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

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.

Resul

SUBMITTER: Moll K 

PROVIDER: S-EPMC9640387 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature