Europe Clears First Flu/COVID Combo Shot From Moderna

Moderna Inc. (NASDAQ:MRNA) shares are up on Tuesday as the company received marketing authorization for its mCOMBRIAX vaccine, the world’s first flu plus COVID-19 combination vaccine.

Moderna Gains EU Nod For Combination Flu-COVID Vaccine

The European Commission approved mCOMBRIAX, which aims to simplify immunization for adults aged 50 and older by combining protection against influenza and COVID-19.

The approval marks a significant advancement for Moderna, as mCOMBRIAX is its fourth authorized product.

Phase 3 Data Supports Approval Across Two Age Cohorts

The approval is based on data from Phase 3 trial of mRNA-1083 in two independent age cohorts of approximately 4,000 adults each.

All primary endpoints demonstrating the non-inferiority of immune responses were met.

Following a single dose, mRNA-1083 elicited statistically significantly higher immune responses against three influenza virus strains and against SARS-CoV-2.

Researchers did not observe a statistically significantly higher immune response to the B/Yamagata strain—no longer recommended for inclusion in seasonal influenza vaccines—in adults aged 65 and older compared to the co-administered licensed comparator vaccines.

Moderna Settles For $950 Million, Eyes Future Growth

In March, Moderna announced a settlement agreement with Arbutus Biopharma Corporation (NASDAQ:ABUS) and Roivant Inc.'s (NASDAQ:ROIV) Genevant Sciences.

The COVID-19 vaccine maker reached a settlement agreement that resolves all litigation related to its COVID-19 vaccine, Spikevax, and its mRESVIA product.

Moderna will make a lump sum payment of $950 million in the third quarter.

Moderna’s investigational flu vaccine, mRNA-1010, is under U.S. Food and Drug Administration (FDA) review.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5 for mRNA-1010, which is aimed at adults aged 50 and older.

MRNA Stock Price Activity: Moderna shares were up 0.36% at $54.78 at the time of publication on Tuesday, according to Benzinga Pro data.

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