- Novavax leapt 7% on Monday after its COVID-19 vaccine won the US Food and Drug Administration’s fast-track authorization.
- The vaccine’s Phase 3 trial was postponed last month because of delays in its manufacturing process.
- A fast-track status would allow Novavax to submit parts of a new drug application on a rolling basis, instead of waiting to provide complete information all at once.
- Shares in US drugmaker Pfizer and German biotech firm BioNTech also leapt on Monday after announcing their COVID-19 vaccine is 90% effective in preventing illness.
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The FDA’s move would help speed up the development of the vaccine, scientifically called NVX-CoV2373, after Novavax delayed its US trial last month to the end of November. It was postponed due to delays in ramping up the vaccine’s manufacturing process.
Novavax shares jumped as much as 7% in early trading, to $US100.99 a share, up from $US89.85 at Friday’s close.
The firm said it expects to begin its pivotal Phase 3 clinical trial in the US and Mexico later this month.
A fast-track status would permit the pharma firm to present parts of a new drug application for review on a rolling basis, rather than waiting for every piece of required information all at once.
Novavax’s attempt at a vaccine would be one among 241 projects in the works, according to the World Health Organisation.
Pfizer and BioNTech also surged 8% in early trading after announcing their experimental COVID-19 vaccine was over 90% effective, based on early data from a large-scale clinical trial.
Aside from Pfizer, a handful of others are in their final testing stages and their effectiveness will likely be known before the end of 2020.