Moderna and Regulatory Agencies Caught Leaving Out Bivalent Vaccine Data, Physicians Skeptical of Timing

FDA and CDC left out clinical data on bivalent booster

A pharmacist holds a vial of the Moderna COVID-19 vaccine in West Haven, Conn., on Feb. 17, 2021. Mike Segar/Reuters

Moderna and regulatory agencies did not present clinical data on bivalent shots at the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) committee meetings in June and September 2022, respectively.

Presentations to the FDA and CDC advisory committee excluded data from Moderna’s own clinical study that showed bivalent boosters may be no better at preventing infections than previous booster shots.