Regulatory Focus™ > News Articles > 2020 > 10 > Marks sheds more light on COVID-19 vaccine EUA guidance

Marks sheds more light on COVID-19 vaccine EUA guidance

Posted 08 October 2020 | By Michael Mezher 

Marks sheds more light on COVID-19 vaccine EUA guidance

Two days after the US Food and Drug Administration’s (FDA) surprise publication of guidance setting criteria for emergency use authorization (EUA) for COVID-19 vaccines, Peter Marks, director of the Center for Biologics Evaluation and Research shared some of the thought process that went in to its recommendations.
One of the most significant recommendations in the guidance is FDA’s insistence on a median of two months of follow-up of Phase 3 trial participants following their last dose. The recommendation has been seen by some as pushing a potential EUA beyond the November election and seeking to provide more confidence in the safety of an authorized vaccine. (RELATED: FDA issues COVID-19 vaccine EUA guidance after clash with White House, Regulatory Focus 6 October 2020).
Speaking at the Food and Drug Law Institute’s annual conference, Marks explained that FDA settled on a median of two months because that would provide data on enough patients for enough time to be able to observe most of the events that concern the agency.
“What are the bad things that tend to happen after vaccination? They’re things like Guillain-Barré syndrome, transverse myelitis, vasculitis…. Those things tend to show up within about six-weeks to two-months after vaccination,” Marks said. “We picked a number where the bulk of people might be past that point and we felt that two-months median follow-up was reasonable because of the size of these trials.”
Marks also said that FDA normally prefers to have at least 3,000 patients in the safety data set, and the two-month median timeframe makes it very likely for there to be at least that many patients who are more than two months out from receiving their last dose.
“It’s not perfect and because of that, whether it’s a [biologics license application (BLA)] or EUA, we’ll have post-deployment safety surveillance monitoring because we want to continue to capture those data,” Marks added, noting that the agency is trying to create a balance between saving lives and characterizing potential adverse events.
The guidance also confirmed that FDA plans to convene its Vaccines and Related Biological Products Advisory Committee to review any COVID-19 vaccine EUAs or BLAs.
An advisory committee meeting would be needed for each subsequent vaccine, “because with each new vaccine that comes on the scene for us, there’s going to be some real question,” Marks said. For example, will the next one “have similar efficacy [or] different efficacy, will it be useful in the same population as the first vaccine or a different population?”
He emphasized the importance of transparency in the process to strengthen public confidence. “We to make sure that the public sees the process that’s going on here, that they understand the pros and cons [because] at some point, some of them have to make a decision: ‘What vaccine do I want?’”
At a vaccine symposium hosted by Johns Hopkins University and University of Washington on Tuesday shortly after FDA released its guidance, former-FDA Commissioner Scott Gottlieb stressed that he thinks vaccine developers will adhere to FDA’s recommendations.
“The sponsors are going to adhere to [the guidance], because the most important thing here from the drugmakers’ perspective, and I think for the public health purpose, is public affirmation of the FDA role in this process. I can’t imagine a circumstance where a sponsor should or would challenge or seek to undermine the FDA’s role here,” Gottlieb said.
Marks, who also spoke at the event, explained how FDA could force drugmakers to be transparent about safety issues in a clinical trial for a COVID-19 vaccine.
“We would encourage any manufacturer of a vaccine … to be as transparent as possible about what is going on here within the realm of keeping the privacy of those enrolled in the trial,” Marks said.
Marks added that if a sponsor were not being adequately transparent, FDA can issue a “Commissioner’s finding where we can make known safety information that would normally be kept secret under an investigational new drug application.”
FDLI Conference


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.