FDA To Facilitate Timely Development Of Safe, Effective COVID-19 Vaccines

1. FDA To Facilitate Timely Development Of Safe, Effective COVID-19 Vaccines The U.S. Food and Drug Administration, an agency within the U.S. Department of Health and Human Services, is going to take necessary actions to help facilitate the timely development of safe and effective vaccines to prevent COVID-19. The authority will provide guidance with recommendations from the experts for those working on the development of COVID-19 vaccines and are looking for licensure. The guidance from FDA will consist of the agency's current recommendations regarding the data required to make it smoother for the clinical development, manufacturing and approval of a COVID-19 vaccine. FDA Commissioner Stephen M. Hahn, M.D. said that the body understands and recognizes the urgent need to develop a safe and effective vaccine to prevent COVID-19. With unique medical solutions, the FDA will work collaboratively with industry, researchers, as well as federal, domestic, and international partners so that the efforts of vaccine production can be accelerated. There will be no cutting corners in the decision making and that they will submit the guidance to meet the regulatory standards. Vaccines have been debated to be the only effective measure right at this point in preventing this fatal virus. The FDA is taking care of all the possible measures through their scientific expertise to evaluate any potential COVID-19 vaccine candidate irrespective of the type of technology used to produce or to administer the vaccine. In this process, there can be a number of different technologies associated such as DNA, RNA, protein and viral vectored vaccines that will be developed by commercial vaccine manufacturers and other entities.

2. Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research also said in one of his statements that the particular crisis has sent so much at stake, that it is critical to speed up vaccine development as much as possible without compromising on the standards for quality, safety, and efficacy. To help build public confidence in the FDA's evaluation process, it is necessary that FDA should maintain a transparent thinking process in its scientific data collection and analysis. Although it is not possible by the FDA or the scientific community to predict how quickly the data can be generated but vaccine clinical trials are on the way. That being said, the FDA will only approve or market and sell a COVID-19 vaccine only if it matches up the high standards. The FDA strongly encourages including diverse populations with different community in all phases of clinical development, which must include the racial and ethnic minorities. It must also consider adequate representation from the late phase trials of elderly individuals and those with medical co- morbidities. There must be equal plans in conducting studies in the development plans that would provide data to support use of the confirmed vaccines during pregnancy. Lastly, the plan must include pediatric assessments as well to get an overall outlook.