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Moderna MRNA announced that it has submitted a regulatory filing with the FDA seeking approval for an updated version of its COVID-19 vaccine Spikevax, designed to target the LP.8.1 variant of the virus.
The submission is based on guidance from the FDA issued last week, which advised vaccine-makers to update their COVID-19 shots to target strains that are part of the JN.1 lineage, with a preference for the LP.8.1 variant. Per the latest CDC data, LP.8.1 currently accounts for about 70% of total cases in the country.
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The announcement also comes days after the FDA issued new guidance for COVID-19 vaccine boosters. As part of this guidance, COVID-19 vaccine makers will be required to conduct randomized, placebo-controlled clinical studies demonstrating the real-world benefit of yearly COVID-19 vaccine boosters in individuals aged under 65 years. Moderna has not disclosed any information regarding the age group that the updated vaccine will target, nor has it mentioned if any clinical studies will be conducted for it.
MRNA Stock Price Performance
Year to date, Moderna’s shares have plummeted 37% compared with the industry’s 6% decline.
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Other Players in the COVID-19 Vaccine Space
Apart from Moderna’s Spikevax, the other vaccines marketed in this space are Pfizer PFE/BioNTech’s BNTX Comirnaty and Novavax’s NVAX Nuvaxovid. Pfizer/BioNTech and Novavax are yet to provide an update on the status of their respective COVID-19 vaccines.
Notably, the COVID-19 vaccines by Moderna and Pfizer/BioNTech are currently the only ones that are allowed for use in individuals aged six months and above. Though Novavax’s vaccine recently received full approval for use in older adults aged 65 and above, its use remains restricted to individuals aged 12-64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. The NVAX vaccine is still not approved for those under 12 years of age.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
MRNA’s 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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This article originally published on Zacks Investment Research (zacks.com).