字數真多，看着就煩，請自行Ctrl+F吧
前幾天世衛的SAGE開了個會，提到了包括新冠疫苗在内的多種疫苗使用建議更新，沒看到有官宣中文版，這裡進行一下全文分享。
考慮到如果進行點評或者建議可能會被誤認為是商業性資訊，故此本次僅完整呈現原文内容，不做解釋或發表意見。
另外如果有翻譯錯的地方，還是老規矩——大家多做自我批評，謝謝配合。
本次會議涉及到的疫苗包括：
1.A肝疫苗；
2.新冠疫苗；
3.傷寒疫苗；
4.HPV疫苗；
5.脊灰疫苗。
接下來進入正文（全文加英文字母近19000字，慎點）：
《免疫接種戰略專家咨詢組會議要點》
Highlights fromthe Meeting of the Strategic Advisory Group of Experts (SAGE) on Immunization
（報告全文将于2022年6月10日在《流行病學周報》上發表，僅報告全文的内容應被視為最終報告）
(Full report will be published in the Weekly Epidemiological Record on10.06.2022, and only
the wording of the full report should be considered as final)
第一部分——全球和區域報告
Session 1 –Global & Regional Reports
世界衛生組織免疫、疫苗和生物制品部的報告
Report from the WHO Department of Immunization, Vaccines& Biologicals
新冠疫苗的推廣速度是前所未有的，幾乎每個國家都在之前12個月内引入了該疫苗。
The speed of the COVID-19 vaccine rollout has been unprecedented withnearly every country introducing the vaccine in under 12 months.
現有的新冠疫苗對新冠病毒Omicron變異株的有效性資料通常顯示對感染的免疫力正在減弱，但對重症病例和死亡病例的有效性較高且較為持久，特别是在加強劑次接種後。世衛組織的一些EUL（緊急使用清單）疫苗的資料仍然非常有限。
Available data of COVID-19 vaccine effectiveness against the Omicronvariant generally show waning immunity against infection but high and moresustained effectiveness against severe disease and death, especially afterbooster doses. Data remain very limited for some of the WHO EUL vaccines.
迄今為止，有21個國家的人口疫苗覆寫率仍低于10%，這導緻最脆弱的人們處于高風險之中。在有資格通過COVAX（新冠肺炎疫苗實施計劃）預先市場承諾機制（AMC）戰略獲得支援的國家中，至少有43個國家将人口覆寫目标定為70%或更高，隻有少數國家設定的目标人口低于其人口的40%。
To date, 21 countries remain below 10% population coverage, leaving athigh risk the most vulnerable populations. Among countries eligible for supportthrough the COVAX Advance Market Commitment (AMC) strategy at least 43 have setpopulation targets at 70% or higher and only a small number have targets below40% of their population.
然而現有資料表明，高度優先群體的覆寫率不足以提供對其所需的保護，以防止重症病例和死亡病例。衛生工作者的覆寫率總體上是65%，但在一些地區（非AMC成員國）的覆寫率低于50%，而老年人的覆寫率是69%，在一些地區低至24%。
However, available data indicate that coverage among the high prioritygroups is insufficient to provide the needed protection against severe diseaseand death. Health worker coverage is 65% overall, with coverage below 50% insome regions (Non-AMC member states), and coverage of older adults is 69% goingas low as 24% in some regions.
正常免疫計劃持續受到幹擾，截至2022年1月10日，37個國家至少有一項接種運動持續推遲，使數百萬兒童面臨疾病暴發的風險。在過去的12個月裡，至少有19個國家爆發了大規模和具有破壞性的麻疹疫情。
Disruptions to routine immunization programmes persist, including theongoing delay of at least one campaign in 37 countries as of 10 January 2022,putting millions of children at risk of disease outbreaks. Large and disruptiveoutbreaks of measles have occurred in at least 19 countries during the past 12months.
新冠疫苗接種響應和投入提供了重要的機遇，正在利用這些機遇來恢複和加強免疫計劃，并增強其适應性。
COVID-19 vaccination response and investments offer importantopportunities that are being leveraged to restore and strengthen immunizationprogrammes and enhance their resilience.
