Novavax NVAX recently announced that the temporary authorization of its COVID-19 vaccine, Nuvaxovid (NVX-CoV2373), has been extended by Swissmedic, the Swiss Agency for Therapeutics, for use in Switzerland. The vaccine will be used in adolescents aged 12 to 17 and as a booster dose for adults 18 years and older.
Swissmedic had previously granted temporary authorization to Nuvaxovid for use in adults 18 years or older in April 2022.
The expanded authorization of the vaccine for use in the population between 12 to 17 years of age is based on the data from the ongoing pediatric expansion of phase III PREVENT-19 study, evaluating the safety, immunogenicity and efficacy of Nuvaxovid in the United States. The vaccine achieved its primary endpoint in the study, exhibiting 82% overall efficacy against the Delta variant.
The booster dose authorization was based on three studies — a phase II study conducted in South Africa, a phase II study data conducted in Australia and a U.K.-sponsored COV-BOOST study. As part of the phase II studies, a booster dose was administered in healthy adults six months after their primary two-dose vaccination series of Nuvaxovid. The third dose produced increased immune responses in the subjects. In the COV-BOOST study as well, Nuvaxovid, when used as a heterologous third booster dose, induced a meaningful antibody response in the subjects.
Investors must note that Nuvaxovid has been granted authorization for use in adolescents aged 12 to 17 years of age in the United States (Aug 2022), the United Kingdom (Aug 2022), the European Union (July 2022), India and several other countries. As a booster dose, the Nuvaxovid vaccine has been authorized for use in New Zealand (Aug 2022), Australia (Jun 2022), and Japan (Apr 2022).
Moreover, Novavax recently received a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for expanded conditional marketing authorization (CMA) for Nuvaxovid as a homologous and heterologous booster dose in adults (aged 18 years and older).
Shares of Novavax have declined 78.8% in the year-to-date period compared with the industry’s fall of 24.7%.
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In separate news, Novavax announced that the World Health Organization (WHO) approved partner SK Biosciences to manufacture and supply the active substances in Nuvaxovid COVID-19 vaccine.
SK Biosciences currently manufactures drug substances from the European Union and both the drug substance and the drug products of Nuvaxovid for the South Korean market.
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Novavax’s COVID-19 vaccine faces stiff competition from the likes of large-cap pharma giants such as Moderna MRNA and Pfizer PFE /BioNTech BNTX.
Pfizer/BioNTech and Moderna’s mRNA-based vaccines have already received full approval for use in adults in the United States. They are also authorized for use in adults as well as younger populations in several countries.
Recently, Pfizer/BioNTech received emergency use authorization (EUA) from the FDA for its 30-µg booster dose of Pfizer-BioNTech’s Omicron BA.1 bivalent COVID-19 vaccine and Omicron BA.4/BA.5 for individuals ages 12 years and older. Moderna’s Omicron-targeting bivalent COVID-19 booster vaccine also received FDA approval for EUA.
Novavax currently has a Zacks Rank #3 (Hold).
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