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.
Pfizer Inc. and Biontech SE submitted new data to the FDA showing its COVID-19 vaccine’s stability can be maintained at temperatures often found in pharmaceutical freezers and refrigerators: -13°F to 5°F (-25°C to -15°C). That’s cold but not nearly as cold as the mRNA-based vaccine’s emergency use authorization label calls for, which is storage in an ultra-cold freezer at temps of between -112 to -76 degrees Fahrenheit (-80 and -60 degrees Celsius).
CAJICA, Colombia – A cooler box with 70 vials allegedly filled with counterfeit COVID-19 vaccines seized from a Chinese couple in Colombia’s El Dorado International Airport on Feb. 17 underscored the growing challenges facing pharmaceutical companies, law enforcement authorities and health care regulators around the world. Patient safety, company liability, and the security of distribution channels have all been areas of growing concern.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dr. Reddy’s, Dynavax, Immunicum, Immunocore, Incyte, Janssen-Cilag, Junshi, RDIF, Travere.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Algernon, AMR, Cleveland Biolabs, Cytocom, Evolus, Fordoz, Jaguar, Life Biosciences, Lipomedix, Medytox, Metabolon, Novavax, Precision Biosciences, Sensorion, SXT, TFF.