Novavax
NVAX
announced that it has entered into an agreement with the U.S. government to supply 3.2 million doses of NVX-CoV2373, its protein-based COVID-19 vaccine.
However, the agreement is contingent on the grant of emergency use authorization (EUA) to NVX-CoV2373 by the FDA in the United States.
The agreement also requires the Novavax vaccine to be recommended for use by the Centers for Disease Control and Prevention (CDC). In fact, a potential recommendation from the CDC will be required to start immunizations with NVX-CoV2373.
Last month, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC)
recommended granting
authorization to the Novavax vaccine for use in adults. The VRBPAC voted 21-0 (with one abstention), recommending the FDA to grant EUA to NVX-CoV2373 for use in adults aged 18 years and older. With an EUA from the regulatory body, Novavax’s COVID-19 vaccine will be the first protein-based shot available in the United States.
Shares of Novavax have plunged 53.1% so far this year compared with the
industry
’s 19% decline.
Image Source: Zacks Investment Research
The FDA filing, seeking an EUA for the COVID-19 vaccine, was
submitted
by NVAX in January this year. The filing is based on data from the two pivotal phase III studies on the vaccine, one (PREVENT-19) conducted in the United States and Mexico, while the other in the United Kingdom. The PREVENT-19 study achieved an overall vaccine efficacy of 90.4%, while data from the study conducted in the United Kingdom demonstrated that vaccine to have achieved an overall efficacy of 89.7%.
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 marketed in partnership with the Serum Institute of India under the trade name Covovax, while the other is produced by itself and marketed under the trade name Nuvaxovid.
Once authorized by the FDA, NVX-CoV2373 will face stiff competition from the COVID-19 vaccines developed by
Moderna
MRNA
and
Pfizer
PFE
/
BioNTech
BNTX
. Novavax is already trailing a lot behind these vaccines. The vaccines developed by the competitors dominate the U.S. market and are the only jabs that 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.
The two vaccines developed by Moderna and Pfizer/BioNTech are based on the mRNA technology, with high efficacy rates. In fact, booster doses of the Moderna and Pfizer/BioNTech vaccines are also authorized for use in adults. Last month, Pfizer and BioNTech also reached an agreement with the United States government to deliver 105 million doses of their COVID-19 vaccine by this year. Upon receiving these doses, the U.S. administration will pay $3.2 billion to the companies. The deal also includes the supply of Pfizer/BioNTech’s Omicron-adapted COVID-19 vaccine, provided the FDA grants it an EUA.
Zacks Rank
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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