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

Details

• Journal Article:
  Morbidity and Mortality Weekly Report (MMWR)
• Personal Author:
  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.
• Description:
  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).
• Subjects:
  Adolescent Adult BNT162 Vaccine COVID-19 Vaccines/adverse Effects COVID-19/epidemiology COVID-19/prevention & Control Humans RNA, Messenger SARS-CoV-2 Vaccines, Synthetic/adverse Effects
• Source:
  MMWR Morbidity Mortal Weekly Rep. 71(44):1401-1406
• Series:
  Weekly Report: Morbidity and Mortality Weekly Report (MMWR)
• DOI:
  http://dx.doi.org/10.15585/mmwr.mm7144a3
• ISSN:
  0149-2195 (print) ; 1545-861X (digital)
• Pubmed ID:
  36327162
• Pubmed Central ID:
  PMC9639436
• Document Type:
  Journal Article
• Place as Subject:
  United States
• Pages in Document:
  6 pdf pages
• Volume:
  71
• Issue:
  44
• Collection(s):
  Morbidity and Mortality Weekly Report (MMWR)
• Main Document Checksum:
  urn:sha-512:c9db33f9ca8a0a14e1d426d9823f02d3c65144c9a7b5b0a6f05c662bd54bf5462e5272df4d8a49ff8da45eed1e726d281b24ec96a9bda457dde3f5f85a5210c4
• Download URL:
  https://stacks.cdc.gov/view/cdc/123138/cdc_123138_DS1.pdf
• File Type:
  [PDF - 309.93 KB ]