In a recent press release, Novavax (NASDAQ:NVAX) announced that Swissmedic, the Swiss Agency for Therapeutics, had renewed the provisional authorization of their COVID-19 vaccine, Nuvaxovid (NVX-CoV2373), for use in Switzerland. Both 12–17-year-olds and adults aged 18 and above will receive the vaccination, with the latter also receiving a booster shot.
Temporary approval of Nuvaxovid for usage in people aged 18 and above was obtained by Swissmedic in April of 2022.
Data from the current pediatric expansion of phase III PREVENT-19 research assessing the safety, immunogenicity, and effectiveness of Nuvaxovid in the United States supported the decision to increase the vaccine’s license to include those aged 12 to 17 years. The study’s primary aim was met, with the vaccination demonstrating 82% overall effectiveness against the Delta strain.
Three studies were used to justify the booster dose: a phase II trial in South Africa, data from a phase II study in Australia, and the COV-BOOST research sponsored by the United Kingdom. Six months following the initial two-dose series of Nuvaxovid vaccinations, a booster dose was given to healthy individuals as part of the phase II research. Subjects’ immunological responses improved after the third dosage. When given as a heterologous third booster dosage, Nuvaxovid elicited a protective antibody response in participants of the COV-BOOST research.
Investors should take notice that Nuvaxovid has received approval for use in teenagers (12-17) in many countries, including the United States (August 2022), the United Kingdom (August 2022), the European Union (July 2022), India, and others. The Nuvaxovid vaccine has been approved for use as a booster dose in New Zealand (August 2022), Australia (June 2022), and Japan (October 2022). (Apr 2022).
In addition, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recently gave Novavax (NASDAQ:NVAX) the green light to seek a broader conditional marketing authorization (CMA) for Nuvaxovid, allowing it to be used as a homologous and heterologous booster dosage in adults (aged 18 years and older).
Novavax’s (NASDAQ:NVAX) stock price decrease of 78.8% year-to-date compares unfavorably to the industry decline of 24.7%.
Novavax (NASDAQ:NVAX) also shared that their WHO-approved vaccine partner SK Biosciences will produce and supply the vaccine’s active ingredients for their Nuvaxovid COVID-19 product.
Featured Image- Megapixl @Syhinstas