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Novavax, swamped with FDA’s manufacturing ‘questions,’ hopes for US coronavirus shot trial within the year

November 30, 2020

With two players in the race for a COVID-19 vaccine nearing the finish line on world-first regulatory approvals, Maryland biotech Novavax continues to lag behind in getting its candidate into a late-stage trial in the U.S. Now, that trial has been pushed back further as the FDA targets its manufacturing plans.

The FDA has lobbed “additional questions” at Novavax’s plan to lean on partner Fujifilm Diosynth Technologies’ North Carolina plant for commercial-scale manufacturing of its vaccine for a phase 3 North American trial, the company said Monday. The added scrutiny has pushed the study’s start date into late December at the earliest.

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