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European Commission Approves MRNA's COVID-19-Influenza Combo Shot
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Key Takeaways
Moderna secured EC approval for mCombriax, a combo COVID-19 and flu vaccine for adults aged 50 .
MRNA's phase III data showed a stronger immune response vs separate COVID and flu shots.
Moderna also initiated a phase III study for its mRNA-based H5 flu vaccine, mRNA-1018, with CEPI backing.
Moderna (MRNA - Free Report) reported that the European Commission (EC) has granted marketing authorization for mCombriax (mRNA-1083), its mRNA combination vaccine for active immunization for the prevention of influenza disease and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and older. mCombriax will be rolled out across the EU, pending national regulatory and access procedures, with Moderna coordinating with national authorities to enable access and adoption.
The approval in the EU was expected as the EMA’s Committee for Medicinal Products for Human Use had recommended granting marketing authorization to mCombriax for the above indication in February. The approval makes mCombriax Moderna’sfourth marketed product in the European Union, after two COVID-19 vaccines, Spikevax and mNexspike, and RSV vaccine mResvia.
This EC approval of mCombriax was supported by data from a pivotal phase III study, which met its primary endpoints. Data from the study showed that a single dose of mCombriax elicited higher immune responses against COVID-19 and influenza compared with licensed standalone COVID and influenza vaccines.
These results are based on a study that evaluated the vaccine in about 8,000 adults, divided equally into two independent age group cohorts. The first cohort includes adults aged 65 years and older and compares mCombriax with the co-administration of Fluzone HD, a high-dose influenza vaccine marketed by Sanofi (SNY - Free Report) , and Spikevax. The second group consists of adults aged 50 to 64 years, comparing the combination vaccine with Fluarix, a standard-dose influenza vaccine marketed by GSK plc (GSK - Free Report) , co-administered with Spikevax.
Year to date, Moderna stock has surged 83.8% compared with the industry’s 2.5% growth.
Image Source: Zacks Investment Research
More on Moderna’s mCombriax
mCombriax combines Moderna’s two vaccines, mNexspike and mRNA-1010, an investigational influenza vaccine. Regulatory filings for mRNA-1010 are currently under review, seeking approval in the United States, Europe, Canada and Australia. A final decision by the FDA is expected by Aug. 5, 2026.
Moderna had initially submitted a regulatory filing for mCombriax with the FDA. This filing was voluntarily withdrawn in May 2025 after the agency requested additional efficacy data for the flu component. The requested data has been submitted as one of the studies supporting the mRNA-1010 filing. The company is currently awaiting further guidance from the FDA for a potential filing of mCombriax.
The heightened scrutiny of vaccines in the United States has been weighing on overall vaccine demand. Initially, the FDA refused to review the regulatory filing for mRNA-1010. Per the agency, the late-stage study supporting the filing was not adequate and well-controlled because the licensed standard-dose seasonal influenza vaccine that the company used as the comparator was not “the best-available standard of care.”
The FDA reversed its decision after Moderna proposed a regulatory pathway for mRNA-1010’s approval, based on age. The regulatory filing was subsequently modified to seek full approval for the vaccine in adults aged 50-64 years and accelerated approval for adults aged 65 years and above.
Moderna Advances mRNA-Based H5 Flu Vaccine to Phase 3
In a separate press release, Moderna announced initiating a phase III study of its investigational mRNA-based H5 pandemic influenza vaccine candidate, mRNA-1018, with the first participants dosed in the United States and the United Kingdom. The late-stage study marks a key step in advancing MRNA’s pandemic preparedness pipeline, targeting H5 influenza (bird flu), which continues to be monitored as a potential global health threat.
The phase III study, supported by up to $54.3 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI), will evaluate the vaccine’s safety and immunogenicity in approximately 4,000 healthy adults aged 18 and older. The collaboration reflects a broader push to accelerate the development of scalable vaccine technologies capable of responding rapidly to emerging infectious diseases.
Moderna’s mRNA platform is central to this effort, with the company positioning its technology as a flexible and efficient approach to pandemic response. The development of mRNA-1018 also builds on progress with mRNA-1010, potentially supporting future global regulatory submissions for the pandemic candidate.
While the current risk of widespread human transmission of avian influenza remains limited, health authorities continue to track the virus’ evolution across animal populations. Against this backdrop, the study represents a proactive step toward strengthening global readiness. Moderna has also committed to allocate 20% of its H5 pandemic vaccine manufacturing capacity to ensure timely access in low- and middle-income countries in the event of a pandemic, per its agreement with CEPI.
