Building on the previous June guidance, the document provides more information on the EUA process for investigational vaccines, including what data will be required regarding the chemistry, manufacturing and controls information, nonclinical and clinical data, and regulatory and administrative information.
While the EUA process is different from the standard drug approval process, the FDA explains that vaccine developers will still be required to submit data demonstrating the safety and effectiveness of investigational COVID-19 vaccines for EUA.
The guidance stated that vaccine candidates will be evaluated for the totality of data and evidence provided. Vaccines must have adequate manufacturing information in terms of quality and consistency, and the benefit of vaccines must outweigh their risks, as evidenced by at least one well-designed phase III clinical trial.
The agency will accept EUA requests based on interim analysis of a clinical endpoint from a phase III efficacy study, given that safety can adequately be assessed from phase I and II studies. In addition, data from phase III studies should include an average follow-up period of at least two months after completion of the full vaccination regimen. The FDA would expect that sponsors continue to collect data in ongoing clinical trials following submission and issuance of any EUA.
The FDA recommends that vaccine sponsors contact the Center for Biologics Evaluation and Research (CBER) Office of Vaccine Research and Review and the Office of Compliance and Biologics Quality, Division of Manufacturing and Product Quality as early and often as possible.
The FDA plans to hold an open session of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) prior to issuing any EUA for COVID-19 vaccines. This is currently scheduled for October 22 to discuss general development, authorization, and/or licensure of COVID-19 vaccines. While this meeting is not intended to discuss specific candidates, the agency noted that it will rapidly schedule additional future meetings with sponsors after submission of any BLA or request for EUA.
The FDA's guidance was released amid concerns about politicization of the review process for COVID-19 vaccines, with election day less than a month away. President Donald Trump has predicted that a vaccine would be available by election day, but most political observers believe that the new FDA rules almost certainly would push any approval past that point.
"The FDA's new guidance on emergency use authorization of COVID-19 vaccines underscores that commitment by further outlining the process and recommended scientific data and information that would support an emergency use authorization decision," said Dr. Peter Marks, PhD, director of CBER. "In addition to outlining our expectations for vaccine sponsors, we also hope the agency's guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved."
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