How the Center for Biologics Evaluation and Research regulates vaccines in the United States.
The Center for Biologics Evaluation and Research (CBER) is the branch of the U.S. Food and Drug Administration (FDA) responsible for ensuring the safety, efficacy, and quality of biologics, including vaccines. CBER regulates vaccines under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.
CBER is led by the Director and comprises several offices responsible for different aspects of biologic regulation:
When a vaccine manufacturer seeks approval, CBER conducts a comprehensive review:
| Feature | BLA (Full Approval) | EUA (Emergency Use Authorization) |
|---|---|---|
| Legal Basis | Federal Food, Drug, and Cosmetic Act + Public Health Service Act | Section 564 of the FD&C Act, during a declared public health emergency |
| Required Data | Complete Phase 1, 2, and 3 clinical trial data, manufacturing quality data, full chemistry review | Available safety and efficacy data sufficient to conclude benefits outweigh risks for intended use |
| Review Timeline | Typically 10-12 months for standard review | Weeks to months, depending on available data |
| Legal Duration | Indefinite once licensed | Duration of the declared emergency, unless revoked or converted to BLA |
| Post-market Requirements | Standard post-market surveillance and reporting | Additional conditions may apply, including enhanced adverse event monitoring |
| Liability Framework | VICP (Vaccine Injury Compensation Program) for routine childhood vaccines | PREP Act / CICP (Countermeasures Injury Compensation Program) |
The distinction between approval and authorization became a major source of public debate during COVID-19 vaccination. Some viewed EUA products as having a different evidentiary foundation than traditionally licensed vaccines, while others argued the emergency context justified an expedited regulatory review.
The evidentiary threshold for EUA differs from a BLA, but it is not absent. An EUA still requires clinical trial data demonstrating safety and efficacy. The difference is primarily in the volume of long-term follow-up data available at the time of authorization and the condensed duration of the review process. A product authorized under EUA meets the emergency evidentiary criteria for its intended use, while a licensed product meets the statutory requirements for BLA licensure.
COVID-19 vaccines initially authorized under EUA subsequently received full BLA approval as longer-term data accumulated. For example, the Pfizer-BioNTech vaccine received BLA approval in August 2021, followed by Moderna in January 2022.
For information on how the authorization pathway affects liability protections, see PREP Act & Liability.
CBER often convenes advisory committees to provide independent expert advice:
CBER has broad authority to enforce regulatory standards: