Effectiveness of mRNA COVID-19 Vaccines as First Booster Doses in England: An Observational Study in OpenSAFELY-TPP.

IF 4.7 2区医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Epidemiology Pub Date : 2024-07-01 Epub Date: 2024-06-24 DOI:10.1097/EDE.0000000000001747

Elsie M F Horne, William J Hulme, Edward P K Parker, Ruth H Keogh, Elizabeth J Williamson, Venexia M Walker, Tom M Palmer, Rachel Denholm, Rochelle Knight, Helen J Curtis, Alex J Walker, Colm D Andrews, Amir Mehrkar, Jessica Morley, Brian MacKenna, Sebastian C J Bacon, Ben Goldacre, Miguel A Hernán, Jonathan A C Sterne

{"title":"Effectiveness of mRNA COVID-19 Vaccines as First Booster Doses in England: An Observational Study in OpenSAFELY-TPP.","authors":"Elsie M F Horne, William J Hulme, Edward P K Parker, Ruth H Keogh, Elizabeth J Williamson, Venexia M Walker, Tom M Palmer, Rachel Denholm, Rochelle Knight, Helen J Curtis, Alex J Walker, Colm D Andrews, Amir Mehrkar, Jessica Morley, Brian MacKenna, Sebastian C J Bacon, Ben Goldacre, Miguel A Hernán, Jonathan A C Sterne","doi":"10.1097/EDE.0000000000001747","DOIUrl":null,"url":null,"abstract":"Background: The UK delivered its first \"booster\" COVID-19 vaccine doses in September 2021, initially to individuals at high risk of severe disease, then to all adults. The BNT162b2 Pfizer-BioNTech vaccine was used initially, then also Moderna mRNA-1273.Methods: With the approval of the National Health Service England, we used routine clinical data to estimate the effectiveness of boosting with BNT162b2 or mRNA-1273 compared with no boosting in eligible adults who had received two primary course vaccine doses. We matched each booster recipient with an unboosted control on factors relating to booster priority status and prior COVID-19 immunization. We adjusted for additional factors in Cox models, estimating hazard ratios up to 182 days (6 months) following booster dose. We estimated hazard ratios overall and within the following periods: 1-14, 15-42, 43-69, 70-97, 98-126, 127-152, and 155-182 days. Outcomes included a positive SARS-CoV-2 test, COVID-19 hospitalization, COVID-19 death, non-COVID-19 death, and fracture.Results: We matched 8,198,643 booster recipients with unboosted controls. Adjusted hazard ratios over 6-month follow-up were: positive SARS-CoV-2 test 0.75 (0.74, 0.75); COVID-19 hospitalization 0.30 (0.29, 0.31); COVID-19 death 0.11 (0.10, 0.14); non-COVID-19 death 0.22 (0.21, 0.23); and fracture 0.77 (0.75, 0.78). Estimated effectiveness of booster vaccines against severe COVID-19-related outcomes peaked during the first 3 months following the booster dose. By 6 months, the cumulative incidence of positive SARS-CoV-2 test was higher in boosted than unboosted individuals.Conclusions: We estimate that COVID-19 booster vaccination, compared with no booster vaccination, provided substantial protection against COVID-19 hospitalization and COVID-19 death but only limited protection against positive SARS-CoV-2 test. Lower rates of fracture in boosted than unboosted individuals may suggest unmeasured confounding. Observational studies should report estimated vaccine effectiveness against nontarget and negative control outcomes.","PeriodicalId":11779,"journal":{"name":"Epidemiology","volume":null,"pages":null},"PeriodicalIF":4.7000,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11191555/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Epidemiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/EDE.0000000000001747","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/6/24 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH","Score":null,"Total":0}

引用次数: 0

Abstract

Background: The UK delivered its first "booster" COVID-19 vaccine doses in September 2021, initially to individuals at high risk of severe disease, then to all adults. The BNT162b2 Pfizer-BioNTech vaccine was used initially, then also Moderna mRNA-1273.

