FDA Claims Licensed Vaccines Do Not Need to Prevent Infections or Transmission

FDA Claims Licensed Vaccines Do Not Need to Prevent Infections or Transmission
- An organization called the Coalition Advocating for Adequately Labeled Medicines (CAALM) filed a petition requesting that the FDA update the COVID-19 vaccine product labeling –for both Pfizer and Moderna products—to reflect their actual safety and efficacy more accurately.

While the principals behind CAALM are experts and offer the FDA valid points in their comments, the FDA flatly rejects the organizations requests, declaring that a licensed vaccine doesn’t need to demonstrate that they prevent infection or transmission nor does a vaccine authorized under provisional emergency use authorization need to demonstrate infection prevention or transmission.

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