On November 28, the FDA’s top vaccine regulator claimed in a staff memo that COVID-19 vaccines are linked to “no fewer than” 10 children’s deaths. The memo suggested the deaths were associated with myocarditis but did not include information about the children’s ages, comorbidities, or how the agency determined cause of death. Many vaccine experts expressed skepticism due to the lack of details and evidence, with one calling the report “dangerous and irresponsible.” Others questioned why the agency didn’t publish the results in a peer-reviewed journal. The news circulated rapidly in anti-vaccine circles, with some asserting that the memo validates their belief that COVID-19 vaccines are dangerous. Some also claimed, without evidence, that the vaccines have killed thousands of children. The FDA memo, which calls for stricter vaccine regulation, was released a week before a December ACIP meeting that will discuss the childhood immunization schedule and hepatitis B vaccines.
Recommendation
Misleading and unproven claims about the safety and alleged risks of COVID-19 vaccines may cause hesitancy and discourage parents from vaccinating their children. Health communicators may note that caution is warranted when addressing the FDA’s internal memo directly to avoid repeating or amplifying an unsupported claim. Continuing to lead with established evidence and preparing for questions is recommended, recognizing that while much of the current conversation is taking place within anti-vaccine or pro-vaccine circles, these discussions are likely to reach broader audiences in the weeks and months to come.
If faced with questions, messaging may emphasize that the science hasn’t changed: five years of evidence show that COVID-19 vaccines are safe for children as young as 6 months, that serious side effects are extremely rare, and that vaccination reduces children’s risk of severe illness and long COVID. Health communicators may explain that there is no evidence of widespread risks associated with COVID-19 vaccines and that the FDA has not provided data to support the claims made in the memo, nor have the claims been validated by external or peer review. Finally, health communicators may continue to direct the public to trustworthy sources for vaccine information, including their health care providers, the Children’s Hospital of Philadelphia Vaccine Education Center, and the AAP.
Fact-checking sources: ABC News, STAT News
Communication resources: Find more talking points about COVID-19
