FDA Chief Floats Idea Of Fast-Track Approval For Eventual Vaccine

The head of the Food and Drug Administration (FDA) says he could fast-track a coronavirus vaccine once one is created – even before Phase Three clinical trials end.

FDA Commissioner Stephen Hahn told the Financial Times on Sunday that he could make the move if officials are sure that the benefits of the vaccine outweigh the risks.

“It is up to the [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application,” Hahn told the outlet. “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 also said if he does so, it will be based solely on scientific data, not political pressure. “This is going to be a science, medicine, data decision,” Hahn said. “This is not going to be a political decision.”

Three pharmaceuticals — AstraZeneca, which is partnering with Oxford University in England; Moderna, collaborating with the US National Institutes of Health, and the Pfizer/BioNTech alliance — are currently in Phase 3 trials.

But the trials, which include half taking the vaccine and half taking placebo, usually take months.

AstraZeneca might be granted an emergency use authorization by the Food and Drug Administration (FDA) for a COVID-19 vaccine, according to another report last week from The Times.

The vaccine, being developed by AstraZeneca and Oxford University, could receive authorization as early as October, the UK paper reported.

“The Trump administration is considering bypassing normal US regulatory standards to fast-track an experimental coronavirus vaccine from the UK for use in America ahead of the presidential election, according to three people briefed on the plan,” The Times reported. “One option being explored to speed up the availability of a vaccine would involve the US Food and Drug Administration awarding ’emergency use authorisation’ (EUA) in October to a vaccine being developed in a partnership between AstraZeneca and Oxford university, based on the results from a relatively small UK study if it is successful, the people said.”

But Fortune reported that “AstraZeneca says it has held no discussions with the U.S. government about emergency authorization for the COVID-19 vaccine it is manufacturing.”

That vaccine is still undergoing late stage human clinical trials in several sites around the world, including in the U.K. and the U.S., making a rapid approval under the criteria the U.S. Food and Drug Administration has established so far a long shot.

Other vaccines are in the testing stage, as well. The world’s largest COVID-19 vaccine study in the world began early this month, with the first of 30,000 Americans volunteering to take the shots. The experimental vaccine, developed by the National Institutes of Health (NIH) and Moderna Inc., is in phase three of the development process, which includes tests at clinical sites across the country.

Meanwhile, Russia said last week that it had approved a vaccine for COVID-19, becoming the first nation in the world to mark the achievement.

President Vladimir Putin, who announced the approval of the vaccine, said one of his two adult daughters has already been inoculated. Putin also said the vaccine underwent all tests to show its effectiveness, although Russian officials offered no data to back up his claim. The approval was granted by Russian health officials after just two months of human testing, Reuters reported.

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