Centro de Integração de Dados e Conhecimentos para Saúde, Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Salvador, Brazil.
Centro de Inteligência Epidemiológica, Secretaria Municipal de Saúde do Rio de Janeiro, Rio de Janeiro, Brazil.
Int J Epidemiol. 2023 Dec 25;52(6):1708-1715. doi: 10.1093/ije/dyad120.
COVID-19 vaccines have been shown to protect pregnant individuals against mild and severe COVID-19 outcomes. However, limited safety data are available for inactivated (CoronaVac) and mRNA (BNT162b2) vaccines during pregnancy regarding their effect on birth outcomes and neonatal mortality, especially in low- and middle-income countries.
We conducted a retrospective population-based cohort study in Rio de Janeiro, Brazil, with 17 513 singleton live births conceived between 15 May 2021 and 23 October 2021. The primary exposure was maternal vaccination with CoronaVac or mRNA BNT162b2 vaccines and sub-analyses were performed by the gestational trimester of the first dose and the number of doses given during pregnancy. The outcomes were pre-term birth (PTB), small for gestational age (SGA), low birthweight (LBW), low Apgar 5 and neonatal death. We used the Cox model to estimate the hazard ratio (HR) with a 95% CI and applied the inverse probability of treatment weights to generate adjusted HRs.
We found no significant increase in the risk of PTB (HR: 0.98; 95% CI 0.88, 1.10), SGA (HR: 1.09; 95% CI 0.96, 1.27), LBW (HR: 1.00; 95% CI 0.88, 1.14), low Apgar 5 (HR: 0.81; 95% CI 0.55, 1.22) or neonatal death (HR: 0.88; 95% CI 0.56, 1.48) in women vaccinated with CoronaVac or BNT162b2 vaccines. These findings were consistent across sub-analyses stratified by the gestational trimester of the first dose and the number of doses given during pregnancy. We found mild yet consistent protection against PTB in women who received different vaccine platforms during the third trimester of pregnancy (any vaccines, HR: 0.78; 95% CI 0.63, 0.98; BNT162b2, HR: 0.75; 95% CI 0.59, 0.99).
This study provides evidence that COVID-19 vaccination in all trimesters of pregnancy, irrespective of the vaccine type, is safe and does not increase the risk of adverse birth outcomes or neonatal deaths.
COVID-19 疫苗已被证明可预防孕妇出现轻症和重症 COVID-19 结局。然而，关于灭活（科兴）和 mRNA（BNT162b2）疫苗在怀孕期间对出生结局和新生儿死亡率的影响，在低中等收入国家，其安全性数据有限。
我们在巴西里约热内卢进行了一项回顾性基于人群的队列研究，纳入了 17513 名单胎活产儿，这些婴儿均于 2021 年 5 月 15 日至 10 月 23 日期间受孕。主要暴露因素为母亲接种科兴或 mRNA BNT162b2 疫苗，亚分析按第一剂的妊娠 trimester 和怀孕期间接种的剂数进行。结局为早产（PTB）、小于胎龄儿（SGA）、低出生体重（LBW）、低阿普加评分 5 分和新生儿死亡。我们使用 Cox 模型估计风险比（HR）及其 95%CI，并应用逆概率治疗权重生成调整后的 HR。
我们未发现接种科兴或 BNT162b2 疫苗的妇女发生 PTB（HR：0.98；95%CI 0.88，1.10）、SGA（HR：1.09；95%CI 0.96，1.27）、LBW（HR：1.00；95%CI 0.88，1.14）、低 Apgar 5 分（HR：0.81；95%CI 0.55，1.22）或新生儿死亡（HR：0.88；95%CI 0.56，1.48）的风险显著增加。这些发现与按第一剂的妊娠 trimester 和怀孕期间接种的剂数分层的亚分析一致。我们发现，在妊娠晚期接受不同疫苗平台接种的妇女中，PTB 有轻度但一致的保护作用（任何疫苗，HR：0.78；95%CI 0.63，0.98；BNT162b2，HR：0.75；95%CI 0.59，0.99）。
本研究提供了证据表明，COVID-19 疫苗在妊娠的所有 trimester 接种，无论疫苗类型如何，均是安全的，不会增加不良出生结局或新生儿死亡的风险。
