Author:
Lloyd Patricia C.,Smith Elizabeth R.,Gruber Joann F.,Ondari Michelle,Wong Hui Lee,Hu Mao,Clarke Tainya C.,McEvoy Rowan,Amend Kandace L.,Beachler Daniel C.,McMahill-Walraven Cheryl N,Seeger John D.,Secora Alex,Djibo Djeneba Audrey,Song Jennifer,Selvam Nandini,DeShazo Jonathan P.,Clifford Robin,Abente Eugenio,Chillarige Yoganand,Forshee Richard A.,Anderson Steven A.,Shoaibi Azadeh
Abstract
AbstractActive monitoring of health outcomes after COVID-19 vaccination provides early detection of rare outcomes post-licensure.ObjectiveTo evaluate health outcomes following bivalent COVID-19 Pfizer-BioNTech (BNT162b2) and Moderna (mRNA-1273.222) vaccination among individuals 6 months and older in the United States.DesignMonthly monitoring of health outcomes from August 2022 to July 2023 in four administrative claims databases. Descriptive analyses monitored vaccine uptake, outcome counts and coadministration of bivalent COVID-19 and influenza vaccines. Sequential analyses tested for elevated risk of each outcome in a prespecified post-vaccination risk interval, or a period of hypothesized elevation based on clinical guidance, compared to a historical baseline.Participants and ExposuresPersons 6 months and older who received a bivalent COVID-19 BNT162b2 or mRNA-1273.222 vaccine during the study period, with continuous enrollment in a medical insurance plan from the start of an outcome-specific clean interval to the COVID-19 vaccination date. Vaccines were identified using product-specific codes from medical coding systems.Health OutcomesTwenty outcomes were monitored in BNT162b2 vaccine recipients 6 months-4 years, and mRNA-1273.222 vaccine recipients 6 months-5 years. Twenty-one outcomes were monitored in BNT162b2 vaccine recipients 5-17 years and mRNA-1273.222 vaccine recipients 6-17 years. Eighteen outcomes were monitored in persons 18 years and older for both mRNA vaccines.ResultsOverall, 13.9 million individuals 6 months and older received a single bivalent COVID-19 mRNA vaccine. The statistical threshold for a signal was met for two outcomes in one database: anaphylaxis following bivalent BNT162b2 and mRNA-1273.222 vaccines in persons 18-64 years and myocarditis/pericarditis following bivalent BNT162b2 vaccines in individuals 18-35 years. There were no signals identified in young children.ConclusionsResults were consistent with prior observations from published studies on COVID-19 vaccine safety. This study supports the safety profile of bivalent COVID-19 mRNA vaccines and the conclusion that the benefits of vaccination outweigh the risks.
Publisher
Cold Spring Harbor Laboratory
Reference50 articles.
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