Novavax Is Trying to Get the FDA’s Permission to Market COVID-19 Booster Dose

Novavax, Inc

The FDA received a regulatory application from Novavax (NASDAQ:NVAX), which aims to extend the emergency use authorization (EUA) given to its protein-based COVID-19 vaccine known as Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373).

Novavax Can Target More Adults in the U.S. With a Booster Dose

The EUA wants the label for the Novavax vaccine to be expanded to include both homologous and heterologous booster doses for adults (aged 18 years and older).

A large portion of this population has already received immunizations with an approved primary regimen of a vaccine developed by Pfizer (NYSE:PFE)/BioNTech (NASDAQ:BNTX), Moderna (NASDAQ:MRNA), and J&J (NYSE:JNJ), even though the vaccine was previously granted EUA (emergency use authorization) in the United States as a primary two-dose regimen for use in adults last month.

According to the Centers for Disease Control and Prevention (CDC), 90% of the country’s adult population has received at least one dose of a vaccine, and 77.2% of the adult population has received all recommended vaccinations (as of August 10, 2022).

If a booster dosage is approved, Novavax can target a larger/broader group of adults in the U.S. market who have already received the vaccination but have not yet received a booster dose. A booster dosage of a different vaccine can be given, unlike the basic regimen of immunizations, which calls for receiving doses of the same vaccine. Only 51.4% of the adult population has received a third or booster dose of an approved vaccination, according to CDC data as of August 10, 2022.

Shares of Novavax have fallen approximately 70% so far this year, underperforming the industry’s 18% decrease.

Data from the phase III PREVENT-19 study (conducted in the United States and Mexico) and the phase II COV-BOOST study (conducted in the United Kingdom), which assessed a booster dose of NVX-CoV2373 in healthy adult participants, are used to support Novavax’s FDA application seeking approval for the booster dose. According to the data from these studies, a third dose of the vaccine produced a greater antibody response in the research subjects than the late-stage studies testing the initial two-dose regimen of NVX-CoV2373. The vaccine also produced a stronger immunological response when given as a heterologous booster dose.

Novavax’s COVID-19 Vaccine Already Approved in Over 40 Countries

The COVID-19 vaccine from Novavax has already received approval for use in more than 40 countries, including Australia, Canada, Europe, and India. The Serum Institute of India and NVAX are partners in the commercialization of two variants of NVX-CoV2373, one of which is sold under the brand name Covovax and the other is sold under the name Nuvaxovid.

Moderna and Pfizer/BioNTech, who sell mRNA-based vaccinations, control the U.S. market for COVID-19 vaccines.

Moderna and Pfizer/BioNTech are far ahead of the curve, but Novavax has yet to realize the American market’s potential fully. They created the only shots with full permission for usage in the U.S., which dominates the vaccine market there. The Pfizer/BioNTech vaccine is approved for use in people 12 years and older, but Moderna’s vaccine is only for adults 18 and older. In the U.S., vaccinations are also approved for emergency use in those six months and older. The FDA has also approved the use of Moderna and Pfizer/BioNTech vaccines in certain age groups with a third and fourth booster dose.

Besides, Novavax disclosed in a separate news release that it had submitted a regulatory application in Taiwan to extend the EUA for its COVID-19 vaccination to teenagers between the ages of 12 and 17. The vaccine is authorized for adult-use since June 2022.

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About the author: Stephanie Bedard-Chateauneuf has over six years of experience writing financial content for various websites. Over the years, Stephanie has covered various industries, with a primary focus on tech stocks, consumer stocks, health stocks, and personal finance. This stock lover likes to invest for the long-term. Stephanie has an MBA in finance.