policy-making
Group or individual work with support from EVIPNet/K2P
The webinar ended with Group work based upon Session 14.
Wrap-up and closing
The final Webinar (#8) will be a Simulation Meeting: Presentation of Formative EBP, with the objective:
To present the draft formative EBPs among countries teams (peer review)
To propose outreach strategies for EBPs
To reflect on next steps (including potential for scale up)
Preparatory work (prior to Webinar 8): To complete the formative EBP
Presentation slides are available here
Date:Thursday, 27 October 2022
Objectives:
A total of 42 participants from Bangladesh, Malawi, Nepal, and Uganda participated in the webinar, together with those from IVI-RADAAR and EVIPNet/WHO.
The preparatory work outlined in Webinar 5 was to:
Feedback from country teams on progress to date (10 minutes per team)
Uganda, Malawi, Nepal briefly shared progress and EVIPNet/K2P team commented on the progress.
Webinar 6 provided a ‘Refresher: from problem statement to policy options‘ on the content of Evidence-to-Policy Briefs (EBP) including the problem statement, options and elements, and implementation considerations; framing the problem, clarifying its underlying causes, the appropriate types of evidence to use in framing problems, and framing, developing, and expanding on the options/ elements to address the problem. The refresher session finished with ‘Case examples’.
The webinar then focused on
Session 11: Identifying Key Implementation Considerations Framing presented by EVIPNet-K2P Center. Session 11 included: approaches to policy implementation (i.e. ‘top-down’ and ‘Bottom-up’); identifying and addressing barriers to implementing policies; health system, and social and political constraints; and tips on developing the implementation considerations.
Session 12: Overview of EBP outline (and semi-structured interviews/litmus) including: the policy brief outline, e.g., identification of how the problem related to risk factors/disease, to a program or service, and/or to the current health system; viable policy or programmatic options to address the problem; and potential barriers that could influence implementation policy options. The session also covered: stake- holder selection framework for litmus testing, and semi-structured interviews with stakeholders.
The next steps for countries include:
To agree on preliminary timeline for the updated policy brief outlines
To coordinate with assigned team lead for each country team
Group or individual work with support from EVIPNet/K2P
The webinar ended with Group work – using the EBP template – based upon Sessions 11 and 12.
Presentation slides are available here
Date:Thursday, 15 September 2022
Objectives:
A total of 51 participants from Bangladesh, Nepal, Uganda, and Malawi attended the webinar, together with those from IVI-RADAAR and EVIPNet/WHO.
The preparatory work outlined in Webinar 4 was to:
The introduction to the webinar provided: an Overview of methodologies to measure antibiotic use, and the use of surveillance data; the link between AMR and use of antimicrobials; and the integrated national action needed on optimal use of antimicrobials, including through data, surveillance, and monitoring.
The webinar then focused on Session 10: Framing Viable Policy Options to Address a Problem: A Step-by-Step Guide presented by EVIPNet-K2P Center. Session 10 included: Content of EBPs (i.e. problem statement, options or elements, and implementation considerations); Developing options/elements to address the problem (i.e. policy options, and health system/governance/financial arrangements/delivery arrangements); Steps for developing options/elements to address the issue (literature review, thematic analysis, tailoring to the country issue/context, and selecting 3-4 options); and practical examples of AMR and underlying causes to policy options.
A Q&A session followed, with questions on the behavioural and economic dimensions of policy response and options; the specificity and feasibility of options; and appropriate types of research evidence for developing options.
The webinar ended with Group work – with support from EVIPNet/K2P and using the EBP template to:
Identify 3-4 policy options/elements to address the problem and its underlying causes
Date:Thursday, 8 September 2022
Objectives:
A total of 57 participants from Bangladesh, Nepal, Uganda, and Malawi attended the webinar, together with those from IVI-RADAAR and EVIPNet/WHO.
Webinar 4 began with the ‘Feedback on preparatory work’ outlined in Webinar 3, which was to:
Dr Fadi El-Jardali from the American University of Beirut updated participants on the progress of the four countries including: on the topics selected (Uganda on irrational antibiotic use; Nepal on AMR National Action Plan (NAP) implementation [adjudged to be more about the solution than the problem]; Malawi on the utilization of AMR evidence generated at facility/national level and translation into policy [also more about the solution than the problem]; and Bangladesh, which had not yet been reviewed. The review also included country search strategies. The feedback included questions from participants.
