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

Keran Moll; Bradley Lufkin; Kathryn R Fingar; Cindy Ke Zhou; Ellen Tworkoski; Chianti Shi; Shayan Hobbi; Mao Hu; Minya Sheng; Jillian McCarty; Shanlai Shangguan; Timothy Burrell; Yoganand Chillarige; Jeff Beers; Patrick Saunders-Hastings; Stella Muthuri; Kathryn Edwards; Steven Black; Jeff Kelman; Christian Reich; Kandace L Amend; Djeneba Audrey Djibo; Daniel Beachler; Rachel P Ogilvie; Alex Secora; Cheryl N McMahill-Walraven; John D Seeger; Patricia Lloyd; Deborah Thompson; Rositsa Dimova; Thomas MaCurdy; Joyce Obidi; Steve Anderson; Richard Forshee; Hui-Lee Wong; Azadeh Shoaibi

doi:10.1016/j.vaccine.2022.11.003

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

Vaccine. 2023 Jan 9;41(2):333-353. doi: 10.1016/j.vaccine.2022.11.003. Epub 2022 Nov 8.

Authors

Keran Moll¹, Bradley Lufkin², Kathryn R Fingar¹, Cindy Ke Zhou³, Ellen Tworkoski², Chianti Shi², Shayan Hobbi¹, Mao Hu², Minya Sheng¹, Jillian McCarty¹, Shanlai Shangguan², Timothy Burrell¹, Yoganand Chillarige², Jeff Beers¹, Patrick Saunders-Hastings⁴, Stella Muthuri¹, Kathryn Edwards¹, Steven Black¹, Jeff Kelman⁵, Christian Reich⁶, Kandace L Amend⁷, Djeneba Audrey Djibo⁸, Daniel Beachler⁹, Rachel P Ogilvie⁷, Alex Secora⁶, Cheryl N McMahill-Walraven⁸, John D Seeger⁷, Patricia Lloyd³, Deborah Thompson³, Rositsa Dimova³, Thomas MaCurdy¹⁰, Joyce Obidi³, Steve Anderson³, Richard Forshee³, Hui-Lee Wong³, Azadeh Shoaibi¹¹

Affiliations

¹ IBM Consulting, Bethesda, MD, USA.
² Acumen LLC, Burlingame, CA, USA.
³ U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.
⁴ Gevity Inc, an Accenture Company, Ottawa, Canada.
⁵ Centers for Medicare & Medicaid Services, Baltimore, MD, USA.
⁶ IQVIA, Falls Church, VA, USA.
⁷ Optum Epidemiology, Boston, MA, USA.
⁸ Aetna, Blue Bell, PA, USA.
⁹ HealthCore, Inc, Wilmington, DE, USA.
¹⁰ Acumen LLC, Burlingame, CA, USA; Department of Economics, Stanford University, Stanford, CA, USA.
¹¹ U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA. Electronic address: Azadeh.Shoaibi@fda.hhs.gov.

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.

Keywords: Adverse events; Background rates; COVID-19; Vaccine safety surveillance.

Published by Elsevier Ltd.

Publication types

Research Support, U.S. Gov't, P.H.S.

MeSH terms

Adult
Aged
Anaphylaxis*
COVID-19 Vaccines / adverse effects
COVID-19* / epidemiology
COVID-19* / prevention & control
Female
Humans
Male
Medicare
Narcolepsy*
United States / epidemiology

Substances

COVID-19 Vaccines