Marks, Hahn confirm COVID vaccine EUA guidance coming

Regulatory NewsRegulatory News | 11 September 2020 |  By 

The US Food and Drug Administration (FDA) will soon issue guidance on the data needed to support an emergency use authorization (EUA) for a vaccine to prevent coronavirus disease (COVID-19) according to Center for Biologics Evaluation and Research (CBER) Director Peter Marks.
Speaking at an event hosted by the Duke Margolis Center for Health Policy on Thursday, Marks hinted that additional guidance on EUAs for COVID-19 vaccines would be coming soon.
“You may want to stay tuned for that,” Marks said. “Those interested might want to check back frequently on our website and our guidance agenda for CBER.” Later, FDA Commissioner Stephen Hahn confirmed the planned guidance on Twitter, tweeting that the guidance will build on the agency’s previous guidance on COVID-19 vaccine development. (RELATED: FDA issues COVID-19 vaccine guidance, setting 50% effectiveness threshold, Regulatory Focus 30 June 2020).
Marks also explained that while an EUA for a COVID-19 vaccine would not require all the data elements that would normally be required for a biologics license application (BLA), the amount of information on safety and effectiveness needed will be, “Similar to those that would be appropriate for a BLA.”
“It’s going to really be like an emergency use authorization plus,” Marks said, noting that, “The substantial information about efficacy and the most important information regarding safety will be there.”
While FDA’s guidance on developing vaccines for COVID-19 calls for at least one year of follow-up of study participants, Marks pointed out that, “Most of the adverse events that will occur after vaccination will occur in a timeframe of about a month and a half after vaccination.” Marks added that FDA will require a pharmacovigilance plan for long-term safety monitoring for any vaccine, whether it receives full BLA approval or an EUA.
“At the time of an emergency use authorization, there will be efficacy data that’s met an interim analysis endpoint and we’d have safety data that would be sufficient on a large number of people,” Marks said. “It’s not exactly what we would have if we had six months or 12 months or the full two years of follow up, but it’s close enough.”
Marks also said that FDA will convene an advisory committee meeting for any vaccine under review, whether the applicant is seeking a BLA or EUA.
“Any vaccine that we issue an emergency use authorization for will go to a public advisory committee meeting, we have committed to that … because that public process is going to be critical,” he said. In an FDA Voices article posted Friday, Hahn and Marks confirm that FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet to review any BLA submissions or requests for EUAs.
As for what population an EUA would cover, “It would be issued in the population that makes sense based on the population that was studied,” Marks said, noting that discussions are underway at the Centers for Disease Control and Prevention, in consultation with the National Academies, as to how an eventual vaccine will be allocated.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy