Novavax looks to expand Covid-19 vaccine authorisation  

Covid-19 vaccines

Pharmaceutical company Novavax is attempting to expand the use of its Covid-19 vaccine Nuvaxovid into adolescents aged 12-17 year and as a booster dose for adults.  

The company has submitted a request to Swissmedic to expand the conditional marketing authorisation (CMA) of Nuvaxovid. The request is based on data from the company’s ongoing PREVENT-19 Phase III clinical trial, which is assessing the vaccine in 2,247 adolescents aged 12 through 17 years across 73 sites in the US1. 

During the trial, Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% clinical efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the US. 

The request for the booster dose is supported by data from the company’s Phase II trial assessing Nuvaxovid as a single dose booster2. During the trial, a single dose of the vaccine was administered to healthy adult participants approximately six months after their primary two-dose vaccination series of Nuvaxovid. Moreso, in the UK-sponsored COV-BOOST trial, Nuvaxovid induced a significant antibody response when used as a heterologous third booster dose. 

Nuvaxovid was granted CMA in April 2022 for use in adults aged 18 and over. Nuvaxovid has also been granted emergency use authorisation in India for individuals aged 12 through 17.  

1: https://ir.novavax.com/2022-02-10-Novavax-Announces-Positive-Results-of-COVID-19-Vaccine-in-Pediatric-Population-of-PREVENT-19-Phase-3-Clinical-Trial 

2: https://ir.novavax.com/2021-12-22-Novavax-Announces-Initial-Omicron-Cross-Reactivity-Data-from-COVID-19-Vaccine-Booster-and-Adolescent-Studies  

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