MRNA Stock Up on Full FDA Nod for COVID-19 Jab in Pediatric Patients

Moderna MRNA announced that the FDA has approved its supplemental biologics license application seeking approval for COVID-19 vaccine, Spikevax, for use in children aged six months to 11 years, who are at increased risk for the disease.

The vaccine was previously available for the pediatric patient population under Emergency Use Authorization from the FDA.

Shares of Moderna were up 4.5% yesterday following the announcement of the news.

Following the full approval from the FDA, Spikevax is now approved for all adults aged 65 and above, as well as individuals aged six months through 64 years, who are considered at increased risk for developing severe COVID-19.

Management stated that the updated Spikevax jab will be ready for eligible patients during the 2025-2026 vaccination season in the United States.

MRNA's Stock Performance

Year to date, shares of Moderna have plunged 17.5% against the industry’s growth of 0.2%.

Other Players in the COVID-19 Vaccine Space

Besides Moderna, the other vaccines marketed in the COVID-19 space are Pfizer PFE /BioNTech’s BNTX Comirnaty and Novavax’s NVAX Nuvaxovid.

Like Moderna, PFE/BNTX’s Comirnaty has also been developed based on the mRNA technology. The Pfizer/BioNTech vaccine is currently approved for use in the same patient population as MRNA’s Spikevax.

Notably, Novavax’s Nuvaxovid is the only non-mRNA-based vaccine in the United States. The NVAX vaccine was recently granted full approval by the FDA for use in older adults aged 65 and above, as well as use in individuals aged 12-64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. Nuvaxovid is still not yet approved for those under 12 years.

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).

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