世衛組織區域更新
WHO Regional Updates
世衛組織所有六個大區的國家免疫計劃都受到了新冠大流行的負面影響，免疫覆寫率和監測品質下降，但受影響程度在地區之間和地區内部有所不同。
National immunization programmes in all six WHO regions were adverselyimpacted by the COVID-19 pandemic through declining immunization coverage andsurveillance quality, though the magnitude of the impact varied between andwithin regions.
由于烏克蘭的持續戰争以及由此造成的大量人口流離失所，歐洲地區也面臨着挑戰。世衛組織區域辦事處和夥伴機構正在采取措施，減輕麻疹、脊髓灰質炎和新冠肺炎等疫苗可預防疾病的暴發風險，同時還将確定繼續提供關鍵的醫療用品和服務。
The European region is also facing a challenge due to the ongoing war inUkraine and the resulting large population displacement. The WHO RegionalOffice and partner agencies are taking measures to mitigate the risks ofvaccine-preventable disease outbreaks such as measles, polio, and COVID-19,while also ensuring continued delivery of critical medical supplies and services.
所有國家都在實施恢複疫苗接種覆寫率的措施，其中一些國家已經确定了補種疫苗的創新戰略。
All countries are implementing measures to restore vaccination coverage,with several having identified innovative strategies for catch up vaccination.
新冠疫苗的推廣在所有地區都取得了進展，盡管各地區之間和各地區内部的疫苗接種情況各不相同，而且低收入和中低收入國家的疫苗接種率相比之下也低得多。在一些國家，疫苗猶豫和較低的風險認知進一步影響了新冠疫苗的接種率。
The rollout of COVID-19 vaccination is progressing in all regions, thoughvaccine uptake varies between and within regions and disproportionately lowervaccination coverage has been observed in low- and low-middle income countries.Vaccine hesitancy and low risk perception are further affecting the uptake of COVID-19 vaccination in several countries.
全球疫苗免疫聯盟報告
Gavi report
在Gavi的2021-2025年戰略（Gavi 5.0）中，通過建設彈性衛生系統來觸達“零劑次免疫兒童”的目的仍然是聯盟的首要任務，估計在本戰略期間，該聯盟的投資将産生超過一半的增效影響。
Reaching the zero-dose children through the building of resilient healthsystems remains a top priority of the Alliance in the Gavi strategy 2021-2025(Gavi 5.0) and is estimated to account for over half the incremental impact ofGavi investments during the strategy period.
2022年下半年将為瘧疾疫苗的推廣打開一個資金視窗，以便在2023年首次引入該疫苗。
A funding window for the rollout of malaria vaccines will be opened inthe second half of 2022 to enable initial vaccine introductions in 2023.
Gavi對2020年全球人乳頭瘤病毒（HPV）疫苗覆寫率因新冠疫情影響因而下降13%表示擔憂，認為這一問題主要是由于學校關閉和疫苗供應有限。人們意識到，建議采用單劑次程式有可能加速引入，并降低操作成本和複雜性。
Gavi expressed concern over the 13% decline of global HPV vaccinecoverage in 2020 due to COVID-19 disruptions, attributing this issue primarilyto school closures and limited supply. It was acknowledged that a recommendationfor a single dose regimen has the potential to accelerate introductions andreduce operational costs and complexity.
COVAX機構為所有AMC國家提供了充足的供應，以在2022年6月之前實作世衛組織70%的新冠疫苗覆寫率目标。新冠疫苗提供夥伴關系正在支援各國克服障礙，實作國家覆寫目标。
The COVAX facility has sufficient supply available for all AMC countriesto achieve the WHO 70% coverage target by June 2022. The COVAX Vaccine DeliveryPartnership is supporting countries to overcome barriers and to achievenational coverage targets.
第2部分——2030年免疫議程和疫苗補種
Session 2 –Immunization Agenda 2030 and catch-up vaccination
SAGE收到了關于新冠肺炎大流行對國家免疫計劃的影響的證據，主要是由于免疫服務的中斷。
SAGE was presented with evidence of the impact of the COVID-19 pandemicon national immunization programmes mainly due to service delivery disruptions.
