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 Moll 1 , Bradley Lufkin 2 , Kathryn R Fingar 1 , Cindy Ke Zhou 3 , Ellen Tworkoski 2 , Chianti Shi 2 , Shayan Hobbi 1 , Mao Hu 2 , Minya Sheng 1 , Jillian McCarty 1 , Shanlai Shangguan 2 , Timothy Burrell 1 , Yoganand Chillarige 2 , Jeff Beers 1 , Patrick Saunders-Hastings 4 , Stella Muthuri 1 , Kathryn Edwards 1 , Steven Black 1 , Jeff Kelman 5 , Christian Reich 6 , Kandace L Amend 7 , Djeneba Audrey Djibo 8 , Daniel Beachler 9, Rachel P Ogilvie 7 , Alex Secora 6 , Cheryl N McMahill-Walraven 8 , John D Seeger 7 , Patricia Lloyd 3 , Deborah Thompson 3 , Rositsa Dimova 3 , Thomas MaCurdy 10 , Joyce Obidi 3 , Steve Anderson 3 , Richard Forshee 3 , Hui-Lee Wong 3 , Azadeh Shoaibi 11
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.
