Novavax, Inc. ( NVAX Quick Quote NVAX - Free Report) have risen 9.2% since the last month compared with the industry’s 2.9% growth. Image Source: Zacks Investment Research
This upside is attributable to Novavax’s progress with its updated protein-based COVID-19 vaccine. This vaccine, designed to target the XBB descendent lineage viruses, has also generated neutralizing antibodies against the newly emerging virus variants, including EG.5.1 (also known as ‘Eris’) and XBB.1.16.6.
Designated by the World Health Organization (“WHO”) as a variant of interest, Eris is the dominant variant in the United States. Per the
latest data from the Centers for Disease Control and Prevention (“CDC”), the Eris variant is responsible for around 21.5% of COVID-19 infections in the country.
Infection cases from XBB.1.16.6 are also growing in the United States. The latest CDC data shows that this variant accounted for 9.2% of all cases nationwide.
Per the CDC, total hospitalizations due to COVID-19
rose by almost 19% in the most recent week. Last month, Reuters reported that the Biden administration will start a fall campaign urging all citizens to inoculate themselves with the updated COVID-19 vaccines.
The updated Novavax vaccine is yet to be authorized by the FDA. If approved/authorized, Novavax’s updated vaccine will be a non-mRNA XBB.1.5 vaccine available in the United States. The company aims to make its updated vaccine available and accessible on par with mRNA-based COVID-19 vaccines marketed by
Pfizer ( PFE Quick Quote PFE - Free Report) / BioNTech ( BNTX Quick Quote BNTX - Free Report) and Moderna ( MRNA Quick Quote MRNA - Free Report) .
Alongside its second-quarter 2023 results, Novavax announced that it had initiated a filing with the FDA for this updated COVID-19 vaccine and intends to submit one in Europe in the coming weeks. Management stated that it is manufacturing the updated vaccine commercially and planning to launch it in the upcoming fall.
With Novavax currently struggling with cash flow needs, a surge for COVID-19 vaccines will help the company generate additional cash resources to fund its business operations. In a quarterly SEC filing last month, management stated they have sufficient cash to fund business for the next twelve months.
Novavax is one of the few companies which has an authorized vaccine for COVID-19 in the United States. However, the company faces stiff competition from Pfizer/BioNTech and Moderna, which currently dominate the COVID vaccination space. These companies have also updated their COVID vaccines, demonstrating robust immune responses against the newer coronavirus variants.
Last month, Moderna
reported preliminary results from a clinical study showing that its updated COVID-19 vaccine mRNA-1273.815 significantly boosted neutralizing antibodies against the Eris and FL.1.5.1 (also known as ‘Fornax’) variants.Moderna has also submitted a regulatory application to the FDA seeking authorization for mRNA-1273.815. A final FDA decision is expected in the coming weeks for the vaccine’s launch for the upcoming fall season. A similar regulatory submission is also currently under review in Europe.
In June, Pfizer/BioNTech submitted filings in the United States and Europe seeking approval for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine. If approved, the companies intend to launch their vaccine for the fall season. In preclinical studies, the updated BioNTech/Pfizer vaccine has shown efficacy against the Eris variant and multiple other XBB variants, including XBB.1.5, XBB.1.16, and XBB.2.3. The companies expect to prepare their updated COVID vaccine for supply immediately post-regulatory approvals.
Novavax currently carries a Zacks Rank #3 (Hold). You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here .