人們意識到迫切需要彌補由此産生的免疫落差，同時也認識到支援免疫計劃的恢複和複原以及減少疫苗可預防疾病暴發風險的重要性。
The urgent need to close resulting immunity gaps was recognized, as wasthe importance of supporting the recovery and resilience of immunizationprogrammes and mitigating the risk of vaccine-preventable disease outbreaks.
SAGE建議各國利用新冠肺炎大流行和新冠疫苗的推廣作為一個轉型的機會，建立彈性免疫計劃并加強初級保健。确定的具體方向包括衛生工作者的疫苗接種、與免疫相關的後勤工作，以及資訊登記、監測、資料和通信。
SAGE recommended that countries use the COVID-19 pandemic and COVID-19vaccination rollout as a transformative opportunity to establish resilientimmunization programmes and strengthen primary health care. Among the specificareas identified were health worker vaccination, immunization logistics andregistries, surveillance, data and communications.
“2022年及之後恢複、建立彈性化和加強的免疫的指導原則”得到了認可，并建議向各個地區和國家免疫技術咨詢小組分發，以便根據當地情況加以調整和使用。
The document “Guiding Principles for recovering, building resiliency,and strengthening of immunization in 2022 and beyond” was endorsed andrecommended for dissemination to regional and national immunization technicaladvisory groups so that it may be adapted and used for their local context.
第三部分——甲型病毒性肝炎疫苗接種
Session 3 –Hepatitis A vaccination
甲型肝炎每年造成超過1億人感染，數萬人死亡，死亡原因主要是由爆發性肝衰竭所緻。兒童早期的感染主要是無症狀的，有症狀和重症的比例随着年齡的增長而逐漸增加。
Hepatitis A accounts for over 100 million infections per year and tensof thousands of deaths, mainly due to fulminant liver failure. Infection inearly childhood is mainly asymptomatic and rates of symptomatic and severedisease increase progressively with age.
當國家從高流行性過渡到中等流行性時，由于感染年齡組的變化，有症狀感染和重症的比例會增加。
When countries transition from high to medium endemicity, rates ofsymptomatic and severe disease increase because of a shift in the age ofinfection.
目前有安全有效的滅活和減毒A肝疫苗。雖然滅活疫苗被授權按兩劑次程式使用，但目前約有10個國家在其普及兒童計劃中采用了标簽外單劑次方案。
Safe and effective inactivated and live attenuated Hepatitis A vaccinesare available. While the inactivated vaccine is authorized for use in a 2-doseschedule, about 10 countries currently apply an off-label single dose schedulein their universal childhood programme.
由SAGE審查的關于長期保護性的新證據表明，單劑次和兩劑次滅活疫苗接種在預防疾病和提供持久血清保護方面同樣有效。是以，以前允許使用單劑次方案而贊成使用兩劑次方案的立場已被修改，現在認為兩種方案同樣可以接受。
New evidence on long-term protection reviewed by SAGE indicates thatsingle- and two-dose schedules of inactivated vaccine are equally effective inpreventing the disease and in providing durable sero-protection. Consequently,the previous position of allowing for a single dose schedule while favouringtwo-doses has been modified to now consider both schedules equally acceptable.
SAGE建議在兒童免疫計劃中使用A肝滅活疫苗，可以是單劑次或兩劑次的方案。在引進疫苗的同時，應制定監測和評估計劃，并定期監測其影響和保護期。
SAGE recommended the use of inactivated hepatitis A vaccines in childhoodimmunization programmes either as a single-dose or two-dose schedule.Introduction of vaccines should be accompanied by monitoring and evaluationplans, and the impact and duration of protection should be regularly monitored.
第4部分——新冠肺炎疫苗
Session 4 –COVID-19 vaccines
具體疫苗産品的建議：康希諾
Vaccine product specific recommendations: CanSino
SAGE審查了康希諾新冠疫苗資料，但在該産品被世衛組織列為緊急用途之前，不會釋出任何建議。
SAGE reviewed data on the CanSino COVID-19 vaccine but will not issueany recommendations until such time as the product is listed by WHO foremergency use.
