COVID-19 Quick Takes: FDA authorizes 15-minute, $5 antigen test from Abbott; plus  updates from IDSA, CEPI, Novavax, VBI, Verndari, AZ, Fluidigm, Tyme

Abbott test cleared for rapid point-of-care
Abbott Laboratories (NYSE:ABT) said FDA granted Emergency Use Authorization (EUA) to a 15-minute point-of-care COVID-19 antigen test that costs $5 and detects SARS-CoV-2 nucleocapsid protein from nasal swabs. In patients suspected of having COVID-19 given the test within seven days of symptom onset, BinaxNOW had a sensitivity of 97.1% and a specificity of 98.5%. Abbott expects to ship tens of millions of tests next month, and 50 million tests a month beginning in October. The company plans to launch a companion mobile app that will display whether a tester was positive or negative. Antigen tests are considered a key technology for asymptomatic screening (see “Asymptomatic Testing Pushes Forward”).

IDSA recommends against EUA path for vaccines
The Infectious Diseases Society of America and the HIV Medicine Association sent a letter Wednesday to FDA Commissioner Stephen Hahn and CBER Director Peter Marks calling on FDA to seek full approval of a COVID-19 vaccine rather than grant an EUA “in light of public distrust of vaccines.” At a minimum, the groups recommended approval or authorization not be issued until Phase III testing is complete. The letter comes after ex-FDA officials criticized an EUA granted Sunday for convalescent plasma as putting politics ahead of science (see “EUA May Be Merited”)...