The U.S. Food and Drug Administration is providing licensure guidance for those companies and organizations developing COVID-19 vaccines.
The guidance, called the “Development and Licensure of Vaccines to Prevent COVID-19,” provides an overview of key considerations to satisfy requirements for chemistry, manufacturing and control, nonclinical and clinical data through development and licensure, and for post-licensure safety evaluation.
“We recognize the urgent need to develop a safe and effective vaccine to prevent COVID-19 and continue to work collaboratively with industry, researchers, as well as federal, domestic, and international partners to accelerate these efforts. While the FDA is committed to expediting this work, we will not cut corners in our decisions and are making clear through this guidance what data should be submitted to meet our regulatory standards. This is particularly important, as we know that some people are skeptical of vaccine development efforts,” FDA Commissioner Stephen Hahn said. “We have not lost sight of our responsibility to the American people to maintain our regulatory independence and ensure our decisions related to all medical products, including COVID-19 vaccines, are based on science and the available data. This is a commitment that the American public can have confidence in and one that I will continue to uphold.”
The FDA strongly encourages the inclusion of diverse populations in all phases of clinical development, including populations most affected by COVID-19. Further, the guidance discusses the importance of ensuring that the sizes of clinical trials are large enough to demonstrate the safety and effectiveness of a vaccine. The FDA would expect that a COVID-19 vaccine would prevent disease or decrease its severity in at least 50 percent of people who are vaccinated.
The guidance also says consideration may be given to the FDA’s Accelerated Approval pathway for vaccine licensure. However, identification of an immune response or another measure that is reasonably likely to predict clinical benefit would be needed for a specific vaccine candidate to use this pathway. It also addresses considerations regarding Emergency Use Authorization (EUA) of an investigational vaccine – making clear that an assessment regarding any potential EUA for a COVID-19 vaccine would be made on a case-by-case basis considering various factors.
“In this particular crisis in which there is so much at stake, we need to help expedite vaccine development as much as we can without sacrificing our standards for quality, safety, and efficacy. We firmly believe that transparency regarding the FDA’s current thinking about the scientific data needed to support approval of safe and effective COVID-19 vaccines will help build public confidence in the FDA’s evaluation process, which will be critical in ensuring their use,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said. “Right now, neither the FDA nor the scientific community can predict how quickly data will be generated from vaccine clinical trials. Once data are generated, the agency is committed to thoroughly and expeditiously evaluating it all. But make no mistake: the FDA will only approve or make available a COVID-19 vaccine if we determine that it meets the high standards that people have come to expect of the agency.”