> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Vaccine Makers Could be Forced to be Transparent: Marks
- URL: https://www.fdaweb.com/vaccine-makers-could-be-forced-to-be-transparent-marks/
- Published: 2020-10-07T12:00:00.000Z
- Updated: 2026-09-14T16:31:43.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5147817

CBER director **Peter Marks** says FDA could deploy the rarely-used “commissioner’s finding” to disclose Covid-19 vaccine safety information if such information is not provided by a vaccine manufacturer. Marks addressed the issue when asked about the clinical hold [imposed](https://www.fdaweb.com/astrazeneca-covid-19-trial-stops-over-safety-signal/) in September on an AstraZeneca investigational Covid vaccine. The discussion took place during an online event hosted by Johns Hopkins University and the University of Washington.

*Bloomberg News* [reports](https://www.bloomberg.com/news/articles/2020-10-06/fda-vaccine-head-warns-drugmakers-on-disclosing-safety-issues?ref=fdaweb.com) that Marks emphasized that he was talking in general terms and not about any specific company. “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.”

The *Bloomberg* article says AstraZeneca did not have a comment on Marks’ statement. The company has said it continues to work with U.S. regulators on the clinical hold that was imposed after a patient who was administered the vaccine came down with a rare but serious neurological side effect.

The University of Oxford, AZ’s partner in the vaccine, has said the patient’s neurological problem likely was not related to the vaccine. It also said clinical trials have resumed in the UK, Brazil, and South Africa, while the hold remains in effect in the U.S. *Bloomberg* says the continuing hold may signal that U.S. regulators have ongoing safety concerns.

A former FDA official who spoke with *Bloomberg*anonymously said Marks’ push for disclosure might have meant that there was an issue with a vaccine that the agency wanted other manufacturers to be aware of for public health reasons. That official reportedly could not recall a time when the commissioner’s finding process was used for a drug or vaccine application.

Marks also reiterated that vaccine data will be reviewed both by agency staff and in an open advisory committee meeting so the public could have confidence in the process. “We are going to vet them in a public venue,” he stressed. “We are not going to allow anything to proceed that we have any significant concerns for safety on.”