感染和疫苗接種引起的免疫力
Infection and vaccination induced immunity
有關感染和疫苗誘導（"混合免疫"）産生的對新冠病毒免疫力的資料被審查和審議。在感染和疫苗接種的基礎上，新冠病毒血清流行率在全球迅速上升。單獨由感染或由聯合疫苗誘導的保護力應被認識到，尤其應注意與其有關的對新冠肺炎疫苗免疫程式存在可能的改變。
Data regarding infection and vaccine-induced (“hybrid”) SARS-CoV-2immunity was reviewed and deliberated. SARS-CoV-2 seroprevalence is risingrapidly globally, on the basis of both infection and vaccination. Theprotective effect of infection-induced immunity, alone or in combination withvaccination needs to be understood, particularly relating to possiblemodifications to the COVID-19 vaccine schedule.
新的證據正在迅速出現，SAGE已經且未來會持續對其密切關注。這些證據包括按地區、年齡組、收入水準、公共衛生和社會措施劃分的血清流行趨勢，以及人口層面的混合免疫與單純疫苗誘導免疫的有效性資料，以及顯示前幾波感染下如何提供保護以防止在下一波感染中被不同的變體再次感染的隊列研究。SAGE認為這些證據是初步的，目前還不足以對目前的指南做出任何修改。
Evidence is emerging rapidly which SAGE has been and will continue tofollow closely. This includes trends on seroprevalence over time, by region,age strata, income levels, and public health and social measures, as well aspopulation level vaccine effectiveness data of hybrid immunity versusvaccine-induced immunity alone, and cohort studies showing how preceding wavesof infection offer protection against re-infection from a different variant ofconcern during a subsequent wave. SAGE assessed this evidence as beingpreliminary, and insufficient to make any changes to the current guidance atthis time.
需要更多的證據來證明混合免疫和疫苗誘導免疫的保護期，并按疾病結果的嚴重程度進行劃分。考慮到普遍存在的科學不确定性和各國不同的人群血清流行率，SAGE建議應繼續收集和審查有關混合免疫的證據。
More evidence is required on duration of protection for both hybridimmunity as well as vaccineinducted immunity, by severity of disease outcome.Considering prevailing scientific uncertainties and the varied populationseroprevalence rates across countries, SAGE recommends that the collection andreview of evidence on hybrid immunity should continue.
未來将起草一份關于混合免疫資料的證據的技術聲明。
A technical statement regarding evidence to data onhybrid immunity will be drafted.
SAGE進一步強調，需要繼續保護高優先群體，按照世衛組織優先事項路線圖的規定，通過完整的疫苗接種程式實作高接種率。
SAGE further emphasized the need to continue to protect high priorityuse groups by achieving high vaccination coverage with full vaccination seriesas outlined in the WHO Priority Roadmap.
第5部分——傷寒結合疫苗接種
Session 5 –Typhoid conjugate vaccination
傷寒的發病率在南亞的估計值仍然很高，在非洲則略低些，盡管在撒哈拉以南的非洲某些地方已經證明了當地的高發病率。發病的高峰年齡是5-19歲的兒童，其次是1-4歲的兒童。
Typhoid fever incidence estimates remain very high in south Asia andsomewhat lower in Africa though high incidence has been demonstrated inselected sites in sub-Saharan Africa. The peak age of incidence is in children 5-19years, followed by children 1 to 4 years.
傷寒杆菌對環丙沙星和阿奇黴素的抗生素耐藥性以及對擴譜頭孢菌素（XDR）耐藥菌株的出現令人擔憂，因為這些限制了治療方案并可導緻嚴重後果。
Antimicrobial resistance in S. Typhi to ciprofloxacin and azithromycinas well as the emergence of strains resistant to extended spectrumcephalosporins (XDR) is of concern since these limit treatment options andresults in severe outcomes.
此前SAGE獲得了新的資料，證明了單劑次傷寒結合疫苗（TCV）在不同環境下的高效性和有效性（總體保護效力在79-88%之間）。這一新證據建立在自2017年以來實行的TCV疫苗政策所依據的免疫原性資料之上，并進一步加強了目前對TCV使用的建議。SAGE還介紹了國家疫苗引進經驗和決策方面的挑戰。
SAGE was presented with new data that demonstrated high efficacy andeffectiveness of a single dose of Typhoid conjugate vaccine (TCV) acrossdiverse settings (overall efficacy between 79- 88%). This new evidence buildson the immunogenicity data underpinning the TCV policy in place since 2017 andfurther strengthens the current recommendations for TCV use. SAGE was also presentedwith country vaccine introduction experiences and challenges indecision-making.
