- The Australian regulatory authority has conditionally approved Novavax Inc's (NASDAQ: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.
- Photo by Daniel Schludi on Unsplash
