Citing three anonymous sources, The Financial Times reported yesterday that the Trump Administration was considering a plan to fast-track approval of the Oxford University, AstraZeneca vaccine — but the drugmakers say this discussion never happened.
The FT sources claimed they were briefed on the White House plan which included an option for the FDA to grant emergency use authorization to AstraZeneca's vaccine if the results are positive from an ongoing late stage 10,000 person clinical trial being conducted in the U.K. The study falls short of the 30,000-people threshold needed for traditional marketing authorization from the FDA.
AstraZeneca responded to the FT report, saying the rumors were not true.
“AstraZeneca has not discussed emergency use authorization with the US government and it would be premature to speculate on that possibility. Late stage Phase II/III trials for [the vaccine] are ongoing in the UK and other markets globally, and we do not anticipate efficacy results until later this year.”
The story emerged as President Trump held a press conference to announce the FDA had granted emergency use authorization for blood plasma from recovered COVID-19 patients to be used to treat those currently suffering from COVID. For many, this convergence of politics and FDA action is dangerously problematic.
In a viewpoint piece published in JAMA in early August, FDA Commissioner Stephen M. Hahn provided reassurance that FDA decisions will continue to be based solely on "good science and data." Hahn also noted that while EUAs are possible for COVID vaccines, "FDA recommends that sponsors of vaccine candidates—as well as sponsors of COVID-19 drugs and biologic products per the agency’s previous guidance—file for review for traditional market authorization considering that any vaccine would be intended for widespread use."
Former FDA Commissioner Scott Gottlieb doubled down on the assertion that the FDA is would not speed or slow any decision due to politics. "I firmly reject the idea that they would slow walk anything or accelerate anything for that matter, based on any kind of political consideration," he said in a Face the Nation interview.