Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Persons Aged ≥12 Years - United States, August 31-October 23, 2022

• Published in: MMWR. Morbidity and mortality weekly report 2022-11, Vol.71 (44), p.1401-1406
• Main Authors: 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
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Adults; Adverse events; Age; BNT162 Vaccine; Call centers; Coronaviruses; COVID-19; COVID-19 - epidemiology; COVID-19 - prevention & control; COVID-19 vaccines; COVID-19 Vaccines - adverse effects; Full Report; Health aspects; Health care; Hospitalization; Humans; Immunization; Influenza; Messenger RNA; mRNA; mRNA Vaccines; Myocarditis; Public health; RNA, Messenger; Safety; Safety and security measures; SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; Surveillance; United States - epidemiology; Vaccination; Vaccines; Vaccines, Synthetic - adverse effects
• ISSN: 0149-2195; 1545-861X
• DOI: 10.15585/mmwr.mm7144a3

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.* 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. 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, 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. 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).