Background rates of adverse events of special interest for COVID-19 vaccine safety monitoring in the United States, 2019-2020

被引：15

作者：

Moll, Keran ^{[1
]}

Lufkin, Bradley ^{[2
]}

Fingar, Kathryn R. ^{[1
]}

Zhou, Cindy Ke ^{[3
]}

Tworkoski, Ellen ^{[2
]}

Shi, Chianti ^{[2
]}

Hobbi, Shayan ^{[1
]}

Hu, Mao ^{[2
]}

Sheng, Minya ^{[1
]}

McCarty, Jillian ^{[1
]}

Shangguan, Shanlai ^{[2
]}

Burrell, Timothy ^{[1
]}

Chillarige, Yoganand ^{[2
]}

Beers, Jeff ^{[1
,5
]}

Saunders-Hastings, Patrick ^{[4
]}

Muthuri, Stella ^{[1
]}

Edwards, Kathryn

Black, Steven ^{[1
]}

Kelman, Jeff

Reich, Christian ^{[6
]}

Amend, Kandace L. ^{[7
,8
]}

Djibo, Djeneba Audrey

Beachler, Daniel ^{[9
]}

Ogilvie, Rachel P. ^{[7
,8
]}

Secora, Alex ^{[6
]}

McMahill-Walraven, Cheryl N.

Seeger, John D. ^{[7
,8
]}

Lloyd, Patricia

Thompson, Deborah ^{[3
]}

Dimova, Rositsa ^{[3
]}

MaCurdy, Thomas ^{[2
,10
]}

Obidi, Joyce ^{[3
]}

Anderson, Steve ^{[3
]}

Forshee, Richard ^{[3
]}

Wong, Hui-Lee

Shoaibi, Azadeh ^{[3
]}

机构：

[1] IBM Consulting, Bethesda, MD USA

[2] Acumen LLC, Burlingame, CA USA

[3] US FDA, Ctr Biol Evaluat & Res, Silver Spring, MD 20993 USA

[4] Accenture Co, Gevity Inc, Ottawa, ON, Canada

[5] Ctr Medicare & Medicaid Serv, Baltimore, MD USA

[6] IQVIA, Falls Church, VA USA

[7] Optum Epidemiol, Boston, MA USA

[8] Aetna, Blue Bell, PA USA

[9] HealthCore Inc, Wilmington, DE USA

[10] Stanford Univ, Dept Econ, Stanford, CA USA

来源：

VACCINE | 2023年 / 41卷 / 02期

关键词：

Background rates; Vaccine safety surveillance; COVID-19; Adverse events;

D O I：

10.1016/j.vaccine.2022.11.003

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Background: 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 vacci-nation. Historical incidence rates (IRs) of AESI are comparators to evaluate safety. Methods: 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 (R), CVS Health, HealthCore Integrated Research Database, IBM (R) MarketScan (R) Commercial Database, Optum pre-adjudicated claims) for adults < 65 years. IRs were estimated by sex, age, race/eth-nicity (Medicare), and nursing home residency (Medicare) in 2019 and for specific periods in 2020. Results: 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 anaphy-laxis (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 data-bases) 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-Barre syndrome, narcolepsy, and hemorrhagic/non-hemorrhagic stroke remained lower in mul-tiple databases after May 2020, whereas some AESI (e.g., disseminated intravascular coagulation)

引用

页码：333 / 353

页数：21

共 32 条

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