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Moderna (MRNA) Updated COVID Jab Effective Against Eris Variant

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Moderna (MRNA - Free Report) reported preliminary results from a clinical study that showed that its updated COVID-19 vaccine mRNA-1273.815 showed a significant boost in neutralizing antibodies against the EG.5 and FL.1.5.1 variants. Yet to be authorized by the FDA, mRNA-1273.815 is designed to target the XBB descendent lineage viruses.

Recently designated by the World Health Organization (“WHO”) as a variant of interest, EG.5 (also known as ‘Eris’) is currently the dominant variant in the United States. Per the latest data from the Centers for Disease Control and Prevention (“CDC”), the variant is responsible for more than 17% of COVID-19 infections in the country.

Infection cases from FL.1.5.1 (also known as ‘Fornax’) are growing in the United States. Based on the latest CDC data, Fornax accounted for 8.6% of all cases nationwide.

At an FDA committee meeting held in June, Moderna presented clinical data that showed that mRNA-1273.815 generated robust neutralizing antibodies against the key circulating XBB strains.

A regulatory filing is currently under the agency’s review 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.

Shares of Moderna have lost 40.9% year to date compared with the industry’s 13.6% decline.

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Management claims it has built an ample supply for mRNA-1273.815 and is ready to ship the same doses for the upcoming fall vaccination season, provided that the FDA authorizes the vaccine.

Apart from Moderna, other COVID vaccine makers like Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Novavax (NVAX - Free Report) have also updated their own vaccines to target the XBB lineages. During the FDA committee meeting held in June, Pfizer/BioNTech and Novavax also presented their pre-clinical findings supporting the use of their own vaccines that target the XBB.1.5 variant.

In June, Pfizer and BioNTech submitted filings in Europe and the United States 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.

Earlier this week, Reuters reported that Pfizer/BioNTech’s updated vaccine was effective against the Eris variant in a study conducted on mice. Pfizer/BioNTech expects to make their updated vaccine ready for supply immediately post-regulatory approvals.

Alongside its second-quarter 2023 results, Novavax announced that it had initiated a filing with the FDA for its updated COVID vaccine and intends to submit one in Europe in the coming weeks. Novavax stated that it is manufacturing its protein-based monovalent XBB.1.5 COVID vaccine candidate at a commercial scale, intended to be in the market during the upcoming fall vaccination campaign. Novavax aims to make its updated vaccine available and accessible on par with other COVID vaccines.

 

Zacks Rank

Moderna 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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