The Food and Drug Administration (FDA) has issued guidance to assist in the development and licensure of vaccines for the prevention of coronavirus disease 2019 (COVID-19).

The guidance includes the Agency’s recommendations for satisfying regulatory requirements for approval, including nonclinical and clinical data as well as post-licensure safety evaluation. Currently, COVID-19 vaccine candidates are being developed using multiple technologies including RNA, DNA, protein, and viral vectored vaccines.

As there are no surrogate end points for which to base the effectiveness of a COVID-19 vaccine, the guidance states that “the goal of development programs should be to pursue traditional approval via direct evidence of vaccine safety and efficacy in protecting humans from [severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)] infection and/or clinical disease.”

The FDA also notes that late phase studies should include thousands of participants, including those with comorbidities, in order to generate sufficient data to meet the requirements for the Biologics License Application. Additionally, the Agency recommends the inclusion of individuals with prior SARS-CoV-2 infection in order to investigate the safety of the vaccine in this population. Late phase trials should also be randomized, double blinded, and placebo controlled. 

According to the guidance, an acceptable primary end point for an efficacy trial would either be lab-confirmed COVID-19 or SARS-CoV-2 infection; the vaccine would be expected to prevent disease or decrease its severity in at least 50% of vaccinated individuals. 

As for safety, assessments should be similar to those previously conducted with other FDA-approved vaccines. Additionally, the FDA recommends manufacturers begin planning pharmacovigilance activities early, as it is likely that a significant number of people will be vaccinated during the early postmarketing period.

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“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,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “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 full guidance, titled “Development and Licensure of Vaccines to Prevent COVID-19” can be found here.

For more information visit fda.gov.