FDA commissioner says he's open to issuing COVID-19 vaccine before human trials are over

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last updated 1 September 2020

In an interview with the Financial Times published Sunday, FDA Commissioner Stephen Hahn said that he is willing to issue an emergency use authorization for a COVID-19 vaccine prior to the conclusion of human trials.

Hahn said this could be done because "the benefit outweighs the risk in a public health emergency," and claimed he would not give in to President Trump or other politicians who have asserted that there will be a vaccine available before the end of the year. "This is going to be a science, medicine, data decision," Hahn told the Financial Times. "This is not going to be a political decision."

Public health experts quickly pushed back at the idea of fast-tracking a vaccine out of the normal testing guidelines. Dr. Angela Rasmussen, a virologist at Columbia University, tweeted that it would be unethical to administer the vaccine before it is proven safe and effective. "We absolutely cannot tolerate or accept an emergency authorization for any COVID-19 vaccine without reliable safety and efficacy data from Phase 3 clinical trials," Rasmussen said, adding that this would put "huge numbers of people at risk for massive potential harm" and deal "a catastrophic blow to public confidence in both vaccines and the regulatory mechanisms in place."