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# Marks Says Covid Vaccine Makers Know Data Expectations
- URL: https://www.fdaweb.com/marks-says-covid-vaccine-makers-know-data-expectations/
- Published: 2020-09-30T12:00:00.000Z
- Updated: 2026-09-14T16:30:52.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5147776

Despite statements from president Trump that a new guidance from FDA on stricter requirements for Covid-19 vaccine makers will need to be approved by the White House, CBER director **Peter Marks** said 9/29 that vaccine makers already know the guidance’s recommendations about what data are necessary to obtain an emergency use authorization (EUA). Speaking at a Friends of Cancer Research [program](https://www.youtube.com/watch?v=7l9OqA%5FxmT0&t=958s&ref=fdaweb.com), Marks dismissed any perceived political interference as “no there there.” The guidance was an exercise on public transparency, Marks said, adding that it is most important to regain the public’s trust in vaccines. He said that the document was intended to help the public understand that an EUA Covid-19 vaccine data requirements are the “moral equivalent” of what would be required in a BLA.

Last week, [Trump said](https://www.fdaweb.com/trump-may-not-back-new-fda-vaccine-guidance/) the new guidance requirements sound like a political move, “because when you have Pfizer, Johnson & Johnson, Moderna, these great companies coming up with these — the vaccines, and they’ve done testing and everything else, I’m saying, ‘Why would they have to be, you know, adding great length to the process?’” Under the proposed guidance ([see earlier story](https://www.fdaweb.com/tighter-covid-vaccine-approval-standards-coming-report/)), the agency reportedly would ask manufacturers seeking EUA to follow participants in late-stage clinical trials for a median of at least two months starting after they receive a second vaccine shot. And the agency reportedly will also look for at least five severe cases of Covid-19 in the placebo group for each trial, as well as some cases of the disease in older people. The new EUA standards will likely make it next to impossible for a vaccine to be authorized before the election. And once FDA receives a submission, the agency will take weeks and possibly months to review the data, Hahn told a Senate Health Education Labor & Pensions Committee hearing.

During the Friends of Cancer Research program, Marks said any EUA will lack some safety data and the length of follow-up normally expected in a BLA. He said FDA will compensate any lack of safety data with “enhanced pharmacovigilance.” All accumulated data will be “balanced crucially” with the current daily Covid-19 U.S. death toll of about 1,000 Americans. He said the idea of waiting months to put together a BLA and months to review such a submission is not a good public health decision.