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FDA to Stiffen Standards for Clinical Trials for New COVID Boosters

The Food and Drug Administration will issue guidelines requiring clinical trials prior to the approval of new COVID-19 boosters, a spokesperson confirmed to The Daily Signal.

The FDA’s new framework for vaccine approvals will prioritize high-risk populations while requiring gold-standard clinical data for individuals under 65 at low risk of COVID-19, Dr. Vinay Prasad, the FDA’s vaccine division chief, and Dr. Martin Makary, the agency’s commissioner, wrote in the New England Journal of Medicine on Tuesday.

“The COVID-19 public health emergency has officially ended, and we are entering a new phase in our response to the virus,” Department of Health and Human Services spokeswoman Emily Hilliard told The Daily Signal. “A rubber-stamping approach to approving COVID boosters in perpetuity without updated clinical trial data under the Biden administration is now…

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