Moll K, Lufkin B, Fingar KR, Ke Zhou C, Tworkoski E, Shi C, Hobbi S, Hu M, Sheng M, McCarty J, Shangguan S, Burrell T, Chillarige Y, Beers J, Saunders-Hastings P, Muthuri S, Edwards K, Black S, Kelman J, Reich C, Amend KL, Djibo DA, Beachler D, Ogilvie RP, Secora A, McMahill-Walraven CN, Seeger JD, Lloyd P, Thompson D, Dimova R, MaCurdy T, Obidi J, Anderson S, Forshee R, Wong HL, and Shoaibi A
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., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [Shayan Hobbi reports financial support was provided by US Food and Drug Administration, Timothy A Burrell reports financial support was provided by US Food and Drug Administration. Timothy A Burrell reports a relationship with IBM that includes: employment, Dr. Edwards has disclosed the following financial relationships. Grant Recipient from CDC (Vaccine Safety with COVID vaccines) Grant Recipient from NIH (Mentoring young investigators in vaccine sciences) Consultant from BioNet (pertussis vaccines) Consultant from IBM (vaccine safety networks) Consultant from Data safety and Monitoring Boards: Sanofi, X-4 Pharma, Seqirus, Moderna, Pfizer, Merck, GSK, Roche, Dr. Black has disclosed the following financial relationships: I am a consultant for CEPI through the SPEAC project and also a consultant for GSK on meeting planning, Djeneba Audrey Djibo reports financial support was provided by US Food and Drug Administration. Djeneba Audrey Djibo reports a relationship with CVS Health that includes: employment and equity or stocks, Daniel C. Beachler reports a relationship with Elevance Health Inc. that includes: employment and equity or stocks, Patricia Lloyd, Deborah Thompson, Rositsa Dimova, Joyce Obidi, Steve Anderson, Richard Forshee, Hui-Lee Wong, Azadeh Shoaibi, Cheryl N McMahill-Walraven reports financial support was provided by US Food and Drug Administration. Cheryl N McMahill-Walraven reports a relationship with CVS Health that includes: employment, John D. Seeger reports financial support was provided by Optum Inc. John D. Seeger reports a relationship with Optum that includes: employment and equity or stocks, Kandace Amend reports financial support was provided by Optum Inc. Kandace Amend reports a relationship with Optum that includes: employment and equity or stocks, Thomas MaCurdy reports financial support was provided by Acumen LLC. Thomas MaCurdy reports a relationship with Acumen LLC that includes: employment and equity or stocks]. All other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Published by Elsevier Ltd.)