Sec. 102. Guidance on vaccine development
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Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall issue final guidance to facilitate the use of accelerated and expedited pathways for the development and licensure of vaccines to prevent— emerging, re-emerging, or rare infectious diseases with respect to which the low prevalence or nature of the disease may render the existence or collection of clinical outcome data unlikely or impractical; and infectious diseases with respect to which currently available vaccines are not addressing the full scope of public health needs.
In developing the guidance required by this section, the Secretary of Health and Human Services shall consider issues relating to clinical development strategies for diseases described in subsection (a), including the development and acceptability of novel clinical and surrogate endpoints, the use of novel or accelerated study designs, the use of observational real-world data, the use of novel adjuvants, the use of new technologies or approaches to collecting and monitoring patient-level data, and the demonstration of efficacy through studies in healthy volunteers for the purpose of licensure.