Novavax NVAX announced that the FDA expanded its emergency use authorization (EUA) for Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373), its protein-based COVID-19 vaccine, to allow its use in adolescents aged 12 through 17 years in the United States.
Last month, NVAX secured its first EUA from the FDA for using its COVID vaccine as a primary two-dose regimen in adults aged 18 years and above.
This label expansion is based on data from the ongoing pediatric expansion of phase III PREVENT study, which evaluated NVX-CoV2373 in 2,247 adolescents. The study achieved its primary efficacy endpoint of NVX-CoV2373 generating neutralizing antibodies in adolescents, similar to the antibody responses in young adult participants (aged between 18 and 26 years), who were administered the vaccine in phase III PREVENT study. The antibody responses were 1.5-fold higher in adolescents than young adults.
The results of this study are based on the data accrued during the period when the Delta variant was the dominating strain in the United States. NVX-CoV2373 demonstrated clinical efficacy of 78.29% against the Delta variant.
Shares of Novavax have plunged 74.7% so far this year compared with the industry’s 20.6% decline.
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Following the EUA grant, the next step for Novavax is to procure a policy recommendation from the Centers for Disease Control and Prevention (CDC). If the CDC grants this recommendation, it will allow the company to supply doses of its COVID vaccine in the United States.
Novavax’s COVID-19 vaccine is already authorized for use in more than 40 countries, including Australia, Canada, the European countries and India. NVAX is currently marketing two versions of NVX-CoV2373 — one in partnership with the Serum Institute of India under the trade name Covovax, and the other, produced by itself and marketed under the trade name Nuvaxovid.
We note that Novavax faces stiff competition from the COVID-19 vaccines developed by Pfizer PFE/BioNTech BNTX and Moderna MRNA, which market mRNA-based vaccines.
While Novavax is yet to tap the potential of the U.S. market, Moderna and Pfizer/BioNTech are currently way ahead of the curve. Per the CDC, as of Aug 17, 2022, around 75.7% of the population (aged 12 years and older) in the United States has already completed the primary regimen of a COVID vaccine developed by these vaccines. These vaccines not only dominate the U.S. market but are also the only jabs that have received full approval for use in the country. While Moderna’s vaccine is approved for use in adults 18 years and older, the Pfizer/BioNTech vaccine is approved for use in individuals 12 years and older.
The Moderna and Pfizer/BioNTech vaccines are also authorized for emergency use in individuals aged six months and above in the United States. The FDA authorized a third and fourth booster dose of Moderna and Pfizer/BioNTech vaccines for use in certain age groups by the FDA.
Last week, Novavax filed a regulatory application with the FDA, seeking to expand the EUA for Novavax COVID-19 Vaccine, Adjuvanted as a homologous and heterologous booster dose in adults.
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Novavax currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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