| アブストラクト | On August 31, 2022, the Food and Drug Administration (FDA) authorized bivalent formulations of BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) COVID-19 vaccines; these vaccines include mRNA encoding the spike protein from the original (ancestral) strain of SARS-CoV-2 (the virus that causes COVID-19) and from the B.1.1.529 (Omicron) variants BA.4 and BA.5 (BA.4/BA.5). These bivalent mRNA vaccines were authorized for use as a single booster dose >/=2 months after completion of primary series or monovalent booster vaccination; Pfizer-BioNTech bivalent booster was authorized for persons aged >/=12 years and Moderna for adults aged >/=18 years.*(,)(dagger) On September 1, 2022, the Advisory Committee on Immunization Practices (ACIP) recommended that all persons aged >/=12 years receive an age-appropriate bivalent mRNA booster dose.( section sign) To characterize the safety of bivalent mRNA booster doses, CDC reviewed adverse events and health impacts reported after receipt of bivalent Pfizer-BioNTech and Moderna booster doses during August 31-October 23, 2022, to v-safe,( paragraph sign) a voluntary smartphone-based U.S. safety surveillance system established by CDC to monitor adverse events after COVID-19 vaccination, and the Vaccine Adverse Event Reporting System (VAERS),** a U.S. passive vaccine safety surveillance system managed by CDC and FDA (1). During August 31-October 23, 2022, approximately 14.4 million persons aged >/=12 years received a bivalent Pfizer-BioNTech booster dose, and 8.2 million adults aged >/=18 years received a bivalent Moderna booster dose.(daggerdagger) Among the 211,959 registrants aged >/=12 years who reported receiving a bivalent booster dose to v-safe, injection site and systemic reactions were frequently reported in the week after vaccination (60.8% and 54.8%, respectively); fewer than 1% of v-safe registrants reported receiving medical care. VAERS received 5,542 reports of adverse events after bivalent booster vaccination among persons aged >/=12 years; 95.5% of reports were nonserious and 4.5% were serious events. Health care providers and patients can be reassured that adverse events reported after a bivalent booster dose are consistent with those reported after monovalent doses. Health impacts after COVID-19 vaccination are less frequent and less severe than those associated with COVID-19 illness (2). |
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| 投稿者 | Hause, Anne M; Marquez, Paige; Zhang, Bicheng; Myers, Tanya R; Gee, Julianne; Su, John R; Blanc, Phillip G; Thomas, Alisha; Thompson, Deborah; Shimabukuro, Tom T; Shay, David K |
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