Association Between BNT162b2 Vaccination and Incidence of SARS-CoV-2 Infection in Pregnant Women
Association Between BNT162b2 Vaccination and Incidence of SARS-CoV-2 Infection in Pregnant Women
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接种 BNT162b2 疫苗与孕妇 SARS-CoV-2 感染率之间的关系
DOI：
10.1001/jama.2021.11035
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发表时间：
2021-07-12
影响因子：
120.7
通讯作者：
Segal, Yaakov
中科院分区：
文献类型：
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作者：
Goldshtein, Inbal;Nevo, Daniel;Segal, Yaakov
关于BNT 162 b2信使RNA（mRNA）疫苗的重要数据（Pfizer-BioNTech）在妊娠期的有效性和安全性目前缺乏，因为孕妇被排除在3期试验之外。这是一项回顾性队列研究，在以色列一家大型国家授权的医疗保健组织的妊娠登记处进行。从2020年12月19日至2021年2月28日接种第一剂疫苗的孕妇与未接种疫苗的妇女按年龄、胎龄、居住地区、人口亚组、产次和流感免疫状态1：1匹配。随访于2021年4月11日结束。暴露定义为接受BNT 162 b2 mRNA疫苗。为了保持可比性，随后接种疫苗的未暴露妇女在暴露后10天被审查，沿着与其匹配的配对。主要结果和测量主要结果是聚合酶链反应验证的SARS-CoV-2感染后28天或更长时间的第一剂疫苗。孕中期和孕晚期分别为46%和33%，平均年龄为31.1岁（SD，4.9岁）。主要结局的中位随访时间为37天（四分位距，21-54天;范围，0-70天）。接种疫苗组有118例SARS-CoV-2感染，未接种疫苗组有202例。在受感染的妇女中，接种疫苗组105人中有88人（83.8%）有症状，而未接种疫苗组179人中有149人（83.2%）有症状（P >= 0.99）。在28至70天的随访期间，接种疫苗组有10例感染，未接种疫苗组有46例感染。接种组和未接种组的感染风险分别为0.33%和1.64%，绝对差异为1.31%（95% CI，0.89%-1.74%），校正风险比为0.22（95% CI，0.11-0.43）。68名患者报告了疫苗相关不良事件;无严重事件。最常报告的症状是头痛（n = 10，0.1%）、全身无力（n = 8，0.1%）、非特异性疼痛（n = 6，
IMPORTANCE Data on BNT162b2 messenger RNA (mRNA) vaccine (Pfizer-BioNTech) effectiveness and safety in pregnancy are currently lacking because pregnant women were excluded from the phase 3 trial.OBJECTIVE To assess the association between receipt of BNT162b2 mRNA vaccine and risk of SARS-CoV-2 infection among pregnant women.DESIGN, SETTING, AND PARTICIPANTS This was a retrospective cohort study within the pregnancy registry of a large state-mandated health care organization in Israel. Pregnant women vaccinated with a first dose from December 19, 2020, through February 28, 2021, were 1:1 matched to unvaccinated women by age, gestational age, residential area, population subgroup, parity, and influenza immunization status. Follow-up ended on April 11, 2021.EXPOSURES Exposure was defined by receipt of the BNT162b2 mRNA vaccine. To maintain comparability, nonexposed women who were subsequently vaccinated were censored 10 days after their exposure, along with their matched pair.MAIN OUTCOMES AND MEASURES The primary outcome was polymerase chain reaction-validated SARS-CoV-2 infection at 28 days or more after the first vaccine dose.RESULTS The cohort included 7530 vaccinated and 7530 matched unvaccinated women, 46% and 33% in the second and third trimester, respectively, with a mean age of 31.1 years (SD, 4.9 years). The median follow-up for the primary outcome was 37 days (interquartile range, 21-54 days; range, 0-70). There were 118 SARS-CoV-2 infections in the vaccinated group and 202 in the unvaccinated group. Among infected women, 88 of 105 (83.8%) were symptomatic in the vaccinated group vs 149 of 179 (83.2%) in the unvaccinated group (P >= .99). During 28 to 70 days of follow-up, there were 10 infections in the vaccinated group and 46 in the unvaccinated group. The hazards of infection were 0.33% vs 1.64% in the vaccinated and unvaccinated groups, respectively, representing an absolute difference of 1.31% (95% CI, 0.89%-1.74%), with an adjusted hazard ratio of 0.22 (95% CI, 0.11-0.43). Vaccine-related adverse events were reported by 68 patients; none was severe. The most commonly reported symptoms were headache (n = 10, 0.1%), general weakness (n = 8, 0.1%), nonspecified pain (n = 6,