Methods: With the approval of the National Health Service England, we used routine clinical data to estimate the effectiveness of boosting with BNT162b2 or mRNA-1273 compared with no boosting in eligible adults who had received two primary course vaccine doses. We matched each booster recipient with an unboosted control on factors relating to booster priority status and prior COVID-19 immunization. We adjusted for additional factors in Cox models, estimating hazard ratios up to 182 days (6 months) following booster dose. We estimated hazard ratios overall and within the following periods: 1-14, 15-42, 43-69, 70-97, 98-126, 127-152, and 155-182 days. Outcomes included a positive SARS-CoV-2 test, COVID-19 hospitalization, COVID-19 death, non-COVID-19 death, and fracture.

Results: We matched 8,198,643 booster recipients with unboosted controls. Adjusted hazard ratios over 6-month follow-up were: positive SARS-CoV-2 test 0.75 (0.74, 0.75); COVID-19 hospitalization 0.30 (0.29, 0.31); COVID-19 death 0.11 (0.10, 0.14); non-COVID-19 death 0.22 (0.21, 0.23); and fracture 0.77 (0.75, 0.78). Estimated effectiveness of booster vaccines against severe COVID-19-related outcomes peaked during the first 3 months following the booster dose. By 6 months, the cumulative incidence of positive SARS-CoV-2 test was higher in boosted than unboosted individuals.

Conclusions: We estimate that COVID-19 booster vaccination, compared with no booster vaccination, provided substantial protection against COVID-19 hospitalization and COVID-19 death but only limited protection against positive SARS-CoV-2 test. Lower rates of fracture in boosted than unboosted individuals may suggest unmeasured confounding. Observational studies should report estimated vaccine effectiveness against nontarget and negative control outcomes.

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

英国 mRNA COVID-19 疫苗首次加强剂量的有效性：OpenSAFELY-TPP 观察性研究。

背景：英国于 2021 年 9 月首次接种 COVID-19 疫苗 "加强剂"，最初接种对象为重症高危人群，随后接种对象为所有成年人。最初使用的是辉瑞生物技术公司的 BNT162b2 疫苗，后来又使用了 Moderna mRNA-1273：方法：经英格兰国民健康服务局批准，我们使用常规临床数据来估算接种 BNT162b2 或 mRNA-1273 与不接种 BNT162b2 或 mRNA-1273 的有效性比较。我们将每个强化接种者与未接受强化接种的对照组进行了匹配，匹配因素包括强化接种优先级和之前的 COVID-19 免疫接种。我们在 Cox 模型中对其他因素进行了调整，估计了强化剂接种后 182 天（6 个月）内的危险比。我们估算了总体的危险比，以及以下时间段内的危险比：1-14 天、15-42 天、43-69 天、70-97 天、98-126 天、127-152 天和 155-182 天。结果包括 SARS-CoV-2 检测呈阳性、COVID-19 住院、COVID-19 死亡、非 COVID-19 死亡和骨折：我们将 8,198,643 名接受强化治疗者与未接受强化治疗的对照组进行了配对。随访 6 个月的调整后危险比为：SARS-CoV-2 检测阳性 0.75（0.74，0.75）；COVID-19 住院 0.30（0.29，0.31）；COVID-19 死亡 0.11（0.10，0.14）；非 COVID-19 死亡 0.22（0.21，0.23）；骨折 0.77（0.75，0.78）。加强接种疫苗对 COVID-19 相关严重后果的估计效果在加强接种后的头 3 个月达到峰值。到 6 个月时，加强接种者的 SARS-CoV-2 检测阳性累积发生率高于未加强接种者：我们估计，接种 COVID-19 加强免疫疫苗比不接种加强免疫疫苗对 COVID-19 住院和 COVID-19 死亡有很大的保护作用，但对 SARS-CoV-2 检测阳性只有有限的保护作用。强化接种者的骨折发生率低于未强化接种者，这可能表明存在未测量的混杂因素。观察性研究应报告疫苗对非目标和阴性对照结果的估计效果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

Epidemiology 医学-公共卫生、环境卫生与职业卫生

CiteScore

6.70

自引率

3.70%

发文量

177

审稿时长

6-12 weeks

期刊介绍： Epidemiology publishes original research from all fields of epidemiology. The journal also welcomes review articles and meta-analyses, novel hypotheses, descriptions and applications of new methods, and discussions of research theory or public health policy. We give special consideration to papers from developing countries.