U.S. President Donald Trump gestures during a tour of the Fujifilm Diosynth Biotechnologies' Innovation Center, a pharmaceutical manufacturing plant where components for a potential COVID-19 vaccine candidate are being developed, in Morrrisville, North Carolina, on July 27, 2020.Carlos Barria/Reuters
The Trump administration is considering fast-tracking an experimental COVID-19 vaccine being developed by AstraZeneca PLC and Oxford University for use in the United States ahead of the Nov. 3 elections, the Financial Times reported.
One option being explored would involve the U.S. Food and Drug Administration awarding “emergency use authorization” in October to the potential vaccine, which was developed by Oxford and licensed to AstraZeneca, the FT reported.
AstraZeneca denied having discussed an emergency use authorization for its potential vaccine with the U.S. government.
“AstraZeneca has not discussed emergency use authorization with the U.S. government and it would be premature to speculate on that possibility,” a spokeswoman for AstraZeneca said in a statement.
The company said that the late-stage Phase 2 and Phase 3 trials for its vaccine candidate are still continuing in Britain and other markets globally and that it did not anticipate efficacy results until later this year.
Mark Meadows, White House chief of staff, and Steven Mnuchin, Treasury secretary, told top Democrats that the administration was considering fast-tracking a vaccine in a July 30 meeting with Nancy Pelosi, the Speaker of the House of Representatives, FT said, citing a person briefed on the meeting.
There are no approved vaccines for COVID-19, but AstraZeneca’s shot, called AZD1222, is widely seen as one of the leading candidates.
However, the relatively small British trial by AstraZeneca was not designed to produce sufficient data of the kind that would be required for emergency authorization in the U.S., sources said.