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Why Hasn’t the FDA Updated COVID Vaccine Labeling?

In a recent opinion piece, drug safety advocates discuss the labeling of Pfizer and Moderna’s COVID-19 vaccines.

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A recent opinion piece from The Hill criticized the FDA-approved labeling of Pfizer and Moderna COVID-19 vaccines, claiming that it’s outdated, misleading, and fails to provide accurate information. The authors requested that the FDA update labeling to reflect the uncertainty surrounding viral transmission reduction and include potential adverse events. However, the FDA denied their requests and didn’t follow the lead of regulators in Europe and Japan. 

The authors also point out the issue of mixed messaging from public health officials, which has led to confusion among the public. They argue that the FDA's failure to update the labeling based on scientific evidence and its double standard in addressing potential harms undermines trust in governmental institutions and compromises patient safety.

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