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

Abstract

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).

FIGURE

Adverse reactions and health impacts reported to v-safe after receipt of COVID-19 vaccine doses among persons with presumed immunocompromised status (N = 4,015), by vaccine dose — United States, January 12–March 28, 2022 * The odds of reporting an event following dose 3 and booster dose were compared for registrants who completed at least one v-safe health check-in survey on days 0–7 after booster dose and ≥1 other dose using a multivariable generalized estimating equations model. This model adjusted for demographic variables and vaccine manufacturer and accounted for repeated measures among doses reported by each registrant (“unable to go to work or school” and “needed medical care” were not adjusted because of small numbers). P-values <0.05 were considered statistically significant. All dose 3 and booster dose differences were statistically significant (p<0.001) except “needed medical care.” † A fourth mRNA dose ≥3 months after dose 3 administered to a registrant aged ≥12 years was presumed to be an mRNA COVID-19 vaccine booster dose administered to an immunocompromised person. Registrants aged ≤15 years must be enrolled by a parent or guardian.