Moderna granted marketing authorization for updated Spikevax by EC
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jul 30 2025
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Should l Buy MRNA?
Moderna Vaccine Authorization: The European Commission has granted marketing authorization for Moderna's updated COVID-19 vaccine Spikevax, which targets the SARS-CoV-2 variant LP.8.1.
Availability Timeline: Doses of the updated vaccine will be available for eligible individuals aged six months and older ahead of the 2025-2026 vaccination season.
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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: 54.230
Low
17.00
Averages
32.47
High
63.00
Current: 54.230
Low
17.00
Averages
32.47
High
63.00
About MRNA
Moderna, Inc. is a biotechnology company advancing a new class of medicines made of messenger ribonucleic acid (mRNA). It is engaged in developing medicines across infectious disease vaccines, oncology therapeutics and rare disease therapeutics. Its platform incorporates advances across three components, mRNA, delivery, and the manufacturing process, to advance its medicines. Its products are Spikevax and mNEXSPIKE (its COVID vaccines), and mRESVIA (its vaccine against respiratory syncytial virus (RSV)). It also has a diverse development pipeline that consists of 35 therapeutic and vaccine programs, six of which are in late-stage development. It has regulatory filings under review for its seasonal flu+COVID vaccine (mRNA-1083) in Europe and Canada and for its seasonal flu vaccine (mRNA-1010) in the United States, Europe, Canada and Australia. Its rare disease programs are Propionic acidemia (mRNA-3927); Methylmalonic acidemia (mRNA-3705), and Cystic Fibrosis (mRNA-3692/VX-522).
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.
MODERNA: EC APPROVES MARKETING AUTHORIZATION FOR MRNA-1083 FOR PEOPLE AGED 50 AND ABOVE
- Moderna's Authorization: Moderna has received market authorization for its mRNA-1083 vaccine for individuals aged 50 years and older.
- Target Demographic: The vaccine is specifically aimed at older adults, addressing their unique health needs.
See More
MODERNA: MCOMBRIAX TO BE RELEASED IN THE EUROPEAN UNION, PENDING NATIONAL REGULATORY AND ACCESS REQUIREMENTS
Availability in Europe: Moderna's new vaccine, MCOMBRIAX, will be made available in the European Union.
Regulatory Compliance: The vaccine's release is subject to national regulatory and access procedures.
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MODERNA'S MRNA COMBINATION VACCINE MCOMBRIAX APPROVED FOR MARKETING BY EUROPEAN COMMISSION FOR INFLUENZA AND COVID-19
Marketing Authorization Granted: Moderna has received marketing authorization from the European Commission for its mRNA combination vaccine, Combrixa.
Targeted Diseases: The vaccine is designed to protect against both influenza and COVID-19.
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Moderna's mCOMBRIAX Vaccine Receives EU Approval
- Vaccine Approval: Moderna's mCOMBRIAX (mRNA-1083) vaccine has received marketing authorization from the European Commission, targeting both COVID-19 and influenza, particularly for individuals aged 50 and older, marking a significant advancement in the company's vaccine development efforts.
- Broad Coverage: The approval applies across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway, indicating its wide applicability in the European market and is expected to significantly enhance Moderna's competitiveness in the vaccine sector.
- Expert Recommendation: This approval follows a recommendation from an expert panel of the European Medicines Agency (EMA) in February, reflecting the vaccine's scientific efficacy and safety, thereby laying a solid foundation for Moderna's future sales.
- Market Launch Plans: Moderna stated it will engage with national healthcare officials to plan the launch of mCOMBRIAX in the EU, although the specific timeline will depend on local regulatory and access procedures, a strategy that will impact its market penetration in Europe.
See More
Moderna Initiates Phase 3 Trial for H5 Influenza Vaccine
- Vaccine Development Progress: Moderna announced the initiation of a Phase 3 trial for its mRNA-1018 H5 influenza vaccine in the U.S. and U.K., targeting nearly 4,000 healthy adults, which aims to support global regulatory submissions and marks a significant milestone in the company's pandemic preparedness efforts.
- Funding Support: The trial is backed by up to $54.3 million from the Coalition for Epidemic Preparedness Innovations (CEPI), highlighting the international commitment to vaccine research and providing Moderna with essential financial resources to advance its development plans.
- Pandemic Threat Response: CEO Stéphane Bancel emphasized that H5 influenza remains a potential global pandemic threat, and the start of the Phase 3 trial not only validates the vaccine's efficacy but also represents a strategic move in global public health safety.
- Policy Context: The trial's initiation follows the Trump administration's termination of a $766 million contract with Moderna, reflecting the company's ongoing efforts and adaptability in vaccine development despite challenges posed by policy changes.
See More
Investment Opportunities in Biotech Stocks
- Moderna's Innovative Potential: Moderna's mRNA vaccine platform allows for faster vaccine design compared to traditional methods, which could drive long-term returns, especially given the increased uncertainty in the COVID-19 vaccine market, where the company's deep pipeline and innovative technology may yield significant investment returns.
