Novavax Inc. reported an overall efficacy rate of 90.4% in a phase III trial of its COVID-19 protein subunit vaccine, NVX-CoV2373, which it conducted in the U.S. and Mexico. The vaccine provided 100% protection against moderate and severe disease and 100% protection against variants of SARS-CoV-2 deemed not to be of concern or interest. Gaithersburg, Md.-based Novavax is on track to file for approval during the third quarter. By the end of that period, it aims to ramp up production to a monthly run rate of 100 million doses and it aims to scale that to a monthly run rate of 150 million doses by the end of the fourth quarter.

The FDA issued a June 10 warning letter to Innova Medical Group Inc. in connection with the company’s rapid antigen tests for the SARS-CoV-2 virus, an action that accompanies a class I recall and a safety communication.

Researchers at the University of Washington reported in the May 31, 2021, issue of Nature Medicine that artificial intelligence (AI) algorithms meant to recognize COVID-19 infections based on chest X-rays picked up on confounders, selecting “shortcuts” such as patient age or positioning in the X-ray as a basis for their predictions.

The FDA has authorized two batches of Johnson & Johnson’s COVID-19 vaccine from a troubled Emergent Biosolutions Inc. manufacturing facility to be made available under emergency use authorization (EUA) while determining that several other batches were unsuitable for use. While the FDA would not confirm the number of unsuitable batches, the newly authorized batches, however, can be used in the U.S. or exported.