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Novavax (NVAX) Updated COVID Jab Effective Against Eris Variant

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Shares of Novavax (NVAX - Free Report) were up 13.5% on Aug 22, after management announced that its updated protein-based COVID-19 vaccine showed a significant boost in neutralizing antibodies against the EG.5.1 (also known as ‘Eris’) and XBB.1.16.6 in studies on small animals and non-human primate. This vaccine is yet to be authorized by the FDA.

The vaccine has been designed to target the XBB descendent lineage viruses.

Recently 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 almost 21% 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 8% of all cases nationwide.

At an FDA committee meeting in June, Novavax presented preclinical data showing that its updated vaccine generated robust neutralizing antibodies against the key circulating XBB strains.

Alongside its second-quarter 2023 results, Novavax announced that it had initiated a filing with the FDA for its 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.

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 - Free Report) /BioNTech (BNTX - Free Report) and Moderna (MRNA - Free Report) .

The rise in stock price can be attributed to the rising COVID-19 infection cases as new subvariants of the virus continue to emerge. Per the latest CDC data, total hospitalizations due to COVID-19 rose by almost 22% in the most recent week. Earlier this week, Reuters reported that the Biden administration will start a fall campaign urging all citizens to inoculate themselves with the updated COVID-19 vaccines.

Shares of Novavax have lost 10.9% year to date compared with the industry’s 13.1% decline.

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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 recent filing with the SEC, management stated that 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, which have demonstrated robust immune responses against the newer coronavirus variants.

Last week, 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 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. Last week, Reuters reported that the updated BioNTech/Pfizer vaccine was effective against the Eris variant in a study conducted on mice. The companies expect to prepare their updated vaccine for supply immediately post-regulatory approvals.

 

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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