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

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.