Source : 'The Pink Sheet'
The US Food and Drug Administration expects coronavirus vaccine sponsors to begin preparing for an advisory committee meeting before their emergency use authorization request is even filed in order to comply with compressed assessment timelines.
New guidance indicates that sponsors should include “briefing materials summarizing data to support the safety and effectiveness of the vaccine to be considered at the open session” of the Vaccines and Related Biological Products Advisory Committee meeting with an EUA request. Separate briefing materials on manufacturing issues also should be submitted for a closed session, if necessary.
The recommendation for briefing package preparation is much sooner than the traditional application assessment timeline, but is intended to allow for as fast an assessment as possible. The agency wrote in the guidance that including “fully releasable” briefing materials will further facilitate “timely consideration of the EUA request by the VRBPAC.”
Norman Baylor, president and CEO of Biologics Consulting and a former director of the FDA Center for Biologics Evaluation and Research’s Office of Vaccines Research and Review, told the Pink Sheet that the requirement increases the burden on sponsors because they will have to do more in less time. But he also said it should have been expected.
Baylor said the timing of the submission is tight, “but it’s doable in my opinion.”
Further complicating the work is the fact that information that may be needed for the briefing package may not be ready upon application submission.
“They will have to provide as much as they can,” Baylor said. “There will be some information they don’t have.”
Given the pressure on the FDA to make a coronavirus vaccine available as soon as possible, agency and sponsor timelines are being shortened. The FDA in particular is expected to need only weeks to consider an EUA request, as opposed to the months that would be necessary for a BLA assessment. (See box for more coverage of the guidance.)
Manufacturing timelines also have been expedited, as the US government funded multiple vaccine sponsors to begin production of their vaccines at-risk, well before clinical trials were completed, to ensure successful products can be distributed as soon as possible. ("Novavax Push For COVID-19 Vaccine Manufacturing Capacity Delays Flu Vaccine Application" "Pink Sheet" )
The FDA intends to convene advisory committee meetings for the vaccine candidates that arrive prior to making decisions on granting an EUA or full licensure. The VRBPAC will meet 22 October to discuss general development and approval issues. ("Televise the COVID-19 Vaccine Advisory Committee Meetings" "Pink Sheet" )
Advisory committee briefing packages are intended to give the sponsor and FDA interpretations of the data and risk-benefit calculus. Both documents are made public at least two business days before the meeting.
Typically, advisory committee preparation begins well after an application is submitted. FDA advisory committee meeting guidance states that the agency will notify the sponsor that an issue will require advisory committee input 55 business days before the meeting date.
Briefing materials that do not require redaction should be submitted 22 business days before the meeting date to allow agency officials to review the documents for completeness and ensure they are appropriate for disclosure.
Baylor said that many coronavirus vaccine sponsors likely already are working on portions of the briefing document. The packages can number in the hundreds of pages and Baylor said they take time to write.
“No matter what, it’s a lot of work on both ends to get this done,” he said.
Unlike the traditional assessment process, the agency does not appear interested in engaging in back-and-forth discussions with sponsors about portions of the briefing document that should be made public or redacted.
A closed session may be necessary if the VRBPAC looks at proprietary CMC issues and would require a separate briefing package. Baylor said since some candidates are being developed using novel platforms, there may be questions about facility inspections and related topics.
Pfizer Inc. and partner BioNTech SE, as well as Moderna, Inc., are developing vaccines using novel mRNA technology. Both are expected to be among the first to file for an EUA or licensure. ("EUA For COVID-19 Vaccine Would Mean Fewer Patient-Years Of Follow-Up But More Pharmacovigilance" "Pink Sheet" )
Sponsors do not need to submit publications with their advisory committee briefing materials. However, briefing packages should include a reference section listing the publications, according to the guidance.
Agency officials also asked for primary and alternative contacts for advisory committee issues, as well as a searchable electronic list of investigators “and the clinical data sites for all clinical trials supporting the submission.”
In addition, the agency wants a list of all presenters and others who will represent the sponsor during the VRBPAC meeting, along with their affiliations. Those include experts who may be answering committee members’ questions “and/or sitting in the sponsor/industry section at the meeting,” according to the guidance.
Of course, the upcoming VRBPAC meetings likely will be virtual, meaning there will be no sponsor section like with in-person sessions. However, listing everyone who could potentially be dialed into the session could be cumbersome.
Copies of speakers’ presentation and back-up slides should be provided five business days before the advisory committee meeting. They will be posted on the FDA website along with other meeting materials, the agency said in the guidance.
The FDA has conducted several virtual public hearings and advisory committee meetings since the pandemic began and best practices already are emerging. ("US FDA Sponsors Eye Best Practices For Virtual AdComms" "Pink Sheet" )
By Derrick Gingery