- Diverse Pipeline Products: Moderna is developing a vaccine for norovirus and a personalized cancer vaccine, mRNA-4157, which has shown significant potential in mid-stage trials to reduce recurrence and death risk in melanoma patients, further enhancing its market competitiveness.
- Regeneron's Market Leadership: Regeneron's Dupixent is a top-selling drug globally, particularly after gaining important label expansions for COPD treatment, expected to continue driving sales growth, while its high-dose Eylea offers a more patient-friendly dosing regimen, attracting patients despite biosimilar competition.
- Diversified Product Pipeline: Regeneron is developing products across various therapeutic areas, including gene therapy for genetic deafness and anti-obesity medications, which, if approved, could boost revenue and earnings, while its dividend and share buyback program demonstrate a commitment to returning capital to shareholders.
See More
MODERNA: EC APPROVES MARKETING AUTHORIZATION FOR MRNA-1083 FOR PEOPLE AGED 50 AND ABOVE
- Moderna's Authorization: Moderna has received market authorization for its mRNA-1083 vaccine for individuals aged 50 years and older.
- Target Demographic: The vaccine is specifically aimed at older adults, addressing their unique health needs.
See More
MODERNA: MCOMBRIAX TO BE RELEASED IN THE EUROPEAN UNION, PENDING NATIONAL REGULATORY AND ACCESS REQUIREMENTS
Availability in Europe: Moderna's new vaccine, MCOMBRIAX, will be made available in the European Union.
Regulatory Compliance: The vaccine's release is subject to national regulatory and access procedures.
See More
MODERNA'S MRNA COMBINATION VACCINE MCOMBRIAX APPROVED FOR MARKETING BY EUROPEAN COMMISSION FOR INFLUENZA AND COVID-19
Marketing Authorization Granted: Moderna has received marketing authorization from the European Commission for its mRNA combination vaccine, Combrixa.
Targeted Diseases: The vaccine is designed to protect against both influenza and COVID-19.
See More
Moderna's mCOMBRIAX Vaccine Receives EU Approval
- Vaccine Approval: Moderna's mCOMBRIAX (mRNA-1083) vaccine has received marketing authorization from the European Commission, targeting both COVID-19 and influenza, particularly for individuals aged 50 and older, marking a significant advancement in the company's vaccine development efforts.
- Broad Coverage: The approval applies across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway, indicating its wide applicability in the European market and is expected to significantly enhance Moderna's competitiveness in the vaccine sector.
- Expert Recommendation: This approval follows a recommendation from an expert panel of the European Medicines Agency (EMA) in February, reflecting the vaccine's scientific efficacy and safety, thereby laying a solid foundation for Moderna's future sales.
- Market Launch Plans: Moderna stated it will engage with national healthcare officials to plan the launch of mCOMBRIAX in the EU, although the specific timeline will depend on local regulatory and access procedures, a strategy that will impact its market penetration in Europe.
See More
Moderna Initiates Phase 3 Trial for H5 Influenza Vaccine
- Vaccine Development Progress: Moderna announced the initiation of a Phase 3 trial for its mRNA-1018 H5 influenza vaccine in the U.S. and U.K., targeting nearly 4,000 healthy adults, which aims to support global regulatory submissions and marks a significant milestone in the company's pandemic preparedness efforts.
- Funding Support: The trial is backed by up to $54.3 million from the Coalition for Epidemic Preparedness Innovations (CEPI), highlighting the international commitment to vaccine research and providing Moderna with essential financial resources to advance its development plans.
- Pandemic Threat Response: CEO Stéphane Bancel emphasized that H5 influenza remains a potential global pandemic threat, and the start of the Phase 3 trial not only validates the vaccine's efficacy but also represents a strategic move in global public health safety.
- Policy Context: The trial's initiation follows the Trump administration's termination of a $766 million contract with Moderna, reflecting the company's ongoing efforts and adaptability in vaccine development despite challenges posed by policy changes.
See More
Investment Opportunities in Biotech Stocks
- Moderna's Innovative Potential: Moderna's mRNA vaccine platform allows for faster vaccine design compared to traditional methods, which could drive long-term returns, especially given the increased uncertainty in the COVID-19 vaccine market, where the company's deep pipeline and innovative technology may yield significant investment returns.
- Diverse Pipeline Products: Moderna is developing a vaccine for norovirus and a personalized cancer vaccine, mRNA-4157, which has shown significant potential in mid-stage trials to reduce recurrence and death risk in melanoma patients, further enhancing its market competitiveness.
- Regeneron's Market Leadership: Regeneron's Dupixent is a top-selling drug globally, particularly after gaining important label expansions for COPD treatment, expected to continue driving sales growth, while its high-dose Eylea offers a more patient-friendly dosing regimen, attracting patients despite biosimilar competition.
- Diversified Product Pipeline: Regeneron is developing products across various therapeutic areas, including gene therapy for genetic deafness and anti-obesity medications, which, if approved, could boost revenue and earnings, while its dividend and share buyback program demonstrate a commitment to returning capital to shareholders.
See More
