COVID-19 Vaccine Developers Don’t Need Pre-Approval Inspections for Emergency Use

The FDA will not make COVID-19 vaccine developers go through pre-approval inspections for an Emergency Use Authorization (EUA), but companies will have to submit detailed manufacturing data and meet certain other requirements, said a senior official in the Center for Biologics Evaluation and Research (CBER).

The agency is taking measures during the pandemic to review vaccine EUA applications when on-site facility inspections aren’t possible, including reviewing previous compliance history and asking for records in advance or in lieu of on-site inspections, explained Jerry Weir, director of CBER’s Division of Viral Products, during last week’s meeting of the agency’s Vaccines Advisory Committee.

He said the agency expects companies to include full manufacturing process details in their EUA submissions. That data should be submitted in advance of an EUA request, he said, and any chemistry, manufacturing and controls (CMC) data that won’t be available at the time of EUA issuance needs to be discussed “in advance, sufficiently justified and judged to have minimal impact on product quality.”

To enable FDA to conduct a meaningful review, an EUA request for a COVID-19 vaccine “must include CMC data, identification of the manufacturing sites and information with respect to current good manufacturing practices (GMP),” Weir said.  “It is critical that adequate manufacturing information be provided to ensure the quality and consistency of EUA vaccines.”

For example, drugmakers will need to include a history of process development that details all changes incorporated into the manufacturing process and include information that documents adequate control of all source material. They will also need to establish a quality control system for all manufacturing stages, Weir said.

The FDA also expects companies to validate their manufacturing process, including data to support its consistency across all manufacturing facilities. Further, the agency expects them to establish a quality control unit and demonstrate that quality release tests, including key tests for vaccine purity, identity and potency, are validated and suitable for their intended purposes.

Drugmakers must additionally establish a comprehensive stability program and comply with all applicable manufacturing facility standards, such as the validation of major utilities, the qualification of all equipment, and the validation of aseptic, cleaning and sterilization processes.

Keith Webber, a former official with CBER and the Center for Drug Evaluation and Research (CDER), advised during an Oct. 20 FDAnews webinar on the FDA’s COVID-19 guidances that biologics facilities should still be ready for inspection at the time companies submit their applications. — James Miessler