"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, M.D. "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."
Vaccines have been highly effective in preventing a range of serious infectious diseases. The FDA has the scientific expertise to evaluate any potential COVID-19 vaccine candidate regardless of the technology used to produce or to administer the vaccine. This includes the different technologies such as DNA, RNA, protein and viral vectored vaccines being developed by commercial vaccine manufacturers and other entities.
"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, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. "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."
The guidance published today, "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. Importantly, given the current understanding of SARS-CoV-2 immunology, the goal of development programs at this time should be to support traditional FDA approval by conducting studies to directly evaluate the ability of the vaccine to protect humans from SARS-CoV-2 infection and/or disease.
The FDA strongly encourages the inclusion of diverse populations in all phases of clinical development, including populations most affected by COVID-19, specifically racial and ethnic minorities, as well as adequate representation in late phase trials of elderly individuals and those with medical comorbidities. Sponsors are also encouraged to include studies in their development plans that would provide data to support use during pregnancy, as well as plan for pediatric assessments of safety and effectiveness.
The guidance also discusses the importance of ensuring that the sizes of clinical trials are large enough to demonstrate the safety and effectiveness of a vaccine. It conveys that the FDA would expect that a COVID-19 vaccine would prevent disease or decrease its severity in at least 50% of people who are vaccinated.
Additionally, after approval by the FDA, the safety of all vaccines, including a COVID-19 vaccine, continues to be closely monitored using various existing surveillance systems. The FDA may also require post-marketing studies to further assess known or potential serious risks.
The guidance also notes that, as more is learned about SARS-CoV-2 immunology and vaccine immune responses, consideration may be given to the FDA’s Accelerated Approval pathway for vaccine licensure. However, identification of an immune response or other measure that is reasonably likely to predict clinical benefit would be needed for a specific vaccine candidate to use of this pathway. Due to the current public health emergency, the guidance 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 the target population, the characteristics of the product, and the totality of the relevant, available scientific evidence, including preclinical and human clinical study data on the product’s safety and effectiveness.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.