FDA's COVID-19 Vaccine Emergency Use Authorization Would Rely on Seriously Deficient Vaccination Data

The U.S. Food and Drug Administration recently increased some requirements for granting an Emergency Use Authorization (EUA) for a COVID-19 vaccine, but serious deficiencies remain, Sidney Wolfe, founder of Public Citizen's Health Research Group, said in testimony Thursday before the agency's Vaccines and Related Biological Products Advisory Committee. The hearing followed a protest outside of the U.S. Department of Health and Human Services building where activists demanded a safe, effective, accessible and free COVID-19 vaccine.

Public confidence in a COVID-19 vaccine continues to wane, and rushing a vaccine through an EUA without complete Phase 3 safety and efficacy data, which could take months to complete, would further undermine public confidence.

Wolfe asked the committee, "Based on incomplete Phase 3 trials, will your advisory committee have enough confidence, despite all this missing data, to recommend authorizing a vaccine, for use in tens of millions of people, when an EUA is requested? The gap between completed Phase 3 trials needed for approval and the current EUA standard, allowing half of Phase 3 trial participants to be followed for less than two months after vaccination does not engender confidence. Saving time by a faster but riskier data-deficient EUA pathway will surely be outweighed by further loss in public confidence in an incompletely tested, vaccine, accompanied by decreased willingness to be vaccinated."