An FDA preprint study monitoring the safety of pediatric COVID-19 vaccines flagged seizures and convulsions as a potential safety signal in children ages 2 to 5. The analysis explains that the new safety signal should be interpreted cautiously due to the study’s limitations, a warning ignored by social media users sharing the study without context. Vaccine opponents, including a popular anti-vaccine organization, are circulating the preliminary safety signal as though it is an established vaccine risk.
Misleading claims about the study are widespread and can potentially promote hesitancy, increasing their risk. Concerns about safety and side effects are among the main reasons parents are hesitant about or oppose COVID-19 vaccines for their children. Any potential safety concern, even an unconfirmed one, may worsen this hesitancy.
Debunking messaging may reiterate the study’s conclusion that the new safety signal “should be interpreted with caution and further investigated” and emphasize that additional preliminary analysis indicates that the results may have been a research artifact (an artificial finding or observation resulting from the study’s design) rather than a real safety signal. Messaging may also explain the importance of investigating all potential safety signals and reiterate that this is an example of our vaccine safety monitoring systems working to detect extremely rare potential risks.
