On January 31, 2023 the Coalition Advocating for Adequately Labeled Medicines (CAALM) petitioned the FDA to “amend current product labeling” for Pfizer-BioNTech’s and Moderna’s COVID-19 mRNA vaccines. The petition was heavily cited.
Stating “[i]ncomplete, inaccurate, or misleading labeling of any medical product can negatively impact the health and safety of Americans, with global ramifications considering the international importance of FDA decisions.”
They noted “[t]here is a widespread (but inaccurate) notion that efficacy against infection and transmission have been established by substantial evidence, and that these vaccines contribute to herd immunity.” Statements that have been inacurately repeated by “authorities”.
On April 18, 2023 the FDA resonded in a letter [1] with the alarming statement:
“FDA authorization and licensure standards for vaccines do not require demonstration of the prevention of infection or transmission…Similarly, a vaccine can meet the EUA standard without any evidence that the vaccine prevents infection or transmission.” [pg 11]
[So what is the purpose of a vaccine?
If a vaccine doesn’t prevent infection or stop transmission how does it contribute to herd immunity?
Define “protection”! Isn’t reducing symptoms (it this is protection) put the product in the category of a drug? Then the product would undergo a more stringent regulatory pathway, and the manufactures be open to liablity claims.]