Monday, January 3, 2022

Lost in the Holidays: FDA Slow-pedaled COVID Variant Tests Before "Now"

Possibly lost over the holidays were several important articles on the FDA's handling of COVID variant assays and Omicron, and how we got to where we are today.

Let's start with the third article, on December 20, in WSJ:  "Omicron Tracking in US is Hindered by Data Gaps."  This includes a lack of variant-specific assays, but also some of the states had wound-down some of the basic reporting resources and staff.   Here.

But in mid-December, Genomeweb/360Dx ran two important articles, one open access and one within the paywall.   On December 15, a staff essay at Genomeweb t alked about the FDA "now considering EUA submissions for COVID variants."   Here.  

But that article is only meaningful, or eye-catching, in the context that previously, FDA hadn't accepted for EUA the same types of variant-confirming assays to have the capabilities in place.  That's where the paywall article becomes important (by Madeleine Johnson at 360Dx here, published on December 17 here).   She had more time to interview companies who were entirely frustrated by prior attempts to get variant-specific assays up and running and certified via EUA.  If you've got a subscription, very worthwhile reading.

The Build-Up to - NYT January 2

So we find this headline in New York Times January 2"With No Way to Identify Omicron and Delta Patients, Doctors Struggle with Treatment Decisions."   Find Christina Jewett's article here.


See also a VOX article, "Supply Chain Not Ready for Omicron," Rebecca Heilweil, December 21, here.

See a transcript of FDA's December 15 town hall, 17pp, here.