FDA Chief Says He Supports Fast-Tracking Coronavirus Vaccine If ‘Appropriate’

Food and Drug Administration (FDA) Commissioner Stephen Hahn said in a new interview that he is willing to fast-track a coronavirus vaccine before clinical trials are complete if it is determined to be “appropriate.”

Hahn stressed politics would play no part in such a move, telling the Financial Times that “this is going to be a science, medicine, data decision.”

“It is up to the sponsor [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application,” Hahn told the newspaper while discussing scenarios in which the FDA grants vaccine approval. “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.”

The comments came as drug manufacturers around the world work to develop a vaccine to protect people from the coronavirus, which has infected nearly 6 million people in the U.S and accounted for more than 182,000 deaths.

Firms including Moderna, AstraZeneca and Pfizer have developed candidates that are now in phase three clinical trials. Novavax, a firm based in Maryland, began phase two tests earlier this month after early trials showed positive signs.

Health experts including Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases, have expressed cautious optimism that a vaccine will be ready by the end of the year. However, some in the medical community have voiced concerns that the Trump administration could move too quickly on treatment options after the president claimed the FDA was making it more difficult for drug companies to test vaccines and therapeutics.

Hahn said that granting a vaccine approval before phase three trials are complete could be done in a safe and effective way. He noted an emergency use authorization could be given for people in certain groups.

“Our emergency use authorization is not the same as a full approval,” he told the Financial Times. “The legal, medical and scientific standard for that is that the benefit outweighs the risk in a public health emergency.”

He acknowledged that the coronavirus pandemic is taking place amid a “political season,” adding, however, that “we’re just going to have to get through that and stick to our core principles.”

President Trump last week announced an emergency use authorization for convalescent plasma from recovered COVID-19 patients to treat current patients. The announcement triggered scrutiny from health experts and Democratic lawmakers, and Hahn later clarified some of the remarks he made about the data linked to the treatment.

Fauci, a key member of the White House coronavirus task force, has repeatedly pushed for a patient approach when it comes to a vaccine. He noted earlier this month that distributing emergency use authorization (EUA) for a vaccine could have drawbacks.

“The one thing that you would not want to see with a vaccine is getting an EUA before you have a signal of efficacy,” Fauci said. “One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial.”


Source Link