Immunization Safety Office, Division of Healthcare Quality Promotion, United States.
Immunization Safety Office, Division of Healthcare Quality Promotion, United States.
Vaccine. 2021 Jan 22;39(4):678-681. doi: 10.1016/j.vaccine.2020.12.045. Epub 2020 Dec 25.
In November 2012, the first cell cultured influenza vaccine, a trivalent subunit inactivated influenza vaccine (Flucelvax(®), ccIIV3), was approved in the United States for adults aged ≥18 years. A quadrivalent version (ccIIV4) was later approved in 2016 and replaced ccIIV3. The safety of ccIIV3 or ccIIV4 (ccIIV) was not assessed for pregnant women or their infants during pre-licensure studies.
To assess the safety of ccIIV administered during pregnancy in pregnant women and their infants whose reports were submitted to VAERS during 2013-2020.
We searched VAERS for United States reports of adverse events (AEs) in pregnant women who received ccIIV from 1 July 2013 through 31 May 2020. Clinicians reviewed reports and available medical records and assigned a primary clinical category for each report. Reports were coded as serious based on the Code of Federal Regulations definition.
VAERS received 391 reports following ccIIV administered to pregnant women. Twenty-four (6.1%) were serious. Two neonatal deaths were reported. No maternal deaths occurred. Among reports with trimester information (n = 340), ccIIV was administered during the second trimester in 170 (50%). The most frequent pregnancy-specific AE was premature delivery in 85 (21.7%) reports, followed by dysmature placenta in 13 (3.3%) and pre-eclampsia/eclampsia in ten (2.3%). The most common non-pregnancy specific conditions were infectious conditions in 32 (8.2%). Among infant conditions, low birth weight was reported in 62 (15.9%) reports. Fifteen birth defects were reported; in 12 with gestational age information, administration of the vaccine occurred late in the second trimester or later.
Review of maternal ccIIV reports in VAERS was not unexpectedly different from other maternal influenza vaccine safety VAERS reviews.
2012 年 11 月，首款细胞培养流感疫苗，即三价亚单位灭活流感疫苗（Flucelvax（®），ccIIV3），获得美国批准，可用于 18 岁及以上成年人。随后在 2016 年批准了四价版本（ccIIV4）并取代了 ccIIV3。在许可前研究中，并未评估 ccIIV3 或 ccIIV4（ccIIV）在孕妇及其婴儿中的安全性。
评估 2013 年至 2020 年期间，向 VAERS 报告的在妊娠期接种 ccIIV 的孕妇及其婴儿的安全性。
我们在 VAERS 中搜索了自 2013 年 7 月 1 日至 2020 年 5 月 31 日期间，接受 ccIIV 接种的孕妇的不良事件（AE）美国报告。临床医生对报告和可用的医疗记录进行了审查，并为每个报告分配了一个主要临床类别。根据《联邦法规》的定义，报告被编码为严重。
VAERS 收到了 391 份在孕妇中接种 ccIIV 后报告的病例。其中 24 例（6.1%）为严重病例。报告了两例新生儿死亡。未发生孕产妇死亡。在有妊娠时间信息的报告中（n=340），ccIIV 在妊娠中期接种的有 170 例（50%）。最常见的妊娠特异性 AE 是早产，有 85 例（21.7%）报告，其次是不成熟胎盘 13 例（3.3%）和子痫前期/子痫 10 例（2.3%）。最常见的非妊娠特异性疾病是传染病 32 例（8.2%）。在婴儿疾病中，低出生体重报告有 62 例（15.9%）。报告了 15 例出生缺陷；在 12 例有妊娠时间信息的病例中，疫苗接种发生在妊娠中期后期或更晚。
对 VAERS 中接受 ccIIV 的孕妇报告进行的审查与其他母体流感疫苗安全性 VAERS 审查并无不同。
