The head of the US food and drug administration (FDA), Stephen Hahn, said in an interview with the Financial Times that he is ready to approve the coronavirus vaccine before the end of the third phase of clinical trials if the benefits exceed the possible risks.
In the United States, there are clinical trials of coronavirus vaccines developed by companies such as Moderna, Pfizer, and AstraZeneca. Earlier, US President Donald Trump said that the COVID-19 vaccine could be ready in the US by the day of the presidential election on November 3.
It is noted that Hahn is willing to circumvent the established process of approving the vaccine, but not to please Trump.
“It depends on the sponsor (the vaccine developer) whether to apply for authorization or approval, and we make an expert opinion on their application. If they do this before the end of the third phase, we may consider it justified. We may consider it unjustified, and we will make a decision,” Hahn said.
Hahn noted that there is a safe way to make the vaccine available to the public before the end of trials, for example, by issuing emergency permits for its use only by certain groups.
“Our emergency authorization does not amount to broad approval. The legal, medical, and scientific standard for this – the benefits outweigh the risks in a public health emergency,” he said.
“This will not be a political decision,” Hahn added.