Novavax NVAX has filed a regulatory application with the FDA, which seeks to extend the emergency use authorization (EUA) granted to its protein-based COVID-19 vaccine called Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373 ).
The EUA is seeking to expand the label for Novavax’s vaccine use as a homologous and heterologous booster dose in adults (aged 18 and older).
Although the vaccine already received EUA in the United States as a two-dose primary schedule for use in adults last month, a large majority of this population has already been immunized with an approved primary schedule of a vaccine developed by Pfizer DFP/BioNTech BTX, Modern MRNA and J&J.
Based on updated data (as of August 10, 2022) from the Centers for Disease Control and Prevention (CDC), 90% of the nation’s adult population has received at least one dose of a vaccine, while 77.2% of the US adult population has been fully immunized.
If licensed for a booster dose, Novavax may target a larger/broader segment of the adult population in the US market who have been previously vaccinated but have not yet received a booster dose of the vaccine. Unlike the primary vaccine regimen, which requires receiving doses of the same vaccine, a booster dose of a different vaccine can be given. CDC data (as of August 10, 2022) indicates that only 51.4% of the nation’s adult population has received a third dose/booster of a licensed vaccine.
Year-to-date, Novavax shares have plunged 70.4% compared to the industry’s 17.9% decline.
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Novavax’s FDA filing seeking booster dose approval is supported by data from the Phase III PREVENT-19 (conducted in the United States and Mexico) and Phase II COV-BOOST (conducted in the United Kingdom) study. -Unie), which evaluated a booster dose of NVX-CoV2373 in healthy adult participants. Data from these studies showed that a third dose of the vaccine generated a higher antibody response in study participants compared to data seen in late-stage studies evaluating the primary two-dose regimen of NVX-CoV2373 . The vaccine also generated a higher immune response when used as a heterologous booster dose.
Novavax’s COVID-19 vaccine is already licensed for use in more than 40 countries, including Australia, Canada, European countries and India. NVAX currently markets 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.
The COVID-19 vaccine market in the United States is dominated by Moderna and Pfizer/BioNTech, which market mRNA-based vaccines.
While Novavax has yet to exploit the potential of the US market, Moderna and Pfizer/BioNTech are currently ahead of the curve. The vaccines they developed dominate the US market and are the only vaccines that have received full approval for use in the country. While Moderna’s vaccine is approved for use in adults 18 and older, the Pfizer/BioNTech vaccine is approved for use in people 12 and older. The vaccines are also licensed for emergency use in people six months and older in the United States. A third and fourth booster dose of Moderna and Pfizer/BioNTech vaccines have also been cleared for use in certain age groups by the FDA.
In a separate press release, Novavax also announced that it had submitted a regulatory application in Taiwan to expand EUA for its COVID-19 vaccine for use in adolescents ages 12-17. The vaccine is currently licensed for use in adults since June 2022.
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Novavax currently wears a Zacks rank #3 (Hold). You can see the full list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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