COVID-19 Vaccines Must Be 50% Effective
The U.S. Food and Drug Administration (FDA) took action today to help facilitate the timely development of safe and effective vaccines to prevent COVID-19 disease.
The FDA issued new guidance with recommendations for those developing COVID-19 vaccines for the ultimate purpose of licensure.
The FDA stated on June 30, 2020, it 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 different technologies such as DNA, RNA, protein, and viral vectored vaccines being developed by commercial vaccine manufacturers and other entities.
“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., in a press statement.
“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 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.
Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, added: “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 new guidance conveys that the FDA would expect that COVID-19 vaccines would prevent disease or decrease its severity in at least 50 percent of people who are vaccinated.
This vaccine’s effectiveness objective is greater than the data reviewed by the annual influenza vaccine.
The U.S. Centers for Disease Control and Prevention (CDC) adjusted vaccine effectiveness estimates for influenza seasons from 2004-2018 indicate a sub-40 percent average.
The FDA 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 measures that is reasonably likely to predict clinical benefit would be needed for a specific vaccine candidate to use 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 is an agency within the U.S. Department of Health and Human Services that protect 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.
COVID-19 vaccine development news published by Precision Vaccinations.