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FDA Will Force Vaccine-Safety Disclosures If Makers Don’t

FDA Threatens to Force Vaccine-Safety Disclosures If Makers Balk

A top Food and Drug Administration official warned vaccine makers that the agency could call upon rarely-used powers to disclose significant safety issues, after being asked about month-old investigation into an experimental Covid-19 shot from by AstraZeneca Plc.

At an online event hosted by Johns Hopkins University and the University of Washington, FDA Center for Biologics Evaluation and Research Director Peter Marks said he “would encourage any manufacturers of a vaccine, any sponsor of a vaccine to be as transparent as possible.”

Marks emphasized that he was not talking specifically about any one company.

He followed up by invoking the potential use of what’s called a commissioner’s finding, a rarely used FDA power by which the agency can announce serious safety concerns on the way to potentially banning use of a product.

“We very rarely, when we are very concerned about a sponsor not being adequately transparent, can have things like a commissioner’s finding where we can make known safety information that would normally be kept secret under an investigational new drug application,” Marks said. “But I would really hope we don’t have to get to those kinds of places here.”

Typically, companies under the FDA’s regulatory powers disclose such information voluntarily, though often with the agency’s encouragement.

A spokeswoman for the FDA declined to immediately comment further.

An AstraZeneca representative didn’t have an immediate comment. On Oct. 2, the company said it was continuing to work with U.S. regulators and that the safety of trial participants was a top priority.

The hold on the final-stage U.S. trial was disclosed in early September after a patient who got the vaccine came down with a rare but serious neurological side effect.

Trials of the vaccine have resumed since then in U.K., Brazil and South Africa, but a major trial remains on hold in the U.S., raising question over whether regulators there have lingering safety concerns. AstraZeneca’s partner, the University of Oxford, has said the patient’s neurological problem was likely not related to the vaccine.

A former FDA official said that if the agency was pushing for disclosure, it could mean that there was an issue with a vaccine that the agency wanted other drugmakers to know about for public-health reasons, such as what could be a broader concern that could be found with other vaccines.

Use of the power is very rare step that would be used only under extraordinary circumstances, said the official, who spoke on condition of anonymity. The official couldn’t recall a time when it had ever been used for a drug or vaccine application.

Vaccine data will be reviewed both by the FDA and in front of an advisory committee, so the public can have confidence in the process, said Marks. “We are going to vet them in a public venue,” he said.

Earlier Tuesday, the FDA released standards for drugmakers to apply for emergency use of a vaccine that will require a median of two months of safety data. While the agency won’t have as wide a range of safety data available for an emergency authorization as it does for a traditional vaccine approval, it won’t sacrifice safety either, Marks said.

“We are not going to allow anything to proceed that we have any significant concerns for safety on,” Marks said.

©2020 Bloomberg L.P.