The Food and Drug Administration Fast Track Program is very rigorous and does not cut corners.
By: Dr. Anthony Salandy
Date: 5th, October 2020
As the FDA points out, filling an unmet medical need is defined as providing a therapy/vaccine where none exists or providing a therapy/vaccine which may be potentially better than available therapies/vaccines. In the case of COVID-19 vaccine, any vaccine being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. Thus, it is prudent to grant a fast track designation to COVID-19 vaccine candidates in phase III clinical trials.
It is also wise because fast tracking a vaccine candidate allows for the following:
- Frequent meetings with FDA to discuss the vaccine’s development plan and ensure collection of appropriate data needed to support approval.
- Frequent written communication from FDA about such things as the design of the proposed clinical trials.
- Eligibility for Accelerated Approval and Priority Review, if relevant criteria in issued FDA guidance are met. FDA has put out guidance for vaccine development particularly those that are fast tracked.
- Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
The frequency of communication between the FDA and the pharmaceutical companies ensure that questions and issues are resolved quickly, often leading to improved vaccine safety. In sum, fast tracking COVID-19 vaccine candidates is designed to make the vaccine development process more efficient and streamlined but it does not cut corners or bypass critical evidence just to garner an FDA recommendation for approval. It just doesn’t work that way.
In the late spring, the US Food and Drug Administration (FDA) awarded “fast track” designation to the Moderna’s vaccine candidate and the Pfizer/BionTech vaccine candidate. Fast track does not mean cutting corners on safety or just speeding drugs through the approval process. Rather, “fast track ” is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs (vaccine in this case) to the public earlier.
Anthony Salandy, Ph.D., M.S.
President and Executive Director
Dr. Salandy is founder of the Institute for COVID-19 Vaccination Advocacy (ICVA). ICVA aims to increase knowledge of the COVID-19 vaccination program, decrease COVID-19 vaccine hesitancy, and improve COVID-19 vaccine coverage around the globe.