CBER Issues Guidance on Datasets for Vaccine Applications

The FDA’s Center for Biologics Evaluation and Research published guidance on information to include in biologics license application datasets, including data on clinical trial endpoints and adverse events.

When clinical disease endpoint efficacy is an objective in the trial, the efficacy data should be primarily reported in the clinical event domain with specific information in the microbiology specimen, vital signs and physical exam domain as necessary, the agency said.

Domains to include from clinical trials in dataset submissions include the trial summary, demographics, subject visits, concomitant medications, exposure, disposition, protocol deviations and medical history, as well as physical exam information and laboratory test results, if applicable.

If laboratory results are outside of the normal range for a particular assessment, it should be reported with the highest level included.