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FDA plans rapid review process for COVID-19 booster shots
2/5/2021

Janet Woodcock, the FDA's acting commissioner, said the agency plans to come up with a rapid process for reviewing new COVID-19 vaccine booster shots in case existing vaccines fail to protect against emerging new variants. The FDA intends to release a proposal on the process in the next few weeks that will likely require safety information and convening of external experts to evaluate the booster shot, but not the type of large trials required for approval or emergency use authorization.

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