COVID-19 vaccine developers should begin testing their vaccines against emerging variants now and assessing booster regimens, the FDA said in an update to its October guidance on emergency use authorizations (EUAs) for the vaccines.
LONDON – The first population-level real-world data on COVID-19 vaccines indicate they are having a dramatic impact on severe disease, with a study in Scotland showing a fall of 85% in hospital admissions for people who received the Pfizer Inc./Biontech SE product, and a drop of 94% for those who had Astrazeneca plc’s vaccine, four weeks after receiving the first dose.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adamis, Amgen, Astrazeneca, Brainstorm, Cassava, Celsion, Curocell, Intra-Cellular, Junshi, Supernus, Zosano.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: BD, Brainstorm Cell Therapeutics, Gala Therapeutics, Integral Diagnostics, Lightdeck Diagnostics, Lucid Diagnostics, Medica, Mediwound, Nuprobe, Paragonix, Pavmed, Pre Diagnostics, Scanwell Health, Seaspine, Solys Diagnostics, Spineway, Tsunami Medical.