In an interview published Sunday, the head of the US Food and Drug Administration raised the possibility that a potential coronavirus vaccine could be granted emergency approval before the end of trials designed to ensure its safety and efficacy. A request for such extraordinary approval, Stephen Hahn told the Financial Times, will have to come from the vaccine manufacturer.
Three Western drug manufacturers are in good company with their Phase 3 clinical trials, involving tens of thousands of individuals. The three are AstraZeneca, partnering with Oxford University in England; Moderna, partnering with the US National Health Institutes, and the Pfizer / BioNTech partnership. It is difficult to predict when accurate results will emerge because of the design of the trials.
As the world is urgently awaiting an effective vaccine against the deadly virus, China and Russia have already approved vaccines without waiting for trial completion — challenging public health officials in other nations , including the United States. More recently, during a news conference with Trump, Hahn gave a far too positive evaluation of the efficacy of convalescent plasma against the virus. He said 35 out of 100 patients could be saved; the more likely figure, experts said, is five in 100.