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.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Caldwell Industries, CM Life Sciences, Dexcom, Encore, Ensodata, Fresenius Medical Care, Humacyte, Integra Molecular, Predictmedix, Sema4, Shockwave Medical, Sientra, Vivante Health.
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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acer, Direct, Genetx, Moderna, Purdue, Soligenix, Ultragenyx.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astra, Biovie, Campbell, Innocan, Lysogene, Mayo, Moderna, Modus, Neurmedix, Recode, Satt Conectus, Splisense, Tel Aviv University, Sorrento, Tabuk, Therapeutic Solutions.
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.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3M, Advanced Human Imaging, Arya III, Autolomous, Avantor, Bio-Techne, C2i, Echonous, Eko, Fittrack, Gynesonics, Inqb8, Intervenn, Nautilus Biotechnology, New England Biolabs, Novogeneait, Paxman Coolers, Peijia, Portal Bioscience, Ritter, Trxade Health, Veranome Biosystems.
The good of the many versus the good of the individual is the age-old question that faced the FDA’s Vaccines and Related Products Advisory Committee (VRPAC) June 10 as it considered the risk-benefit issues of COVID-19 vaccines in children. Panelist Cody Meissner, director of pediatric infectious disease at Tufts Medical Center, said while he believes a vaccine is needed for children, he wants to know that the safety of the vaccine is greater than the risk of hospitalization for people younger than 18.
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