Novavax Files COVID-19 Vaccine Candidate With UK Regulator
Product Still Under Rolling Review In EU
The company says it expects a “positive decision” on the first approval application for a protein-based coronavirus vaccine in the UK. If approved, NVX-CoV2373 would become the fifth COVID-19 jab to reach the market there.
You may also be interested in...
A US FDA review panel has given a lukewarm reception to molnupiravir, while Inovio is assessing its vaccine candidates against the new omicron variant, J&J nears a South African vaccine deal with Aspen, and South Korea brings in new COVID-19 measures. Meanwhile, Serum exports Novavax vaccine, Bharat looks at Covaxin in Omicron and Ocugen's Covaxin trial put on hold.
Having completed a rolling review, the vaccine is now being evaluated by the European Medicines Agency for conditional marketing authorization under an accelerated timeline.
Quality and the measure of a firm: Toyobo’s particulates and resins, Galenicko’s sanitation, Breckenridge’s product chemistry and Fujifilm’s cross-contamination risk.