"It is up to the sponsor to apply for authorisation or approval, and we make an adjudication of their application … If they do that before the end of Phase Three, we may find that appropriate. We may find that inappropriate, we will make a determination", Hahn said, adding that the FDA’s authorisation was possible if "the benefit outweighs the risk in a public health emergency."
At the moment, three pharmaceutical companies, namely AstraZeneca, Moderna and Pfizer, are conducting phase three trials in the United States, and President Donald Trump has said that vaccine could be approved in the country before the 3 November presidential election. Hahn told the FT that the FDA was ready to bypass the usual process for a vaccine authorisation but would not do so just to please the president.
The FDA head also mentioned that the agency’s authorisation for the emergency use of a potential vaccine did not equal its full approval.
At the same time, Hahn said that FDA’s decisions would be based on science and medicine, and not on politics or the upcoming election.
