Moderna's mCOMBRIAX Vaccine Receives Positive Opinion from EMA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 3 days ago
0mins
Should l Buy MRNA?
Moderna announced that the European Medicines Agency's, EMA, Committee for Medicinal Products for Human Use, CHMP, has adopted a positive opinion recommending marketing authorization in the European Union for mCOMBRIAX, Moderna's combination vaccine indicated for active immunization for the prevention of influenza and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and older. "The CHMP's positive opinion represents an important milestone for respiratory virus vaccination and for Moderna, with the introduction of the world's first flu plus COVID combination vaccine. If approved, this would be Moderna's fourth marketed product in Europe," said Stephane Bancel, Chief Executive Officer of Moderna. "Combination vaccines have the potential to simplify vaccination and support improved health outcomes. We appreciate the EMA's rigorous scientific review."
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Analyst Views on MRNA
Wall Street analysts forecast MRNA stock price to fall
20 Analyst Rating
1 Buy
16 Hold
3 Sell
Hold
Current: 53.570
Low
17.00
Averages
32.47
High
63.00
Current: 53.570
Low
17.00
Averages
32.47
High
63.00
About MRNA
Moderna, Inc. is a biotechnology company. The Company is advancing a new class of medicines made of messenger ribonucleic acid (mRNA). It is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that have a therapeutic or preventive benefit with the potential to address a spectrum of diseases. The Company’s diverse development pipeline consists of 44 therapeutic and vaccine programs, 11 of which are in late-stage development. Its commercial products include Spikevax (its COVID vaccine) and mRESVIA (its respiratory syncytial virus (RSV) vaccine). Additionally, it has achieved four positive Phase III data readouts for its COVID vaccine (mRNA-1283), its RSV vaccine for high-risk adults aged 18 to 59 (mRNA-1345), its seasonal flu+COVID vaccine (mRNA-1083), and its seasonal flu vaccine (mRNA-1010).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Vaccine Approval Recommendation: The European Medicines Agency has recommended marketing authorization for Moderna's combined COVID-19 and influenza vaccine, mCombriax, highlighting its significance for the elderly population.
- Clinical Trial Data: The recommendation is based on data from 8,000 individuals aged 50 and older, demonstrating that antibody levels against flu and SARS-CoV-2 were non-inferior to those receiving the COVID vaccine Spikevax and flu vaccines Fluzone HD or Fluarix, indicating its efficacy.
- Market Potential: Targeting individuals aged 50 and older, mCombriax addresses the dual protection needs of the elderly, which is expected to drive further growth for Moderna in the vaccine market.
- Regulatory Dynamics: Although Moderna withdrew its application with the US FDA in May 2025, the EMA's recommendation may pave the way for future global market promotion of the vaccine.
See More
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Moderna's Anticipated Expansion: Moderna is planning to make its mRNA vaccine, Comirnaty, more widely available by 2027.
Focus on Accessibility: The company aims to enhance the distribution and accessibility of its vaccine to a broader population.
See More
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See More
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