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Moderna (MRNA) Seeks Full FDA Approval for COVID-19 Vaccine

Moderna (MRNA) completes rolling submission of BLA to the FDA seeking full approval of its COVID-19 vaccine candidate, mRNA-1273, in the United States...

This story originally appeared on Zacks

Moderna, Inc. MRNA announced that it has submitted a biologics license application (“BLA”) to the FDA seeking full approval of its mRNA-based COVID-19 vaccine, mRNA-1273, in the United States. This marks the first BLA submission for any of the company’s pipeline candidates.

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Moderna has requested a Priority Review designation for the said vaccine to prevent COVID-19 infection in individuals aged 18 years and above. Moderna initiated the rolling submission of the BLA in June.

The above-mentioned BLA was based on data from the phase III COVE study which evaluated the COVID-19 vaccine in more than 30,000 participants in the United States. In the final analysis of said study, the vaccine demonstrated 93% efficacy, which remained through six months after the second dose was administered.

Shares of Moderna have skyrocketed 280.8% so far this year compared with industry’s rise of 0.8%.

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We note that mRNA-1273, is currently available in the United States under an Emergency Use Authorization (“EUA”) for use in individuals aged 18 years and above. The company has already supplied more than 300 million doses of its COVID-19 vaccine to the U.S. government.

Moderna has also filed for an EUA with the FDA for its COVID-19 vaccine to address adolescents aged 12 years and above. In July 2021, the company received authorization for conditional/temporary use of mRNA-1273 in adolescents 12 years of age and older in Europe and Japan.

In August 2021, the FDA expanded the EUA for mRNA-1273, to include a third dose for certain immuno-compromised individuals.

Moderna’s vaccine generated sales of nearly $6 billion in the first half of 2021. The company expects total COVID-19 vaccine revenues to be approximately $19.2 billion for full-year 2021.

Please note that if the FDA grants full approval to Moderna’s mRNA-1273 in the United States, it will become the second vaccine to get a full approval from the regulatory body.

Earlier this week, the FDA granted full approval to Pfizer PFE/BioNTech’s BNTX mRNA-based COVID-19 vaccine, Comirnaty, to prevent COVID-19 in individuals 16 years of age and older. Comirnaty is now the first vaccine to have been granted full approval by the FDA.

Pfizer/BioNTech has also initiated filing of a supplemental BLA to the FDA seeking approval for a third, or booster dose of Comirnaty for individuals aged 16 years and older.

J&J JNJ, on Aug 25, released data supporting use of the booster shot, which showed that its COVID-19 vaccine booster, after the single-dose primary regimen, provided rapid and robust increase in spike-binding antibodies. J&J’s single-shot adeno-virus-based COVID-19 vaccine has also been granted EUA by the FDA.

Zacks Rank

Moderna currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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