Lopez Bernal Jamie, Andrews Nick, Gower Charlotte, Robertson Chris, Stowe Julia, Tessier Elise, Simmons Ruth, Cottrell Simon, Roberts Richard, O'Doherty Mark, Brown Kevin, Cameron Claire, Stockton Diane, McMenamin Jim, Ramsay Mary
Public Health England, London, UK
NIHR Health Protection Research Unit in Vaccines and Immunisation, London School of Hygiene and Tropical Medicine, London, UK.
BMJ. 2021 May 13;373:n1088. doi: 10.1136/bmj.n1088.
To estimate the real world effectiveness of the Pfizer-BioNTech BNT162b2 and Oxford-AstraZeneca ChAdOx1-S vaccines against confirmed covid-19 symptoms (including the UK variant of concern B.1.1.7), admissions to hospital, and deaths.
Test negative case-control study.
Community testing for covid-19 in England.
156 930 adults aged 70 years and older who reported symptoms of covid-19 between 8 December 2020 and 19 February 2021 and were successfully linked to vaccination data in the National Immunisation Management System.
Vaccination with BNT162b2 or ChAdOx1-S.
Primary outcomes were polymerase chain reaction confirmed symptomatic SARS-CoV-2 infections, admissions to hospital for covid-19, and deaths with covid-19.
Participants aged 80 years and older vaccinated with BNT162b2 before 4 January 2021 had a higher odds of testing positive for covid-19 in the first nine days after vaccination (odds ratio up to 1.48, 95% confidence interval 1.23 to 1.77), indicating that those initially targeted had a higher underlying risk of infection. Vaccine effectiveness was therefore compared with the baseline post-vaccination period. Vaccine effects were noted 10 to 13 days after vaccination, reaching a vaccine effectiveness of 70% (95% confidence interval 59% to 78%), then plateauing. From 14 days after the second dose a vaccination effectiveness of 89% (85% to 93%) was found compared with the increased baseline risk. Participants aged 70 years and older vaccinated from 4 January (when ChAdOx1-S delivery commenced) had a similar underlying risk of covid-19 to unvaccinated individuals. With BNT162b2, vaccine effectiveness reached 61% (51% to 69%) from 28 to 34 days after vaccination, then plateaued. With ChAdOx1-S, effects were seen from 14 to 20 days after vaccination, reaching an effectiveness of 60% (41% to 73%) from 28 to 34 days, increasing to 73% (27% to 90%) from day 35 onwards. On top of the protection against symptomatic disease, a further 43% (33% to 52%) reduced risk of emergency hospital admission and 51% (37% to 62%) reduced risk of death was observed in those who had received one dose of BNT162b2. Participants who had received one dose of ChAdOx1-S had a further 37% (3% to 59%) reduced risk of emergency hospital admission. Follow-up was insufficient to assess the effect of ChAdOx1-S on mortality. Combined with the effect against symptomatic disease, a single dose of either vaccine was about 80% effective at preventing admission to hospital with covid-19 and a single dose of BNT162b2 was 85% effective at preventing death with covid-19.
Vaccination with either one dose of BNT162b2 or ChAdOx1-S was associated with a significant reduction in symptomatic covid-19 in older adults, and with further protection against severe disease. Both vaccines showed similar effects. Protection was maintained for the duration of follow-up (>6 weeks). A second dose of BNT162b2 was associated with further protection against symptomatic disease. A clear effect of the vaccines against the B.1.1.7 variant was found.
评估辉瑞 - 生物科技公司的BNT162b2疫苗和牛津 - 阿斯利康公司的ChAdOx1-S疫苗针对确诊的新冠病毒疾病症状(包括英国关注的变异株B.1.1.7)、住院治疗及死亡情况的真实世界有效性。
检测阴性病例对照研究。
英格兰针对新冠病毒疾病的社区检测。
2020年12月8日至2021年2月19日期间报告有新冠病毒疾病症状且成功与国家免疫管理系统中的疫苗接种数据相关联的156930名70岁及以上成年人。
接种BNT162b2或ChAdOx1-S疫苗。
主要结局为聚合酶链反应确诊的有症状的严重急性呼吸综合征冠状病毒2感染、因新冠病毒疾病住院治疗及死于新冠病毒疾病。
2021年1月4日前接种BNT162b2疫苗的80岁及以上参与者在接种后的前九天新冠病毒检测呈阳性的几率更高(优势比高达1.48,95%置信区间为1.23至1.77),这表明最初目标人群的潜在感染风险更高。因此将疫苗有效性与接种疫苗后的基线期进行比较。接种疫苗10至13天后观察到疫苗效果,疫苗有效性达到70%(95%置信区间为59%至78%),随后趋于平稳。与增加的基线风险相比,第二剂接种后14天起疫苗有效性为89%(85%至93%)。1月4日(ChAdOx1-S疫苗开始接种时)起接种疫苗的70岁及以上参与者的新冠病毒潜在风险与未接种疫苗者相似。使用BNT162b2疫苗时,接种后28至34天疫苗有效性达到61%(51%至69%),随后趋于平稳。使用ChAdOx1-S疫苗时,接种后14至20天观察到效果,28至34天有效性达到60%(41%至73%),从第35天起增至73%(27%至90%)。除了预防有症状疾病外,接种一剂BNT162b2的人群中,急诊住院风险进一步降低43%(33%至52%),死亡风险降低51%(37%至62%)。接种一剂ChAdOx1-S的参与者急诊住院风险进一步降低37%(3%至59%)。随访时间不足以评估ChAdOx1-S对死亡率的影响。结合对有症状疾病的预防效果,两种疫苗的单剂接种对预防因新冠病毒疾病住院的有效性约为80%,单剂BNT162b2对预防死于新冠病毒疾病的有效性为85%。
接种一剂BNT162b2或ChAdOx1-S疫苗均与老年人有症状的新冠病毒疾病显著减少相关,并对重症疾病有进一步保护作用。两种疫苗效果相似。在随访期间(>6周)保护作用持续存在。接种第二剂BNT16b2疫苗与预防有症状疾病的进一步保护作用相关。发现疫苗对B.1.1.7变异株有明显效果。