Novavax' Sees Conditional Approval Of COVID-19 Vaccine Booster In Australia As US FDA Delays Its Decision

The Australian regulatory authority has conditionally approved Novavax Inc's NVAX Nuvaxovid (NVX-CoV2373) COVID-19 vaccine as a booster in individuals aged 18 and over.
The provisional registration was based on data from Novavax's Phase 2 trial conducted in Australia, wherein a single booster dose of Nuvaxovid was administered to healthy adult participants approximately six months after their primary two-dose vaccination series of Nuvaxovid.
The third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials. In the COV-BOOST trial, Nuvaxovid induced a robust antibody response when used as a heterologous third booster dose.
In the Novavax-sponsored trials, local and systemic reactions were generally short-lived, with a median duration of approximately two days. The incidence of Grade 3 or higher events remained relatively low.
The Australian authority granted provisional registration in January 2022 for using Nuvaxovid in individuals aged 18 and over.
Novavax filed for expanded provisional registration in Australia for use in adolescents aged 12 through 17 in May 2022.
According to last week's CNBC report, the FDA said it needs to review recent adjustments to Novavax's manufacturing process before it can authorize the company's vaccine.
Price Action: NVAX shares are down 12.10% at $35.72 during the market session on the last check Monday.
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