Novavax
NVAX
announced that the Centers for Disease Control and Prevention (CDC) has endorsed its protein-based COVID-19 vaccine called Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373), as a primary two-dose regimen for use in adults aged 18 years and older.
Last week, Novavax was
granted
emergency use authorization (EUA) for its COVID-19 vaccine as a primary two-dose regimen for use in adults.
As a result of this CDC endorsement, Novavax can now
execute
the agreement it had signed with the U.S. government to supply 3.2 million doses of its COVID vaccine. The agreement was announced earlier this month. In a few weeks’ time, the vaccine will be made available for free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers.
The CDC endorsement comes a few hours after its Advisory Committee on Immunization Practices (“ACIP”) recommended the use of Novavax’s vaccine in adults. The ACIP voted unanimously in favor of Novavax’s COVID-19 vaccine for use in adults.
Novavax COVID-19 Vaccine’s emergency approval and CDC’s endorsement were based on data from the pivotal phase III PREVENT-19 study on the vaccine, conducted in the United States and Mexico. Data from the study showed that Novavax COVID-19 Vaccine, Adjuvanted, was 90.4% effective in preventing COVID-19 infections.
Shares were up 11.6% on Jul 19, following the announcement of the ACIP recommendation. Shares were also up 2% in after-market trading on the same day, when the company announced that the CDC had also endorsed the ACIP recommendation. In the year-to-date period, the stock has plunged 59.5% compared with the
industry
’s 22.3% decline.
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Novavax’s COVID-19 vaccine is already authorized for use in more than 40 countries, including Australia, Canada, 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.
Currently, the U.S. COVID-19 vaccine market is dominated by
Moderna
MRNA
and
Pfizer
PFE
/
BioNTech
BNTX
, which market mRNA-based vaccines. Per the CDC, as of Jul 13, 2022, around 71% of the population (aged five years and older) in the United States has already completed the primary regimen of a COVID vaccine developed by J&J, Moderna or Pfizer/BioNTech. Novavax COVID-19 Vaccine, Adjuvanted, will provide the unvaccinated population with an option to be vaccinated with a protein-based vaccine.
While Novavax is yet to tap the potential of the U.S. market, Moderna and Pfizer/BioNTech are currently way ahead of the curve. The vaccines developed by them dominate the U.S. market and are the only jabs that have received full approval for use in the country. While Moderna’s vaccine is approved for use in adults aged 18 years and older, the Pfizer/BioNTech vaccine is approved for use in individuals aged 12 years and older. The vaccines are also authorized for use in individuals aged six months and above in the United States.A third and fourth booster dose of both Moderna and Pfizer/BioNTech vaccines have also been authorized for use in certain age groups by the FDA.
In a separate press release, Novavax also announced that it has expanded its partnership with SK bioscience, wherein the latter will now also manufacture and supply Novavax’s Omicron-based COVID-19 vaccine. In addition, SK bioscience will also manufacture and supply Novavax’s COVID vaccine in pre-filled syringes. Presently, SK bioscience manufactures the drug substance for Novavax’s COVID vaccine.
Zacks Rank
Novavax currently carries a Zacks Rank #2 (Buy). You can see
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