沒有迹象表明接種TCV的2年後免疫力會減弱。在大于45歲至65歲的成人中，單劑次Typbar-TCV接種後的血清轉化率很高，與18-45歲的年輕成人相當，目前該疫苗已獲得準許。
There is no indication of waning immunity over 2 years. Seroconversionfollowing a single dose of Typbar-TCVin adults >45 to 65 years was high and comparable toyounger adults 18-45 years of age for whom the vaccine is currently licensed.
在未來1-2年内，預計會有更多涉及到保護期、TCV加強劑量的潛在需求以及大于45歲的成年人的年齡指征等懸而未決問題的資料，在此基礎上可以考慮更新世衛組織對傷寒疫苗接種的立場。
More data are expected in the next 1-2 years on outstanding questionsabout the duration of protection and the potential need for booster doses ofTCV and an age indication for adults >45 years, on which basis an update ofWHO’s position on typhoid vaccination could be considered.
第6部分——人乳頭瘤病毒疫苗接種
Session 6 –Human Papillomavirus vaccination
人們對人乳頭瘤病毒（HPV）疫苗引進的速度放緩、人口覆寫率低，特别是新冠肺炎大流行導緻的覆寫率倒退表示擔憂。SAGE警惕的指出，HPV疫苗接種的實施沒有達到2030年全球宮頸癌消除戰略的目标。然而，人們注意到HPV疫苗的供應情況和供應商根基在短期和中期内有所改善。
Concern was expressed with the slowing pace of HPV vaccineintroductions, the low population coverage, and especially the coveragebacksliding as a result of the COVID-19 pandemic. SAGE noted with alarm thatHPV vaccination implementation is not on track to meet the 2030 global cervicalcancer elimination strategy targets. However, the HPV vaccine supply situationand supplier base were noted as improving in the short- and medium term.
注意到這種不斷改善的HPV疫苗供應狀況，SAGE建議所有國家立即為9-14歲的女童這一主要目标引入HPV疫苗，并在可行和可負擔的情況下，優先通過多年齡組的疫苗接種來彌補年齡較大的組群和錯過免疫機會的女性。在疫苗供應不受限制之前，應謹慎考慮男童和年齡較大群體的HPV疫苗接種工作。
Noting this improving HPV supply situation, SAGE recommended that allcountries urgently introduce the HPV vaccine for the primary target of9-14-year-old girls and, when feasible and affordable, prioritize catching upolder cohorts and missed girls through multi-age cohort vaccination.Vaccination of boys and older cohorts should be carefully managed until thereis unconstrained supply of vaccine.
SAGE審查了關于單劑次HPV疫苗有效性的新證據。基于所有可用的證據，SAGE建議各國現在可以在9-14歲女孩的單劑次或兩劑次方案之間做出選擇。這種标簽外的單劑次程式用于正常或多個年齡組群體補種是由于疫苗可以提供相當高的個人保護水準，同時從公共衛生的角度來看，其效率更高（每預防一例癌症的平均劑次更少），資源密集度更低，并且比兩劑次方案更容易實施。本建議适用于那些已經收集了相應的單劑次接種資料的HPV疫苗。
SAGE reviewed new evidence on the efficacy of a single dose HPV vaccine schedule.Based on all available evidence, SAGE advised that countries may now choosebetween a one- or two-dose schedule for 9–14-year-old girls. This off-labelsingle-dose option for routine and multi-age cohort catch-up vaccination wasconsidered because it provides comparable and high levels of individualprotection while from a public health perspective being more efficient (fewerdoses per cancer case prevented), less resource-intensive and is easier toimplement than a two-dose schedule. This advice applies to those HPV vaccinesfor which corresponding 1-dose data have been collected.
同樣，對于15至20歲的年輕女性，可以采用單劑次或兩劑次的方案，而對于21歲以上的女性，應該采用兩劑次方案，間隔6個月。男童和年長的男性可以采用與女性相同的劑次方案，同時能夠對這一群體的單劑次方案的有效性和免疫原性産生更多證據。
Similarly, either a one- or a two-dose schedule may be applied foryoung women aged 15 to 20 years old, while two doses with a 6-month intervalshould be used for females older than 21 years. Boys and older males can followthe same dose schedule as females, while additional evidence is generated onthe efficacy and immunogenicity of a single dose schedule in this group.
