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The guidance document provides recommendations regarding data needed for the manufacturing, development, and approval of a COVID-19 vaccine.
Editor's note: This article has been updated to include FDA's vaccine efficacy requirements.
FDA published guidance on June 30, 2020 providing industry with recommendations regarding the data that are needed in the development, manufacture, and approval of a vaccine for COVID-19. Development and Licensure of Vaccines to Prevent COVID-19 presents requirements for chemistry, manufacturing, and control and nonclinical data and clinical data needed for the development and licensure, as well as post-licensure, of COVID-19 vaccines. The agency stresses that the goal of development programs should be to support traditional FDA approval and conduct studies to evaluate the ability of a vaccine to protect against SARS-CoV-2.
The guidance states, "to ensure that a widely deployed COVID-19 vaccine is effective, the primary efficacy endpoint point estimate for a placebo-controlled efficacy trial should be at least 50%, and the statistical success criterion should be that the lower bound of the appropriately alpha-adjusted confidence interval around the primary efficacy endpoint point estimate is >30%."
Diverse populations should be included in all phases of clinical development, including those most affected by COVID-19, racial and ethnic minorities, elderly individuals, and people with medical comorbidities, according to the agency. Studies that provide data to support use during pregnancy and pediatric assessments are encouraged. The guidance states that consideration may be given to the agency’s Accelerated Approval pathway for licensure as more information is learned about the virus. Emergency Use Authorization (EUA) is also discussed in the guidance, stating that EUA for a COVID-19 vaccine would be made on a case-by-case basis
“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,” said FDA Commissioner Stephen M. Hahn, MD in a press release. “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.”
“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,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a press release. “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.”