Menni Cristina, Klaser Kerstin, May Anna, Polidori Lorenzo, Capdevila Joan, Louca Panayiotis, Sudre Carole H, Nguyen Long H, Drew David A, Merino Jordi, Hu Christina, Selvachandran Somesh, Antonelli Michela, Murray Benjamin, Canas Liane S, Molteni Erika, Graham Mark S, Modat Marc, Joshi Amit D, Mangino Massimo, Hammers Alexander, Goodman Anna L, Chan Andrew T, Wolf Jonathan, Steves Claire J, Valdes Ana M, Ourselin Sebastien, Spector Tim D
Department of Twin Research & Genetic Epidemiology, King's College London, London, UK.
School of Biomedical Engineering & Imaging Sciences, King's College London, London, UK.
Lancet Infect Dis. 2021 Jul;21(7):939-949. doi: 10.1016/S1473-3099(21)00224-3. Epub 2021 Apr 27.
The Pfizer-BioNTech (BNT162b2) and the Oxford-AstraZeneca (ChAdOx1 nCoV-19) COVID-19 vaccines have shown excellent safety and efficacy in phase 3 trials. We aimed to investigate the safety and effectiveness of these vaccines in a UK community setting.
In this prospective observational study, we examined the proportion and probability of self-reported systemic and local side-effects within 8 days of vaccination in individuals using the COVID Symptom Study app who received one or two doses of the BNT162b2 vaccine or one dose of the ChAdOx1 nCoV-19 vaccine. We also compared infection rates in a subset of vaccinated individuals subsequently tested for SARS-CoV-2 with PCR or lateral flow tests with infection rates in unvaccinated controls. All analyses were adjusted by age (≤55 years vs >55 years), sex, health-care worker status (binary variable), obesity (BMI <30 kg/mvs ≥30 kg/m), and comorbidities (binary variable, with or without comorbidities).
Between Dec 8, and March 10, 2021, 627 383 individuals reported being vaccinated with 655 590 doses: 282 103 received one dose of BNT162b2, of whom 28 207 received a second dose, and 345 280 received one dose of ChAdOx1 nCoV-19. Systemic side-effects were reported by 13·5% (38 155 of 282 103) of individuals after the first dose of BNT162b2, by 22·0% (6216 of 28 207) after the second dose of BNT162b2, and by 33·7% (116 473 of 345 280) after the first dose of ChAdOx1 nCoV-19. Local side-effects were reported by 71·9% (150 023 of 208 767) of individuals after the first dose of BNT162b2, by 68·5% (9025 of 13 179) after the second dose of BNT162b2, and by 58·7% (104 282 of 177 655) after the first dose of ChAdOx1 nCoV-19. Systemic side-effects were more common (1·6 times after the first dose of ChAdOx1 nCoV-19 and 2·9 times after the first dose of BNT162b2) among individuals with previous SARS-CoV-2 infection than among those without known past infection. Local effects were similarly higher in individuals previously infected than in those without known past infection (1·4 times after the first dose of ChAdOx1 nCoV-19 and 1·2 times after the first dose of BNT162b2). 3106 of 103 622 vaccinated individuals and 50 340 of 464 356 unvaccinated controls tested positive for SARS-CoV-2 infection. Significant reductions in infection risk were seen starting at 12 days after the first dose, reaching 60% (95% CI 49-68) for ChAdOx1 nCoV-19 and 69% (66-72) for BNT162b2 at 21-44 days and 72% (63-79) for BNT162b2 after 45-59 days.
Systemic and local side-effects after BNT162b2 and ChAdOx1 nCoV-19 vaccination occur at frequencies lower than reported in phase 3 trials. Both vaccines decrease the risk of SARS-CoV-2 infection after 12 days.
ZOE Global, National Institute for Health Research, Chronic Disease Research Foundation, National Institutes of Health, UK Medical Research Council, Wellcome Trust, UK Research and Innovation, American Gastroenterological Association.
辉瑞 - 生物科技公司（BNT162b2）和牛津 - 阿斯利康公司（ChAdOx1 nCoV - 19）的新冠疫苗在3期试验中显示出了出色的安全性和有效性。我们旨在调查这些疫苗在英国社区环境中的安全性和有效性。
在这项前瞻性观察性研究中，我们通过“新冠症状研究”应用程序，调查了接种一剂或两剂BNT162b2疫苗或一剂ChAdOx1 nCoV - 19疫苗的个体在接种疫苗8天内自我报告的全身和局部副作用的比例及概率。我们还将一部分接种疫苗后通过聚合酶链反应（PCR）或侧向流动检测进行SARS-CoV-2检测的个体的感染率与未接种疫苗的对照组的感染率进行了比较。所有分析均根据年龄（≤55岁与>55岁）、性别、医护人员身份（二元变量）、肥胖（BMI<30kg/m²与≥30kg/m²）以及合并症（二元变量，有或无合并症）进行了调整。
在2021年12月8日至3月10日期间，627383人报告接种了655590剂疫苗：282103人接种了一剂BNT162b2，其中28207人接种了第二剂，345280人接种了一剂ChAdOx1 nCoV - 19。接种第一剂BNT162b2后，13.5%（282103人中的38155人）的个体报告有全身副作用；接种第二剂BNT162b2后，22.0%（28207人中的6216人）报告有全身副作用；接种第一剂ChAdOx1 nCoV - 19后，33.7%（345280人中的116473人）报告有全身副作用。接种第一剂BNT162b2后，71.9%（208767人中的150023人）的个体报告有局部副作用；接种第二剂BNT162b2后，68.5%（13179人中的9025人）报告有局部副作用；接种第一剂ChAdOx1 nCoV - 19后，58.7%（177655人中的104282人）报告有局部副作用。既往感染过SARS-CoV-2的个体出现全身副作用的情况比未感染过的个体更常见（接种第一剂ChAdOx1 nCoV - 19后为1.6倍，接种第一剂BNT162b2后为2.9倍）。既往感染过的个体出现局部副作用的情况同样比未感染过的个体更高（接种第一剂ChAdOx1 nCoV - 19后为1.4倍，接种第一剂BNT162b2后为1.2倍）。103622名接种疫苗的个体中有3106人、464356名未接种疫苗的对照组中有50340人SARS-CoV-2检测呈阳性。从第一剂接种后12天开始，感染风险显著降低，ChAdOx1 nCoV - 19在21 - 44天降低60%（95%CI 49 - 68），BNT162b2在21 - 44天降低69%（66 - 72），BNT162b2在45 - 59天后降低72%（63 - 79）。
接种BNT162b2和ChAdOx1 nCoV - 19疫苗后全身和局部副作用的发生频率低于3期试验报告。两种疫苗在接种12天后均降低了SARS-CoV-2感染风险。
ZOE全球公司、英国国家卫生研究院、慢性病研究基金会、美国国立卫生研究院、英国医学研究理事会、惠康基金会、英国研究与创新署、美国胃肠病学会。