The webinar then focused on the next (of the 15) training sessions:
Session 9. Preparing the EBPs: clarifying and framing the problem including:
Knowledge Translation (KT). Which facilitates the process of translating research into policy and action; and KT products which allow evidence generated from systematic reviews – the basic units of KT – to be packaged in a user-friendly format, written in clear language, and with key messages to increase the likelihood of adoption by policy-makers, and resonance among different target audiences. The use of systematic reviews enable policy-makers to scan large bodies of research evidence to address key features of any policy issue of interest.
– Problem statement: A policy problem that summarizes the best available evidence to clarify the size and nature of the problem and its underlying causes.
– Options or elements: Three or more viable policy and programmatic options described.
– Implementation considerations: Potential barriers to implementing the options/elements and strategies for addressing those.
The EBP does not provide recommendations for action.
The remainder of Webinar 4 featured the Group work exercise facilitated by Racha Fadlallah from K2P Lebanon (and support from EVIPNet). The group work comprised four groups – one for each country (including representatives from WHO country offices, and observers from EVIP/RADAAR) – with the aim:
A template was provided by EVIP facilitators (based on the presentation from Session 9) with sections for completion by country groups.
Presentation slides are available here
Date:Thursday, 25 August 2022
Objectives:
A total of 59 participants from Bangladesh, Nepal, Uganda, and Malawi attended the webinar, together with those from IVI-RADAAR and EVIPNet/WHO.
Webinar 3 began with the ‘Feedback on preparatory work’ outlined in Webinar 2, which was to:
Fadi El-Jardali from the American University in Beirut updated participants on the progress of the four countries and provided further guidance for countries on completing these two crucial stages. Malawi was used as an example applicable to other countries, in terms of structuring thinking in relation to identifying the issue, the political context, what has already been done in terms of AMR, what is missing and why, and stakeholder mapping. Country participants summarised their experiences. The feedback ended with a discussion on the priority areas of focus for the Evidence Brief for Policy (EBP), with updates from countries.
Following feedback reporting, the webinar focused on the next two (of 15) training sessions:
Session 7. Designing search strategies to identify and access research evidence on priority topics including: the importance of effective searches (6,500 medical articles published daily); the use of ‘Boolean Operators (e.g., And, Or, Not); identification of search terms; building a search strategy, including formulating the question/issue, choosing appropriate databases, dividing the question/issue into 2 or 3 concepts, generating search terms for each concept, and combining concepts – and search terms within concepts – using Boolean operators; and validating/documenting the search.
An example of a ‘search’ template was presented, and which participants would complete in the group work at the end of the webinar. The template included: the Problem/Issue being addressed, the Options, the Concepts, the Search terms for each concept, and Combining concepts using Boolean operators
The importance of collecting the best available evidence for EBPs was stressed: local evidence and global research evidence from systematic reviews. Guidance was provided on where to search for such information, including local and national databases, websites of relevant organisations, search engines, ‘grey’ literature, and systematic reviews.
Session 8: Understanding the role of systematic reviews in influencing policy decisions including: the Concept of a systematic review; key databases to search – and how to search – for reviews (e.g., Health Systems Evidence, Cochrane, PubMed); a live demonstration of a search on Health Systems Evidence and PubMed databases; and assessing the quality of reviews (e.g., using AMSTAR).
The remainder of Webinar 3 featured the Group work exercise facilitated by Racha Fadlallah and
Lama Bou Karroum from K2P Lebanon (with support from EVIPNet). The group work was comprised of four groups
– one for each country (including representatives from WHO country offices, with observers from EVIP/RADAAR) – with the aim: To develop a search strategy and search key databases for systematic reviews.
A template was provided by EVIP facilitators (based on the presentation from Session 7) with sections for completion by country groups as follows: the Topic/Issue being addressed, the Concepts, the Search terms for each concept, Combining concepts using Boolean operators, and the Databases searched.
Date:Thursday, 18 August 2022
Objectives:
A total of 65 participants from Bangladesh, Nepal, Uganda, and Malawi attended the webinar, together with those from IVI-RADAAR and WHO.
After a brief introduction, Webinar 2 began with ‘Feedback on preparatory work’ outlined in Webinar 1:
The EBP Team is responsible for developing the EBP and conducting key informant interviews (KIIs), hence an appropriate mixture of expertise is key to a successful team, including members with experience in: methods of writing an EBP; administration; evidence search, appraisal and synthesis; technical expertise on the topic being addressed in the EBP; and communication. Each country must also appoint an EBP steering committee to support the EBP development process, comprising: 4-6 multisectoral, multidisciplinary and high-level stakeholders from government/policy-makers/researchers knowledgeable in the topic and able to contribute to the development of the EBP for AMR.
