Emergent COVID-19 Vaccine Plant’s Quality Issues Draw Unusual Spotlight From US FDA Topsiders
Remediation must be quick and sure, say FDA’s Woodcock and Marks, despite challenges with facilities, equipment, processes and personnel training.
You may also be interested in...
Novavax said it would start shipping supplies of its vaccine to Europe starting in late 2021, while Vaxart delayed the start of its Phase II study due to issues with Emergent BioSolutions. Meanwhile, Roche India received an EUA for Regeneron's antibody cocktail
Coronavirus Notebook: EMA Begins Rolling Review of Sinovac Vaccine, Looks At Comirnaty In 12-15-Year Age Group
Moderna and Sweden are donating vaccines to the COVAX Facility, and an African trial is investigating a combination of nitazoxanide and ciclesonide in people with mild-to-moderate COVID-19.
BIO chief calls US Defense Production Act ‘misguided’ as India seeks more COVID vaccines; America will donate AstraZeneca vaccine – just as soon as the FDA determines it was adequately manufactured.