FDA issues guidance on EUA for COVID-19 vaccines, despite Trump wrath

7 October 2020

On Tuesday, the US Food and Drug Administration issued guidance with recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an emergency use authorization (EUA) for an investigational vaccine intended to prevent COVID-19.

The announcement comes despite efforts by the White House to block the guidelines, clearing the way for requirements that are widely expected to prevent the introduction of a vaccine before Election Day, according to various US press reports. Most controversial is that the FDA said vaccine makers should follow trial participants for at least two months to rule out any major side effects before seeking emergency approval, meaning a vaccine could not be authorized before November 3.

The recommendations in the guidance describe key information and data that would support issuance of an EUA, including chemistry, manufacturing and controls information, nonclinical and clinical data, and regulatory and administrative information.
This guidance provides further information on the EUA process for investigational vaccines and provides additional context to the information provided in the agency's June guidance regarding the development and licensure of COVID-19 vaccines.
An EUA is a different standard than an approval, as noted in the June guidance, however, in the case of an investigational vaccine developed for the prevention of COVID-19, both pathways require the submission of data demonstrating any vaccine's safety and effectiveness.
This guidance reiterates that any assessment regarding an EUA will be made on a case-by-case basis considering the target population, the characteristics of the product, the pre-clinical and human clinical study data on the product, and the totality of the available scientific evidence relevant to the product.

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