Moderna (MRNA) Seeks FDA Nod for Omicron-Based COVID Jab

Moderna MRNA completed the submission of a regulatory application to the FDA, which seeks Emergency Use Authorization (EUA) for the use of a 50-µg booster dose of its bivalent BA.4/BA.5 Omicron-targeting COVID-19 vaccine, mRNA-1273.222, in individuals 18 years of age and older.

This bivalent vaccine is a combination of Spikevax (mRNA-1273), Moderna’s currently marketed COVID vaccine and a vaccine candidate targeting the Omicron BA.4 and BA.5 subvariants, the most prevalent variants of concern in the United States.

The filing is supported by data based on preclinical studies conducted on mRNA-1273.222 and data from the phase II/III study, which evaluated mRNA-1273.214, another bivalent candidate developed by Moderna to target the Omicron BA.1 subvariant. The phase II/III study on the Omicron BA.1 targeting vaccine has achieved all its primary endpoints. Data from the study showed that a 50-µg dose of mRNA-1273.214 generated superior antibodies against the Omicron variant in comparison to those who received a 50 µg booster dose of Spikevax. mRNA-1273.214 (irrespective of prior infection or age) also generated potent neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared with those who received abooster dose of Spikevax.

Though management is currently evaluating mRNA-1273.222 in phase II/III study, it is ready to manufacture and deliver the vaccine doses by September, provided the FDA grants an EUA. Last month, Moderna secured an advance purchase agreement with the U.S. government to supply up to 300 million mRNA-1273.222 doses for a payment of $1.74 billion.

Shares of Moderna have declined 43.4% so far this year compared with the industry’s 21.9% fall.

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The development of mRNA-1273.222 was initiated after the FDA recommended vaccine makers develop bivalent booster vaccines targeting the Omicron BA.4 and BA.5 subvariants. In fact, the vaccine has been developed specifically to cater to the U.S. market. Presently, these two subvariants are the most prevalent in the country. Per the CDC, more than 90% of cases of COVID-19 infections are caused by both BA.4 and BA.5 subvariants.

Like Moderna, Pfizer PFE and its partner BioNTech BNTX have alsocompleted filing an application seeking EUA for a 30-µg booster dose of their bivalent Omicron-based COVID-19 vaccine that targets the BA.4/BA.5 Omicron variant for individuals 12 years of age and older.

The filing includes data from studies on their bivalent Omicron BA.1-adapted vaccine as well as preclinical and manufacturing data from their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. Pfizer/BioNTech have already scaled production of the Omicron BA.4/BA.5-adapted bivalent boosters and will be ready to ship doses as soon as the FDA grants EUA.

In June, Pfizer and BioNTech also announced that they reached an agreement with the United States government to supply 105 million doses of their COVID-19 vaccine by this year. Upon receiving these doses, the U.S. government will pay $3.2 billion to the companies. The agreement also includes the supply of their Omicron-adapted COVID-19 vaccine, provided a EUA is granted by the FDA.

Moderna, Inc. Price

Moderna, Inc. price | Moderna, Inc. Quote

Zacks Rank & Key Pick

Moderna currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is Morphic MORF, which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 30 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.38 to $1.75. Loss estimates for 2023 have narrowed from $3.91 to $3.77 during the same period. Shares of Morphic have lost 35.1% in the year-to-date period.

Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%.

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