INDUSTRY BACKS CLEAR FDA VACCINE STANDARDS

ABSTRACT

In spelling out the data expected for such authorization, agency officials emphasized the importance of fully vetting the safety and efficacy of any new coronovirus vaccine through a highly transparent process to boost public confidence in the ability of vaccines to save lives. Countering vaccine hesitancy Through the debate, officials in the Center for Biologics Evaluation and Research (CBER) emphasized that the EUA safety data requirement was already well known to vaccine manufacturers and that one aim was to assure manufacturers that FDA would hold all vaccine development programs to the same standards. Center for Biologics Evaluation and Research (CBER) Director Peter Marks further emphasized that the guidance sought to reassure the public that granting an EUA would not be a rushed decision on vaccine safety and efficacy to meet political goals, and that a vaccine EUA would require more data than for the more usual emergency authorizations for therapeutics and other medical products.