Shares of
Novavax,
Inc.
NVAX
have surged 26.8% in the past month compared with the
industry
’s 1.9% rise.
Image Source: Zacks Investment Research
This share price rally was primarily driven by authorizations received for the company’s COVID-19 vaccine, NVX-CoV2373, in multiple countries. However, this COVID vaccine is not yet authorized for use in the United States.
NVX-CoV2373 is a protein-based vaccine that utilizes Novavax’s proprietary nanoparticle technology. 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 version produced by Novavax that is marketed under the trade name, Nuvaxovid. Covovax has been granted emergency use authorization (EUA) in Bangladesh, India, Indonesia, the Philippines and Thailand. Meanwhile, Nuvaxovid has been granted authorization for use in multiple markets, including Australia, Canada and Europe. These authorizations mainly pertain to the use of the vaccine in adults aged 18 years and older.
The rise in NVAX’s share prices started last month after management announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (“VRBPAC”) recommended granting EUA to NVX-CoV2373. This EUA, which seeks emergency approval for the use of NVX-CoV2373 in adults, was filed by management in January 2022.
The VRBPAC voted 21-0 (with one abstention), recommending the FDA to grant EUA to NVX-CoV2373 for use in adults. Though the FDA is not bound to follow the VRBPAC’s recommendation, it usually follows the same.
If the FDA grants EUA to Novavax’s COVID-19 vaccine, it will be the first protein-based shot available in the United States. A potential authorization in the country will also give a boost to the company’s revenues.
While the protein-based COVID vaccine has already demonstrated efficacy in adults, clinical studies have also shown that the vaccine is also effective in adolescents aged between 12 and 17 years of age.
Earlier this week, NVAX
received
conditional marketing authorization (CMA) in Europe for use in adolescents. This CMA follows the positive recommendation of the European Medicines Agency’s Committee for Medicinal Products for Human Use, which recommended the use of Nuvaxovid in adolescents between 12 and 17 years last month.
Novavax secured authorization for its COVID vaccine in Taiwan. The company is also developing its Omicron-specific vaccine, targeting the BA.4/5 Omicron subvariants and is expected to provide one by the year’s end.
Once authorized by the FDA, Novavax 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. These vaccines dominate the U.S. market and are the only ones to have received full approval for use in adults in the country.
The two vaccines developed by Moderna and Pfizer/BioNTech are based on the mRNA technology, with high efficacy rates. In fact, the booster doses of the Moderna and Pfizer/BioNTech vaccines are also authorized for use in adults.
The vaccines developed by Moderna and Pfizer/BioNTech are currently the only ones authorized for use in individuals aged six months and above in the United States.
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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