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Background rates of adverse events of special interest for COVID-19 vaccine safety monitoring in the United States, 2019-2020.
Moll, Keran; Lufkin, Bradley; Fingar, Kathryn R; Ke Zhou, Cindy; Tworkoski, Ellen; Shi, Chianti; Hobbi, Shayan; Hu, Mao; Sheng, Minya; McCarty, Jillian; Shangguan, Shanlai; Burrell, Timothy; Chillarige, Yoganand; Beers, Jeff; Saunders-Hastings, Patrick; Muthuri, Stella; Edwards, Kathryn; Black, Steven; Kelman, Jeff; Reich, Christian; Amend, Kandace L; Audrey Djibo, Djeneba; Beachler, Daniel; Ogilvie, Rachel P; Secora, Alex; McMahill-Walraven, Cheryl N; Seeger, John D; Lloyd, Patricia; Thompson, Deborah; Dimova, Rositsa; MaCurdy, Thomas; Obidi, Joyce; Anderson, Steve; Forshee, Richard; Wong, Hui-Lee; Shoaibi, Azadeh.
  • Moll K; IBM Consulting, Bethesda, MD, USA.
  • Lufkin B; Acumen LLC, Burlingame, CA, USA.
  • Fingar KR; IBM Consulting, Bethesda, MD, USA.
  • Ke Zhou C; U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.
  • Tworkoski E; Acumen LLC, Burlingame, CA, USA.
  • Shi C; Acumen LLC, Burlingame, CA, USA.
  • Hobbi S; IBM Consulting, Bethesda, MD, USA.
  • Hu M; Acumen LLC, Burlingame, CA, USA.
  • Sheng M; IBM Consulting, Bethesda, MD, USA.
  • McCarty J; IBM Consulting, Bethesda, MD, USA.
  • Shangguan S; Acumen LLC, Burlingame, CA, USA.
  • Burrell T; IBM Consulting, Bethesda, MD, USA.
  • Chillarige Y; Acumen LLC, Burlingame, CA, USA.
  • Beers J; IBM Consulting, Bethesda, MD, USA.
  • Saunders-Hastings P; Gevity Inc, an Accenture Company, Ottawa, Canada.
  • Muthuri S; IBM Consulting, Bethesda, MD, USA.
  • Edwards K; IBM Consulting, Bethesda, MD, USA.
  • Black S; IBM Consulting, Bethesda, MD, USA.
  • Kelman J; Centers for Medicare & Medicaid Services, Baltimore, MD, USA.
  • Reich C; IQVIA, Falls Church, VA, USA.
  • Amend KL; Optum Epidemiology, Boston, MA, USA.
  • Audrey Djibo D; Aetna, Blue Bell, PA, USA.
  • Beachler D; HealthCore, Inc, Wilmington, DE, USA.
  • Ogilvie RP; Optum Epidemiology, Boston, MA, USA.
  • Secora A; IQVIA, Falls Church, VA, USA.
  • McMahill-Walraven CN; Aetna, Blue Bell, PA, USA.
  • Seeger JD; Optum Epidemiology, Boston, MA, USA.
  • Lloyd P; U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.
  • Thompson D; U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.
  • Dimova R; U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.
  • MaCurdy T; Acumen LLC, Burlingame, CA, USA; Department of Economics, Stanford University, Stanford, CA, USA.
  • Obidi J; U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.
  • Anderson S; U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.
  • Forshee R; U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.
  • Wong HL; U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.
  • Shoaibi A; U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA. Electronic address: Azadeh.Shoaibi@fda.hhs.gov.
Vaccine ; 2022 Nov 08.
Article in English | MEDLINE | ID: covidwho-2233421
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.
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Observational study Topics: Vaccines Language: English Year: 2022 Document Type: Article Affiliation country: J.vaccine.2022.11.003

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Observational study Topics: Vaccines Language: English Year: 2022 Document Type: Article Affiliation country: J.vaccine.2022.11.003