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June 14, 2022

Australia grants provisional registration for Novavax’s Covid-19 booster

The latest provisional registration is based on findings from two Phase II trials and the COV-BOOST trial of the vaccine.

The Australian Therapeutic Goods Administration (TGA) has granted provisional registration for Novavax’s Nuvaxovid (NVX-CoV2373) Covid-19 vaccine as a booster in people aged 18 years and above.

With the latest development, Nuvaxovid became the first protein-based Covid-19 vaccine to receive registration in Australia for use as a booster, irrespective of prior vaccination history.

The provisional registration was based on findings from a Phase II clinical trial of the vaccine carried out in Australia, another Phase II trial in South Africa, and the UK-sponsored COV-BOOST trial.

A single booster dose of Nuvaxovid was given to healthy adults nearly six months following their initial two-dose regimen in the Phase II trials.

Findings showed that the third vaccine dose elicited elevated immune responses similar to or greater than levels linked to protection in Phase III trials. 

Furthermore, when administered as a heterologous third booster dose in the COV-BOOST trial, Nuvaxovid stimulated a strong antibody response. 

Following the administration of the booster in the Novavax-sponsored trials, local and systemic reactions were found to be short-lived with a median duration of nearly two days. 

The occurrence of Grade 3 or higher events was reported to be relatively low. 

Safety reporting of reactogenicity events demonstrated a rising occurrence across all three doses of the vaccine, indicating the elevated immunogenicity observed with a third dose. 

Biocelect is the sponsor of Novavax in Australia. 

Novavax president and CEO Stanley Erck said: “The 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.”

Earlier this month, the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee recommended the grant of Emergency Use Authorization for Novavax’s Covid-19 vaccine, NVX-CoV2373, for individuals aged 18 years and above.

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