Index Entries

Richard A. Forshee, Elizabeth R. Smith, Zhiruo Wan, Kandace L. Amend, Alex Secora, Djeneba Audrey Djibo, Kamran Kazemi, Jennifer Song, Lauren E. Parlett, John D. Seeger, Nandini Selvam, Cheryl N. McMahill-Walraven, Mao Hu, Yoganand Chillarige, and Steven A. Anderson
March 19, 2024
Food and Drug Administration (FDA)

"Importance. The United States Food and Drug Administration noted a potential safety concern for seizure in children aged 2-5 years receiving the ancestral monovalent COVID-19 mRNA vaccines.

Objective. To evaluate febrile seizure risk following monovalent COVID-19 mRNA vaccination among children aged 2-5 years.

Design, Setting, and Participants. ... A self-controlled case series analysis was performed in three commercial insurance databases to compare the risk of seizure in the risk interval (0-1 days) to a control interval (8-63 days)...

Results. The primary meta-analysis found a statistically significant increased incidence of febrile seizure in the 0-1 days following mRNA-1273 vaccination compared to the control interval (IRR: 2.52, 95% CI: 1.35 to 4.69, risk difference (RD)/100,000 doses = 3.22 (95%CI −0.31 to 6.75))."

document
adverse events,COVID-19,vaccines