Therapy Areas: Vaccines
Novavax's Nuvaxovid (NVX-CoV2373) receives Australian regulator's provisional registration
14 June 2022 -

Novavax, Inc. (NASDAQ: NVAX), a US-based biotechnology company, announced on Monday that the Australian Therapeutic Goods Administration (TGA) has granted provisional registration of Nuvaxovid (NVX-CoV2373) COVID-19 vaccine as a booster in individuals aged 18 and over.

The company received provisional registration based on data from Novavax' Phase two trial carried out in Australia, from a separate phase two trial conducted in South Africa and from the UK-sponsored COV-BOOST trial. Under the phase two trials, a single booster dose of Nuvaxovid was administered to healthy adult participants around six months after their primary two-dose vaccination series of Nuvaxovid. The third dose produced raised immune responses comparable to or exceeding levels associated with protection in Phase three clinical trials.

Stanley C. Erck, Novavax president and chief executive officer, said: "Today's provisional registration for Nuvaxovid as a booster in Australia is an important step in ensuring broad global access to diversified vaccine options. As COVID-19 continues to persist and evolve, we are pleased to be able to offer the first protein-based COVID-19 vaccine registered for use as both a primary series and now booster regardless of previous vaccine history."