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Covid-19 Vaccine Effectiveness against the Omicron (B.1.1.529) Variant. ​

文献信息 ​

DOI10.1056/NEJMoa2119451
PMID35249272
期刊The New England journal of medicine
影响因子78.5
JCR 分区Q1
发表年份2022
被引次数1330
关键词新冠疫苗, Omicron变异株, 疫苗有效性, 加强针, 症状性疾病
文献类型Journal Article, Research Support, Non-U.S. Gov't
ISSN0028-4793
页码1532-1546
期号386(16)
作者Nick Andrews, Julia Stowe, Freja Kirsebom, Samuel Toffa, Tim Rickeard, Eileen Gallagher, Charlotte Gower, Meaghan Kall, Natalie Groves, Anne-Marie O'Connell, David Simons, Paula B Blomquist, Asad Zaidi, Sophie Nash, Nurin Iwani Binti Abdul Aziz, Simon Thelwall, Gavin Dabrera, Richard Myers, Gayatri Amirthalingam, Saheer Gharbia, Jeffrey C Barrett, Richard Elson, Shamez N Ladhani, Neil Ferguson, Maria Zambon, Colin N J Campbell, Kevin Brown, Susan Hopkins, Meera Chand, Mary Ramsay, Jamie Lopez Bernal

一句话小结 ​

本研究评估了在英格兰，接种不同新冠疫苗后对omicron和delta变异株引起的有症状疾病的疫苗有效性，发现接种两剂疫苗对omicron的保护效果有限，但加强剂可显著提高保护效果，且保护力随着时间推移而减弱。研究结果强调了针对omicron变异株的疫苗保护不足，提示需要持续监测和优化疫苗接种策略。

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新冠疫苗 · Omicron变异株 · 疫苗有效性 · 加强针 · 症状性疾病

摘要 ​

背景
由于严重急性呼吸综合症冠状病毒2型的omicron（B.1.1.529）变异株在高度接种疫苗的人群中导致新冠病毒病2019（Covid-19）病例快速增加，引发了对现有疫苗有效性的担忧。

方法
我们采用了测试阴性病例对照设计，以评估在英格兰由omicron和delta（B.1.617.2）变异株引起的有症状疾病的疫苗有效性。疫苗有效性是在接种两剂BNT162b2（辉瑞-BioNTech）、ChAdOx1 nCoV-19（阿斯利康）或mRNA-1273（莫德纳）疫苗后的初次免疫接种以及接种BNT162b2、ChAdOx1 nCoV-19或mRNA-1273的加强剂后计算的。

结果
在2021年11月27日至2022年1月12日期间，共识别到886,774名感染omicron变异株的符合条件人员，204,154名感染delta变异株的符合条件人员，以及1,572,621名符合条件的测试阴性对照者。在所有调查的时间点和所有初次接种与加强疫苗的组合中，针对有症状疾病的疫苗有效性在delta变异株上高于在omicron变异株上。在接种两剂ChAdOx1 nCoV-19后20周起，未观察到对omicron变异株的保护效果，而接种两剂BNT162b2后的疫苗有效性在2至4周时为65.5%（95%可信区间[CI]，63.9至67.0），在25周或更长时间后降至8.8%（95% CI，7.0至10.5）。在接种ChAdOx1 nCoV-19初次课程的受试者中，在接种BNT162b2加强剂后2至4周，疫苗有效性增加至62.4%（95% CI，61.8至63.0），但在10周或更长时间后降至39.6%（95% CI，38.0至41.1）。在接种BNT162b2初次课程的受试者中，在接种BNT162b2加强剂后2至4周，疫苗有效性增加至67.2%（95% CI，66.5至67.8），但在10周或更长时间后降至45.7%（95% CI，44.7至46.7）。在接种ChAdOx1 nCoV-19初次课程后，在接种mRNA-1273加强剂后2至4周，疫苗有效性增加至70.1%（95% CI，69.5至70.7），在5至9周后降至60.9%（95% CI，59.7至62.1）。在接种BNT162b2初次课程后，mRNA-1273加强剂将疫苗有效性提高至73.9%（95% CI，73.1至74.6）在2至4周；疫苗有效性在5至9周后降至64.4%（95% CI，62.6至66.1）。

结论
接种两剂ChAdOx1 nCoV-19或BNT162b2疫苗对由omicron变异株引起的有症状疾病提供的保护有限。在接种ChAdOx1 nCoV-19或BNT162b2初次课程后，接种BNT162b2或mRNA-1273加强剂显著提高了保护效果，但这种保护随着时间的推移而减弱。（由英国卫生安全局资助）。

英文摘要 ​

BACKGROUND A rapid increase in coronavirus disease 2019 (Covid-19) cases due to the omicron (B.1.1.529) variant of severe acute respiratory syndrome coronavirus 2 in highly vaccinated populations has aroused concerns about the effectiveness of current vaccines.

