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.
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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
Remediation must be quick and sure, say FDA’s Woodcock and Marks, despite challenges with facilities, equipment, processes and personnel training.
An EUA would carve out a market advantage, although Moderna should be releasing similar data soon for its COVID-19 vaccine.