The following is fromThe Vaccine Reaction.
The US Food and Drug Administration (FDA) has notified six influenza vaccine manufacturers that they must add a warning about the risk of febrile (fever-related) seizures to their product labels.
According toThe Vaccine Reaction, the notices were issued Jan. 9, 2026, under the FDA’s authority to mandate safety labeling changes. The manufacturers include Sanofi, AstraZeneca, GlaxoSmithKline (GSK), and CSL Seqirus.
The FDA cited postmarketing safety data from the 2023–2024 and 2024–2025 flu seasons showing a statistically significant increase in febrile seizures within one day of vaccination among children ages six months through four years.
The agency stated the analyses “suggest a causal relationship” and estimated:
Febrile seizures are convulsions triggered by fever and typically occur in infants and young children. The CDC has acknowledged that certain childhood vaccines may be associated with a higher risk of febrile seizures, particularly when administered during the same visit.
The FDA instructed manufacturers to include new label language noting that:
“In two separate postmarketing observational studies, an increased risk of febrile seizures was observed during the first day following vaccination with standard dose trivalent (2024–2025) and quadrivalent (2023–2024) influenza vaccines in children 6 months through 4 years of age.”
Manufacturers have 30 days to accept the revised language, propose alternative wording, or formally rebut the changes.
For more information, read the full articlehere.
Source: Sharyl Attkisson
