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The US Food and Drug Administration (FDA) has released guidance with recommendations for the manufacturing, clinical development and approval of a Covid-19 vaccine.
While the development and review processes are being accelerated to address the ongoing pandemic, the FDA will require data to be submitted to meet its regulatory standards.
Named Development and Licensure of Vaccines to Prevent Covid-19, the guidance covers requirements for chemistry, manufacturing and control, nonclinical and clinical data. This includes development and licensure, as well as post-licensure safety evaluation.
FDA Commissioner Stephen Hahn noted: “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.”
For clinical trials, the regulator calls for the recruitment of diverse populations in all phases of development, including racial and ethnic minorities, elderly and people with comorbidities.
The FDA guidance also recommended studies to capture data on the use of vaccine during pregnancy, along with safety and effectiveness evaluation in the paediatric population.
Furthermore, the sizes of clinical trials should be large enough to validate the safety and effectiveness of a vaccine, expected to prevent disease or mitigate its severity in at least 50% of people vaccinated.
FDA Center for Biologics Evaluation and Research director Peter Marks said: “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.”
Following FDA approval, the safety of vaccines will be tracked using different existing surveillance systems.