Confirming not only a clear commitment to data, the FDA re-iterated its inclusion of diverse populations in COVID-19 vaccine development.
“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.” – Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research
In late June, the U.S. Food and Drug Administration (FDA) announced an initiative to, “help facilitate the timely development of safe and effective vaccines to prevent COVID-19 by providing guidance with recommendations for those developing COVID-19 vaccines for the ultimate purpose of licensure.” Acting as a playbook for companies, researchers and health professionals, the FDA’s guidance was aimed at explaining the process around vaccine approval.
FDA Commissioner Stephen M. Hahn, M.D. illustrated the urgency of vaccine development and success saying, “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.”
Focused on creating a vaccine solution that is vetted and accessible, the Dr. Hahn stated the FDA would refuse to cut corners, and decisions would be based on data in clinical trials. Ensuring health professionals are educated in the FDA’s next steps, one of the published documents, “Development and Licensure of Vaccines to Prevent COVID-19”, provides a roadmap of overview information and key considerations in the vaccine’s development and next steps.
A resource for helping to educate teams in clinical settings and helping answer patient questions about the vaccine and its availability, the document is available on the FDA’s SARS-CoV-2 infection dashboard.
Confirming not only a clear commitment to data, the FDA re-iterated its inclusion of diverse populations in the vaccine’s development, including those marginalized or under-represented, including racial and ethic minorities and the elderly. The FDA also recommended that vaccine sponsors, “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.”
For vaccine developers who want to learn more about the FDA’s process, they suggest going to the Accelerated Approval pathway for vaccine licensure to learn more.