METHODS We used a test-negative case-control design to estimate vaccine effectiveness against symptomatic disease caused by the omicron and delta (B.1.617.2) variants in England. Vaccine effectiveness was calculated after primary immunization with two doses of BNT162b2 (Pfizer-BioNTech), ChAdOx1 nCoV-19 (AstraZeneca), or mRNA-1273 (Moderna) vaccine and after a booster dose of BNT162b2, ChAdOx1 nCoV-19, or mRNA-1273.

RESULTS Between November 27, 2021, and January 12, 2022, a total of 886,774 eligible persons infected with the omicron variant, 204,154 eligible persons infected with the delta variant, and 1,572,621 eligible test-negative controls were identified. At all time points investigated and for all combinations of primary course and booster vaccines, vaccine effectiveness against symptomatic disease was higher for the delta variant than for the omicron variant. No effect against the omicron variant was noted from 20 weeks after two ChAdOx1 nCoV-19 doses, whereas vaccine effectiveness after two BNT162b2 doses was 65.5% (95% confidence interval [CI], 63.9 to 67.0) at 2 to 4 weeks, dropping to 8.8% (95% CI, 7.0 to 10.5) at 25 or more weeks. Among ChAdOx1 nCoV-19 primary course recipients, vaccine effectiveness increased to 62.4% (95% CI, 61.8 to 63.0) at 2 to 4 weeks after a BNT162b2 booster before decreasing to 39.6% (95% CI, 38.0 to 41.1) at 10 or more weeks. Among BNT162b2 primary course recipients, vaccine effectiveness increased to 67.2% (95% CI, 66.5 to 67.8) at 2 to 4 weeks after a BNT162b2 booster before declining to 45.7% (95% CI, 44.7 to 46.7) at 10 or more weeks. Vaccine effectiveness after a ChAdOx1 nCoV-19 primary course increased to 70.1% (95% CI, 69.5 to 70.7) at 2 to 4 weeks after an mRNA-1273 booster and decreased to 60.9% (95% CI, 59.7 to 62.1) at 5 to 9 weeks. After a BNT162b2 primary course, the mRNA-1273 booster increased vaccine effectiveness to 73.9% (95% CI, 73.1 to 74.6) at 2 to 4 weeks; vaccine effectiveness fell to 64.4% (95% CI, 62.6 to 66.1) at 5 to 9 weeks.

CONCLUSIONS Primary immunization with two doses of ChAdOx1 nCoV-19 or BNT162b2 vaccine provided limited protection against symptomatic disease caused by the omicron variant. A BNT162b2 or mRNA-1273 booster after either the ChAdOx1 nCoV-19 or BNT162b2 primary course substantially increased protection, but that protection waned over time. (Funded by the U.K. Health Security Agency.).

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主要研究问题 ​

  1. 针对不同疫苗的免疫机制，如何解释它们在对抗Omicron变种时的效果差异？
  2. 在高疫苗接种率的群体中，Omicron变种的传播特点与其他变种相比有何不同？
  3. 除了接种疫苗外，还有哪些因素可能影响Omicron变种的感染率和疫苗有效性？
  4. 随着时间的推移，疫苗有效性下降的机制是什么？这对未来疫苗的开发有何启示？
  5. 针对Omicron变种的疫苗增强剂的研发进展如何？是否有新的疫苗组合在研究中？

核心洞察 ​

研究背景和目的 ​

随着Omicron变异株（B.1.1.529）在高接种率人群中迅速传播，COVID-19疫苗的有效性受到广泛关注。本研究旨在评估针对Omicron和Delta（B.1.617.2）变异株的疫苗有效性，特别是在接种两剂疫苗和加强剂后的效果。

主要方法/材料/实验设计 ​

本研究采用测试阴性病例对照设计，评估疫苗对症状性COVID-19的有效性。研究对象为18岁及以上的成年人，比较PCR阳性病例与PCR阴性对照的疫苗接种情况。

流程图 ​

Mermaid diagram
  • 数据来源：包括PCR检测数据和疫苗接种数据。
  • 疫苗接种情况：记录接种的疫苗类型、接种时间和剂量。
  • 统计分析：使用Logistic回归模型调整年龄、性别、社会经济地位等混杂因素。

