How US FDA Will Unleash Attack On COVID-19 Variants Once Global Consensus Is Reached
Agency outlines plans to authorize variant COVID-19 vaccines and therapeutics based on swift quality assessments.
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US FDA considering approach that is similar to, but more stringent than, influenza strain changes, CBER Director Marks says. Meanwhile, vaccine developers face challenge of when to change antigens to get the best results, NIH’s Graham notes. As FDA and sponsors gain more experience with tweaking the vaccines to account for new coronavirus variants and strains, the process may be expedited further.
Agency explains how it will model vaccine authorization process on its licensing process for matters like inspections and lot release.
Two batches were authorized because they were made before production waste jammed Emergent BioSolutions' Bayview plant.