The Food and Drug Administration (FDA) issued this week recommendations pertaining to issuance of emergency use authorization (EUA) for investigational vaccines against infection with the SARS-CoV2 virus (COVID-19).
The new guidance describes the information and data that must be supplied by a manufacturer to support the authorization, including chemistry, manufacturing and controls information, nonclinical and clinical data, and regulatory administration information.
Click through notes on FDA's statement and requirements of data submitted from phase 3 clinical trials in support of the EUA below.
In a statement, FDA noted that any assessment regarding an EUA would be made on a case-by-case basis considering target population, charactieristics, clinical study data on the product, totality of evidence to support the product.
•According to the FDA, data from phase 3 studies should include a median follow-up duration of at least 2 months after completion of the full vaccination regimen.
•The Agency also will not considersupporting an EUA request for an investigational vaccine without phase 3 data that include the information on the slides to follow.
Data from phase 3 clinical trials of candidate COVID-19 vaccine must include:
• Local and systemic solicited adverse reactions collected for the protocol-defined duration of follow-up in an adequate number of individuals to characterize reactogenicity in each protocol-defined age cohort participating in the trial. • All safety data, including well over 3000 vaccine recipients followed for serious adverse events and adverse events of special interest for at least 1 month after completion of a full vaccination regimen.
Data from phase 3 clinical trials of candidate COVID-19 vaccine must include:
• A sufficient number of cases of severe COVID-19 among participants to support low risk for vaccine-induced enhanced respiratory disease. • Subgroup analyses of safety andefficacy endpoints stratified by prior infection status at study entry, as determined by pre-vaccination serology or medical history, as screening for prior infection is unlikely to occur prior to administration of vaccines under EUA.
Data from phase 3 clinical trials of candidate COVID-19 vaccine must include:
• A plan for active follow-up for safety (including deaths and hospitalizations, and other serious or clinically significant adverse events) among individuals who receive the vaccine under an EUA, to inform ongoing benefit/risk determinations in support of EUA continuation.
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The new guidance is published ahead of the Vaccines and Related Biological Products Advisory Committee meeting, which is scheduled for October 22nd. The expert panel will discuss the general development, authorization and/or licensure of COVID-19 vaccines.
