New COVID-19 tests can bypass FDA
Teachers now are "essential workers," and another study shows children can transmit COVID-19.
Just a quick update today with a couple of regulatory items of note.
Changing the rules mid-game 1: Earlier this week, the Wall Street Journal published a blockbuster article that dissected the USA’s COVID-19 test development missteps. The article included the fact that the declaration of a public health emergency imposed additional regulatory hoops before new COVID-19 tests could be used. On Thursday, the Trump Administration formally removed FDA authority over diagnostic tests developed by laboratories (such as private, state or academic medical labs.) This means that new diagnostic tests can be introduced without FDA review of the test’s sensitivity or specificity.
Changing the rules mid-game 2: As it did with meat factory workers, the Trump Administration declared that teachers are “essential workers” and therefore may be exempted from COVID-19 quarantine guidelines. The administration’s guidelines are available here.
A small Swiss study published by the U.S. Centers for Disease Control and Prevention found that about half the children tested shed infectious COVID-19, even if the children have no symptoms of disease. The researchers say the results suggest that children are capable of spreading COVID-19, regardless of age.
That’s it for today. Please comment and share this. Have a good and safe weekend.