Safety Monitoring of COVID-19 Vaccine Booster Doses Among Adults — U.S. September 22, 2021–February 6, 2022

Details

• Journal Article:
  Morbidity and Mortality Weekly Report (MMWR)
• Personal Author:
  Hause, Anne M. ; Baggs, James ; Marquez, Paige ; Myers, Tanya R. ; Su, John R. ; Blanc, Phillip G. ; Gwira Baumblatt, Jane A. ; Woo, Emily Jane ; Gee, Julianne ; Shimabukuro, Tom T. ; Shay, David K.
• Description:
  During September 22, 2021-February 6, 2022, approximately 82.6 million U.S. residents aged ≥18 years received a COVID-19 vaccine booster dose.* The Food and Drug Administration (FDA) has authorized a booster dose of either the same product administered for the primary series (homologous) or a booster dose that differs from the product administered for the primary series (heterologous). These booster authorizations apply to all three COVID-19 vaccines used in the U.S. (1-3).| The Advisory Committee on Immunization Practices (ACIP) recommended preferential use of an mRNA COVID-19 vaccine (mRNA-1273 [Moderna] or BNT162b2 [Pfizer-BioNTech]) for a booster, even for persons who received the Ad26.COV2.S (Janssen [Johnson & Johnson]) COVID-19 vaccine for their single-dose primary series.| To characterize the safety of COVID-19 vaccine boosters among persons aged ≥18 years during September 22, 2021-February 6, 2022, CDC reviewed adverse events and health impact assessments following receipt of a booster that were reported to v-safe, a voluntary smartphone-based safety Surveillance system for adverse events after COVID-19 vaccination, and adverse events reported to the Vaccine Adverse Event Reporting System (VAERS), a passive vaccine safety Surveillance system managed by CDC and FDA. Among 721,562 v-safe registrants aged ≥18 years who reported receiving a booster, 88.8% received homologous COVID-19 mRNA vaccination. Among registrants who reported a homologous COVID-19 mRNA booster dose, systemic reactions were less frequent following the booster (58.4% [Pfizer-BioNTech] and 64.4% [Moderna], respectively) than were those following dose 2 (66.7% and 78.4%, respectively). The adjusted odds of reporting a systemic reaction were higher following a Moderna Covid-19 Vaccine booster, irrespective of the vaccine received for the primary series. VAERS has received 39,286 reports of adverse events after a COVID-19 mRNA booster vaccination for adults aged ≥18 years, including 36,282 (92.4%) nonserious and 3,004 (7.6%) serious events. Vaccination providers should educate patients that local and systemic reactions are expected following a homologous COVID-19 mRNA vaccine booster; however, these reactions appear less common than those following dose 2 of an mRNA-based vaccine. CDC and FDA will continue to monitor vaccine safety and provide data to guide vaccine Rec.and protect public Health
• Subjects:
  Adult Adverse Drug Reaction Reporting Systems Aged COVID-19 COVID-19 Vaccines Female Humans Immunization, Secondary Male Middle Aged Safety SARS-CoV-2

  More +
• Source:
  MMWR Morbidity Mortal Weekly Rep. 71(7):249-254
• Series:
  Weekly Report: Morbidity and Mortality Weekly Report (MMWR)
• DOI:
  http://dx.doi.org/10.15585/MMWRmm7107e1
• ISSN:
  0149-2195 (print) ; 1545-861X (digital)
• Pubmed ID:
  35176008
• Pubmed Central ID:
  PMC8853473
• Document Type:
  Journal Article
• Place as Subject:
  United States
• Pages in Document:
  6 pdf pages
• Volume:
  71
• Issue:
  7
• Collection(s):
  Morbidity and Mortality Weekly Report (MMWR)
• Main Document Checksum:
  urn:sha-512:8dbcc6e6894aaff612893a28997e3650397c543a31f9172f09b76faa9de3e103149491099bec0aeebc6b4852a58614e1dfffcaff8c92ce977df206d8384a6b09
• Download URL:
  https://stacks.cdc.gov/view/cdc/115070/cdc_115070_DS1.pdf
• File Type:
  [PDF - 289.28 KB ]