IBM Consulting, Bethesda, MD, USA.
Acumen LLC, Burlingame, CA, USA.
Vaccine. 2023 Jan 9;41(2):333-353. doi: 10.1016/j.vaccine.2022.11.003. Epub 2022 Nov 8.
The U.S. Food and Drug Administration (FDA) Biologics Effectiveness and Safety (BEST) Initiative conducts active surveillance of adverse events of special interest (AESI) after COVID-19 vaccination. Historical incidence rates (IRs) of AESI are comparators to evaluate safety.
We estimated IRs of 17 AESI in six administrative claims databases from January 1, 2019, to December 11, 2020: Medicare claims for adults ≥ 65 years and commercial claims (Blue Health Intelligence®, CVS Health, HealthCore Integrated Research Database, IBM® MarketScan® Commercial Database, Optum pre-adjudicated claims) for adults < 65 years. IRs were estimated by sex, age, race/ethnicity (Medicare), and nursing home residency (Medicare) in 2019 and for specific periods in 2020.
The study included >100 million enrollees annually. In 2019, rates of most AESI increased with age. However, compared with commercially insured adults, Medicare enrollees had lower IRs of anaphylaxis (11 vs 12-19 per 100,000 person-years), appendicitis (80 vs 117-155), and narcolepsy (38 vs 41-53). Rates were higher in males than females for most AESI across databases and varied by race/ethnicity and nursing home status (Medicare). Acute myocardial infarction (Medicare) and anaphylaxis (all databases) IRs varied by season. IRs of most AESI were lower during March-May 2020 compared with March-May 2019 but returned to pre-pandemic levels after May 2020. However, rates of Bell's palsy, Guillain-Barré syndrome, narcolepsy, and hemorrhagic/non-hemorrhagic stroke remained lower in multiple databases after May 2020, whereas some AESI (e.g., disseminated intravascular coagulation) exhibited higher rates after May 2020 compared with 2019.
AESI background rates varied by database and demographics and fluctuated in March-December 2020, but most returned to pre-pandemic levels after May 2020. It is critical to standardize demographics and consider seasonal and other trends when comparing historical rates with post-vaccination AESI rates in the same database to evaluate COVID-19 vaccine safety.
美国食品和药物管理局（FDA）生物制品有效性和安全性（BEST）倡议对 COVID-19 疫苗接种后的特殊关注不良事件（AESI）进行主动监测。历史发生率（IR）是评估安全性的对照。
我们从 2019 年 1 月 1 日至 2020 年 12 月 11 日，在六个行政索赔数据库中估计了 17 个 AESI 的 IR：医疗保险索赔适用于≥65 岁的成年人和商业索赔（Blue Health Intelligence®、CVS Health、HealthCore 综合研究数据库、IBM® MarketScan®商业数据库、Optum 预裁决索赔）适用于<65 岁的成年人。在 2019 年，通过性别的年龄、种族/民族（医疗保险）和疗养院居住情况（医疗保险）来估计 IR，在 2020 年的特定期间内进行了估计。
该研究每年包括>1000 万参保人。2019 年，大多数 AESI 的发病率随着年龄的增长而增加。然而，与商业保险的成年人相比，医疗保险参保人发生过敏反应（每 10 万人年 11-19 例）、阑尾炎（80-117-155 例）和发作性睡病（38-41-53 例）的风险较低。在所有数据库中，大多数 AESI 的男性发病率均高于女性，且因种族/民族和疗养院状况（医疗保险）而异。急性心肌梗死（医疗保险）和过敏反应（所有数据库）的发病率随季节而异。与 2019 年 3 月至 5 月相比，2020 年 3 月至 5 月大多数 AESI 的发病率较低，但 2020 年 5 月后恢复到大流行前水平。然而，2020 年 5 月后，多个数据库中贝尔麻痹、格林-巴利综合征、发作性睡病和出血性/非出血性中风的发病率仍较低，而某些 AESI（例如，弥漫性血管内凝血）的发病率在 2020 年 5 月后与 2019 年相比有所上升。
AESI 的背景率因数据库和人口统计学特征而异，并在 2020 年 3 月至 12 月期间波动，但在 2020 年 5 月后大多数恢复到大流行前水平。在同一数据库中，将历史率与接种疫苗后 AESI 率进行比较以评估 COVID-19 疫苗安全性时，必须标准化人口统计学特征并考虑季节性和其他趋势。
