FDA head open to fast-tracking COVID-19 vaccine if "appropriate"

FDA Commissioner Stephen Hahn indicated that he would be willing to consider granting emergency authorisation for a vaccine against SARS-CoV-2 before clinical trials have been completed if the benefits outweigh the risks. "It is up to the [vaccine developer] to apply for authorisation or approval, and we make an adjudication of their application," Hahn said, adding that "if they do that before the end of Phase III, we may find that appropriate. We may find that inappropriate, we will make a determination."

However, he insisted that the agency would not be pressured to rush out a vaccine by the Trump administration. "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," Hahn said, noting "this is going to be a science, medicine, data decision. This is not going to be a political decision."

Convalescent plasma controversy

President Donald Trump implied recently that some people at the FDA were trying to delay approvals of potential COVID-19 treatments and vaccines in an effort to hurt his re-election chances this coming November. Shortly after Trump made the claims, the FDA issued an emergency authorisation for convalescent plasma as a potential treatment for COVID-19 despite a group of senior US health officials reportedly concerned that emerging data on the treatment were too weak.

Meanwhile, Hahn stirred controversy when at the press conference announcing the authorisation, he overstated the benefits of the therapy and had his remarks echoed by others in the US administration. The commissioner later walked back his remarks, saying he deserved the criticism and that he should have been clearer that "the data show a relative risk reduction not an absolute risk reduction."

Anthony Fauci, head of the US National Institute of Allergy and Infectious Diseases and a member of the White House coronavirus task force, has warned of the risks of applying political pressure on the FDA to extend emergency-use authorisation for a COVID-19 vaccine before there was a "signal of efficacy." Companies including Moderna, AstraZeneca, Johnson & Johnson and a partnership between Pfizer and BioNTech have developed COVID-19 vaccine candidates that are either now in or about to begin Phase III trials.

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