Safety Monitoring of COVID-19 mRNA Vaccine First Booster Doses Among Persons Aged ≥12 Years with Presumed Immunocompromise Status — United States, January 12, 2022–March 28, 2022

Details

• Journal Article:
  Morbidity and Mortality Weekly Report (MMWR)
• Personal Author:
  Hause, Anne M. ; Baggs, James ; Marquez, Paige ; Abara, Winston E. ; Baumblatt, Jane Gwira ; Thompson, Deborah ; Su, John R. ; Myers, Tanya R. ; Gee, Julianne ; Shimabukuro, Tom T. ; Shay, David K.
• Description:
  Persons with moderate to severe immunocompromising conditions are at risk for severe COVID-19, and their immune response to COVID-19 vaccination might not be as robust as the response in persons who are not immunocompromised* (1). The Advisory Committee on Immunization Practices (ACIP) recommends that immunocompromised persons aged ≥12 years complete a 3-dose primary mRNA COVID-19 vaccination series followed by a first booster dose (dose 4) ≥3 months after dose 3 and a second booster dose (dose 5) ≥4 months after dose 4.| To characterize the safety of first booster doses among immunocompromised persons aged ≥12 years during January 12, 2022-March 28, 2022, CDC reviewed adverse events and health impact assessments reported to v-safe and the Vaccine Adverse Event Reporting System (VAERS) during the week after receipt of an mRNA COVID-19 first booster dose. V-safe is a voluntary smartphone-based safety surveillance system for adverse events after COVID-19 vaccination. VAERS is a passive surveillance system for all vaccine-associated adverse events co-managed by CDC and the Food and Drug Administration (FDA). A fourth mRNA dose reported to v-safe or VAERS during January 12, 2022-March 28, 2022, was presumed to be an mRNA COVID-19 vaccine booster dose administered to an immunocompromised person because no other population was authorized to receive a fourth dose during that period (2,3). In the United States, during January 12, 2022-March 28, 2022, approximately 518,113 persons aged ≥12 years received a fourth dose. Among 4,015 v-safe registrants who received a fourth dose, local and systemic reactions were less frequently reported than were those following dose 3 of their primary series. VAERS received 145 reports after fourth doses; 128 (88.3%) were nonserious and 17 (11.7%) were serious. Health care providers, immunocompromised persons, and parents of immunocompromised children should be aware that local and systemic reactions are expected after a first booster mRNA COVID-19 vaccine dose, serious adverse events are rare, and safety findings were consistent with those previously described among nonimmunocompromised persons (4,5).
• Subjects:
  Adverse Drug Reaction Reporting Systems COVID-19 COVID-19 Vaccines Humans Immunization, Secondary MRNA Vaccines Vaccines, Synthetic
• Source:
  MMWR Morbidity Mortal Weekly Rep. 71(28):899-903
• Series:
  Weekly Report: Morbidity and Mortality Weekly Report (MMWR)
• DOI:
  http://dx.doi.org/10.15585/mmwr.mm7128a3
• ISSN:
  0149-2195 (print) ; 1545-861X (digital)
• Pubmed ID:
  35834416
• Pubmed Central ID:
  PMC9290389
• Document Type:
  Journal Article
• Place as Subject:
  United States
• Pages in Document:
  5 pdf pages
• Volume:
  71
• Issue:
  28
• Collection(s):
  Morbidity and Mortality Weekly Report (MMWR)
• Main Document Checksum:
  urn:sha-512:d4a9137cdf0164b19267555c704b5837136cd69dc2f8b4542eec5fd034508eef5b4ebecdd0a51bbc509d32d6cb7a9b10051a1b8e809cedcb89281a569bc1c451
• Download URL:
  https://stacks.cdc.gov/view/cdc/119946/cdc_119946_DS1.pdf
• File Type:
  [PDF - 237.58 KB ]