Background Rates of Adverse Events of Special Interest for COVID-19 Vaccine Safety Monitoring in the United States, 2019–2020

30 Pages Posted: 8 Sep 2022

See all articles by Keran Moll

Keran Moll

IBM Consulting

Bradley Lufkin

Acumen, LLC

Kathryn R. Fingar

IBM Consulting

Cindy Ke Zhou

U.S. Food and Drug Administration

Ellen Tworkoski

Acumen, LLC

Chianti Shi

Acumen, LLC

Shayan Hobbi

IBM Consulting

Mao Hu

Acumen, LLC

Minya Sheng

IBM Consulting

Jillian McCarty

IBM Consulting

Shanlai Shangguan

Acumen, LLC

Timothy Burrell

IBM Consulting

Yoganand Chillarige

Acumen, LLC

Jeff Beers

IBM Consulting

Patrick Saunders-Hastings

Gevity Inc

Kathryn Edwards

IBM Consulting

Stella Muthuri

IBM Consulting

Steven Black

IBM Consulting

Jeffrey A. Kelman

Centers for Medicare and Medicaid Services

Christin Reich

IQVIA - Real World Solutions

Kandace Amend

Epidemiology, Optum

Djeneba Audrey Djibo

Aetna, Inc.

Daniel C. Beachler

Anthem Inc. - HealthCore

Rachel P. Ogilvie

Epidemiology, Optum

Alex Secora

IQVIA

Cheryl N. McMahill-Walraven

Aetna, Inc.

Seeger John

Epidemiology, Optum

Patricia Lloyd

U.S. Food and Drug Administration

Deborah Thompson

Acumen, LLC

Rositsa Dimova

Acumen, LLC

Thomas MaCurdy

Acumen, LLC

Joyce Obidi

U.S. Food and Drug Administration

Steven A. Anderson

U.S. Food and Drug Administration

Richard A. Forshee

U.S. Food and Drug Administration

Hui-Lee Wong

U.S. Food and Drug Administration

Azadeh Shoaibi

U.S. Food and Drug Administration

Abstract

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 vaccination. 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®, 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.

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 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.

Conclusion: 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.

Note:

Funding Information: This work was supported by the U.S. Food and Drug Administration through the Department of Health and Human Services (HHS) Contract number HHSF223201810022I Task Order 75F40120F19003.

Declaration of Interests: The authors have no competing interests to declare.

Ethics Approval Statement: The study involved no personally identifiable information and the data used in this study were deidentified and anonymized before use. This study was conducted as a public health mandate and not as a research activity. Our study practices were performed in accordance with the Declaration of Helsinki guidelines.

Keywords: background rates, vaccine safety surveillance, COVID-19, adverse events

Suggested Citation

Moll, Keran and Lufkin, Bradley and Fingar, Kathryn R. and Zhou, Cindy Ke and Tworkoski, Ellen and Shi, Chianti and Hobbi, Shayan and Hu, Mao and Sheng, Minya and McCarty, Jillian and Shangguan, Shanlai and Burrell, Timothy and Chillarige, Yoganand and Beers, Jeff and Saunders-Hastings, Patrick and Edwards, Kathryn and Muthuri, Stella and Black, Steven and Kelman, Jeffrey A. and Reich, Christin and Amend, Kandace and Djibo, Djeneba Audrey and Beachler, Daniel C. and Ogilvie, Rachel P. and Secora, Alex and McMahill-Walraven, Cheryl N. and John, Seeger and Lloyd, Patricia and Thompson, Deborah and Dimova, Rositsa and MaCurdy, Thomas and Obidi, Joyce and Anderson, Steven A. and Forshee, Richard A. and Wong, Hui-Lee and Shoaibi, Azadeh, Background Rates of Adverse Events of Special Interest for COVID-19 Vaccine Safety Monitoring in the United States, 2019–2020. Available at SSRN: https://ssrn.com/abstract=4208245 or http://dx.doi.org/10.2139/ssrn.4208245

Keran Moll

IBM Consulting ( email )

Bradley Lufkin

Acumen, LLC ( email )

500 Airport Blvd
# 365
Burlingame, CA 94010
United States

Kathryn R. Fingar

IBM Consulting ( email )

Cindy Ke Zhou

U.S. Food and Drug Administration ( email )

Ellen Tworkoski

Acumen, LLC ( email )

500 Airport Blvd
# 365
Burlingame, CA 94010
United States

Chianti Shi

Acumen, LLC ( email )

Shayan Hobbi

IBM Consulting ( email )

Mao Hu

Acumen, LLC ( email )

500 Airport Blvd
# 365
Burlingame, CA 94010
United States

Minya Sheng

IBM Consulting ( email )

Jillian McCarty

IBM Consulting ( email )

Shanlai Shangguan

Acumen, LLC ( email )

Timothy Burrell

IBM Consulting ( email )

Yoganand Chillarige

Acumen, LLC ( email )

500 Airport Blvd
# 365
Burlingame, CA 94010
United States

Jeff Beers

IBM Consulting ( email )

Kathryn Edwards

IBM Consulting ( email )

Stella Muthuri

IBM Consulting ( email )

Steven Black

IBM Consulting ( email )

Jeffrey A. Kelman

Centers for Medicare and Medicaid Services ( email )

7500 Security Boulevard
Baltimore, MD 21244
United States

Christin Reich

IQVIA - Real World Solutions ( email )

Kandace Amend

Epidemiology, Optum ( email )

Djeneba Audrey Djibo

Aetna, Inc. ( email )

Daniel C. Beachler

Anthem Inc. - HealthCore ( email )

Rachel P. Ogilvie

Epidemiology, Optum ( email )

Alex Secora

IQVIA ( email )

Seeger John

Epidemiology, Optum ( email )

Patricia Lloyd

U.S. Food and Drug Administration ( email )

Silver Spring, MD
United States

Deborah Thompson

Acumen, LLC ( email )

Rositsa Dimova

Acumen, LLC ( email )

500 Airport Blvd
# 365
Burlingame, CA 94010
United States

Thomas MaCurdy

Acumen, LLC ( email )

Joyce Obidi

U.S. Food and Drug Administration ( email )

Steven A. Anderson

U.S. Food and Drug Administration ( email )

Silver Spring, MD
United States

Richard A. Forshee

U.S. Food and Drug Administration ( email )

Silver Spring, MD
United States

Hui-Lee Wong

U.S. Food and Drug Administration ( email )

Silver Spring, MD
United States

Azadeh Shoaibi (Contact Author)

U.S. Food and Drug Administration ( email )

Silver Spring, MD
United States

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