The head of the US Food and Drug Administration (FDA) has said he is willing to bypass the normal approval process to authorise a Covid-19 vaccine as soon as possible – but has insisted he will not do so to please President Donald Trump.
Stephen Hahn said his agency was prepared to authorise a vaccine before phase three clinical trials were complete as long as officials believed the benefits outweighed the risks. However, he defended his embattled organisation against accusations that it was rushing the process to boost Mr Trump’s re-election prospects.
“It is up to the sponsor [vaccine developer] to apply for authorisation or approval, and we make an adjudication of their application,” Dr Hahn said. “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.”
Dr Hahn’s decision whether to give the go-ahead for a Covid-19 vaccine is likely to be one of the most important and sensitive in US public health history.
China and Russia have both approved vaccines without waiting for the end of phase three trials, which are the largest and most rigorous of all the tests of a potential new drug. However, they have been criticised by public health officials – including ones in the US – who have warned that doing so could be unsafe.
Dr Hahn insisted there was a safe way to make a vaccine available before the end of phase three trials – potentially by issuing an emergency authorisation for use by certain groups rather than a blanket approval.
“Our emergency-use authorisation is not the same as a full approval,” he said. “The legal, medical and scientific standard for that is that the benefit outweighs the risk in a public health emergency.”
However. he insisted he would not rush a vaccine to please the president amid reports that Mr Trump wants one to be available before November’s election to help improve his chance of victory.
“We have a convergence of the Covid-19 pandemic with the political season and we’re just going to have to get through that and stick to our core principles. This is going to be a science, medicine, data decision. This is not going to be a political decision.”
Bruising week
Dr Hahn was speaking at the end of a bruising week for him and the administration he leads.
Last Saturday, Mr Trump accused “deep state” elements at the FDA of moving too slowly in approving new treatments for coronavirus in an effort to harm him politically.
A day later Dr Hahn and Mr Trump jointly announced emergency authorisation for convalescent plasma, which uses the plasma of recovered Covid-19 patients as a treatment. Dr Hahn was immediately criticised for overstating its benefits.
The FDA chief said he regretted his comment that plasma treatment would have saved the lives of 35 out of 100 patients. Figures suggest that figure is closer to five out of 100.
“I certainly regret contributing to any misperception,” he said. “I could have done a much better job last Sunday explaining relative risks.” – Copyright The Financial Times Limited 2020
