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US FDA Expects COVID-19 Vaccine To Meet ‘EUA Plus’ Standards, Marks Says

US FDA Expects COVID-19 Vaccine To Meet ‘EUA Plus’ Standards, Marks Says

Source : 'The Pink Sheet'

Center for Biologics Evaluation and Research Director Peter Marks confirmed that the US Food and Drug Administration likely will employ the emergency use authorization pathway to make a coronavirus vaccine available, but with the more stringent safety and efficacy standards typical for full licensure.

Marks characterized the approach as “emergency use authorization plus” during a 10 September virtual Duke-Margolis Center for Health Policy meeting on safe and effective COVID-19 vaccination. He said that if an EUA allows for a relatively low evidentiary bar, and a BLA requires a substantial level of evidence, the goal is for the coronavirus vaccine data package be closer to a BLA.

CBER Director Peter Marks

“Along that spectrum it’s going to be closer to the BLA even if it’s not exactly identical,” Marks said. “The amount of manufacturing information, the amount of secondary analyses, data tables, administrative work, conformance, ... the length of the safety follow-up, all of that for a typical license application won’t be there at the time. But the substantial information about efficacy and the most important information regarding safety will be there.” 

The comments are another clarification of FDA’s thinking with several vaccine candidates moving through Phase III clinical trials and questions still swirling about public confidence in any product that could be made available.

Stakeholders worry about polling suggesting a significant amount of the population may not get a coronavirus vaccine because it is perceived as being rushed to market, as well as White House influence of the process. Nine vaccine makers publicly pledged to wait until Phase III clinical trials are completed to submit an application in part to calm those fears. ("COVID-19 Vaccine Sponsors Pledge To Wait For Phase III Helps US FDA" "Pink Sheet" )

Marks said that for FDA to grant an EUA, a vaccine candidate will have enough efficacy data to meet an interim analysis endpoint, as well as enough safety data so that agency assessors are reasonably confident in the adverse event profile. On the safety side, he said the agency is hoping for a median of two months of follow-up on study subjects.

“It’s not exactly what we would have if we had had six months or 12 months or the full two years of follow-up, but it’s close enough and closer to the side of a biologics license application than it is to the emergency use authorization standard,” he said.

Marion Gruber, director of the CBER Office of Vaccines Research and Review, said during the meeting that manufacturers already are sending data packages to agency officials, and assessors are pointing out information gaps to be corrected when an EUA or BLA package would be submitted.

CBER Office of Vaccines Research and Review Director Marion Gruber

Former FDA Commissioner Scott Gottlieb has predicted that a staged EUA likely would be used to gradually roll out a coronavirus vaccine, perhaps first authorizing it for at-risk patients and health care workers, and then expanding the target population as more data is generated. ("Gottlieb Staged Access To Coronavirus Vaccine Possible Through EUA" "Pink Sheet" )

CBER is also working on additional guidance on the EUA process. When asked whether a document would be issued, Marks suggested stakeholders stay tuned and check the center’s website frequently.

The agency posted a same-day update to the CBER guidance agenda, which now includes an “Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry” document. “We intend to ... provide recommendations regarding the data and information needed to support the issuance of an EUA for vaccines to prevent COVID-19,” the agenda states.

The agenda also still lists a pending document on “Development and Licensure of Vaccines to Prevent COVID-19,” which was the title of the guidance issued on 30 June. It is unclear whether an update is planned.

That guidance document – hailed for including a minimal efficacy threshold for development of coronavirus vaccines – describes the possibility of an EUA once safety and efficacy are demonstrated and adequate manufacturing information is available. ("COVID19 Vaccine Should Demonstrate At Least 50 Effectiveness US FDA Says" "Pink Sheet" )

Marks and FDA Commissioner Stephen Hahn also pledged to conducting product-specific advisory committee meetings when vaccine candidates are received.

“We have committed to that, and we’ve committed to doing it timely for anyone that comes in because that public process is going to be critical,” Marks said.

The agency already has scheduled a Vaccines and Related Biological Products Advisory Committee meeting for 22 October to discuss general issues related to coronavirus vaccine development and approval. ("COVID-19 Vaccine Advisory Committee May Help Determine US FDA Approach To Licensure" "Pink Sheet" )

Hahn, who had previously said that the agency would schedule product-specific advisory committee meetings “as appropriate,” remarked during a same-day event sponsored by The Economic Club of Washington DC that “if we get a vaccine application outside of that timeframe [of the 22 October meeting], we will arrange for additional vaccine advisory committee meetings to look at the specific data on that application.”

Sarah Karlin-Smith contributed to this report.

By Derrick Gingery