关键结果和发现 ​

  • 在2021年11月27日至2022年1月12日期间，研究共识别出886,774例Omicron感染者和204,154例Delta感染者。
  • 针对Omicron变异株的疫苗有效性明显低于Delta变异株：
    • 两剂ChAdOx1 nCoV-19疫苗后，20周后几乎无保护效果。
    • 两剂BNT162b2疫苗在接种2至4周后有效性为65.5%，而在25周后降至8.8%。
    • 接种加强剂（BNT162b2或mRNA-1273）后，有效性显著提升，但随时间推移逐渐减弱。

主要结论/意义/创新性 ​

本研究表明，接种两剂ChAdOx1 nCoV-19或BNT162b2疫苗对Omicron变异株的保护作用有限。加强接种可显著提高保护效果，但这种保护随着时间的推移而减弱。这一发现强调了在高度接种人群中，继续推广加强接种的重要性，以对抗Omicron变异株的传播。

研究局限性和未来方向 ​

  • 局限性：由于Omicron病例较少，难以准确评估其对重症疾病的保护效果。此外，研究的对照组中未接种者比例较小，可能影响有效性估计。
  • 未来方向：需继续监测疫苗对重症和死亡的保护效果，评估加强剂的长期效果，并探索针对新变异株的疫苗改进策略。

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引用本文的文献 ​

  1. Behaviour, booster vaccines and waning immunity: modelling the medium-term dynamics of SARS-CoV-2 transmission in England in the Omicron era. - Rosanna C Barnard;Nicholas G Davies; ;Mark Jit;W John Edmunds - medRxiv : the preprint server for health sciences (2022)
  2. Omicron: What Makes the Latest SARS-CoV-2 Variant of Concern So Concerning? - Christoph Jung;Dorota Kmiec;Lennart Koepke;Fabian Zech;Timo Jacob;Konstantin M J Sparrer;Frank Kirchhoff - Journal of virology (2022)
  3. Current evidence on efficacy of COVID-19 booster dose vaccination against the Omicron variant: A systematic review. - Santenna Chenchula;Padmavathi Karunakaran;Sushil Sharma;Madhavrao Chavan - Journal of medical virology (2022)
  4. Effect of mRNA Vaccine Boosters against SARS-CoV-2 Omicron Infection in Qatar. - Laith J Abu-Raddad;Hiam Chemaitelly;Houssein H Ayoub;Sawsan AlMukdad;Hadi M Yassine;Hebah A Al-Khatib;Maria K Smatti;Patrick Tang;Mohammad R Hasan;Peter Coyle;Zaina Al-Kanaani;Einas Al-Kuwari;Andrew Jeremijenko;Anvar H Kaleeckal;Ali N Latif;Riyazuddin M Shaik;Hanan F Abdul-Rahim;Gheyath K Nasrallah;Mohamed Ghaith Al-Kuwari;Adeel A Butt;Hamad Eid Al-Romaihi;Mohamed H Al-Thani;Abdullatif Al-Khal;Roberto Bertollini - The New England journal of medicine (2022)
  5. Omicron BA.1 and BA.2 neutralizing activity elicited by a comprehensive panel of human vaccines. - John E Bowen;Kaitlin R Sprouse;Alexandra C Walls;Ignacio G Mazzitelli;Jennifer K Logue;Nicholas M Franko;Kumail Ahmed;Asefa Shariq;Elisabetta Cameroni;Andrea Gori;Alessandra Bandera;Christine M Posavad;Jennifer M Dan;Zeli Zhang;Daniela Weiskopf;Alessandro Sette;Shane Crotty;Najeeha Talat Iqbal;Davide Corti;Jorge Geffner;Renata Grifantini;Helen Y Chu;David Veesler - bioRxiv : the preprint server for biology (2022)
  6. SARS-CoV-2 infection during the Omicron surge among patients receiving dialysis: the role of circulating receptor-binding domain antibodies and vaccine doses. - Maria E Montez-Rath;Pablo Garcia;Jialin Han;LinaCel Cadden;Patti Hunsader;Curt Morgan;Russell Kerschmann;Paul Beyer;Mary Dittrich;Geoffrey A Block;Shuchi Anand;Julie Parsonnet;Glenn M Chertow - medRxiv : the preprint server for health sciences (2022)
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  10. Update on SARS-CoV-2 Omicron Variant of Concern and Its Peculiar Mutational Profile. - Mohammad Alkhatib;Romina Salpini;Luca Carioti;Francesca Alessandra Ambrosio;Stefano D'Anna;Leonardo Duca;Giosuè Costa;Maria Concetta Bellocchi;Lorenzo Piermatteo;Anna Artese;Maria Mercedes Santoro;Stefano Alcaro;Valentina Svicher;Francesca Ceccherini-Silberstein - Microbiology spectrum (2022)

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