Safety of 20-Valent Pneumococcal Conjugate Vaccine (PCV20) in Children in the Vaccine Adverse Event Reporting System.

OBJECTIVE

To assess the safety of 20-valent pneumococcal conjugate vaccine (PCV20) in children in the US using data from the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous surveillance system.

STUDY

DESIGN

We searched VAERS for reports of adverse events (AEs) after administration of PCV20 in children aged 0-17 years who received PCV20 from June 22, 2023, through January 24, 2025. We reviewed reports and available medical records for all serious reports and for AEs of special interest (seizures, anaphylaxis, hypotonic hyporesponsive episode, Kawasaki disease). We used empirical Bayesian data mining to identify AEs that were disproportionally reported.

RESULTS

VAERS received 1040 reports after receipt of PCV20 in children aged 0-17 years; 107 (10.3%) were serious, which included 26 (2.5%) death reports. In 970 (93.3%) reports, PCV20 was concomitantly administered with another vaccine. The most reported AEs were fever (109, 10.4%), rash (75, 7.2%), urticaria (68, 6.5%), and injection-site erythema (54, 5.2%). The most commonly reported AE of special interest was seizure (42; 4.0%). Empirical Bayesian data mining revealed disproportionate reporting for "wrong product administered," but no adverse health events were associated with this vaccination error.

CONCLUSIONS

Most reports after PCV20 administration in children were nonserious. The most common AEs were local and systemic reactions, consistent with prelicensure clinical trials. Although the VAERS system is not designed to assess causation of vaccination and AEs, no signals of new or unexpected AEs were identified, reinforcing the safety of PCV20 in US children.