The agency is rolling back emergency use authorizations for some Covid-19 tests, and decontamination systems used to sterilize N95 masks for re-use, among other devices. Hospitals will need a system to keep close track of which devices they’re using and which ones are no longer authorized.
Moderna is using a Roche antibody test in clinical trials of its Covid-19 vaccine. The test can measure the antibodies created through vaccination, offering a window into how long protection lasts.
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The vaccine was developed in record time, a big scientific accomplishment, even though the agency's move follows an unusual level of pressure from President Trump's White House, renewing concerns that politics drove the vaccine process even as the first doses are shipped.
The nonbinding recommendation is a final hurdle before an official emergency use authorization for the vaccine, which could be the first shot approved for use in the U.S. Distribution, however, will remain a challenge.