On June 18, 2022, CDC Director Rochelle Walensky posted a tweet with a video of herself discussing the CDC’s recent recommendation of the COVID-19 shots for children under 5. In the video, Dr. Walensky made the following two claims:
- “We now know based on rigorous scientific review that the vaccines available here in the United States can be used safely and effectively in children under 5.”
- “We have taken another important step together on our fight against COVID-19 by making safe and effectivevaccines available for our little ones.”
But as Dr. Walensky should certainly be aware, in issuing Emergency Use Authorizations (EUAs), the FDA has not(under its ridiculously low standards) made a finding that these vaccines are “safe and effective.” Instead, the grant of an EUA means only that the FDA has determined “it is reasonable to believe that [each vaccine] may be effective” and that “it is reasonable to conclude, based on the totality of scientific evidence available, that the known and potential benefits of [each vaccine] outweigh the known and potential risks of the vaccine.”
By claiming – two separate times – that these vaccines are “safe and effective,” Dr. Walensky is misleading the public by suggesting these vaccines have met the legal standard required for licensure.
Worse yet, because her tweet is “descriptive printed matter” that is both advertising and promoting Pfizer’s and Moderna’s vaccines, the tweet itself is in violation of both EUAs issued to these companies because it does not “clearly and conspicuously” contain the required disclaimer that these products have not yet been licensed as safe and effective by the FDA.
ICAN, through its attorneys, has sent Dr. Walensky a formal letter demanding that she immediately remove the misleading tweet and we will keep you posted on the CDC’s response.