必須産生進一步的證據，證明減少接種劑次的方案對免疫力低下的人群保護作用。在獲得這些證據之前，相關的9歲及以上人群應被優先考慮接種，并接受至少兩劑次疫苗，在可行的情況下，三劑次接種将被視為最佳方案。鑒于免疫力低下人群、HIV感染者和面臨性虐待的女童與HPV相關的癌症發病率很高，SAGE建議在标準年齡資格範圍内外都考慮為他們接種HPV疫苗。
Further evidence must be generated on protection in immunocompromisedindividuals by reduced dose schedules. Until such evidence is available,persons from this population aged 9 years and older should be prioritized andreceive at least two doses, though three doses would be considered optimal ifprogrammatically feasible. Given the high incidence of HPV-related cancers inimmunocompromised persons, those living with HIV, and girls who face sexualabuse, SAGE recommends that they be considered for vaccination against HPV bothwithin and outside of standard eligibility age-range.
在修訂世衛組織關于HPV疫苗接種的立場檔案之前，世衛組織将就這些重要的政策變化進行利益攸關方磋商。
Before revising the WHO Position Paper on HPV vaccination, WHO willconduct a stakeholder consultation on these important policy changes.
第7部分——脊髓灰質炎病毒疫苗
Session 7 –Poliovirus vaccines
1型野生脊髓灰質炎病毒的流行病學情況仍然良好，在12個月内報告的野生脊髓灰質炎病例數量為曆史最低，自2021年1月下旬以來僅有6例，巴基斯坦在15個月内沒有任何病例。然而，SAGE對最近在馬拉威發現的脊灰野病毒表示嚴重關切，該病毒的傳播曾被阻斷，并對正在傳播的疫苗衍生脊髓灰質炎病毒（cVDPV2）表示嚴重關切，特别是在奈及利亞仍面臨循環2型疫苗衍生脊灰病毒（cVDPV2）疫情的非洲地區。
The epidemiology of wild poliovirus type 1 continues to be favourable,with the lowest number of wild polio cases ever reported in a 12-month period,including just 6 cases since late January 2021 and none in Pakistan in 15months. However, SAGE expressed serious concern about the recent detection ofwild poliovirus in Malawi where transmission had been interrupted, as well asabout ongoing transmission of circulating Vaccine Derived Polioviruses(cVDPV2), particularly in the African region where Nigeria still confrontscVDPV2 outbreaks.
會議強調了2021年在烏克蘭境内發現的cVDPV2疫情進一步擴散的風險，并認識到其有可能出口到接收烏克蘭難民的國家。SAGE指出，支援和加強整個歐洲地區的脊髓灰質炎病毒監測非常重要。
The risk of further spread of cVDPV2 from an outbreak detected in 2021within Ukraine was stressed, with recognition of its potential exportation tocountries receiving Ukrainian refugees. SAGE stated the importance of supportand strengthening of poliovirus surveillance throughout the European region.
SAGE注意到關于新型2型口服脊髓灰質炎減毒疫苗（nOPV2）的安全性和遺傳穩定性資料能夠證明該疫苗的安全性和遺傳穩定性良好。SAGE指出，正在制定一個全面分析nOPV2性能的架構，并要求定期更新nOPV2的安全性和遺傳穩定性資料。
SAGE noted the data on the safety and genetic stability data on novelOPV2 (nOPV2) confirming a good safety profile and genetic stability of thevaccine. SAGE noted that a framework for a comprehensive analysis of nOPV2performance is under development and requested periodic updates on the safetyand genetic stability data of nOPV2.
會議準許成立"口服脊髓灰質炎疫苗（OPV）停用小組"，以便在脊灰野病毒被證明已經被根除一年後，能夠有效地規劃和實施從正常免疫計劃中撤出OPV。
The establishment of an “Oral Polio Vaccine (OPV) Cessation Team” wasendorsed to enable efficient planning and implementation of the withdrawal ofOPV from routine immunization programs one year after certification of wildpoliovirus eradication.
願天下無疫。
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