COVID-19 Vaccines: BIO Pushes For EUA Guidance, While HHS’ Azar Downplays Its Importance
Guidance's release would provide regulatory clarity to scientists and strengthen public confidence in any vaccine authorized by the FDA, trade group says, but Alex Azar tells Congress the controversy over the unpublished document is overblown and making a ‘mountain out of a molehill.'
You may also be interested in...
The political spotlight on the Food & Drug Administration during the COVID-19 pandemic has renewed the long-standing debate as to whether FDA should be made an independent, Cabinet-level federal agency and freed from direct HHS oversight.
Everyone but Donald Trump seems happy that the guidance is finally here, with release appearing to be driven by FDA's disclosure of advisory committee materials.
In remarks fleshing out the ‘EUA Plus’ guidance before it became a political football, Operation Warp Speed’s Slaoui said that an FDA analysis concluded that 90% of adverse events related to vaccination take place within the first 42 days.