Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK: a prospective observational study.
Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK: a prospective observational study.
复制标题
DOI：
10.1016/s1473-3099(21)00224-3
复制
发表时间：
2021-07
期刊：
影响因子：
--
通讯作者：
Spector TD
中科院分区：
文献类型：
--
作者：
Menni C;Klaser K;May A;Polidori L;Capdevila J;Louca P;Sudre CH;Nguyen LH;Drew DA;Merino J;Hu C;Selvachandran S;Antonelli M;Murray B;Canas LS;Molteni E;Graham MS;Modat M;Joshi AD;Mangino M;Hammers A;Goodman AL;Chan AT;Wolf J;Steves CJ;Valdes AM;Ourselin S;Spector TD
辉瑞-BioNTech（BNT 162 b2）和牛津-阿斯利康（ChAdOx 1 nCoV-19）COVID-19疫苗在3期试验中显示出优异的安全性和有效性。我们的目的是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，我们使用COVID症状研究应用程序检查了接种一剂或两剂BNT 162 b2疫苗或一剂ChAdOx 1 nCoV-19疫苗的个体在接种后8天内自我报告的全身和局部副作用的比例和概率。我们还比较了一个接种疫苗的个体的感染率，随后用PCR或侧流试验检测SARS-CoV-2与未接种疫苗的对照组的感染率。所有分析均根据年龄（≤55岁vs >55岁）、性别、医护人员状态（二元变量）、肥胖（BMI <30 kg/m2 vs ≥30 kg/m2）和合并症（二元变量，有或无合并症）进行调整。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BNT 162 b2，其中28207人接种了第二剂，345280人接种了一剂ChAdOx 1 nCoV-19。在BNT 162 b2首次给药后，13.5%（38155/282103）的个体报告了全身性副作用，在BNT 162 b2第二次给药后，22.0%（6216/28207），在ChAdOx 1 nCoV-19首次给药后，33.7%（116473/345280）。BNT 162 b2首次给药后，71.9%（208 767例中的150 023例）的个体报告了局部副作用，BNT 162 b2第二次给药后，68.5%（13 179例中的9025例）报告了局部副作用，ChAdOx 1 nCoV-19首次给药后，58.7%（177 655例中的104 282例）报告了局部副作用。全身性副作用在既往有SARS-CoV-2感染的个体中比在无已知既往感染的个体中更常见（ChAdOx 1 nCoV-19首次给药后为1.6倍，BNT 162 b2首次给药后为2.9倍）。在既往感染的个体中，局部效应同样高于既往无感染史的个体（ChAdOx 1 nCoV-19首次给药后为1.4倍，BNT 162 b2首次给药后为1.2倍）。在103622名接种疫苗的个体中有3106人和464356名未接种疫苗的对照中有50340人检测出SARS-CoV-2感染阳性。在首次给药后12天开始观察到感染风险显著降低，ChAdOx 1 nCoV-19在21-44天达到60%（95% CI 49-68），BNT 162 b2在45 - 59天达到69%（66-72），BNT 162 b2在45-59天达到72%（63-79）。BNT 162 b2和ChAdOx 1 nCoV-19疫苗接种后的全身和局部副作用发生频率低于3期试验中报告的频率。这两种疫苗都能降低12天后感染SARS-CoV-2的风险。ZOE Global、国家健康研究所、慢性病研究基金会、国家卫生研究院、英国医学研究理事会、惠康信托基金会、英国研究与创新、美国胃肠病协会。
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/m2vs ≥30 kg/m2), 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.