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

Autor: Oliveira M; Federal University of Sao Paulo, R. Napoleão de Barros, 754-Vila Clementino, São Paulo, SP, 04024-002, Brazil. mayrammo@gmail.com., Marquez P; Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia, USA., Ennulat C; Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia, USA., Blanc P; Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA., Welsh K; Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA., Nair N; Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA., Taminato M; Federal University of Sao Paulo, R. Napoleão de Barros, 754-Vila Clementino, São Paulo, SP, 04024-002, Brazil., Moro PL; Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Jazyk: angličtina
Zdroj: Drug safety [Drug Saf] 2024 Dec 12. Date of Electronic Publication: 2024 Dec 12.
DOI: 10.1007/s40264-024-01498-2
Abstrakt: 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.
Competing Interests: Declarations. Part of this research was presented during the February 29, 2024 meeting of the Advisory Committee on Immunization Practices in Atlanta, Georgia. Funding: No funding from any organization, agency or entity was received for this study. Conflicts of interest: None of the authors have conflicts of interest that are directly relevant to the content of this article. Disclaimer: The findings and conclusions in this manuscript are those of the author and do not necessarily represent the official position of the CDC or FDA. Ethics approval: This activity was reviewed by the CDC and was considered to be consistent with applicable federal law and CDC policy. Informed consent was not obtained for this secondary use of existing information; see 45 CFR part 46.102(l)(2), 21 CFR part 56, 42 USC §241(d), 5 USC §552a, and 44 USC §3501 et seq. Consent for publication and consent to participate: Not applicable Availability of data and materials: Data from the VAERS system is available to everyone through the VAERS Wonder database available at: https://wonder.cdc.gov/vaers.html . Anyone with internet access may use this site and conduct basic analysis to confirm some of the findings described in the manuscript. However there are data in this manuscript which come from review of medical records of the patients who experienced an adverse event. The data cannot be shared openly to protect patient privacy. Code availability: Not applicable Author contributions: PLM and MMO originated the study, supervised its implementation, conducted the analysis, and led the writing of the manuscript summarizing the findings. PM, CE, PB, KW, NN, and MT assisted in one or more aspects, including study design, review of VAERS reports and medical records, technical advice, administrative support, and writing of the report. All authors read and approved the final version.
(© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)
Databáze: MEDLINE
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