Post-licensure Safety Surveillance of 20-Valent Pneumococcal Conjugate Vaccine (PCV20) Among US Adults in the Vaccine Adverse Event Reporting System (VAERS)

Mayra Oliveira (), Paige Marquez, Carol Ennulat, Phillip Blanc, Kerry Welsh, Narayan Nair, Monica Taminato and Pedro L. Moro
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Mayra Oliveira: Federal University of Sao Paulo
Paige Marquez: Centers for Disease Control and Prevention
Carol Ennulat: Centers for Disease Control and Prevention
Phillip Blanc: Center for Biologics Evaluation and Research, Food and Drug Administration
Kerry Welsh: Center for Biologics Evaluation and Research, Food and Drug Administration
Narayan Nair: Center for Biologics Evaluation and Research, Food and Drug Administration
Monica Taminato: Federal University of Sao Paulo
Pedro L. Moro: Centers for Disease Control and Prevention

Drug Safety, 2025, vol. 48, issue 3, No 7, 279-286

Abstract: Abstract Background On June 8, 2021, a new 20-valent pneumococcal conjugate vaccine (PCV20, PREVNAR 20®, Pfizer, Inc.) was licensed for use in adults aged ≥ 18 years by the US Food and Drug Administration (FDA). Objective To describe reports to the Vaccine Adverse Event Reporting System (VAERS) after administration of the 20-valent pneumococcal conjugate vaccine in adults. Methods We searched the VAERS for reports of adverse events involving persons aged ≥ 19 years who received PCV20 during October 20, 2021, through December 31, 2023. Our evaluation included automated analysis of reports, clinical review of serious reports and pre-specified events of special interest, empirical Bayesian data mining to assess for disproportionate reporting, and estimation of reporting rates for reports of Guillain-Barré syndrome (GBS). Results The VAERS received 1976 reports after PCV20 administration in persons aged ≥ 19 years (6% of reports involved serious events). The most common adverse events among persons aged 19–64 years (n = 798) were injection-site reactions (231, 29%), pain (134, 17%), erythema (118, 15%), and fever (117, 15%). For persons aged ≥ 65 years (n = 1178), the most common adverse events were injection-site reactions (417, 35%), pain (180, 15%), pain in extremity (162, 14%), and erythema (158, 13%). A data mining alert (EB05 = 3.812) for the MedDRA Preferred Term “Guillain-Barre syndrome” was observed for serious reports. Clinical review verified 11 of 20 GBS reports; 7/11 vaccine recipients were aged ≥ 65 years. Among the 11 verified cases, the median time from vaccination to symptom onset was 14 days. Five persons received another vaccine on the same visit. The reporting rate of GBS after PCV20 receipt was 0.5 cases per million doses distributed. No other safety concern was identified. Conclusions During the period of this post-licensure review of PCV20, we found most reports were non-serious and comprised mostly local and systemic (e.g., fever) reactions consistent with prelicensure studies. In serious reports, we also identified a data mining alert for GBS after receipt of PCV20, which Centers for Disease Control and Prevention and the FDA are investigating further. No other new or unexpected safety concern was identified.

Date: 2025
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DOI: 10.1007/s40264-024-01498-2

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