Each of the four countries reported briefly on the steps taken to form the Core Team, Steering Committee, and in identifying AMR stakeholders (some countries had also informed RADAAR/EVIP prior to the Webinar via email).
Following reporting, the Webinar focused on the next two (of 15) training sessions:
Session 5. Understanding the political and health system and outlining key areas to keep in mind when mapping the policy and political context including: the importance of context-specific and actionable evidence, in particular the political/policy context (e.g., characteristics of government structures, civil service – and interests of – policy-making stakeholders, societal values and external factors, such as social and economic); and health system context (e.g., evidence on health system inputs, processes, and outputs and the analysis of how they combine to produce outcomes, such as – the WHO defined – service delivery, health workforce, information, medical technologies, finance, and leadership/governance).
Session 6:Stakeholder mapping including: on stakeholder interests, i.e., concerns over how a policy may impact them; their positions, i.e., degree of agreement or disagreement with the policy; and their power, i.e., capacity to influence policy. The steps in stakeholder mapping include: defining the goal and implications of the proposed policy change; listing interest groups involved in the issue; categorizing stakeholders according to their influence and power over, and level of interest in the issue; determining a strategy to engage relevant stakeholders; conducting KIIs; and presenting stakeholder analysis.
Stakeholders identified include: decision-/policy-makers (e.g., ministries, government agencies, parliamentarians, municipalities); influencers (e.g., NGOs/CSOs, religious leaders, media, private sector); and the public (e.g., those affected by AMR).
A case example from Ghana was presented to highlight the steps in stakeholder mapping.
Webinar 2 concluded with a Group work exercise (with support from EVIPNet/K2P)
Group work was comprised of four groups – one for each country (including representatives from WHO country offices) – with the aim of:
A template was provided by facilitators with nine questions to capture the above details including: the issue; progress made in addressing the issue; previous related policies/laws/regulations; whether the issue is on the government agenda; windows of opportunity; requirements to reach the policy objective; how laws/regulations are implemented to this purpose; stakeholders involved; and the power interplay among/between stakeholders. The questions provided background information to enable completion of full ‘Stakeholder Mapping’ template (including stakeholder, description, name, power, interest).
Date:Thursday, 11 August 2022
Objectives:
A total of 88 participants from Bangladesh, Nepal, Uganda, and Malawi attended the webinar, together with those from IVI-RADAAR and WHO.
After an introduction to evidence-informed policy-making (EIP) and EVIPNet, Webinar 1 included the first four (of 15) training sessions:
Session 1. Brief overview of the policy-making process including: promoting the use of research evidence in policy-making to improve health systems; increasing country capacity in/institutionalising knowledge translation (KT); approaches to increase research utilization; developing evidence briefs to inform health policy deliberations, and assess the impacts of policy options; and the evidence-action cycle, including priority-setting, evidence, convening deliberative dialogue, and policy implementation.
Presentation slides are available here
Session 2: Understanding role of evidence in policy-making process and efforts to support use of evidence in policy-making including: policy process overview; major public policy theories/frameworks; stages in public policy making, i.e., definition, agenda setting, and policy instruments/implementation/ evaluation; importance of robust research/data/evidence, as well as KT tools/strategies; and enhancing awareness/capacity of, and engaging policy-makers/stakeholders early, and sustaining engagement.
Session 3: Knowledge generation and knowledge translation as a spectrum: evidence on establishing and/or strengthening national health research system using a systems approach and the need of cross evidence ecosystem collaboration including: the National health research system (NHRS); WHO guides/ tools; key workstreams of the evidence ecosystem, i.e., partnering for complementary support in decision-making; HO workstreams, i.e., data analytics, guidelines, health technology assessment (HTA), evidence-informed policy-making supports, modelling, and behavioral research; and the evidence ecosystem framework and policy/action cycle.
Session 4: Learning from success stories of EVIPNet Member Countries: development of evidence briefs for policy on AMR including: Slovenia case study on ‘Translating AMR data and evidence into effective policies (EBP development); driving factors, challenges, and lessons learned; importance of a multi-level/sectoral approach; the need to integrate local evidence; the crucial role of Ministries of Health to put options on the political agenda (and sufficient capacity within the MoH and NIPH).
