疫苗不良事件报告系统中孕妇二价 mRNA COVID-19 疫苗安全性监测-美国，2022 年 9 月 1 日-2023 年 3 月 31 日。
Safety monitoring of bivalent mRNA COVID-19 vaccine among pregnant persons in the vaccine adverse event reporting System - United States, September 1, 2022 - March 31, 2023.
机构信息
Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Zoonotic and Emerging Infectious Diseases, USA.
Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Zoonotic and Emerging Infectious Diseases, USA.
出版信息
Vaccine. 2024 Apr 2;42(9):2380-2384. doi: 10.1016/j.vaccine.2024.02.084. Epub 2024 Mar 11.
BACKGROUND
Pregnant persons are at increased risk of severe COVID-19 illness. Bivalent mRNA COVID-19 vaccination is recommended for everyone, including pregnant persons. However, data are limited on the safety of bivalent mRNA COVID-19 vaccination during pregnancy.
OBJECTIVE
To evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system, among pregnant persons who received bivalent mRNA COVID-19 vaccine.
METHODS
VAERS U.S. reports of adverse events (AEs) in pregnant persons who received the bivalent mRNA COVID-19 vaccine from 9/1/2022-03/31/2023 were identified. Clinicians reviewed all reports and available medical records. AEs of these reports were compared with AEs reported to VAERS following monovalent mRNA COVID-19 booster vaccination in pregnancy.
RESULTS
VAERS received 136 reports for pregnant persons who received bivalent mRNA COVID-19 vaccine; 87 (64 %) after BNT162b2 (Pfizer-BioNTech), and 48 (35 %) after mRNA-1273 (Moderna); 28 (20.6 %) reports were classified as serious. The most common pregnancy-specific outcomes reported included 12 (8.8 %) spontaneous abortions (<20 weeks gestation), 6 (4.4 %) episodes of preterm delivery, and 5 (3.7 %) reports of preeclampsia. One stillbirth (≥20 weeks gestation) was reported. No maternal or infant deaths were reported. There were 6 reports of AEs in infants, which included 3 reports of admissions to the neonatal intensive care unit: two infants with low birth weight, and one infant with a patent ductus arteriosus and patent foramen ovale. Non-pregnancy-specific adverse events were mostly COVID-19 infection and systemic reactions (e.g., headache, fatigue). Pregnancy-specific conditions were reported less frequently after bivalent mRNA COVID-19 vaccination compared to monovalent mRNA COVID-19 booster vaccination (3rd and 4th dose).
CONCLUSIONS
Based on this review of reports to VAERS, the safety profile of bivalent mRNA COVID-19 vaccination in pregnant persons was comparable to that observed for monovalent mRNA COVID-19 booster vaccination (3rd and 4th dose) in pregnant persons.
背景
孕妇患严重 COVID-19 疾病的风险增加。建议所有人群（包括孕妇）接种 b ivalent mRNA COVID-19 疫苗。然而，关于 bivalent mRNA COVID-19 疫苗在怀孕期间接种的安全性数据有限。
目的
评估和总结 2022 年 9 月 1 日至 2023 年 3 月 31 日期间 bivalent mRNA COVID-19 疫苗接种的孕妇向美国疫苗不良事件报告系统（VAERS）报告的不良事件（AE）。
方法
从 VAERS 中确定了在怀孕期间接受 bivalent mRNA COVID-19 疫苗接种的孕妇的不良事件报告。临床医生审查了所有报告和可用的病历。将这些报告的不良事件与在怀孕期间接受单价 mRNA COVID-19 加强针接种后向 VAERS 报告的不良事件进行比较。
结果
VAERS 收到 136 份孕妇 bivalent mRNA COVID-19 疫苗接种报告；87 份（64%）来自 BNT162b2（辉瑞-BioNTech），48 份（35%）来自 mRNA-1273（Moderna）；28 份（20.6%）报告为严重。报告的最常见妊娠特异性结局包括 12 例（8.8%）自然流产（<20 周妊娠）、6 例（4.4%）早产和 5 例（3.7%）子痫前期。报告了一例死胎（≥20 周妊娠）。没有母婴死亡报告。有 6 份婴儿不良事件报告，其中包括 3 份新生儿重症监护病房入院报告：两名婴儿出生体重低，一名婴儿动脉导管未闭和卵圆孔未闭。与单价 mRNA COVID-19 加强针接种（第 3 剂和第 4 剂）相比，接种 bivalent mRNA COVID-19 疫苗后报告的非妊娠特异性不良事件更为常见。
结论
根据 VAERS 的报告审查，bivalent mRNA COVID-19 疫苗在孕妇中的安全性与在孕妇中接种单价 mRNA COVID-19 加强针（第 3 剂和第 4 剂）的安全性相当。
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