Convergence: FDA officials on future COVID vaccine updates, remote inspections and hiring

Regulatory NewsRegulatory News | 14 September 2022 |  By 

PHOENIX, AZ – The US Food and Drug Administration would like to adopt an annual update process for the COVID-19 vaccine, according to Peter Marks, director of the Center for Biologics Evaluation and Research (CBER). Such a process he said will help health officials, manufacturers and others better coordinate efforts to fight the SARS-CoV-2 virus as it evolves.
 
Speaking on a panel alongside other FDA officials including Peter Stein, director of the Office of New Drugs at the Center for Drug Evaluation and Research (CDER), and Christopher Joneckis, CBER associate director for review management, Marks was asked about whether FDA is talking to COVID-19 vaccine developers about developing an annual vaccine update process, or if they are still addressing new variants on an ad hoc basis.
 
Marks prefaced his answer by saying FDA has been wrong in the past about the coronavirus, but he hopes that they understand enough about it to set up a process for future booster development.
 
“It's easy to be wrong, but I think what we're hoping is this is a transitional year,” said Marks. “I was on a call with some global colleagues earlier and I think tentatively everyone is hoping that we're able to move towards an annual process.”
 
Last month, FDA authorized bivalent boosters that incorporate components of the BA.4/5 lineage and the original strain based on data from nonclinical studies, a clinical study of a bivalent BA.1-targetted vaccine, and the “totality of available evidence” for the mRNA shots.
 
Marks said he hopes that over the next year public health officials will be able to consolidate the primary series and booster into either being bivalent vaccines or a single composition. By the summer of 2023, he said he hopes that the next composition will be settled on.
 
“The problem is that we still don't know exactly how this will pan out,” Marks cautioned. “I think we have to also be ready to react.”
 
Ideally, Marks said that FDA would like for the COVID-19 vaccine to go through an annual update process because it would give public health officials the most organized way to work together across borders, leverage manufacturing and address other issues.
 
Meetings
 
The FDA officials were also asked about when companies can expect to get back to having face-to-face meetings with agency officials.
 
“We don't have a timeline and we've heard from many of our industry colleagues that the virtual meetings have actually been quite effective,” said Stein.
 
Stein added that FDA officials are discussing when it will be appropriate to resume face-to-face meetings with industry and no longer see COVID-19 as a barrier to hold such meetings. While they don’t have a timeline yet, he urged people to keep checking back with the agency.
 
“I'm sure we'll be talking about that more and there will be more information to come,” said Stein.
 
The FDA officials were also asked what they foresee this year and beyond in terms of remote inspections and assessments of manufacturing facilities and research centers.
 
“Our thoughts here are that that there will be a time and a place for in-person inspections and for remote inspections,” said Marks.
 
As an example, he noted that there are significant benefits for FDA staff to go inspect a vaccine manufacturing facility initially to see first-hand how products are being made. Inversely, he said that if inspectors have already been to a facility in Asia before and simply need to do a surveillance inspection it makes more sense to do remote inspections to ensure their products are compliant.
 
Stein said that CDER holds similar views, and noted that the agency’s ability to do in-person inspections over the past few years has been up and down as various COVID-19 surges impacted travel.
 
“Remote inspections have really filled a gap and have been very effective, and I think we'll probably continue to utilize those as we've been able to do more in-person inspections,” he said. “There are situations where we've been unable to use remote inspections or inspections where a remote review is done and clearly indicated the need for an on-site inspection.”
 
Joneckis also noted that FDA is committed to looking at various types of inspection tools as the agency is mandated under the Prescription Drug User Fee Act (PDUFA VII) agreement to publish a draft guidance by September 2023 on the use of alternative inspection tools.
 
Attendees also asked the agency is considering hiring more geographically diverse staff, especially considering the agency has allowed staff to work remotely. They also asked how long it will take the agency to get to the staffing level set in the PDUFA VII, which has yet to be enacted by Congress.
 
Marks said while it will take longer than he would like to hit staffing levels, though it is one of the agency’s highest priorities after the pandemic. He’s optimistic that FDA will be able to ramp up hiring, partly because the agency is now more open to hiring people beyond the Washington, DC metro.
 
“The pandemic has been terrible in so many ways, but the fact is that it has freed us a little bit from our centricity in the in the DC, Maryland, Virginia area for getting expertise,” he said. “It may be helpful here because it may help us to be able to staff up somewhat more quickly than we would be otherwise.”

 

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