Scientists worry FDA could be pressured to approve COVID vaccine before it’s fully tested

President Trump says he anticipates a COVID-19 vaccine “very soon,” but some scientists are concerned the FDA could yield to pressure to approve a vaccine before it is adequately tested. Peter Marks, MD, PhD, who heads the FDA’s vaccine group, told Reuters that he has faced no political pressure to release a vaccine without sufficient data on safety and effectiveness, and that he would step down if that were to occur. Jesse Goodman MD, PhD, director of Georgetown University’s Center on Medical Product Access, Safety and Stewardship, says it could make sense to grant an Emergency Use Authorization for a COVID-19 vaccine if full data from a Phase III clinical trial demonstrated robust safety and clear evidence in reducing disease, and all that remained were certain “technical or administrative issues or steps.” If FDA were to do that, the vaccine would likely be used only for people at high risk of COVID-19 exposure or illness, he says. It would be “critical that recipients understand clearly that the product is not FDA-approved and why, and what is known and not known about the product’s safety and effectiveness,” according to Goodman.