Those requirements — which mimic the guidance document that the White House has so far quashed — are designed to ensure that there is adequate safety data on any vaccine before it is authorized for emergency use, FDA said. POLITICO reported yesterday that the White House had blocked the release of the standards after officials close to President Donald Trump told him that the pharmaceutical industry objected to FDA’s stance.
FDA’s decision to hold vaccine developers to the stricter criteria, which go beyond initial guidance the agency released in June, will likely push any vaccine authorization beyond Election Day. Trump has repeatedly promised to deliver a vaccine before then, contradicting predictions of top federal health officials.
Background: The news that the FDA is plowing ahead with the stricter standards comes after almost a month of back and forth between the White House and the agency over how to set the bar for vaccine authorization.