Near real-time surveillance and tree-based data mining to assess the safety of respiratory syncytial virus vaccines in older adults in the vaccine safety datalink.
Donahue James G, Cocoros Noelle M, Kieke Burney A, Hanson Kayla E, Weintraub Eric S, Yih W Katherine, Scotty Erica, McClure David L, Fireman Bruce, Boyce Thomas G, Maro Judith C, Bartlett Joan, Glanz Jason M, Haapala Jacob L, Horberg Michael, Hurley Laura, Irving Stephanie A, Jackson Lisa A, Kim Seohyun, Klein Nicola P, McNeil Michael M, Myers Tanya R, Qian Lei, Smith Ning, Sundaram Maria E, Tartof Sara, Wang Lily, Xu Stanley, Belongia Edward A
Vaccine · 2025 · PMID 41138438 · 인용 2
BACKGROUND: Two respiratory syncytial virus (RSV) vaccines, Pfizer's Abrysvo and GSK's Arexvy, were licensed in 2023 in the U.S. However, population-based assessments of their safety in adults ≥60 years have not been widely published. We provide results from two complementary investigations of vaccinated adults in the Vaccine Safety Datalink (VSD).
METHODS: The rapid cycle analysis (RCA) used a sequential cohort design and biweekly analyses of near real-time data to compare the incidence of 12 pre-specified outcomes in two post-vaccination risk intervals (1-21, 1-42 days) with the incidence in comparison intervals. The surveillance period was August 1, 2023, through September 28, 2024; nine of 13 VSD sites participated. Statistically significant signals were investigated by medical record review with re-analysis of confirmed outcomes. The self-controlled tree-based data mining analysis was designed to identify temporal clustering of ICD-10 diagnosis codes in the inpatient or emergency department settings 1-56 days post-vaccination, without pre-specifying outcomes or risk intervals. The study period was July 1, 2023, through December 31, 2023; 10 sites participated.
RESULTS: The RCA analysis included 436,823 persons who received an RSV vaccine. No statistical signal was identified for 11 of 12 adverse events. A signal was detected for immune thrombocytopenic purpura following Arexvy, but re-analysis following medical record review did not confirm an association. The tree-based data mining analysis included 248,056 vaccinees, identified 53,734 counts of 3429 diagnosis codes, and identified no statistically significant clusters for either vaccine.
CONCLUSIONS: These post-licensure safety assessments provide evidence supporting the safety of RSV vaccines in older adults. As more data accrue, additional monitoring is warranted for rare adverse events.