(A50) Characterization of U.S. Adults Aged 18–64 Years Vaccinated Against Mpox within the Food and Drug Administration Biologics Effectiveness and Safety (BEST) Initiative
Epidemiologist US Food and Drug Administration, United States
Background: The recent monkeypox (mpox) outbreak began in early May 2022. Cases have been reported in more than 50 countries, including several which have not historically reported mpox cases, and cases have primarily been reported among men who have sex with men. The first case in the United States (US) occurred in mid-May 2022, and the US had 30,123 cases and 28 deaths as of February 1, 2023. In the US, two vaccines, JYNNEOS (2 doses, 4 weeks apart) and ACAM2000 (1 dose), have been used to prevent mpox.
Objectives: To describe the frequency and trends in administration of vaccines used to prevent mpox and characterize the vaccinated population in the US.
Methods: Data from three US commercial claims databases in the US Food and Drug Administration (FDA) Biologics Effectiveness and Safety (BEST) Initiative were used: CVS Health/Aetna Clinical Trial Services (CVS Health/Aetna), Optum, and HealthCore, Inc. (HCI). To increase the capture of vaccines, claims data were linked to available Immunization Information System (IIS) data from local and state jurisdictions. Counts of JYNNEOS and ACAM2000 doses were assessed among adults 18–64 years of age from May 10, 2022 to November 30, 2022 (CVS Health/Aetna), January 7, 2023 (Optum), and November 7, 2022 (HCI). We assessed the counts and proportion of vaccine brands, trends in JYNNEOS doses, and the demographic and geographic characteristics of the JYNNEOS-vaccinated population within each database.
Results: A total of 103,752 doses of JYNNEOS or ACAM2000 were administered during the study period among adults 18–64 years (54,039 (CVS Health/Aetna), 18,982 (Optum), and 30,731 (HCI)). Most doses administered were JYNNEOS (99.7% (CVS Health/Aetna), 99.2% (Optum), and 99.9% (HCI)). Of those who received a first JYNNEOS dose, 62.4%, 51.0%, and 57.4% received a second dose in CVS Health/Aetna, Optum, and HCI, respectively. Across all databases, the peak number of first and second JYNNEOS doses occurred in August and September 2022, respectively. Most JYNNEOS doses were administered to males (94.1% (CVS Health/Aetna), 95.8% (Optum), and 93.6% (HCI)); those aged 25–34 years old (36.6% (CVS Health/Aetna), 34.8% (Optum), and 35.6% (HCI)); and those who lived in urban areas (99.3% (CVS Health/Aetna), 98.9% (Optum), 97.4% (HCI)).
Conclusions: Linked claims-IIS from three FDA BEST Initiative data partners captured information on vaccines used to prevent mpox. These data facilitated the characterization of doses and the vaccinated population during the 2022 mpox outbreak in the US. Trends in doses and characteristics of the vaccinated population were similar across the three databases.