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European Commission Approves MRNA's COVID-19-Influenza Combo Shot
Key Takeaways
Moderna (MRNA - Free Report) reported that the European Commission (EC) has granted marketing authorization for mCombriax (mRNA-1083), its mRNA combination vaccine for active immunization for the prevention of influenza disease and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and older. mCombriax will be rolled out across the EU, pending national regulatory and access procedures, with Moderna coordinating with national authorities to enable access and adoption.
The approval in the EU was expected as the EMA’s Committee for Medicinal Products for Human Use had recommended granting marketing authorization to mCombriax for the above indication in February. The approval makes mCombriax Moderna’sfourth marketed product in the European Union, after two COVID-19 vaccines, Spikevax and mNexspike, and RSV vaccine mResvia.
This EC approval of mCombriax was supported by data from a pivotal phase III study, which met its primary endpoints. Data from the study showed that a single dose of mCombriax elicited higher immune responses against COVID-19 and influenza compared with licensed standalone COVID and influenza vaccines.
These results are based on a study that evaluated the vaccine in about 8,000 adults, divided equally into two independent age group cohorts. The first cohort includes adults aged 65 years and older and compares mCombriax with the co-administration of Fluzone HD, a high-dose influenza vaccine marketed by Sanofi (SNY - Free Report) , and Spikevax. The second group consists of adults aged 50 to 64 years, comparing the combination vaccine with Fluarix, a standard-dose influenza vaccine marketed by GSK plc (GSK - Free Report) , co-administered with Spikevax.
Year to date, Moderna stock has surged 83.8% compared with the industry’s 2.5% growth.
Image Source: Zacks Investment Research
More on Moderna’s mCombriax
mCombriax combines Moderna’s two vaccines, mNexspike and mRNA-1010, an investigational influenza vaccine. Regulatory filings for mRNA-1010 are currently under review, seeking approval in the United States, Europe, Canada and Australia. A final decision by the FDA is expected by Aug. 5, 2026.
Moderna had initially submitted a regulatory filing for mCombriax with the FDA. This filing was voluntarily withdrawn in May 2025 after the agency requested additional efficacy data for the flu component. The requested data has been submitted as one of the studies supporting the mRNA-1010 filing. The company is currently awaiting further guidance from the FDA for a potential filing of mCombriax.
The heightened scrutiny of vaccines in the United States has been weighing on overall vaccine demand. Initially, the FDA refused to review the regulatory filing for mRNA-1010. Per the agency, the late-stage study supporting the filing was not adequate and well-controlled because the licensed standard-dose seasonal influenza vaccine that the company used as the comparator was not “the best-available standard of care.”
The FDA reversed its decision after Moderna proposed a regulatory pathway for mRNA-1010’s approval, based on age. The regulatory filing was subsequently modified to seek full approval for the vaccine in adults aged 50-64 years and accelerated approval for adults aged 65 years and above.
Moderna Advances mRNA-Based H5 Flu Vaccine to Phase 3
In a separate press release, Moderna announced initiating a phase III study of its investigational mRNA-based H5 pandemic influenza vaccine candidate, mRNA-1018, with the first participants dosed in the United States and the United Kingdom. The late-stage study marks a key step in advancing MRNA’s pandemic preparedness pipeline, targeting H5 influenza (bird flu), which continues to be monitored as a potential global health threat.
The phase III study, supported by up to $54.3 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI), will evaluate the vaccine’s safety and immunogenicity in approximately 4,000 healthy adults aged 18 and older. The collaboration reflects a broader push to accelerate the development of scalable vaccine technologies capable of responding rapidly to emerging infectious diseases.
Moderna’s mRNA platform is central to this effort, with the company positioning its technology as a flexible and efficient approach to pandemic response. The development of mRNA-1018 also builds on progress with mRNA-1010, potentially supporting future global regulatory submissions for the pandemic candidate.
While the current risk of widespread human transmission of avian influenza remains limited, health authorities continue to track the virus’ evolution across animal populations. Against this backdrop, the study represents a proactive step toward strengthening global readiness. Moderna has also committed to allocate 20% of its H5 pandemic vaccine manufacturing capacity to ensure timely access in low- and middle-income countries in the event of a pandemic, per its agreement with CEPI.
Moderna, Inc. Price and Consensus
Moderna, Inc. price-consensus-chart | Moderna, Inc. Quote
MRNA’s Zacks Rank & Stock to Consider
Moderna currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Catalyst Pharmaceuticals (CPRX - Free Report) , sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 EPS have increased from $2.55 to $2.87. CPRX shares have gained 9.9% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.