FDA memo sparks concern with unsupported COVID-19 vaccine claims

A CDC leadership appointment also sparked fears about future vaccine policy as whooping cough deaths underscored the dangers of declining vaccination rates.

At the end of November, an internal FDA memo erroneously linked COVID-19 vaccines to at least 10 pediatric deaths despite offering no supporting evidence. The claim drew swift condemnation from scientific and medical experts, while social media users amplified concerns about vaccine safety and questioned the integrity of federal health agencies. Just days earlier, the CDC faced criticism for appointing as deputy director a Louisiana health official whose department delayed issuing a public warning about a growing whooping cough (pertussis) outbreak. The disease has claimed the lives of several infants and children this year—including two in Louisiana and a third in Kentucky in late November—intensifying public fears about the consequences of declining childhood immunization.

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What’s trending in vaccine conversation:

On November 28, a memo sent to FDA staff claimed that COVID-19 vaccines are responsible for the deaths of “no fewer than” 10 children. Although the memo links the deaths to myocarditis, it provides no supporting evidence or details about the cases. Reactions were polarized: Some argued that the FDA cannot be trusted and that COVID-19 vaccines should never have been approved for children, while others highlighted the lack of substantiation. Experts questioned why more information was not provided, warning that issuing such a claim without evidence is “dangerous and irresponsible.” The memo also indicates that stricter vaccine regulations are pending, raising alarm in the days leading up to a CDC vaccine advisory panel meeting, which includes a vote on infant hepatitis B vaccines.

The CDC has appointed Louisiana’s surgeon general as its deputy director, sparking concern among public health figures due to his prior statements expressing vaccine skepticism. Earlier this year, Louisiana’s health department ended vaccination campaigns and waited months to issue a health alert about a whooping cough outbreak that had already killed two infants. The appointment drew criticism online, with some fearing the official may sow doubt about vaccine safety or promote policies that conflict with established science. Vaccine opponents, meanwhile, celebrated the decision, describing it as a win for “health freedom” advocates.

Whooping cough cases continue to rise nationwide in November as Kentucky reported that a third child has died from the infection this year. All three children were unvaccinated, as were their mothers, prompting experts and health officials to encourage parents to ensure that they and their children remain up to date on pertussis vaccinations. Some social media users suggested, without evidence, that the deaths were not caused by whooping cough and blamed the outbreak on immigrants, while others falsely claimed that pertussis vaccines are ineffective or more dangerous than the disease. In contrast, several posters discussed the importance of pertussis vaccine boosters for adults and encouraged people to get vaccinated to protect their children and grandchildren.

Read the fact checks: 

• ABC News: FDA links 10 children’s deaths to COVID-19 vaccines. Doctors want proof
• National Academies: Are vaccines safe? 
• Public Good News: What families should know about whooping cough

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Recommendations for public health professionals

The Infodemiology.com team will provide messaging recommendations in response to some of the trending narratives outlined above. Use these helpful tips when creating content, updating web pages and FAQs, and to inform strategy for messaging about vaccines.

Misleading and unsupported claims about COVID-19 vaccine safety may influence parents’ decision to vaccinate, especially when the claims come from health authorities. Using caution when addressing such claims is recommended to avoid repeating or amplifying them. Leading with established evidence and preparing for questions is also recommended, as is continuing to direct the public to trustworthy sources for vaccine information. These sources include their health care providers, the Children’s Hospital of Philadelphia Vaccine Education Center, and HealthyChildren.org from the American Academy of Pediatrics. Messaging may emphasize that the science hasn’t changed: Five years of evidence show that COVID-19 vaccines are safe, serious side effects are extremely rare, and vaccination reduces children’s risk of severe illness and long COVID. Health communicators may explain that the FDA has not provided evidence to support claims made about COVID-19 vaccine safety, nor have the claims been validated by experts or peer-reviewed research.

High-ranking health officials may influence public opinion on issues like vaccine safety, especially when their positions conflict with established vaccine science. Health communicators may continue to highlight decades of evidence showing that routine vaccines are safe and effective and help protect children from preventable diseases like measles and whooping cough. Messaging may emphasize the importance of vaccination and herd immunity in preventing outbreaks and keeping communities safe.

Online conversations about ongoing whooping cough outbreaks provide an opportunity for health communicators to share information about ways for the public to protect themselves and their families. Messaging may emphasize that whooping cough is a serious disease and that pertussis vaccines are safe and help protect against infection and severe illness. Messaging may explain that the AAP recommends that children receive five doses of the pertussis vaccine beginning at 2 months and that the American College of Obstetricians and Gynecologists recommends that all pregnant people receive the Tdap (tetanus, diphtheria, and pertussis) vaccine during the third trimester.