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.

Screen Shot 2022 04 18 At 2 39 20 Pm
Getty Images

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piece from The Hill criticized the FDA-approved labeling of Pfizer and Moderna COVID-19 vaccines, claiming that it’s outdated, misleading, and fails to provide accurate information.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. 

Medical Device Innovations Report
Cutting-edge packaging technologies are transforming the medical device sector in PMMI’s “Innovation in Medical Device” report, featuring advanced materials, smart solutions, and evolving regulations. Editors share insights from nearly 300 PACK EXPO booth visits—each product deemed new and truly innovative—alongside video demonstrations of the equipment and materials on display.
Learn More
Medical Device Innovations Report
FDA warning letters surge - is your team prepared?
New guide reveals expert strategies to prevent regulatory issues and respond effectively to FDA enforcement actions in pharmaceutical and medical device manufacturing.
Read More
FDA warning letters surge - is your team prepared?